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  1. subfolder_0/A Cross-National Survey on Health Perceptions and Adopted Lifestyle-Related Behavior during the COVID-19 Pandemic.txt +1550 -0
  2. subfolder_0/A Pilot Study on Evaluating Cardiovascular Functions during the Practice of Bahir Kumbhaka (External Breath Retention).txt +349 -0
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  6. subfolder_0/AUTONOMIC CHANGES WHILE MENTALLY REPEATING TWO SYLLABLES.txt +21 -0
  7. subfolder_0/AWARENESS OF COMPUTER¬USE RELATED HEALTH RISKS IN SOFTWARE COMPANIES IN BANGALORE.txt +71 -0
  8. subfolder_0/Add-on Effect of Hot Sand Fomentation to Yoga on Pain, Disability, and Quality of Life in Chronic Neck Pain Patients.txt +696 -0
  9. subfolder_0/Anxiolytic effects of a yoga program in early breast cancer patients undergoing conventional treatment_a randomized controlled trial..txt +944 -0
  10. subfolder_0/Application of integrated yoga therapy to increase imitation skills in children with autism.txt +552 -0
  11. subfolder_0/Association between a guided meditation practice, sleep and psychological well-being in type 2 diabetes mellitus patients.txt +231 -0
  12. subfolder_0/BASELINE OCCUPATIONAL STRESS LEVELS AND PHYSIOLOGICAL RESPONSES.txt +33 -0
  13. subfolder_0/BREATHING THROUGH A PARTICULAR NOSTRIL CAN ALTER METABOLISM AND AUTONOMIC.txt +14 -0
  14. subfolder_0/Brainstem auditory evoked potentials in two mditative mental states.txt +473 -0
  15. subfolder_0/CLINICAL STUDY OF YOGA TECHNIQUES IN UNIVERSITY STUDENTS WITH ASTHMA A CONTROLLED TRIAL.txt +6 -0
  16. subfolder_0/CYCLIC MEDITATION A MOVING MEDITATION REDUCES ENERGY EXPENDITURE MORE THAN SUPINE REST.txt +25 -0
  17. subfolder_0/Cancer Prevention and rehabilitation through yoga.txt +152 -0
  18. subfolder_0/Challenges faced in diabetes risk prediction among an indigenous South Asian population in India using the Indian Diabetes Risk Score.txt +363 -0
  19. subfolder_0/Changes in Heart Rate Variability Following Yogic Visual Concentration (Trataka)_unlocked.txt +335 -0
  20. subfolder_0/Combination of Ayurveda and Yoga therapy reduces pain intensity and improves quality of life in patients with migraine headache.txt +1390 -0
  21. subfolder_0/Comments to Health realizationInnate health Can a quiet mind and a positive feeling state be accessible over the lifespan wit.txt +734 -0
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  23. subfolder_0/Coping Strategy, Life Style and Health Status During Phase 3 of Indian National Lockdown for COVID-19 Pandemic—A Pan-India Survey.txt +2005 -0
  24. subfolder_0/Correlation between Excessive Smartphone usage, Basic Psychological Needs, and Mental Health of University Students.txt +736 -0
  25. subfolder_0/DEVELOPMENT AND STANDARDIZATION OF JATARAGNI IMPAIRMENT CHECKLIST (JIC).txt +983 -0
  26. subfolder_0/Design and validation of integrated yoga therapy module for antarctic expeditioners.txt +406 -0
  27. subfolder_0/Development of a Trans-disciplinary Intervention Module for Adolescent Girls on Self-awareness.txt +643 -0
  28. subfolder_0/Diabetic yoga protocol improves glycemic, anthropometric and lipid levels in high risk individuals for diabetes a randomized controlled trial from Northern India..txt +1072 -0
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  30. subfolder_0/Effect of Bhramari Pranayama on response inhibition.txt +376 -0
  31. subfolder_0/Effect of Holistic Module of Yoga and Ayurvedic.txt +1081 -0
  32. subfolder_0/Effect of Mind Sound Resonance Technique.txt +602 -0
  33. subfolder_0/Effect of Needling at CV-12 (Zhongwan) on Blood Glucose Levels in Healthy Volunteers_.txt +353 -0
  34. subfolder_0/Effect of Trataka on cognitive functions in the elderly.txt +779 -0
  35. subfolder_0/Effect of Yoga Based Lifestyle Intervention on Patients with Knee Osteoarthritis A Randomized Controlled Trial.txt +1082 -0
  36. subfolder_0/Effect of Yoga as an Add-on Therapy in the Modulation of Heart Rate Variability in Children with Duchenne Muscular Dystrophy.txt +308 -0
  37. subfolder_0/Effect of a diet enriched with fresh coconut saturated fats on plasma lipids and erythrocyte fatty acid composition in normal adults.txt +760 -0
  38. subfolder_0/Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint A randomized control study.txt +384 -0
  39. subfolder_0/Effect of holistic yoga program on anxiety symptoms in adolescent girls with polycysti.txt +1111 -0
  40. subfolder_0/Effect of integrated approach of Yoga therapy on chronic constipation.txt +0 -0
  41. subfolder_0/Effect of integrated yoga therapy on nerve conduction velocity in type -2 diabetics a cross sectional clinical study.txt +712 -0
  42. subfolder_0/Effect of pranayama and meditation as an add-on therapy in rehabilitation of patients with Guillain-Barré syndrome.txt +704 -0
  43. subfolder_0/Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity..txt +944 -0
  44. subfolder_0/Effect of yoga on self-rated visual discomfort in computer users.txt +571 -0
  45. subfolder_0/Effect of yoga on somatic indicators of distress in professional computer users.txt +238 -0
  46. subfolder_0/Effect of yoga therapy on quality of life and depression in premenopausal nursing students with mastalgia A randomized controlled trial.txt +1046 -0
  47. subfolder_0/Effects of an integrated yoga program on chemotherapy induced nausea and emesis in breast cancer patients..txt +1710 -0
  48. subfolder_0/Effects of integrated yoga on quality of life and interpersonal relationship of pregnant women.txt +1107 -0
  49. subfolder_0/Effects of yoga program on quality of life and affect the early breast cancer.txt +898 -0
  50. subfolder_0/Efficacy of yoga based life style modification program on medication score and lipid profile in type 2 diabetes.txt +1100 -0
subfolder_0/A Cross-National Survey on Health Perceptions and Adopted Lifestyle-Related Behavior during the COVID-19 Pandemic.txt ADDED
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1
+ Original Paper
2
+ Health Perceptions and Adopted Lifestyle Behaviors During the
3
+ COVID-19 Pandemic: Cross-National Survey
4
+ Nandi Krishnamurthy Manjunath1, PhD; Vijaya Majumdar1, PhD; Antonietta Rozzi2, MA; Wang Huiru3, PhD; Avinash
5
+ Mishra4, PhD; Keishin Kimura5; Raghuram Nagarathna1, MD; Hongasandra Ramarao Nagendra1, PhD
6
+ 1Swami Vivekananda Yoga Anusandhana Samsthana University, Bengaluru, India
7
+ 2Sarva Yoga International, Sarzana SP, Italy
8
+ 3Shanghai Jiao Tong University, Shanghai, China
9
+ 4Vivekananda Yoga China, Shanghai, China
10
+ 5Japan Yoga Therapy Society, Yonago City, Japan
11
+ Corresponding Author:
12
+ Vijaya Majumdar, PhD
13
+ Swami Vivekananda Yoga Anusandhana Samsthana University
14
+ #19, Eknath Bhavan, Gavipuram Circle
15
+ KG Naga
16
+ Bengaluru, 560019
17
+ India
18
+ Phone: 91 08026995163
19
20
+ Abstract
21
+ Background: Social isolation measures are requisites to control viral spread during the COVID-19 pandemic. However, if these
22
+ measures are implemented for a long period of time, they can result in adverse modification of people’s health perceptions and
23
+ lifestyle behaviors.
24
+ Objective: The aim of this cross-national survey was to address the lack of adequate real-time data on the public response to
25
+ changes in lifestyle behavior during the crisis of the COVID-19 pandemic.
26
+ Methods: A cross-national web-based survey was administered using Google Forms during the month of April 2020. The
27
+ settings were China, Japan, Italy, and India. There were two primary outcomes: (1) response to the health scale, defined as
28
+ perceived health status, a combined score of health-related survey items; and (2) adoption of healthy lifestyle choices, defined
29
+ as the engagement of the respondent in any two of three healthy lifestyle choices (healthy eating habits, engagement in physical
30
+ activity or exercise, and reduced substance use). Statistical associations were assessed with linear and logistic regression analyses.
31
+ Results: We received 3371 responses; 1342 were from India (39.8%), 983 from China (29.2%), 669 from Italy (19.8%), and
32
+ 377 (11.2%) from Japan. A differential countrywise response was observed toward perceived health status; the highest scores
33
+ were obtained for Indian respondents (9.43, SD 2.43), and the lowest were obtained for Japanese respondents (6.81, SD 3.44).
34
+ Similarly, countrywise differences in the magnitude of the influence of perceptions on health status were observed; perception
35
+ of interpersonal relationships was most pronounced in the comparatively old Italian and Japanese respondents (β=.68 and .60,
36
+ respectively), and the fear response was most pronounced in Chinese respondents (β=.71). Overall, 78.4% of the respondents
37
+ adopted at least two healthy lifestyle choices amid the COVID-19 pandemic. Unlike health status, the influence of perception of
38
+ interpersonal relationships on the adoption of lifestyle choices was not unanimous, and it was absent in the Italian respondents
39
+ (odds ratio 1.93, 95% CI 0.65-5.79). The influence of perceived health status was a significant predictor of lifestyle change across
40
+ all the countries, most prominently by approximately 6-fold in China and Italy.
41
+ Conclusions: The overall consistent positive influence of increased interpersonal relationships on health perceptions and adopted
42
+ lifestyle behaviors during the pandemic is the key real-time finding of the survey. Favorable behavioral changes should be bolstered
43
+ through regular virtual interpersonal interactions, particularly in countries with an overall middle-aged or older population. Further,
44
+ controlling the fear response of the public through counseling could also help improve health perceptions and lifestyle behavior.
45
+ However, the observed human behavior needs to be viewed within the purview of cultural disparities, self-perceptions, demographic
46
+ variances, and the influence of countrywise phase variations of the pandemic. The observations derived from a short lockdown
47
+ period are preliminary, and real insight could only be obtained from a longer follow-up.
48
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 1
49
+ https://formative.jmir.org/2021/6/e23630
50
+ (page number not for citation purposes)
51
+ Manjunath et al
52
+ JMIR FORMATIVE RESEARCH
53
+ XSL•FO
54
+ RenderX
55
+ (JMIR Form Res 2021;5(6):e23630) doi: 10.2196/23630
56
+ KEYWORDS
57
+ health behavior; self-report; cross-national survey; COVID-19; behavior; perception; lifestyle; nutrition; real-time
58
+ Introduction
59
+ The World Health Organization (WHO) declared the outbreak
60
+ of COVID-19 a pandemic on March 11, 2020 [1]. As of March
61
+ 24, 2020, the most affected regions in the world were the
62
+ Western Pacific region (China, the Republic of Korea, Japan,
63
+ etc), with a total of 96,580 reported confirmed cases, and the
64
+ European region (Italy, Spain, Germany, the United Kingdom,
65
+ etc), which accounted for a total of 195,511 positive cases [2].
66
+ There was a global panic due to the shifting of the COVID-19
67
+ epicenters from China to Europe, mainly Italy, which reported
68
+ the worst outcomes up to March 25, 2020 (69,176 reported cases
69
+ and the maximum number of COVID-19 deaths of 6820) [2].
70
+ Global disease outbreaks impact varied aspects of physical and
71
+ mental health, even suicidality [3-5]. As observed in the
72
+ infectious disease epidemic of severe acute respiratory syndrome
73
+ (SARS) in 2003, exposure to new pathogens can manifest as a
74
+ qualitatively distinct mental impact [6]. Social isolation
75
+ measures
76
+ (large-scale
77
+ quarantines,
78
+ long-term
79
+ home
80
+ confinements, and nationwide lockdowns) [7-11], although
81
+ essential for controlling viral spread, go against the inherent
82
+ human instinct of social relationships [12,13]. If these measures
83
+ are implemented for a long duration, they can be detrimental
84
+ to mental health, as observed in recent reports from China and
85
+ Vietnam [14-17], and they are expected to result in modification
86
+ of people’s lifestyle behaviors, such as increased adoption of
87
+ unhealthy dietary habits and sedentary behavior. These changes
88
+ can exacerbate the burden of the “pandemics” of behavioral and
89
+ cardiovascular diseases that already prevail in modern societies
90
+ [18,19]. The latest trends of re-emergences of such infectious
91
+ disease outbreaks merit timely preparedness involving
92
+ community engagement and focus on healthy lifestyle behaviors
93
+ [20,21]. Although the mental impact of the COVID-19 pandemic
94
+ is being addressed in a timely fashion [22,23], the associated
95
+ real-time influences on people’s health perceptions and lifestyle
96
+ choices remain underresearched [24,25]. Careful consideration
97
+ of the demographic and cultural impact of tailored public health
98
+ intervention strategies on human behavior is also greatly needed
99
+ when designing such strategies. Here, we report the findings of
100
+ a cross-national survey that aimed to generate rapid perspectives
101
+ on the status of health-related perceptions and their influence
102
+ on the likelihood of adoption of healthy lifestyle choices during
103
+ the COVID-19 pandemic. The settings were China and Japan,
104
+ two nations in the Western Pacific region that were greatly
105
+ impacted by COVID-19; Italy, from the European region; and
106
+ India, a highly populous South Asian country that was a
107
+ potential threat region at the time of the survey [2,7-9,11].
108
+ Methods
109
+ Sampling and Data Collection
110
+ Given the restricted mobility restrictions and confinement due
111
+ to
112
+ the
113
+ COVID-19
114
+ lockdown,
115
+ we
116
+ conducted
117
+ a
118
+ cross-sectional survey using a web-based platform. We
119
+ disseminated the survey through the circulation of a Google
120
+ Form via institutional websites and private social media
121
+ networks, such as Facebook and WhatsApp. We also used the
122
+ group email lists of a few social organizations, universities,
123
+ academic institutions, and their interconnections to share the
124
+ questionnaire links, which further facilitated the snowball
125
+ sampling. The respondents were residents of China, Japan, Italy,
126
+ and India who were aged 18 years or older. We anonymized
127
+ the data to preserve and protect confidentiality. The study was
128
+ approved by the institutional review boards and institutional
129
+ ethics committees of the respective nations: Swami Vivekananda
130
+ Yoga Anusandhana Samsthana (SVYASA), India; Sarva Yoga
131
+ International, Italy; Shanghai Jiao Tong University, China; and
132
+ Japan Yoga Therapy Society, Japan. Respondents were informed
133
+ about the objectives of the survey and the anonymity of their
134
+ responses. Informed consent was obtained through a declaration
135
+ of the participants of their voluntary participation, the
136
+ confidentiality of the data, and the use of the collected
137
+ information for research purposes only. The survey period was
138
+ April 3-28, 2020. Once submitted, the responses were directly
139
+ used for the analysis, and revisions of the responses were not
140
+ allowed.
141
+ Questionnaire Structure
142
+ We chose a short format for the questionnaire, with 19 questions
143
+ to facilitate rapid administration. The first set of questions
144
+ (Q1-Q5) were related to the respondents’ demographic details:
145
+ age, gender, country of residence, working status, and the
146
+ presence of any chronic illness or disability diagnosed by a
147
+ physician. The next set (Q6-Q14) contained perception-related
148
+ questions on self-rated physical and mental health, sleep quality,
149
+ coping ability, energy status (a psychological state defined as
150
+ an individual's potential to perform mental and physical activity
151
+ [26,27]), coping flexibility, and perceptions related to
152
+ interpersonal relationships as well as the fear of the pandemic.
153
+ The questions were phrased as statements, with responses
154
+ recorded on 3- or 5-point scales. For example, the respondents
155
+ were requested to self-rate their mental and physical health
156
+ status with the questions “How do you rate your physical health
157
+ at present as” and “How do rate your mental health at present
158
+ as” with answer modalities of (1) excellent, (2) very good, (3)
159
+ good, (4) average, and (5) poor. These single-item self-health
160
+ assessment questions are validated tools used in national surveys
161
+ and epidemiological studies to assess health perceptions among
162
+ individuals, strongly related to various morbidities, and
163
+ mortality, and they have been validated across various ethnicities
164
+ [28-33]. A further set of questions (Q15-Q19) focused on items
165
+ related to the respondents’ recent lifestyle behavior choices:
166
+ eating habits, engagement in physical activity or exercise, and
167
+ substance use. Permitted responses for these behavior-related
168
+ questions were either yes or no. For eating habits, the
169
+ respondents provided self-rated scores for their time of eating;
170
+ nourishment related to intake of vegetables and fibers; and daily
171
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 2
172
+ https://formative.jmir.org/2021/6/e23630
173
+ (page number not for citation purposes)
174
+ Manjunath et al
175
+ JMIR FORMATIVE RESEARCH
176
+ XSL•FO
177
+ RenderX
178
+ intake of “junk food” (described as packaged and processed
179
+ sweets or salty snacks); the combined scores were dichotomized
180
+ into “good” (score ≥3) and “poor” (score ≤2).
181
+ Data Analysis
182
+ An exploratory factor analysis using the principal axis factoring
183
+ and varimax rotation suggested that three factors were present
184
+ in the data. Items related to health perceptions were used to
185
+ form a scale for perceived health status (the health scale); the
186
+ scores were represented as mean (SD). For the remaining two
187
+ factors, we could not form scales, as they scored Cronbach α
188
+ values <.6; instead, we used the most relevant single item to
189
+ represent the factor. The two primary outcomes of the study
190
+ were the health scale and the adoption of healthy lifestyle
191
+ choices. The health scale was derived as mentioned above;
192
+ further health scale scores were categorized based on tertile
193
+ distribution into low (poor), middle (average), and high (good)
194
+ scores. Adoption of healthy lifestyle choices was defined as the
195
+ engagement of the respondent in any two of three healthy
196
+ lifestyle choices (eating habits, substance use, and exercise).
197
+ Multivariate linear and logistic regression analyses were used
198
+ to test the influence of the perceptions and the personal variables
199
+ on the primary outcomes. Most of the items in the survey were
200
+ recorded as 3-point responses. Hence, to achieve homogeneity
201
+ in the analyses of the survey items, the 5-point Likert responses
202
+ of the self-rated health items, excellent, very good, good,
203
+ average, and poor, were collapsed into three categories: (1) very
204
+ good/excellent, (2) good, and (3) average/poor. Analysis of
205
+ variance was used to assess comparisons between continuous
206
+ variables, and P<.05 was considered significant. Chi-square
207
+ analysis was used for cross-country comparisons for categorical
208
+ variables.
209
+ Results
210
+ The aim of this survey was to understand the cross-national
211
+ psychosocial and behavioral impact of the lockdowns and social
212
+ isolations imposed due to the COVID-19 pandemic. We received
213
+ 3370 responses: 1342 from India (39.8%), 983 from China
214
+ (29.2%), 669 from Italy (19.8%), and 377 from Japan (11.2%).
215
+ The demographic profiles of the respondents are presented in
216
+ Table 1.
217
+ Table 1. Countrywise representation of the personal characteristics of the survey participants.
218
+ P valuea
219
+ Italy (n=669)
220
+ Japan (n=377)
221
+ China (n=983)
222
+ India (n=1342)
223
+ Overall (N=3371)
224
+ Variable
225
+ <.001
226
+ 48.43 (13.65)
227
+ 53.49 (9.35)
228
+ 29.77 (11.98)
229
+ 29.42 (12.29)
230
+ 36.04 (15.54)
231
+ Age (years), mean (SD)
232
+ <.001
233
+ Age group (years), n (%)
234
+ 31 (4.7)
235
+ 1 (0.3)
236
+ 490 (49.8)
237
+ 685 (51.0)
238
+ 1200 (35.6)
239
+ 18-24
240
+ 84 (12.5)
241
+ 4 (1.1)
242
+ 152 (15.5)
243
+ 267 (19.9)
244
+ 503 (14.9)
245
+ 25-34
246
+ 309 (46.2)
247
+ 217 (57.5)
248
+ 314 (32.0)
249
+ 330 (24.6)
250
+ 1176 (34.9)
251
+ 35-54
252
+ 169 (25.2)
253
+ 98 (26.0)
254
+ 21 (2.1)
255
+ 40 (3.0)
256
+ 330 (9.8)
257
+ 55-64
258
+ 76 (11.4)
259
+ 57 (15.1)
260
+ 6 (0.6)
261
+ 20 (1.5)
262
+ 162 (4.8)
263
+ >65
264
+ <.001
265
+ 506 (75.6)
266
+ 348 (92.0)
267
+ 802 (81.6)
268
+ 880 (65.6)
269
+ 2535 (75.2)
270
+ Female gender, n (%)
271
+ <.001
272
+ 395 (59.0)
273
+ 335 (89.0)
274
+ 406 (41.3)
275
+ 582 (43.4)
276
+ 1709 (50.7)
277
+ Working, n (%)
278
+ <.001
279
+ 314 (46.9)
280
+ 151 (40.0)
281
+ 84 (8.5)
282
+ 169 (12.6)
283
+ 647 (19.2)
284
+ Has a chronic illness, n (%)
285
+ aCross-country comparisons for categorical variables were conducted using chi-square analysis. Analysis of variance was conducted to assess comparisons
286
+ among the continuous variable of age. A P value <.05 was considered significant.
287
+ The mean age of the respondents was 36.04 years (SD 15.54)
288
+ (Table 1); the average age of the Indian and Chinese respondents
289
+ (29.42 years, SD 12.29, and 29.77 years, SD 11.98, respectively)
290
+ was lower than that of the Japanese and Italian respondents
291
+ (53.49 years, SD 9.35, and 48.43 years, SD 3.65, respectively).
292
+ Overall, there was a higher representation of the female gender
293
+ (2535/3371, 75.2%). Japan had the highest representation of
294
+ women (348/377, 92.0%) and working people (335/377, 89.0%)
295
+ (Table 1). Italy and Japan had the highest representations of
296
+ respondents with a known status of chronic illness (314/669,
297
+ 46.9%, and 151/377, 40.0%, respectively).
298
+ Table 2 shows the countrywise status of the perceptions of health
299
+ and psychosocial factors reported in response to the ongoing
300
+ outbreak of COVID-19. The health status score was highest for
301
+ Indian respondents (9.43, SD 2.43) and lowest for Japanese
302
+ respondents (6.81, SD 3.44). Overall, 846/3371 (25.1%) of the
303
+ respondents had good health status; Japanese and Chinese
304
+ respondents had the highest representation of low health status
305
+ (236/377, 62.6%, and 562/983, 57.2%, respectively). Sleep
306
+ quality was perceived well by the majority of Indians (917/1342,
307
+ 68.3%), and the majority of Japanese and Chinese respondents
308
+ perceived their sleep quality as average/poor (264/377, 70%,
309
+ and 554/983, 56.3%, respectively). Italian respondents had
310
+ almost equal representations of good and average sleep qualities.
311
+ Coping abilities during social isolation were perceived as good
312
+ by 1264/3371 (37.5%) of the overall population, with the
313
+ countrywise trend of India (672/1342, 50.1%) > Italy (283/669,
314
+ 42.3%) > Japan (131/377, 34.8%) > China (178/983, 18.1%).
315
+ Fear response was almost equally distributed in positive or
316
+ intermediate categories for most of the country respondents,
317
+ except for Italians, among whom the intermediate or partial fear
318
+ response was the most evident (469/669, 70.1%). Coping
319
+ flexibility responses were very similar across all the countries
320
+ except Japan, wherein the majority of respondents (317/377,
321
+ 84.1%) reported experiencing little challenging response to
322
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 3
323
+ https://formative.jmir.org/2021/6/e23630
324
+ (page number not for citation purposes)
325
+ Manjunath et al
326
+ JMIR FORMATIVE RESEARCH
327
+ XSL•FO
328
+ RenderX
329
+ sudden changes in living norms. Responses to interpersonal
330
+ relationships followed the trend of India (733/1342, 54.6%) >
331
+ Japan (183/377, 48.5%) > Italy (287/669, 42.9%) > China
332
+ (337/983, 34.3%). Adopted lifestyle behavior yielded the trend
333
+ of India (1129/1342, 83.9%) > Italy (361/669, 54.0%) > China
334
+ (436/983, 44.4%) > Japan (137/377, 36.2%).
335
+ Based on the regression analysis on the perceived health status,
336
+ female respondents had a 0.14 lower score compared to male
337
+ respondents (Table 3). Participants with a positive history of
338
+ chronic illness and those who were not working also had lower
339
+ health status scores, by 0.11 and 0.04, respectively, compared
340
+ to their counterparts. Increased personal relationships and
341
+ positive fear response were associated with increases in health
342
+ status across all the countries, particularly Japan, which showed
343
+ the highest value of β (.60). For Indian respondents, an increase
344
+ in age was significantly associated with increase in health status
345
+ by a score of 0.12.
346
+ Increased interpersonal relationships was a significant predictor
347
+ of adoption of health lifestyle choices across the respondents
348
+ in all the countries except for Italy (adjusted OR 1.93, 95% CI
349
+ 0.65-5.79) (Table 4). Positive perception of fear was
350
+ significantly associated with likelihood of adoption of healthy
351
+ lifestyle choices only in Indian respondents (adjusted OR 2.41,
352
+ 95% CI 1.18-4.96). Perceived health status categories were
353
+ significantly associated with the likelihood of adoption of
354
+ healthy lifestyle choices across all the countries; most
355
+ prominently, high health status increased adoption of healthy
356
+ lifestyle choices by approximately 6-fold in China and Italy.
357
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 4
358
+ https://formative.jmir.org/2021/6/e23630
359
+ (page number not for citation purposes)
360
+ Manjunath et al
361
+ JMIR FORMATIVE RESEARCH
362
+ XSL•FO
363
+ RenderX
364
+ Table 2. Countrywise representation of perceptions and behavioral changes among the survey respondents related to the COVID-19 outbreak.
365
+ P valuea
366
+ Italy (n=669)
367
+ Japan (n=377)
368
+ China (n=983)
369
+ India (n=1342)
370
+ Overall
371
+ (N=3371)
372
+ Perception or behavior and response
373
+ First factorb
374
+ .01
375
+ 8.43 (2.56)
376
+ 6.81 (3.44)
377
+ 7.09 ( 2.92)
378
+ 9.43 (2.43)
379
+ 8.26 (3.36)
380
+ Health status, mean (SD)
381
+ 150 (22.4)
382
+ 69 (18.3)
383
+ 71 (7.2)
384
+ 556 (41.4)
385
+ 846 (25.1)
386
+ High, n (%)
387
+ Medium, n (%)
388
+ 225 (33.6)
389
+ 72 (19.1)
390
+ 350 (35.6)
391
+ 413 (30.8)
392
+ 1062 (31.5)
393
+ 294 (43.9)
394
+ 236 (62.6)
395
+ 562 (57.2)
396
+ 413 (30.8)
397
+ 1463 (43.4)
398
+ Low, n (%)
399
+ <.001
400
+ Self-rated physical health, n (%)
401
+ 173 (25.9)
402
+ 88 (23.3)
403
+ 467 (47.5)
404
+ 629 (46.9)
405
+ 1357 (40.2)
406
+ Excellent/very good
407
+ 375 (56.0)
408
+ 135 (35.8)
409
+ 200 (20.3)
410
+ 573 (42.7)
411
+ 1283 (38.1)
412
+ Good
413
+ 121 (18.1)
414
+ 154 (40.8)
415
+ 316 (32.1)
416
+ 140 (10.4)
417
+ 731 (21.7)
418
+ Poor/average
419
+ <.001
420
+ Self-rated mental health, n (%)
421
+ 206 (30.8)
422
+ 93 (24.7)
423
+ 0 (0)
424
+ 645 (48.1)
425
+ 944 (28.0)
426
+ Excellent/very good
427
+ 371 (55.4)
428
+ 122 (32.4)
429
+ 642 (65.3)
430
+ 535 (39.9)
431
+ 1670
432
+ (49.5)
433
+ Good
434
+ 92 (13.8)
435
+ 162 (43.0)
436
+ 341 (34.7)
437
+ 162 (12.1)
438
+ 757 (22.5)
439
+ Poor/average
440
+ <.001
441
+ Self-rated sleep quality, n (%)
442
+ 328 (49.0)
443
+ 113 (29.9)
444
+ 429 (43.6)
445
+ 917 (68.3)
446
+ 1787 (53.0)
447
+ Good
448
+ 240 (35.9)
449
+ 234 (62.1)
450
+ 477 (48.5)
451
+ 354 (26.4)
452
+ 1305
453
+ (38.7)
454
+ Average
455
+ 101 (15.1)
456
+ 30 (8.0)
457
+ 77 (7.8)
458
+ 71 (5.3)
459
+ 279
460
+ (8.3)
461
+ Poor
462
+ <.001
463
+ Self-rated coping abilities, n (%)
464
+ 283 (42.3)
465
+ 131 (34.8)
466
+ 178 (18.1)
467
+ 672 (50.1)
468
+ 1264 (37.5)
469
+ Good
470
+ 298 (44.5)
471
+ 139 (36.8)
472
+ 516 (52.5)
473
+ 539 (40.1)
474
+ 1492 (44.3)
475
+ Average
476
+ 88 (13.2)
477
+ 107 (28.5)
478
+ 289 (29.4)
479
+ 131 (9.8)
480
+ 615 (18.2)
481
+ Poor
482
+ Second factor , n (%)
483
+ <.001
484
+ Fear/anxiety related to COVID-19c
485
+ 125 (18.7)
486
+ 157 (41.6)
487
+ 470 (47.8)
488
+ 628 (46.8)
489
+ 1380 (40.9)
490
+ Not at all (positive)
491
+ 469 (70.1)
492
+ 213 (56.5)
493
+ 485 (49.3)
494
+ 662 (49.3)
495
+ 1829 (54.3)
496
+ Partially (intermediate)
497
+ 75 (11.2)
498
+ 7 (1.9)
499
+ 28 (2.8)
500
+ 52 (3.9)
501
+ 162 (4.8)
502
+ Extremely (negative)
503
+ <.001
504
+ Self-perception of low energy
505
+ 261 (39.0)
506
+ 239 (63.4)
507
+ 282 (28.7)
508
+ 667 (49.7)
509
+ 1449 (43.0)
510
+ Never
511
+ 390 (58.3)
512
+ 132 (35.0)
513
+ 672 (68.4)
514
+ 641 (47.8)
515
+ 1835 (54.5)
516
+ Sometimes
517
+ 18 (2.7)
518
+ 6 (1.6)
519
+ 29 (3.0)
520
+ 34 (2.5)
521
+ 87 (2.6)
522
+ All the time
523
+ <.001
524
+ Challenging response to sudden changes in living norms (coping flexibility)
525
+ 144 (21.5)
526
+ 44 (11.7)
527
+ 221 (22.5)
528
+ 436 (32.5)
529
+ 845 (25.1)
530
+ Least/not at all/little
531
+ 309 (46.2)
532
+ 317 (84.1)
533
+ 411 (41.8)
534
+ 417 (31.1)
535
+ 1454 (43.1)
536
+ Little
537
+ 216 (32.3)
538
+ 16 (4.2)
539
+ 351 (35.7)
540
+ 489 (36.4)
541
+ 1072 (31.8)
542
+ Extremely/somewhat
543
+ Third factor, n (%)
544
+ <.001
545
+ Interpersonal relationshipsc
546
+ 287 (42.9)
547
+ 183 (48.5)
548
+ 337 (34.3)
549
+ 733 (54.6)
550
+ 1540 (45.7)
551
+ Increased
552
+ 310 (46.3)
553
+ 179 (47.5)
554
+ 550 (56.0)
555
+ 533 (39.7)
556
+ 1572 (46.6)
557
+ Not changed
558
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 5
559
+ https://formative.jmir.org/2021/6/e23630
560
+ (page number not for citation purposes)
561
+ Manjunath et al
562
+ JMIR FORMATIVE RESEARCH
563
+ XSL•FO
564
+ RenderX
565
+ P valuea
566
+ Italy (n=669)
567
+ Japan (n=377)
568
+ China (n=983)
569
+ India (n=1342)
570
+ Overall
571
+ (N=3371)
572
+ Perception or behavior and response
573
+ 72 (10.8)
574
+ 15 (4.0)
575
+ 96 (9.8)
576
+ 76 (5.7)
577
+ 259 (7.7)
578
+ Reduced
579
+ <.001
580
+ Motivating influence of COVID-19 on lifestyle
581
+ 221 (33.0)
582
+ 132 (35.0)
583
+ 217 (22.1)
584
+ 605 (45.1)
585
+ 1175 (34.8)
586
+ Completely
587
+ 360 (53.8)
588
+ 223 (59.2)
589
+ 695 (70.7)
590
+ 641 (47.8)
591
+ 1919 (57.0)
592
+ Partially
593
+ 88 (13.2)
594
+ 22 (5.8)
595
+ 71 (7.2)
596
+ 96 (7.1)
597
+ 277 (8.2)
598
+ Not at all
599
+ <.001
600
+ 485 (72.5)
601
+ 283 (75.1)
602
+ 750 (76.3)
603
+ 1126 (83.9)
604
+ 2643 (78.4)
605
+ Adoption of ≥2 healthy lifestyle choices
606
+ <.001
607
+ 361 (54.0)
608
+ 137 (36.3)
609
+ 436 (44.4)
610
+ 867 (64.6)
611
+ 1801 (53.4)
612
+ Adoption of healthy eating behavior
613
+ <.001
614
+ 623 (93.1)
615
+ 355 (94.1)
616
+ 918 (93.4)
617
+ 1277 (95.2)
618
+ 3173 (94.1)
619
+ Decreased dependency on and use
620
+ of tobacco, alcohol, or any other
621
+ substances
622
+ <.001
623
+ 426 (63.7)
624
+ 272 (72.1)
625
+ 672 (68.4)
626
+ 910 (67.8)
627
+ 2280 (67.6)
628
+ Increased engagement in exercise
629
+ or similar activities
630
+ aCross-country comparisons for categorical variables were conducted using chi-square analysis; all the P values were significant.
631
+ bAn exploratory factor analysis using principal axis factoring and varimax rotation suggested that there were 3 factors present in the data. The first
632
+ factor consisted of health-related perceptions; composite scores for perceived health were generated as summative scores of the included items.
633
+ cFor the remaining 2 factors, scales could not be formed; rather, the single items that were thought to best summarize the respective factors were
634
+ considered for further association analyses.
635
+ Table 3. Multivariate linear regression analysis (β coefficients, standard errors, and t and P values) of the association between health status, personal
636
+ variables, and perceptions.
637
+ Italy
638
+ Japan
639
+ China
640
+ India
641
+ Overall
642
+ Predic-
643
+ tors
644
+ P
645
+ t
646
+ SE
647
+ β
648
+ P
649
+ t
650
+ SE
651
+ β
652
+ P
653
+ t
654
+ SE
655
+ β
656
+ P
657
+ t
658
+ SE
659
+ β
660
+ P
661
+ t
662
+ SE
663
+ β
664
+ Demographic variables
665
+ .51
666
+ –0.66
667
+ 0.02
668
+ –.07
669
+ 0.12
670
+ 1.55
671
+ 0.02
672
+ .08
673
+ .07
674
+ 1.79
675
+ 0.01
676
+ .07
677
+ <.001
678
+ 3.74
679
+ 0.01
680
+ .12
681
+ <.001
682
+ 5.12
683
+ 0.01
684
+ .14
685
+ Age
686
+ Gender (reference: male)
687
+ .97
688
+ –0.03
689
+ 0.52
690
+ <.001
691
+ 0.77
692
+ –0.30
693
+ 0.64
694
+ .01
695
+ .72
696
+ –0.35
697
+ 0.23
698
+ –.01
699
+ <.001
700
+ –3.24
701
+ 0.14
702
+ –.09
703
+ <.001
704
+ –7.51
705
+ 0.12
706
+ –.14
707
+ Fe-
708
+ male
709
+ Working status (reference: working)
710
+ .72
711
+ –0.36
712
+ 0.55
713
+ –.03
714
+ 0.48
715
+ –0.71
716
+ 0.56
717
+ –.04
718
+ .59
719
+ –0.54
720
+ 0.23
721
+ –.02
722
+ .75
723
+ –0.32
724
+ 0.15
725
+ –.01
726
+ .04
727
+ –2.04
728
+ 0.13
729
+ –.04
730
+ Not
731
+ work-
732
+ ing
733
+ Chronic illness (reference: no)
734
+ .34
735
+ –0.96
736
+ 0.47
737
+ –.09
738
+ 0.01
739
+ –2.81
740
+ 0.35
741
+ –.14
742
+ .04
743
+ –2.04
744
+ 0.31
745
+ –.06
746
+ <.001
747
+ –6.12
748
+ 0.20
749
+ –.16
750
+ <.001
751
+ –5.63
752
+ 0.15
753
+ –.11
754
+ Yes
755
+ Perceptions
756
+ Interpersonal relationships (reference: decreased)
757
+ .03
758
+ 2.17
759
+ 0.68
760
+ .27
761
+ <.001
762
+ 4.86
763
+ 0.85
764
+ .60
765
+ <.001
766
+ 4.12
767
+ 0.31
768
+ .21
769
+ <.001
770
+ 6.48
771
+ 0.28
772
+ .38
773
+ <.001
774
+ 10.76
775
+ 0.21
776
+ .37
777
+ In-
778
+ creased
779
+ .12
780
+ 1.56
781
+ 0.66
782
+ 019
783
+ 0.01
784
+ 2.66
785
+ 0.84
786
+ .33
787
+ .28
788
+ 1.08
789
+ 0.29
790
+ .05
791
+ <.001
792
+ 3.71
793
+ 0.29
794
+ .21
795
+ <.001
796
+ 4.15
797
+ 0.21
798
+ .14
799
+ No
800
+ change
801
+ Fear response (reference: poor)
802
+ <.001
803
+ 3.03
804
+ 1.02
805
+ .50
806
+ 0.01
807
+ 2.72
808
+ 1.38
809
+ .54
810
+ <.001
811
+ 8.02
812
+ 0.52
813
+ .71
814
+ <.001
815
+ 8.69
816
+ 0.33
817
+ .59
818
+ <.001
819
+ 10.84
820
+ 0.30
821
+ .54
822
+ Posi-
823
+ tive
824
+ .08
825
+ 1.77
826
+ 0.97
827
+ .30
828
+ 0.20
829
+ 1.30
830
+ 1.37
831
+ .26
832
+ <.001
833
+ 4.35
834
+ 0.51
835
+ .38
836
+ <.001
837
+ 5.22
838
+ 0.33
839
+ .35
840
+ <.001
841
+ 5.82
842
+ 0.30
843
+ .29
844
+ Fair
845
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 6
846
+ https://formative.jmir.org/2021/6/e23630
847
+ (page number not for citation purposes)
848
+ Manjunath et al
849
+ JMIR FORMATIVE RESEARCH
850
+ XSL•FO
851
+ RenderX
852
+ Table 4. Role of perceptions in the adoption of healthy lifestyle choices.
853
+ Italy
854
+ Japan
855
+ China
856
+ India
857
+ Overall
858
+ Perception
859
+ Adjusted OR
860
+ (95% CI)
861
+ OR
862
+ (95% CI)
863
+ Adjusted OR
864
+ (95% CI)
865
+ OR
866
+ (95% CI)
867
+ Adjusted OR
868
+ (95% CI)
869
+ OR
870
+ (95% CI)
871
+ Adjusted OR
872
+ (95% CI)
873
+ OR
874
+ (95% CI)
875
+ AdjustedbOR
876
+ (95% CI)
877
+ ORa
878
+ (95% CI)
879
+ Health status (reference: low)
880
+ 6.22
881
+ (1.90- 20.40)
882
+ 3.33
883
+ (2.01-
884
+ 5.51)
885
+ 2.83
886
+ (1.18-6.77)
887
+ 3.64
888
+ (1.59-
889
+ 8.37)
890
+ 5.83
891
+ (2.30-4.79)
892
+ 6.02
893
+ (2.38-
894
+ 15.20)
895
+ 2.62
896
+ (1.75-3.92)
897
+ 2.98
898
+ (2.07-
899
+ 4.28)
900
+ 3.42
901
+ (2.51-4.64)
902
+ 3.67
903
+ (2.87-
904
+ 4.68)
905
+ High
906
+ 2.46
907
+ (1.03-5.83)
908
+ 2.10
909
+ (1.42-
910
+ 3.12)
911
+ 1.06
912
+ (0.54-2.08)
913
+ 1.33
914
+ (0.72-
915
+ 2.45)
916
+ 2.43
917
+ (1.72-3.45)
918
+ 2.61
919
+ (1.85-
920
+ 3.69)
921
+ 1.57
922
+ (1.07-2.31)
923
+ 1.76
924
+ (1.24-
925
+ 2.50)
926
+ 2.00
927
+ (1.59-2.50)
928
+ 2.09
929
+ (1.72-
930
+ 2.54)
931
+ Medium
932
+ Interpersonal relationshipsc (reference: decreased)
933
+ 1.93
934
+ (0.65-5.79)
935
+ 1.86
936
+ (1.07-
937
+ 3.22)
938
+ 5.25
939
+ (1.46-8.92)
940
+ 4.43
941
+ (1.49-
942
+ 13.15)
943
+ 1.77
944
+ (1.03-3.05)
945
+ 2.01
946
+ (1.18-
947
+ 3.41)
948
+ 2.16
949
+ (1.15-4.08)
950
+ 1.86
951
+ (1.03-
952
+ 3.37)
953
+ 2.42
954
+ (1.70-3.45)
955
+ 2.21
956
+ (1.64-
957
+ 2.98)
958
+ In-
959
+ creased
960
+ 1.40
961
+ (0.50-3.96)
962
+ 1.59
963
+ (0.93-
964
+ 2.73)
965
+ 1.88
966
+ (0.54-6.52)
967
+ 1.87
968
+ (0.65-
969
+ 5.42)
970
+ 0.99
971
+ (0.61-1.62)
972
+ 1.03
973
+ (0.64-
974
+ 1.68)
975
+ 1.18
976
+ (0.63-2.21)
977
+ 1.09
978
+ (0.60-
979
+ 1.97)
980
+ 1.18
981
+ (0.84-1.66)
982
+ 1.25
983
+ (0.94-1.7)
984
+ Not
985
+ changed
986
+ Fear responsec (reference: poor)
987
+ 2.20
988
+ (0.41-11.71)
989
+ 1.62
990
+ (0.86-
991
+ 3.04)
992
+ 4.85
993
+ (0.73-32.19)
994
+ 1.84
995
+ (0.34-
996
+ 9.99)
997
+ 2.18
998
+ (0.96-4.94)
999
+ 2.38
1000
+ (1.06-
1001
+ 5.33)
1002
+ 2.41
1003
+ (1.18-4.96)
1004
+ 2.72
1005
+ (1.38-
1006
+ 5.36)
1007
+ 2.50
1008
+ (1.54-4.05)
1009
+ 2.43
1010
+ (1.69-
1011
+ 3.50)
1012
+ Positive
1013
+ 1.25
1014
+ (0.27-5.80)
1015
+ 1.34
1016
+ (0.80-
1017
+ 2.27)
1018
+ 1.97
1019
+ (0.31-12.55)
1020
+ 0.93
1021
+ (0.18-
1022
+ 4.93)
1023
+ 1.32
1024
+ (0.59-2.96)
1025
+ 1.46
1026
+ (0.66-
1027
+ 3.23)
1028
+ 1.32
1029
+ (0.65-2.65)
1030
+ 1.37
1031
+ (0.71-
1032
+ 2.65)
1033
+ 1.33
1034
+ (0.83-2.14)
1035
+ 1.36
1036
+ (0.95-
1037
+ 1.93)
1038
+ Fair
1039
+ aOR: odds ratio.
1040
+ bAdjusted for sex, age, work status, and history of chronic illness.
1041
+ cFactor represented by a single item that was thought to best represent the underlying notion.
1042
+ Discussion
1043
+ The aims of this short cross-national behavioral survey study
1044
+ were to generate rapid ideas regarding perspectives on health
1045
+ and lifestyle behavior and to provide initial insights into
1046
+ designing global but culturally tailored public health policies.
1047
+ Health Perceptions: Countrywise Status
1048
+ A differential countrywise response was observed toward
1049
+ perceived health status across the survey participants; Indians
1050
+ had a better representation of high health status (41.4%)
1051
+ compared to respondents from other countries (China, 7.2%,
1052
+ Japan, 18.2%, and Italy, 22.5%). Despite the inconsistencies in
1053
+ health perceptions, there was a consistent influence of social
1054
+ support measured by perceptions of interpersonal relationships
1055
+ and fear of perceived health status. However, there were
1056
+ countrywise differences in the magnitude of the impact of
1057
+ perceptions on health status; perception of interpersonal
1058
+ relationships was most pronounced in the comparatively older
1059
+ Italian and Japanese respondents (β=.68 and .60, respectively)
1060
+ and that of fear in the Chinese respondents (β=.71). These
1061
+ findings favor the implementation of regularized virtual
1062
+ interpersonal interactions toward combating the adverse health
1063
+ impact of the pandemic, particularly in countries with a higher
1064
+ proportion of older people [34]. Controlling the fear response
1065
+ through counseling would also aid the improvement of health
1066
+ outcomes in populations affected by pandemics. The findings
1067
+ of this survey related to the influence of gender on health
1068
+ perceptions (the health status score of female respondents was
1069
+ lower by 0.14 units compared to that of male respondents) are
1070
+ in line with the global trend of poorer health perception in
1071
+ women than in their male counterparts [35]. These real-time
1072
+ findings observed during the pandemic also relate with reports
1073
+ documented before the COVID-19 pandemic, with a generally
1074
+ higher prevalence of adverse mental health symptoms in women
1075
+ compared to men [36]. Overall, there seemed to be a differential
1076
+ influence of demographic variables on health perceptions across
1077
+ the global population during the pandemic.
1078
+ The comparatively high scores of the perceived health status in
1079
+ Indian respondents could be underlined by an early phase of
1080
+ the pandemic with slower progression in India during the survey
1081
+ period [11]. The younger age of the Indian respondents (mean
1082
+ age 29.42 years, SD 12.29) seemed to further facilitate
1083
+ interpersonal relationships (54.6%) during the lockdown, which
1084
+ also explains their better health status (β=.38) [34,37]. Younger
1085
+ age identity has been associated with well-being and better
1086
+ perceptions of health [38]. However, in this survey, an
1087
+ unexpectedly positive linear relationship was observed between
1088
+ increasing age and better perception of health status (β=.12) in
1089
+ young Indian respondents. This finding can be attributed to the
1090
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 7
1091
+ https://formative.jmir.org/2021/6/e23630
1092
+ (page number not for citation purposes)
1093
+ Manjunath et al
1094
+ JMIR FORMATIVE RESEARCH
1095
+ XSL•FO
1096
+ RenderX
1097
+ compounding effect of the COVID-19 pandemic on already
1098
+ existing emotional distress among young adults (related to their
1099
+ examinations, uncertainties, social relationships, etc) [39].
1100
+ Unfortunately, in line with previous reports [14,15], we could
1101
+ also observe a continued/posttraumatic impact of the pandemic
1102
+ in Chinese respondents, reflected in their comparatively low
1103
+ perception of health status (poor health status was reported by
1104
+ 57.2% of these respondents). We believe the poor health
1105
+ perceptions in the Chinese respondents is due to the underlying
1106
+ influence of fear perceptions (β=.71). Further, since the country
1107
+ had successfully emerged from the first wave of the pandemic
1108
+ during the survey, and social norms had also almost returned
1109
+ to normal, with fewer imposed lockdowns, the moderate increase
1110
+ in interpersonal relationships (34.3%) may not be sufficient to
1111
+ facilitate health status.
1112
+ The observed low status of perceived health in the Japanese
1113
+ respondents (low health status, 62.6%) is in accord with a health
1114
+ paradox in that country, which is a tendency to perceive health
1115
+ poorly despite the advanced economy [40,41]. Although this
1116
+ influence is not direct, an indirect influence of the comparatively
1117
+ old, middle-aged demographic profile of the Japanese
1118
+ respondents along with the mediatory impact of chronic diseases
1119
+ on health status (β=–.14) could also underlie the lower health
1120
+ perceptions of the Japanese respondents [42]. The perception
1121
+ of poor sleep quality in the Japanese respondents also needs
1122
+ attention, as this finding is in line with reports of the suicidal
1123
+ tendencies in this country [43].
1124
+ On a positive note, amid the aggravated pandemic at the time
1125
+ of the survey, the majority of the Italian respondents who were
1126
+ middle-aged perceived only partial fear of the pandemic (70.1%
1127
+ response), and they reported better health perceptions (health
1128
+ status score 8.43, SD 2.56) than Japanese respondents (health
1129
+ status score 6.81, SD 3.44) and Chinese respondents (health
1130
+ status score 7.09, SD 2.92). Approximately 55% of the responses
1131
+ for self-rated physical and mental health were in the
1132
+ moderate/fair tier, which is in accord with the reported tendency
1133
+ of Italian people toward intermediate categories of health
1134
+ perception [44]. The lack of negative influence of middle age
1135
+ and chronic illness on health perception can be attributed to the
1136
+ highly efficient medical care and adequate access to social
1137
+ support provided in Italy during the lockdown (improved
1138
+ interpersonal relationships were reported by 42.9% of Italian
1139
+ respondents).
1140
+ Role of Perceptions in the Adoption of Lifestyle
1141
+ Choices: Countrywise Comparisons
1142
+ Despite the imposed social isolation and home confinement and
1143
+ the prevailing fear during the COVID-19 pandemic, we observed
1144
+ a positive behavioral response toward lifestyle. Overall, 78.4%
1145
+ of the respondents adopted at least 2 healthy lifestyle choices
1146
+ during the COVID-19 pandemic. The majority of the
1147
+ respondents (67.6%) reported increased engagement in physical
1148
+ activity or exercise as opposed to the expected sedentary
1149
+ behavior due to home confinement. This favorable although
1150
+ unexpected outcome can be attributed to the timely release of
1151
+ the advisory recommendations made by various global and
1152
+ government agencies, including the WHO, on home-based or
1153
+ other easy‐to‐perform exercises under physical restrictions
1154
+ [45,46]. One of the crucial affirmative responses observed in
1155
+ this survey was the overwhelming response toward substance
1156
+ use (94.1%), which is more justifiable by lack of availability
1157
+ [47] than motivational influence. Along similar lines, in a recent
1158
+ survey on the immediate response to COVID-19, a 3% reduction
1159
+ in smoking was reported in Italians, which was attributed to the
1160
+ fear of increased risk of respiratory distress or mortality [48].
1161
+ To this end, we suggest the implementation of internet-based
1162
+ and cost-effective behavioral therapies, particularly cognitive
1163
+ behavioral therapy, which may aid the successful alleviation of
1164
+ maladaptive coping tendencies, thereby reducing the risk of
1165
+ future health catastrophes in the post–COVID-19 era [49,50].
1166
+ Social connectedness is an important dimension that controls
1167
+ population health and healthy lifestyle behavior [51]. In this
1168
+ cross-national survey, perception of increased social support
1169
+ and capital, manifested through enhanced interactions among
1170
+ close friends and family members (measured as interpersonal
1171
+ relationships in the survey), seemed to fill the void of missing
1172
+ social connectedness and encouraged the adoption of healthy
1173
+ lifestyle choices (adjusted OR 2.42, 95% CI 1.70-3.45). The
1174
+ substantial representation of the adoption of healthy lifestyle
1175
+ choices in Chinese and Japanese respondents (~75%),
1176
+ irrespective of their overall poor health perceptions, could be
1177
+ related to reverse causality. In the Japanese respondents (who
1178
+ had an older, middle-aged demographic profile), their working
1179
+ status (OR 4.37, 95% CI 1.19-16.02) (Table S1, Multimedia
1180
+ Appendix 1) and interpersonal relationships (OR for the
1181
+ adoption of healthy lifestyle choices 5.25, 95% CI 1.46-18.92)
1182
+ also seemed to contribute significantly to the adoption of healthy
1183
+ lifestyle behavior.
1184
+ The influence of interpersonal relationships on the adoption of
1185
+ healthy lifestyle choices was not consistent across different
1186
+ countries and was absent in the Italian respondents. However,
1187
+ this finding aligns with the previously reported relationship
1188
+ between a healthy lifestyle and self-perceived health in the
1189
+ European population [52]. Perception of good health was a
1190
+ prominent predictor of adoption of a healthy lifestyle (adjusted
1191
+ OR 6.22, 95% CI 1.90-20.40) in the middle-aged Italian
1192
+ respondents, with a 36.6% proportion of older individuals (>55
1193
+ years). Even intermediate scores of health perceptions (health
1194
+ status) also significantly predicted the likelihood of the adoption
1195
+ of healthy lifestyle choices (OR 2.43, 95% CI 1.72-3.45) in the
1196
+ Chinese respondents compared to the respondents from other
1197
+ countries, explained by their demographic characteristic of
1198
+ younger age. These countrywise differential cultural influences
1199
+ of perceptions on health and health behaviors during pandemics
1200
+ indicate that endorsement of the same, such as family support
1201
+ and togetherness, should consider existing disparities, especially
1202
+ for western countries [13].
1203
+ The findings of this report, particularly those regarding varied
1204
+ health perceptions and their differential influence on the
1205
+ likelihood of adopting healthy lifestyle choices, should be
1206
+ considered within the purview of the survey period with
1207
+ countrywise phase variations of the pandemic. Chinese
1208
+ respondents displayed the continued impact of the pandemic,
1209
+ as they had already witnessed one phase of the pandemic [2].
1210
+ Younger Indian respondents scored better for their health- and
1211
+ behavior-related perceptions due to the stable and early phase
1212
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 8
1213
+ https://formative.jmir.org/2021/6/e23630
1214
+ (page number not for citation purposes)
1215
+ Manjunath et al
1216
+ JMIR FORMATIVE RESEARCH
1217
+ XSL•FO
1218
+ RenderX
1219
+ of the pandemic (as of April 22, there was a comparatively
1220
+ steady expansion of COVID-19 cases in India compared to other
1221
+ countries, with 18,985 confirmed cases [11]). However, the
1222
+ responses of Japanese and Italian respondents related to their
1223
+ older age; these countries were also witnessing rising waves of
1224
+ COVID-19 at the time of the survey [7,53]. Japan was under
1225
+ an extended state of national emergency, as the number of
1226
+ “untraceable” cases was soaring [7]. Italy was also under an
1227
+ extended period of lockdown and was one of the hardest-hit
1228
+ nations, with an apparent mortality rate of approximately 13%
1229
+ [53,54].
1230
+ The observed predominantly female participation in the survey
1231
+ indicates a lack of stringent sampling but also highlights the
1232
+ active involvement of women, who are considered to be at high
1233
+ risk of socioeconomic vulnerability toward disease outbreaks
1234
+ such as the COVID-19 pandemic. The positive response for
1235
+ self-care in women is also a sign of improving gender equity
1236
+ toward health awareness. The observed overwhelmingly female
1237
+ participation level (75.2%) could not be ascribed to the gender
1238
+ representation of countries such as India and China [55] but
1239
+ could be ascribed to the high readiness of the female population
1240
+ to interactively use the internet, in particular to research
1241
+ health-related information and programs, as observed in recent
1242
+ reports [56-58].
1243
+ The study is limited by the lack of inclusion of perceptions of
1244
+ preventive behaviors and did not compare the respondents’
1245
+ views on precautionary measures, such as the use of face masks
1246
+ [59]. In a recent cross-country comparison between Polish and
1247
+ Chinese respondents, higher use of face masks in Chinese
1248
+ respondents (Polish respondents, 35.0%; Chinese respondents,
1249
+ 96.8%; P<.001) was found to be associated with better physical
1250
+ and mental impact of the COVID-19 pandemic [59]. Further,
1251
+ the observations of the adopted lifestyle choices presented here
1252
+ are derived from a short lockdown period during the COVID-19
1253
+ pandemic and are preliminary, influenced mostly by
1254
+ self-perception; demographic and cultural differences and
1255
+ realistic insight could only be obtained from a longer follow-up.
1256
+ Due to the self-reported nature of the observations, positive
1257
+ behavioral responses toward lifestyle are likely to be inflated.
1258
+ Good perceived health was associated with improved
1259
+ interpersonal relationships. Older respondents were least likely
1260
+ to report a positive relationship change, as observed in the
1261
+ responses of Italian and Japanese survey participants. However,
1262
+ there was a strong influence of improved interpersonal
1263
+ relationships on perceived health as well as adoption of healthy
1264
+ lifestyle choices in Japanese respondents. These findings
1265
+ indicate the potential of regularized virtual interpersonal
1266
+ interactions to attenuate the adverse psychosocial impact of
1267
+ such pandemics.
1268
+ In conclusion, the key finding of the survey is that the consistent
1269
+ positive influence of increased interpersonal relationships and
1270
+ good perceptions of health were found to have a significant
1271
+ influence on adopted lifestyle behaviors during the adverse time
1272
+ course of the COVID-19 pandemic. These favorable behavioral
1273
+ perceptions should be bolstered through enhanced health
1274
+ awareness, and regularized virtual interpersonal interactions,
1275
+ particularly in countries with an overall middle-aged or older
1276
+ population. Simultaneously, controlling the fear response
1277
+ through counseling would also help improve health outcomes
1278
+ in nations affected by pandemics. However, the observed human
1279
+ behavior has cultural influences, and it may not be globally
1280
+ generalizable.
1281
+ Data Availability Statement
1282
+ The data that support the findings of this study are available on
1283
+ request from the corresponding author.
1284
+ Acknowledgments
1285
+ The authors gratefully acknowledge the contributions of Dr Ravi Kulkarni and Dr Kousthubha for facilitating the data processing
1286
+ and providing technical support for preparing Google Forms, etc. There was no funding source for this study.
1287
+ Authors' Contributions
1288
+ MNK conceptualized the survey, performed the literature search, collected data from public sources, and contributed to the
1289
+ manuscript writing. VM wrote the manuscript and performed the literature search and statistical analyses. NR conceptualized the
1290
+ study and revised the manuscript. HR reviewed the manuscript. MNK and VM finalized the manuscript. The corresponding author
1291
+ had full access to all the data in the study and had final responsibility for the decision to submit for publication.
1292
+ Conflicts of Interest
1293
+ None declared.
1294
+ Multimedia Appendix 1
1295
+ Supplementary table.
1296
+ [DOCX File , 20 KB-Multimedia Appendix 1]
1297
+ References
1298
+ 1.
1299
+ Listings of WHO’s response to COVID-19. World Health Organization. URL: https://www.who.int/news-room/detail/
1300
+ 29-06-2020-covidtimeline [accessed 2021-05-10]
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+ XSL•FO
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+ RenderX
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+ Abbreviations
1526
+ SARS: severe acute respiratory syndrome
1527
+ SVYASA: Swami Vivekananda Yoga Anusandhana Samsthana
1528
+ WHO: World Health Organization
1529
+ Edited by G Eysenbach; submitted 18.08.20; peer-reviewed by P Mathur, R Ho, A Videira-Silva; comments to author 26.10.20; revised
1530
+ version received 03.12.20; accepted 11.04.21; published 01.06.21
1531
+ Please cite as:
1532
+ Manjunath NK, Majumdar V, Rozzi A, Huiru W, Mishra A, Kimura K, Nagarathna R, Nagendra HR
1533
+ Health Perceptions and Adopted Lifestyle Behaviors During the COVID-19 Pandemic: Cross-National Survey
1534
+ JMIR Form Res 2021;5(6):e23630
1535
+ URL: https://formative.jmir.org/2021/6/e23630
1536
+ doi: 10.2196/23630
1537
+ PMID: 33900928
1538
+ ©Nandi Krishnamurthy Manjunath, Vijaya Majumdar, Antonietta Rozzi, Wang Huiru, Avinash Mishra, Keishin Kimura, Raghuram
1539
+ Nagarathna, Hongasandra Ramarao Nagendra. Originally published in JMIR Formative Research (https://formative.jmir.org),
1540
+ 01.06.2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License
1541
+ (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium,
1542
+ provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information,
1543
+ a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included.
1544
+ JMIR Form Res 2021 | vol. 5 | iss. 6 | e23630 | p. 12
1545
+ https://formative.jmir.org/2021/6/e23630
1546
+ (page number not for citation purposes)
1547
+ Manjunath et al
1548
+ JMIR FORMATIVE RESEARCH
1549
+ XSL•FO
1550
+ RenderX
subfolder_0/A Pilot Study on Evaluating Cardiovascular Functions during the Practice of Bahir Kumbhaka (External Breath Retention).txt ADDED
@@ -0,0 +1,349 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Original Research Paper
2
+ A pilot study on evaluating cardiovascular functions during the practice
3
+ of Bahir Kumbhaka (external breath retention)
4
+ L. Nivethitha*, A. Mooventhan, N.K. Manjunath
5
+ Department of Research and Development, S-VYASA University, Bengaluru, Karnataka, India
6
+ A R T I C L E
7
+ I N F O
8
+ Article history:
9
+ Received 21 October 2016
10
+ Received in revised form 16 January 2017
11
+ Accepted 17 January 2017
12
+ Available online xxx
13
+ Keywords:
14
+ Cardiovascular functions
15
+ Kumbhaka
16
+ Pranayama
17
+ A B S T R A C T
18
+ Background: Breath is the dynamic bridge between body and mind and Pranayama (breathing techniques)
19
+ is one of the most important yogic practices. There is a lack of scientific evidence on cardiovascular
20
+ functions during the practice of pranayama techniques, especially Kumbhaka. Hence, this present study
21
+ aims at evaluating the cardiovascular functions of healthy volunteers during the practice of Bahir
22
+ Kumbhaka (BK) (external breath retention).
23
+ Materials and methods: Nineteen healthy volunteers with the mean (standard deviation) age of 23.53
24
+ (3.08) were recruited. All the subjects were asked to perform BK for the duration of 30 s (1 round) and
25
+ repeat the same for 3-rounds with the rest period of 1 min between each round. Baseline, during and post
26
+ assessments were taken before, during and immediately after the practice. Statistical analysis was
27
+ performed using repeated measures of analysis of variance with the use of statistical package for the
28
+ social sciences, version 16.
29
+ Results: Result of this study showed a significant increase in systolic blood pressure (SBP) and rate
30
+ pressure product (RPP) during the practice of BK which was revert back to normal after the practice; and a
31
+ significant increase in diastolic blood pressure (DBP), mean arterial pressure (MAP) and double product
32
+ (Do-P) during the practice of BK which did not revert back to normal even after the practice.
33
+ Conclusion: The result of this pilot study suggests that the practice of BK increases the SBP, DBP, MAP, RPP
34
+ and Do-P during the practice.
35
+ © 2017 Elsevier Ltd. All rights reserved.
36
+ 1. Background
37
+ Yoga is an ancient Indian science and the way of life, which
38
+ includes the practice of specific posture (asana), regulated
39
+ breathing (Pranayama) and meditation. Breath is the dynamic
40
+ bridge between body and mind and Pranayama is an art of
41
+ prolongation and control of breath which is one the most
42
+ important yogic practices [1]. It consists of 4-important aspects
43
+ like 1) Pooraka (inhalation), 2) Rechaka (exhalation), 3) Antar
44
+ kumbhaka (internal breath retention), and 4) Bahir Kumbhaka
45
+ (external breath retention) [2].
46
+ Previous studies reported the effect of various pranayamas such
47
+ as breath awareness, right nostril breathing, left nostril breathing
48
+ [3],
49
+ alternate
50
+ nostril
51
+ breathing [3,4],
52
+ Kapalabhati,
53
+ Bhastrika,
54
+ Kukkuriya, Savitri, Pranav [4] and Bhramari Pranayama [5] on
55
+ cardiovascular variables before and after the practice. Only very
56
+ few studies have reported the cardiovascular effect of particular
57
+ pranayama technique during the practice [6].
58
+ Though Kumbhaka (breath retention) is one of the important
59
+ aspects of pranayama, it should only be practiced for as long as is
60
+ comfortable and is not recommended for people with cardiovas-
61
+ cular diseases (CVD) and high blood pressure (BP) [2]. The scientific
62
+ reason for not recommending it to such people is less known and to
63
+ the best of our knowledge there is no known study reported the
64
+ cardiovascular
65
+ effect
66
+ of
67
+ Kumbhaka
68
+ practice
69
+ especially
70
+ Bahir
71
+ (External) Kumbhaka (BK) either in healthy or people with CVD.
72
+ Hence, this present pilot study aims at evaluating the cardiovas-
73
+ cular effect of BK in healthy volunteers.
74
+ 2. Materials and methods
75
+ 2.1. Subjects
76
+ Nineteen healthy volunteers with the mean (standard devia-
77
+ tion) age of 23.53 (3.08) were recruited from a university, South
78
+ India based on the following inclusion and exclusion criteria.
79
+ Inclusion criteria: age = 18 years and above; gender = both male and
80
+ female; subjects who are willing to participate in the study.
81
+ Exclusion criteria: subject with the history of any systemic and
82
+ * Corresponding author.
83
+ E-mail address: [email protected] (L. Nivethitha).
84
+ http://dx.doi.org/10.1016/j.aimed.2017.01.001
85
+ 2212-9588/© 2017 Elsevier Ltd. All rights reserved.
86
+ Advances in Integrative Medicine xxx (2016) xxx–xxx
87
+ G Model
88
+ AIMED 105 No. of Pages 3
89
+ Please cite this article in press as: L. Nivethitha, et al., A pilot study on evaluating cardiovascular functions during the practice of Bahir
90
+ Kumbhaka (external breath retention), Adv Integr Med (2017), http://dx.doi.org/10.1016/j.aimed.2017.01.001
91
+ Contents lists available at ScienceDirect
92
+ Advances in Integrative Medicine
93
+ journal homepage: www.elsevier.com/locate/aimed
94
+ mental illness; regular use of medication for any diseases; chronic
95
+ smoking or alcoholism; subject who is unable to perform BK. The
96
+ study protocol was approved by the institutional ethical commit-
97
+ tee and a written informed consent was obtained from each
98
+ participant.
99
+ 2.2. Design of the study
100
+ This is a single group repeated measure study, in which all the
101
+ subjects were asked to perform BK. The baseline, during and post
102
+ assessments were taken before, during and after the practice.
103
+ 2.3. Assessment
104
+ Height: By using a standard measuring tape, height in cm of
105
+ each subject was measured.
106
+ Weight: By using a standard weighing machine, the weight in kg
107
+ of each subject was measured.
108
+ Body mass index (BMI): It has been derived by using height and
109
+ weight in the formula of weight in kg divided by height in meter
110
+ square [1].
111
+ Cardiovascular variables:
112
+ A beat to beat changes in the cardiovascular variables such as
113
+ systolic blood pressure (SBP), diastolic blood pressure (DBP), mean
114
+ arterial pressure (MAP), heart rate (HR), stroke volume (SV), left
115
+ ventricular ejection time (LVET), cardiac output (CO), pulse interval
116
+ (PI), and total peripheral resistant (TPR) were assessed in sitting
117
+ position using non-invasive blood pressure monitoring system
118
+ (Finapres
119
+ Continuous
120
+ Non-Invasive
121
+ Blood
122
+ Pressure
123
+ Systems,
124
+ Netherlands). A finger cuff of suitable size was placed on the left
125
+ middle finger, in between the interphalangeal joints. A Non-
126
+ invasive blood pressure cuff was placed on the upper arm of the
127
+ same hand at the level of the heart and the marker on the cuff was
128
+ directly above the brachial artery. The hand was placed at the knee
129
+ and flexed at the elbow. A brachial correction was also made for
130
+ each subject before assessment. Assessments were taken at rest
131
+ before starting of the pranayama (baseline), during and after each
132
+ pranayama practice. Data were extracted in off-line and exported
133
+ to Microsoft excel 2007.
134
+ Assessments such as pulse pressure (PP), rate pressure product
135
+ (RPP), and double product (Do-P) were derived by using following
136
+ formulas. PP was calculated as (SP  DP); RPP as (HR  SP/100); and
137
+ Do-P as (HR  MP/100) [7].
138
+ 2.4. Intervention
139
+ Bahir Kumbhaka (BK) (External breath retention): Subjects were
140
+ asked to perform breath holding/retention after exhalation [2] for
141
+ the duration of 30-s. This is one round and it was repeated for 3-
142
+ rounds with a rest (normal breath) period of 1-min between each
143
+ round.
144
+ 2.5. Data analysis
145
+ Statistical analysis was performed using repeated measures of
146
+ analysis of variance and post hoc analysis with Bonferroni
147
+ adjustment for multiple comparisons with the use of Statistical
148
+ Package for the Social Sciences (SPSS) for Windows, Version 16.0.
149
+ Chicago, SPSS Inc. p-value <0.05 was considered as significant.
150
+ 3. Results
151
+ Demographic variables of the study group have been provided
152
+ in Table 1. Results of this present study showed a significant
153
+ increase in SBP and RPP during the practice of BK that revert back
154
+ to normal after the practice; and a significant increase in DBP, MAP
155
+ and Do-P during the practice of BK that did not revert back to
156
+ normal even after the practice; and no such significant changes
157
+ were observed in rest of the variables (Table 2).
158
+ 4. Discussion
159
+ SBP, DBP, PP, and MAP are known as the best predictors of CVD
160
+ risks [8]. Results of this present study showed a significant increase
161
+ in SBP during the practice of BK and revert back to normal after the
162
+ practice. It might attribute to the combined effect of increased level
163
+ of CO due to increased level of HR and increased level of TPR during
164
+ the practice of BK because SBP = CO  peripheral resistance (PR)
165
+ [7].
166
+ A significant increase in DBP, MAP during the practice of BK
167
+ might attribute to the increase in TPR during the practice but these
168
+ changes did not revert back to normal even after the practice and
169
+ even though there was a reduction in TPR after the practice of BK.
170
+ Hence, the mechanism behind the sustained effect of increased
171
+ level of DBP and MAP even after the practice is unclear.
172
+ The increase in RPP and Do-P might attribute to the increase in
173
+ HR and BP. RPP and Do-P are the important indirect indicators of
174
+ myocardial oxygen consumption and load on the heart [7]. A
175
+ significant increase of these variables in this study indicates strain
176
+ increasing effects of BK on the heart during the practice and
177
+ relieved after the practice.
178
+ Since Yoga is becoming popular throughout the world, people
179
+ are
180
+ very
181
+ much
182
+ interested
183
+ in practicing
184
+ various
185
+ techniques
186
+ especially the advanced techniques which include Kumbhaka
187
+ practice within a short span of period. According to a Yogic text, the
188
+ practice of advanced techniques should begin only after we
189
+ become master over the basic techniques. And these advanced
190
+ techniques has to be practiced gradually in order to get adopt the
191
+ body and mind with the practice, to reach the final stage. If, it is not
192
+ followed then that might lead to certain adverse effects [2]. This
193
+ Table 1
194
+ Demographic variables of the study group (n = 19).
195
+ Variables
196
+ Study group (n = 19)
197
+ Age (years)
198
+ 23.53  3.08
199
+ Gender
200
+ Males (n = 18) and female (n = 1)
201
+ Height (m)
202
+ 1.70  0.09
203
+ Weight (kg)
204
+ 60.42  8.60
205
+ Body mass index (kg/m2)
206
+ 20.90  2.30
207
+ Table 2
208
+ Cardiovascular changes while practicing Bahir Kumbhaka (n = 19) (RMANOVA).
209
+ Variables
210
+ Baseline
211
+ During
212
+ Post
213
+ SBP (mmHg)
214
+ 115.93  14.35
215
+ 129.22  18.53*
216
+ 119.53  12.75
217
+ DBP (mmHg)
218
+ 71.54  8.87
219
+ 80.84  11.12*
220
+ 74.05  8.77*
221
+ MAP (mmHg)
222
+ 88.74  10.24
223
+ 100.07  13.75*
224
+ 92.01  9.81*
225
+ PP (mmHg)
226
+ 44.39  8.23
227
+ 48.38  9.86
228
+ 45.48  7.30
229
+ RPP (Units)
230
+ 97.91  16.71
231
+ 113.31  23.21*
232
+ 103.35  15.65
233
+ Do P (Units)
234
+ 74.97  12.29
235
+ 87.72  17.27*
236
+ 79.67  12.69*
237
+ HR (beats/mint)
238
+ 84.61  10.82
239
+ 87.94  13.68
240
+ 86.82  11.92
241
+ SV (l)
242
+ 70.42  13.35
243
+ 69.95  12.36
244
+ 70.20  13.03
245
+ LVET (ms)
246
+ 267.86  17.03
247
+ 259.49  20.82
248
+ 261.90  18.86
249
+ Cardiac output (l/mint)
250
+ 5.89  1.24
251
+ 6.07  1.40
252
+ 6.00  1.15
253
+ Pulse interval (ms)
254
+ 730.50  98.08
255
+ 712.26  133.55
256
+ 716.63  116.19
257
+ TPR (mmHg min/l)
258
+ 1.04  0.29
259
+ 1.11  0.31
260
+ 1.02  0.27
261
+ Note: All values are in mean  standard deviation. SBP = systolic blood pressure;
262
+ DBP = diastolic blood pressure; MAP = mean arterial pressure; PP = pulse pressure;
263
+ RPP = rate pressure product; Do-P: double product; HR = heart rate; SV = stroke
264
+ volume; LVFT = left ventricular ejection time; TPR = total peripheral resistant.
265
+ * p < 0.05.
266
+ 2
267
+ L. Nivethitha et al. / Advances in Integrative Medicine xxx (2016) xxx–xxx
268
+ G Model
269
+ AIMED 105 No. of Pages 3
270
+ Please cite this article in press as: L. Nivethitha, et al., A pilot study on evaluating cardiovascular functions during the practice of Bahir
271
+ Kumbhaka (external breath retention), Adv Integr Med (2017), http://dx.doi.org/10.1016/j.aimed.2017.01.001
272
+ present study results also supporting the above mentioned
273
+ concept by showing the increased level of SBP, DBP, MAP, RPP
274
+ and Do-P during the practice of BK (one of the advanced aspects of
275
+ pranayama) even in healthy volunteers. Hence, in order to avoid
276
+ complications of high-BP, this kind of practices should not be
277
+ recommended suddenly to the people with hypertension and other
278
+ CVD. Care must be taken in administrating this breathing
279
+ technique by mastering over the basic practices (slow/yogic
280
+ breathing techniques) and then a gradual increase in the duration
281
+ of practice to get adopt with the practice. Because, regular practice
282
+ of slow inspiration and expiration for longer duration would help
283
+ in training the stretch receptors of respiratory muscles, chest wall
284
+ and walls of the alveoli to support the breath holding along with
285
+ acclimatizing the central and peripheral chemoreceptors for both
286
+ hypercapnoea and hypoxia.
287
+ Breath holding time is one of the most important variables used
288
+ to measure the respiratory function [9]. Longer the breath holding
289
+ time, better the pulmonary function. Since, BK is one of the breath
290
+ holding techniques that was shown to increase BP as well as RPP
291
+ and Do-P (indirect measure of cardiac workload), regular practice
292
+ of BK alone or along with other pranayama practices might be
293
+ considered in cardio-respiratory training of healthy individuals to
294
+ strengthen the system and to prevent the various cardio-
295
+ respiratory problems.
296
+ Strengths of this present study: First study evaluating the
297
+ cardiovascular effect of BK during the practice itself; Beat to beat
298
+ changes in the blood pressure was measured using standard
299
+ advanced non-invasive blood pressure monitoring systems.
300
+ Limitations of this study: Small sample size; subjects were
301
+ healthy volunteers which is limiting the scope of this study in
302
+ people with pathological conditions; autonomic function assess-
303
+ ments such as heart rate variability, galvanic skin resistance, pulse
304
+ plethesmogram; baroreflex sensitivity would have provided more
305
+ information. Hence, further studies are required with larger
306
+ sample size using all the above mentioned objective variables in
307
+ both healthy and people with pathological conditions for the better
308
+ understanding.
309
+ 5. Conclusion
310
+ The result of this study suggests that the practice of BK
311
+ increases the SBP, DBP, MAP, RPP and Do-P during the practice.
312
+ Source of funding
313
+ Nil.
314
+ Conflict of interest
315
+ None declared.
316
+ References
317
+ [1] A. Mooventhan, V. Khode, Effect of Bhramari pranayama and OM chanting on
318
+ pulmonary function in healthy individuals: a prospective randomized control
319
+ trial, Int. J. Yoga 7 (2014) 104–110.
320
+ [2] S. Saraswati, Asana Pranayama Mudra Bandha, 4th rev. edition, Yoga
321
+ Publications Trust, Munger, Bihar, India, 2008.
322
+ [3] P. Raghuraj, S. Telles, Immediate effect of specific nostril manipulating yoga
323
+ breathing practices on autonomic and respiratory variables, Appl.
324
+ Psychophysiol. Biofeedback 33 (2008) 65–75.
325
+ [4] V.K. Sharma, M. Trakroo, V. Subramaniam, M. Rajajeyakumar, A.B. Bhavanani, A.
326
+ Sahai, Effect of fast and slow pranayama on perceived stress and cardiovascular
327
+ parameters in young health-care students, Int. J. Yoga 6 (2013) 104–110.
328
+ [5] T. Pramanik, B. Pudasaini, R. Prajapati, Immediate effect of a slow pace breathing
329
+ exercise Bhramari Pranayama on blood pressure and heart rate, Nepal Med. Coll.
330
+ J. 12 (2010) 154–157.
331
+ [6] S. Telles, S.K. Sharma, A. Balkrishna, Blood pressure and heart rate variability
332
+ during yoga-based alternate nostril breathing practice and breath awareness,
333
+ Med. Sci. Monit. Basic Res. 20 (2014) 184–193.
334
+ [7] A. Mooventhan, Immediate effect of ice bag application to head and spine on
335
+ cardiovascular changes in healthy volunteers, Int. J. Health Allied Sci. 5 (2016)
336
+ 53–56.
337
+ [8] H.D. Sesso, M.J. Stampfer, B. Rosner, C.H. Hennekens, J.M. Gaziano, J.E. Manson,
338
+ et al., Systolic and diastolic blood pressure, pulse pressure, and mean arterial
339
+ pressure as predictors of cardiovascular disease risk in men, Hypertension 36
340
+ (2000) 801–807.
341
+ [9] P.S. Karthik, M. Chandrasekhar, K. Ambareesha, C. Nikhil, Effect of pranayama
342
+ and suryanamaskar on pulmonary functions in medical students, J. Clin. Diagn.
343
+ Res. 8 (2014) BC04–BC06.
344
+ L. Nivethitha et al. / Advances in Integrative Medicine xxx (2016) xxx–xxx
345
+ 3
346
+ G Model
347
+ AIMED 105 No. of Pages 3
348
+ Please cite this article in press as: L. Nivethitha, et al., A pilot study on evaluating cardiovascular functions during the practice of Bahir
349
+ Kumbhaka (external breath retention), Adv Integr Med (2017), http://dx.doi.org/10.1016/j.aimed.2017.01.001
subfolder_0/A randomized controlled study on assessment of health status, depression, and anxiety in coal miners with copd.txt ADDED
@@ -0,0 +1,940 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ 137
2
+ © 2016 International Journal of Yoga | Published by Wolters Kluwer - Medknow
3
+ A randomized controlled study on assessment of health
4
+ status, depression, and anxiety in coal miners with chronic
5
+ obstructive pulmonary disease following yoga training
6
+ Rajashree Ranjita, Sumati Badhai, Alex Hankey, Hongasandra R Nagendra
7
+ Division of Yoga and Life Science, Swami Vivekananda Yoga Anusandhana Samsthana Yoga University, Bengaluru, Karnataka, India
8
+ Address for correspondence: Dr. Rajashree Ranjita,
9
+
10
+ Swami Vivekananda Yoga Anusandhana Samsthana, No. 19, Eknath Bhavan, Gavipuram Circle,
11
+
12
+ Kempegowda Nagar, Bengaluru ‑ 560 019, Karnataka, India.
13
+
14
+ E‑mail: [email protected]
15
+ increasingly affect the psychological well‑being of working
16
+ populations,[4] coal miners being more susceptible due to
17
+ highly risky and stressful working environments.[5] Prior
18
+ studies have documented association of depression and
19
+ anxiety among COPD patients[6‑9] more than non‑COPD
20
+ individuals.[10] Clinically significant symptoms of
21
+ depression were found in around half COPD patients[11,12]
22
+ while the prevalence of anxiety has been estimated at
23
+ INTRODUCTION
24
+ Chronic obstructive pulmonary disease (COPD) is a
25
+ complex, treatment‑resistant disease with multiple
26
+ comorbidities, depression, and anxiety being the two of
27
+ the most important and least treated among them.[1] Other
28
+ than cigarette smoking, there is an increasing evidence
29
+ of occupational exposures as a major risk factor for
30
+ COPD[2,3] found the prevalence of COPD in nonsmoking
31
+ coal miners was 19% in a study. Depression and anxiety
32
+ Original Article
33
+ Context: Psychological comorbidities are prevalent in coal miners with chronic obstructive pulmonary disease (COPD) and
34
+ contribute to the severity of the disease reducing their health status. Yoga has been shown to alleviate depression and anxiety
35
+ associated with other chronic diseases but in COPD not been fully investigated.
36
+ Aim: This study aimed to evaluate the role of yoga on health status, depression, and anxiety in coal miners with COPD.
37
+ Materials and Methods: This was a randomized trial with two study arms (yoga and control), which enrolled 81 coal miners,
38
+ ranging from 36 to 60 years with stage II and III stable COPD. Both groups were either on conventional treatment or combination
39
+ of conventional care with yoga program for 12 weeks.
40
+ Results: Data were collected through standardized questionnaires; COPD Assessment Test, Beck Depression Inventory and
41
+ State and Trait Anxiety Inventory at the beginning and the end of the intervention. The yoga group showed statistically significant
42
+ (P < 0.001) improvements on all scales within the group, all significantly different (P < 0.001) from changes observed in the
43
+ controls. No significant prepost changes were observed in the control group (P > 0.05).
44
+ Conclusion: Yoga program led to greater improvement in physical and mental health status than did conventional care. Yoga
45
+ seems to be a safe, feasible, and effective treatment for patients with COPD. There is a need to conduct more comprehensive,
46
+ high‑quality, evidence‑based studies to shed light on the current understanding of the efficacy of yoga in these chronic conditions
47
+ and identify unanswered questions.
48
+ Key words: Anxiety; COPD assessment test; chronic obstructive pulmonary disease; depression; yoga.
49
+ ABSTRACT
50
+ Access this article online
51
+ Website:
52
+ www.ijoy.org.in
53
+ Quick Response Code
54
+ DOI:
55
+ 10.4103/0973-6131.183714
56
+ How to cite this article: Ranjita R, Badhai S, Hankey A,
57
+ Nagendra HR. A randomized controlled study on assessment of health
58
+ status, depression, and anxiety in coal miners with chronic obstructive
59
+ pulmonary disease following yoga training. Int J Yoga 2016;9:137-44.
60
+ This is an open access article distributed under the terms of the Creative
61
+ Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
62
+ others to remix, tweak, and build upon the work non‑commercially, as long as the
63
+ author is credited and the new creations are licensed under the identical terms.
64
+ For reprints contact: [email protected]
65
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
66
+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
67
+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
68
+ 138
69
+ 40%.[13‑15] About one‑third of COPD sufferers is afflicted
70
+ by both.[16] The presence of these comorbid symptoms
71
+ significantly contributes to the impaired health status
72
+ in patients with COPD[17,18] irrespective of the degree of
73
+ airflow limitation.[19] Therefore, optimizing the health
74
+ status is an important goal in COPD management.[20] In a
75
+ systematic review, it has been reported that comprehensive
76
+ pulmonary rehabilitation benefits in a reduction in
77
+ short‑term depression and anxiety.[21] Limited evidence is
78
+ available on the effect of mindfulness‑based treatments
79
+ such as yoga for the management of depression and anxiety
80
+ in COPD patients.
81
+ Yoga is a way of life, mainly has four primary
82
+ components: Physical postures to develop strength and
83
+ flexibility, breathing exercises to enhance respiratory
84
+ functioning, deep relaxation techniques to cultivate the
85
+ ability to release anxiety, and meditation/mindfulness
86
+ practices to promote emotion and stress regulation
87
+ skills.[22] Psychosomatic ailments arise due to a
88
+ disturbance in the mind.[23] The level of documented
89
+ evidence of yoga’s psychophysiological benefits for
90
+ depression and anxiety is progressively increasing.[24‑32]
91
+ Similarly, some research has been conducted on
92
+ yoga’s application to COPD[33‑37] but no study has been
93
+ published assessing the effect of yoga on coal miners,
94
+ for whom the condition is a major work‑related health
95
+ hazard. Hence, this study was aimed to evaluate the
96
+ effects of a 12 weeks program of the Integrated Approach
97
+ of Yoga Therapy (IAYT) on health status, depression, and
98
+ anxiety of COPD in coal miners compared to controls on
99
+ conventional care, based on the hypothesis that it would
100
+ improve the health status by decreasing depression and
101
+ anxiety symptoms. IAYT is a combination of breathing
102
+ practices, physical postures, pranayama, kriya,
103
+ meditation, relaxation techniques, and lectures.[22] Its
104
+ therapeutic applications as a supplementary therapy
105
+ for chronic health conditions in asthma,[38] cancer,[39]
106
+ diabetes,[40] schizophrenia,[41] and low back pain[42] are
107
+ well established.
108
+ MATERIALS AND METHODS
109
+ Participants
110
+ Eighty‑one male nonsmoking coal miners with ages ranging
111
+ from 36 years to 60 years were recruited for the study.
112
+ They were all present coal miners of Rampur Colliery,
113
+ Odisha. A total of 279 coal miners were screened, of
114
+ whom 36 declined to sign the informed consent form.
115
+ Rest 243 underwent clinical examination, of these 162 met
116
+ any one of exclusion criteria and finally 81 registered for
117
+ the trial and were randomized into two groups, yoga and
118
+ waitlist controls. Figure 1 depicts the flow diagram of
119
+ the study, showing screening, enrollment, intervention,
120
+ assessments, and analysis.
121
+ Inclusion criteria
122
+ The inclusion criteria were as follows: Physician diagnosed
123
+ COPD with spirometric evidence of chronic airflow
124
+ limitation (forced expiratory volume in 1 s/forced vital
125
+ capacity, post bronchodilator <0.70), Global initiative for
126
+ Obstructive Lung Disease (GOLD) stage I and II COPD;[1]
127
+ clinically stable for at least 3 months; literate to complete
128
+ the questionnaires.
129
+ Exclusion criteria
130
+ Exclusion criteria were: Prior experience of yoga; recent
131
+ COPD exacerbation; cognitive impairment; myocardial
132
+ infarction or recurrent angina within the previous
133
+ 6 months; hospitalization within 3 months; and respiratory
134
+ tract infection within 1 month of enrollment.
135
+ Informed consent
136
+ The aim of the study was conveyed to those agreeing to
137
+ participate in the study; signed informed consent was
138
+ obtained from all participants prior to baseline assessment.
139
+ Design
140
+ This is a randomized, waitlist control, single‑blind clinical
141
+ trial in which 81 participants were assigned to two groups
142
+ (yoga and control) using a computer generated random
143
+ number table obtained from http://www.randomizer.org.
144
+ Numbered opaque envelopes were used to implement
145
+ the random allocation to conceal the sequence until
146
+ interventions were assigned.
147
+ Study protocol
148
+ At enrollment, medical, exposure histories, pulmonary
149
+ symptoms, and information about current pharmacological
150
+ treatments were obtained, and clinical examinations
151
+ performed by a specialist physician. Comorbid diagnoses
152
+ were established from clinical histories and examination
153
+ findings, supported by reviews of available medical
154
+ records. The yoga group practiced a set of integrated
155
+ yoga practices specially designed for COPD for 90 min
156
+ daily, 6 days/week for 12 weeks. Participants of control
157
+ group continued conventional therapy, completing all
158
+ assessments at the same times as the yoga group; they
159
+ were offered yoga at the end of the study. All participants
160
+ were asked to refrain from participating in any other yoga
161
+ classes during the study period.
162
+ Blinding and masking
163
+ Double blinding is not considered possible for yoga
164
+ interventions, where participants and trainer can
165
+ recognize group assignment. However, giving and scoring
166
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
167
+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
168
+ 139
169
+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
170
+ the assessments were masked wherever feasible. The
171
+ statistician responsible for randomization, and subsequent
172
+ data analysis was not involved in administering the
173
+ intervention and was thus blind to the source of the data.
174
+ The clinical psychologist who administered and scored the
175
+ psychological questionnaires and the staff, who carried out
176
+ assessments, were blind to membership of the intervention
177
+ groups. Coded answer sheets were analyzed only after the
178
+ study’s completion.
179
+ Study approval
180
+ The study was approved by the Institution Ethics
181
+ Committee (Swami Vivekananda Yoga University,
182
+ Bangalore) through RES/IEC/28/2014 in accordance with
183
+ the Helsinki Declaration.
184
+ Intervention
185
+ The IAYT module was developed by Swami Vivekananda
186
+ Yoga Anusandhana Samasthana specifically for COPD. It
187
+ included simple and safe practices at physical, mental,
188
+ emotional, and intellectual levels. The yoga practice
189
+ protocol was designed in consultation with S‑VYASA’s
190
+ Medical Director. The daily schedule is detailed in
191
+ Table 1.
192
+ Assessments
193
+ Assessments were made on both groups before and after
194
+ the 12 weeks of intervention. The following questionnaires
195
+ were completed by all participants.
196
+ COPD assessment test
197
+ COPD Assessment Test (CAT) is a short questionnaire
198
+ developed for assessing and monitoring COPD in
199
+ routine clinical practice. It provides a valid, reliable, and
200
+ standardized measure of the impact of COPD on a patient’s
201
+ health and well‑being.[43,44] It consists of 8 items rated using
202
+ a Likert‑type scale of 0–5, providing a score out of 40,
203
+ higher scores representing the poorer quality of life (QoL).
204
+ Despite the small number of items, it covers a broad range
205
+ of effects on patients’ health. It takes less time to complete
206
+ than other health‑related QoL questionnaires.[45] CAT is
207
+ sensitive to changes in disease progression over time and
208
+ to the effectiveness of treatments.[46,47] Internal consistency
209
+ is excellent with Cronbach’s α =0.88 and test‑retest
210
+ reliability good in stable patients (ICCC = 0. 8).[43]
211
+ Beck depression inventory
212
+ All participants completed the Beck Depression
213
+ Inventory (BDI), 2nd edition.[48] BDI‑II is a self‑report
214
+ Total patients screened
215
+ (n = 279)
216
+ Declined informed consent
217
+ (n = 36)
218
+ Underwent clinical examination
219
+ (n = 243)
220
+ Did not meet the inclusion
221
+ criteria (n = 162)
222
+ Random assignment (n = 81)
223
+ Yoga group
224
+ (n = 41)
225
+ Control group
226
+ (n = 40)
227
+ Intervention 12
228
+ weeks
229
+ Drop outs
230
+ (n = 5)
231
+ Drop outs
232
+ (n = 4)
233
+ Incomplete questionnaires
234
+ (n = 1)
235
+ Illness (n = 2)
236
+ Out of station (n = 1)
237
+ Reasons for
238
+ drop out
239
+ Incomplete questionnaires
240
+ (n = 2)
241
+ Illness (n = 1)
242
+ Less attendance (n = 2)
243
+ Final analysis
244
+ Yoga (n = 36)
245
+ Final analysis
246
+ Control (n = 36)
247
+ Figure 1: Flow of participants over study period
248
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
249
+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
250
+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
251
+ 140
252
+ questionnaire of 21 items scored from 0 to 3. It is
253
+ designed to assess depressive symptoms experienced
254
+ within the previous 2 weeks. It has high internal
255
+ consistency (Cronbach’s α =0.92); mean test‑retest
256
+ reliability is 0.72.[49] BDI‑II scores range from 0 to 63,
257
+ with categorical depression ratings of “minimal” (0–13),
258
+ “mild” (14–19), “moderate” (20–28), and “severe”
259
+ (29–63). BDI is considered a valid measure of depressed
260
+ mood for diverse populations.
261
+ State trait anxiety inventory
262
+ State and Trait Anxiety Inventory (STAI) is a reliable,
263
+ valid, and widely used measure of anxiety for clinical
264
+ practice and research, with a high degree of internal
265
+ consistency.[50] Cronbach’s α is 0.85 for the total scores.[51]
266
+ It includes separate measures of state anxiety and trait
267
+ anxiety each comprising 20 items rated on a 4 point
268
+ scale from 0 to 3 which range from 20, minimum, to 80,
269
+ maximum. Form S evaluates state anxiety, how subjects,
270
+ feel “at this moment;” while Form T assesses trait anxiety,
271
+ how the respondent feels “most of the time.” In India,
272
+ its reliability and validity are well established following
273
+ extensive use in adult populations. State anxiety reflects
274
+ subjective and transitory emotional states characterized
275
+ by consciously perceived feelings of nervousness, tension,
276
+ worries, and apprehension, and heightened autonomic
277
+ nervous system activity. In contrast, trait anxiety refers
278
+ to relatively stable individual differences in anxiety
279
+ proneness as a personality attribute that denotes general
280
+ tendency to respond with anxiety to perceived threats in
281
+ the environment.
282
+ Data collection
283
+ Clinical and demographic information were collected
284
+ using medical records and study‑specific forms. Adherence
285
+ and compliance were monitored through the use of daily
286
+ patient diaries and attendance records kept by the yoga
287
+ instructors. No make‑up sessions were provided for missed
288
+ classes. All participants were instructed to continue their
289
+ routine daily activities during the 12‑week intervention
290
+ period but were asked not to start a new yoga or exercise
291
+ regimen on their own during that time. A feedback form
292
+ was used to assess enjoyment and helpfulness of the
293
+ yoga intervention, and to ask whether participants would
294
+ recommend it to others.
295
+ Table 1: Integrated approach of yoga therapy for
296
+ chronic obstructive pulmonary disease used in this study
297
+ Name of the practices
298
+ Duration (min)
299
+ Breathing practices
300
+ 10
301
+ Standing
302
+ Hands in and out breathing
303
+ 1
304
+ Hands stretch breathing
305
+ 1
306
+ Ankle stretch breathing
307
+ 1
308
+ Sitting
309
+ Dog breathing
310
+ 1
311
+ Rabbit breathing
312
+ 1
313
+ Tiger breathing
314
+ 1
315
+ Sasäìkäsana breathing (moon pose)
316
+ 1
317
+ Prone
318
+ Bhujaìgäsana breathing
319
+ 1
320
+ Śalabhāsana breathing
321
+ 1
322
+ Supine
323
+ Straight leg raising breathing
324
+ 1
325
+ Loosening practices
326
+ 10
327
+ Forward and backward bending
328
+ 1
329
+ Side bending
330
+ 1
331
+ Twisting
332
+ 1
333
+ Pawanmuktäsana kriyä (alternate leg)
334
+ 1×2
335
+ Rocking and rolling
336
+ 1×2
337
+ Surya Namaskära × 3 rounds
338
+ 1×3
339
+ Yogäsanas (physical postures)
340
+ 20
341
+ Standing
342
+ Ardhakati cakräsana (lateral arc pose)
343
+ 2
344
+ Pädahastäsana (forward bend pose)
345
+ 2
346
+ Ardha cakräsana (half wheel pose)
347
+ 2
348
+ Sitting
349
+ Vakräsana (twisting posture)
350
+ 2
351
+ Ardhamatsyendräsana (half spinal twist posture)
352
+ 2
353
+ Paścimottānāsana (sleeping thunderbolt posture)
354
+ 2
355
+ Prone
356
+ Bhujaìgäsana (serpent pose)
357
+ 2
358
+ Śalabhāsana (locust pose)
359
+ 2
360
+ Supine
361
+ Sarväìgäsana (shoulder stand pose)
362
+ 2
363
+ Matsyäsana (fish pose)
364
+ 2
365
+ Yogä chair breathing
366
+ 10
367
+ Instant relaxation technique
368
+ 1
369
+ Neck muscle relaxation with chair support
370
+ 1
371
+ Neck movements in Vajräsana
372
+ 1
373
+ Sasäìkäsana movement
374
+ 1
375
+ Relaxation in Tadäsana
376
+ 1
377
+ Neck movements in Tadäsana
378
+ 1
379
+ Ardha cakräsana - Pädahastäsana
380
+ 1
381
+ Quick relaxation technique
382
+ 3
383
+ Präëäyäma
384
+ 10
385
+ Kapälabhäti (frontal brain cleansing)
386
+ 2
387
+ Vibhägiya präëäyäma (sectional breathing)
388
+ 2
389
+ Näòéśodhana präëäyäma (alternate nostril
390
+ breathing)
391
+ 2
392
+ Ujjayi präëäyäma (diaphragmatic breathing)
393
+ 2
394
+ Bhrämaré präëäyäma (bee breathing)
395
+ 2
396
+ Meditation
397
+ 10
398
+ Nädänusandhäna (alternate day)
399
+ 10
400
+ Om Meditation (alternate day)
401
+ 10
402
+ DRT in Çaväsana (corpse pose)
403
+ 10
404
+ Yogic counseling/lectures
405
+ 10
406
+ Yoga philosophy and health, basis and applications
407
+ of yoga, Pancakoña viveka (five layers of existence),
408
+ COPD causes, complications and relation to
409
+ stress, Stress reaction and its management. Lifestyle
410
+ modification, diet and exercise, emotion and coping
411
+ Table 1: Contd...
412
+ Name of the practices
413
+ Duration (min)
414
+ Kriyä (once a week)
415
+ 90
416
+ Theory on kriyä
417
+ 10
418
+ Jala Neti
419
+ 20
420
+ Sutra Neti
421
+ 20
422
+ Vamana Dhouti
423
+ 25
424
+ DRT
425
+ 15
426
+ DRT = Deep relaxation technique, COPD = Chronic obstructive pulmonary disease
427
+ Contd...
428
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
429
+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
430
+ 141
431
+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
432
+ Statistical analysis
433
+ Data were analyzed using SPSS version 18.0
434
+ (IBM Corporation, USA). Within group changes and between
435
+ group treatment effects associated with participation in the
436
+ yoga intervention were evaluated using Chi‑square tests
437
+ for categorical data and paired t‑tests and independent
438
+ sample t‑tests for continuous data. P < 0.05 was considered
439
+ significant.
440
+ RESULTS
441
+ Descriptive features
442
+ The study population initially consisted of 81 coal miners
443
+ with COPD. Five and four participants dropped out of
444
+ yoga and control group, respectively, for personal reasons
445
+ unrelated to the study, giving a final sample size of 72 (36
446
+ in each group). Total participants in GOLD stage II category
447
+ were 52.8% in yoga and 58.3% in controls, and in GOLD
448
+ stage III 47.2% in yoga and 41.7% in controls. Demographic
449
+ variables of patient’s average age, duration of employment
450
+ in coal mines, and duration of disease since diagnosis were
451
+ comparable as were initial test scores at baseline (all P >
452
+ 0.05) [Table 2].
453
+ COPD assessment test
454
+ The practice of yoga for 12 weeks has significantly
455
+ lowered the CAT scores (P < 0.001) in the yoga group,
456
+ indicating better health status, whereas no significant
457
+ difference was observed in the control group (P = 0.294).
458
+ The results further revealed that the change occurred in
459
+ the yoga group was 23.05% and in the control group was
460
+ − 2.52%. Between‑group differences were statistically
461
+ significant (P < 0.001, independent t‑test) [Table 3].
462
+ Beck depression inventory
463
+ In both the groups, mean depression scores were reduced,
464
+ but the magnitude of change is statistically significant
465
+ and higher (P < 0.001, 25.53%) in the yoga group as
466
+ compared to the control group (P = 0.095, 3.23%). In
467
+ addition, significant group mean differences were observed
468
+ between yoga and control group’s post intervention scores
469
+ (P = 0.002) [Table 3].
470
+ State and trait anxiety inventory
471
+ The yoga group showed significantly lower scores in both
472
+ state and trait anxiety (P < 0.001), but controls showed no
473
+ significant change (P = 0.192 and P = 0.383, respectively).
474
+ State anxiety decreased by 15.98% in yoga and increased
475
+ by 1.98% in controls. A similar trend was observed in trait
476
+ anxiety also. It decreased by 13.35% in yoga and increased
477
+ by 1.46% in controls. Independent t‑tests gave statistically
478
+ significant differences between groups at posttest, P = 0.032
479
+ and P = 0.034, respectively. Overall anxiety score was
480
+ significantly reduced by 14.64% within the yoga group
481
+ (P < 0.001), whereas and there was slight increase by 1.71%
482
+ (P = 0.054) reported in the control group [Table 3].
483
+ DISCUSSION
484
+ To the best of our knowledge, this is the first
485
+ randomized‑controlled study investigating physical and
486
+ psychological health benefits associated with yoga practice
487
+ on coal miners with COPD. The study evaluated the impact
488
+ of yoga on their disease‑specific health status, depression, and
489
+ anxiety levels. Results suggested that IAYT practice facilitates
490
+ improvements in health status and reduces self‑reported
491
+ depression and anxiety levels after 12 weeks of practice.
492
+ The results are consistent with previously reported
493
+ interventions based on yoga, which demonstrated positive,
494
+ beneficial effects on psychological and psychosocial
495
+ factors in diverse conditions such as diabetes,[40] cancer,[52]
496
+ CAD,[53] low back pain,[54] osteoarthritis of the knee,[55] and
497
+ pregnancy.[56,57] It is reported in a study that pranayama
498
+ (yogic breathing) mitigates posttraumatic stress disorder
499
+ and depression.[58] Another study on patients who
500
+ participated in education and stress management in
501
+ addition to exercise training during a 12‑week intervention
502
+ reported reductions in depression and anxiety.[59]
503
+ A study reported that changes in depression and state and
504
+ trait anxiety did not significantly differ between the two
505
+ interventions (6 weeks of weekly yoga classes together
506
+ with exercise, compared to a 6 weeks weekly group
507
+ exercise) (GDS15, P = 0.749, STAI‑S, P = 0.595, STAI‑T,
508
+ P = 0.407).[60] Another study has similarly obtained unclear
509
+ effects following yoga intervention.[61]
510
+ The pathophysiology of depression and anxiety among
511
+ COPD patient is complex and poorly understood. The
512
+ Table 2: Baseline characteristics of participants in both
513
+ yoga and control group
514
+ Variables
515
+ Mean±SD
516
+ P (independent
517
+ sample t-test)
518
+ Yoga
519
+ (n=36)
520
+ Control
521
+ (n=36)
522
+ Age
523
+ 53.69±5.66
524
+ 54.36±5.40
525
+ 0.611*
526
+ Duration of employment
527
+ in coal mines
528
+ 28.36±4.62
529
+ 27.72±4.23
530
+ 0.543*
531
+ Duration of disease
532
+ since diagnosis
533
+ 9.92±3.25
534
+ 10.69±2.54
535
+ 0.262*
536
+ CAT
537
+ 20.69±5.53
538
+ 21.81±5.48
539
+ 0.395*
540
+ BDI
541
+ 22.25±8.47
542
+ 24.14±9.21
543
+ 0.368*
544
+ STAI (S)
545
+ 39.61±8.73 37.92±10.92
546
+ 0.469*
547
+ STAI (T)
548
+ 41.06±7.82
549
+ 39.86±8.88
550
+ 0.547*
551
+ STAI (total)
552
+ 80.67±16.06 77.78±19.27
553
+ 0.492*
554
+ *Not significant. CAT = COPD assessment test, BDI = Beck depression inventory,
555
+ STAI = State-trait anxiety inventory, STAI (S) = State anxiety, STAI (T) = Trait anxiety,
556
+ SD = Standard deviation, COPD = Chronic obstructive pulmonary disease
557
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
558
+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
559
+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
560
+ 142
561
+ physical, emotional, and social impact of COPD may cause
562
+ a self‑perpetuating cycle that has a severe impact on a
563
+ patient’s physical and mental health status.[21] It has been
564
+ shown that high scores on perceived stress and anxiety
565
+ are related to increase in hypothalamic‑pituitary‑adrenal
566
+ (HPA) axis activity.[62] The effects of yoga in our results can
567
+ be explained by reduction in levels of psychophysiological
568
+ arousal via triggering neurohormonal mechanisms
569
+ that suppress sympathetic activity,[63,64] balance in the
570
+ autonomic nervous system responses,[65] alterations in
571
+ neuroendocrine arousal[66,67] through better regulation
572
+ of the HPA axis[68] resulting in reductions in stress and
573
+ anxiety.[32] Better psychological health resulting from stress
574
+ reduction might be due to relaxation techniques[69] which
575
+ contribute to the observed improvements in CAT scores in
576
+ our study. Thus, these psychological changes may explain
577
+ the physiological changes observed as better outcomes
578
+ seen in previous studies on integrated yoga in asthma.[38]
579
+ Yoga unites body, mind, and spirit; and enhances attention
580
+ by calming down the restless mind.[22] Thus, the deep
581
+ physiological rest that is achieved by the components of
582
+ pranayama, meditation, and other mindfulness practices
583
+ incorporated in the integrated yoga program could be
584
+ the major factors explaining observed benefits. Overall,
585
+ antidepressant effects of yoga programs can be attributed
586
+ to stress reduction.[70] Another study concluded the
587
+ practice of meditation strengthens the mental resolve
588
+ and hence decreases anxiety.[71] Yoga practices decrease
589
+ parasympathetic nervous system and GABAergic activity
590
+ that underlies stress‑related disorders which result in
591
+ amelioration of disease symptoms.[72] Reductions in
592
+ psychological hyper‑reactivity and emotional instability
593
+ achieved by yoga may be due to reduced efferent vagal
594
+ reactivity[73] already recognized as a main psychosomatic
595
+ factor in asthma,[74] might have similar physiology in
596
+ COPD also.
597
+ This study is the first of its kind to conclude that integrated
598
+ yoga can act as an imperative line of therapy in the
599
+ management of COPD in coal miners. The novel aspects
600
+ of this study were (a) the randomized control design,
601
+ (b) good sample size, (c) incorporation of integrated yoga
602
+ approach, and (d) good compliance. A major constraint of
603
+ the study is the lack of an active control group. It would
604
+ have been valuable to include physiological measures of
605
+ stress such as Galvanic Skin Response and Heart Rate
606
+ Variability to overcome the subjectivity of self‑report
607
+ and to throw light on the mechanisms. In spite of the
608
+ aforementioned limitations, significant results were
609
+ manifested in a short time suggesting yoga therapy could
610
+ be a non‑pharmacological alternative for the management
611
+ of COPD. The current state of understanding necessitates
612
+ further assessment to evaluate benefits of yoga for COPD in
613
+ diverse populations, especially associated with depression
614
+ and anxiety followed over longer time periods. Robust
615
+ effectiveness and implementation studies are required
616
+ to determine whether yoga therapy can decrease medical
617
+ utilization. In addition, the findings of this study may
618
+ also provide evidence supporting the incorporation of
619
+ yoga into standardized pulmonary rehabilitation programs
620
+ as a practical adjunct to improve the management of
621
+ psychosocial symptoms associated with COPD.
622
+ CONCLUSION
623
+ In this study, 12 weeks of integrated yoga enhanced health
624
+ status and reduced depression and anxiety in coal miners
625
+ with COPD. Any system that can bring symptomatic relief
626
+ and improve different aspects of QoL of COPD patients
627
+ merits incorporation into standard COPD treatments.
628
+ Further research is warranted to confirm these preliminary
629
+ findings and facilitate implementation in clinical settings.
630
+ Acknowledgment
631
+ The authors would like to express gratitude Mr. Rajeev Lochan
632
+ and Soubhagyalaxmi Mohanty for assisting with manuscript
633
+ preparation. Thanks are due to Mr. Kunja Bihari Badhai,
634
+ senior yoga instructor for his experienced support and
635
+ advice. Also to Mr. Arjun Biswal for coordinating the
636
+ program. Special thanks to Dr. R Nagarathna, who offered
637
+ critical and thoughtful recommendations in the initial
638
+ development of the program and Dr. Balaram Pradhan, Ph.D.
639
+ for statistical analysis.
640
+ Table 3: Change scores within yoga and control, and difference between groups with 95% CI
641
+ Variables
642
+ Yoga (n=36)
643
+ Control (n=36)
644
+ Between group
645
+ Pre$
646
+ Post$
647
+ Pre$
648
+ Post$
649
+ Post
650
+ versus
651
+ post#
652
+ P
653
+ Group ×
654
+ time
655
+ interaction
656
+ P
657
+ Mean±SD
658
+ CI (LB-UB)
659
+ Mean±SD
660
+ CI (LB-UB)
661
+ Mean±SD
662
+ CI (LB-UB)
663
+ Mean±SD
664
+ CI (LB-UB)
665
+ CAT
666
+ 20.69±5.53 18.82-22.56 15.92±6.51*** 13.71-18.12 21.81±5.48 19.95-23.66 22.36±5.65 20.45-24.27 0.001
667
+ <0.001
668
+ BDI II
669
+ 22.25±8.47 19.38-25.12 16.56±7.03*** 14.18-18.93 24.14±9.21 21.02-27.25 23.36±10.49 19.81-26.91 0.002
670
+ <0.001
671
+ STAI (S)
672
+ 39.61±8.73 36.66-42.56 33.28±9.92*** 29.92-36.63 37.92±10.92 34.22-41.61 38.67±10.92 34.97-42.36 0.032
673
+ <0.001
674
+ STAI (T)
675
+ 41.06±7.82 38.41-43.70 35.58±9.14*** 32.49-38.67 39.86±8.88 32.49-38.67 40.44±9.89 37.10-43.79 0.034
676
+ <0.001
677
+ STAI total 80.67±16.06 75.23-86.10 68.86±17.96*** 62.79-74.94 77.78±19.27 71.26-84.30 79.11±19.77 72.42-85.80 0.024
678
+ <0.001
679
+ $Paired t-test; #Independent t-test. BDI = Beck depression inventory, STAI = State-trait anxiety inventory, STAI (S) = State anxiety, STAI (T) = Trait anxiety, SD = Standard
680
+ deviation, CI = Confidence interval, LB = Lower bound, UB = Upper bound, CAT = COPD assessment test, COPD = Chronic obstructive pulmonary disease.
681
+ ***Highly significant
682
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
683
+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
684
+ 143
685
+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
686
+ Financial support and sponsorship
687
+ Nil.
688
+ Conflicts of interest
689
+ There are no conflicts of interest.
690
+ REFERENCES
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+ 32. Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, et al.
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+ Randomized controlled trial of mindfulness meditation for generalized
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+ anxiety disorder: Effects on anxiety and stress reactivity. J Clin Psychiatry
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+ 2013;74:786‑92.
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+ 33. Desveaux L, Lee A, Goldstein R, Brooks D. Yoga in the management
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+ of chronic disease: A systematic review and meta‑analysis. Med Care
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+ 2015;53:653‑61.
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+ 34. Donesky‑Cuenco D, Nguyen HQ, Paul S, Carrieri‑Kohlman V. Yoga therapy
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+ decreases dyspnea‑related distress and improves functional performance in
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+ people with chronic obstructive pulmonary disease: A pilot study. J Altern
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+ Complement Med 2009;15:225‑34.
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+ 35. Fulambarker A, Farooki B, Kheir F, Copur AS, Srinivasan L, Schultz S. Effect
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+ of yoga in chronic obstructive pulmonary disease. Am J Ther 2012;19:96‑100.
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+ 36. Santana MJ, S‑Parrilla J, Mirus J, Loadman M, Lien DC, Feeny D. An
815
+ assessment of the effects of Iyengar yoga practice on the health‑related quality
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+ of life of patients with chronic respiratory diseases: A pilot study. Can Respir
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+ J 2013;20:e17‑23.
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+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
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+ Ranjita, et al.: Effect of yoga on depression, anxiety in COPD
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+ International Journal of Yoga • Vol. 9 • Jul-Dec-2016
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+ 144
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+ 37. Soni R, Munish K, Singh K, Singh S. Study of the effect of yoga training
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+ on diffusion capacity in chronic obstructive pulmonary disease patients: A
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+ controlled trial. Int J Yoga 2012;5:123‑7.
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+ 38. Nagarathna R, Nagendra HR. Yoga for bronchial asthma: A controlled study.
826
+ Br Med J (Clin Res Ed) 1985;291:1077‑9.
827
+ 39. Chandwani KD, Perkins G, Nagendra HR, Raghuram NV, Spelman A,
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+ Nagarathna R, et al. Randomized, controlled trial of yoga in women with
829
+ breast cancer undergoing radiotherapy. J Clin Oncol 2014;32:1058‑65.
830
+ 40. McDermott KA, Rao MR, Nagarathna R, Murphy EJ, Burke A, Nagendra RH,
831
+ et al. A yoga intervention for type 2 diabetes risk reduction: A pilot randomized
832
+ controlled trial. BMC Complement Altern Med 2014;14:212.
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+ 41. Duraiswamy G, Thirthalli J, Nagendra HR, Gangadhar BN. Yoga therapy as
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+ an add‑on treatment in the management of patients with schizophrenia – A
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+ randomized controlled trial. Acta Psychiatr Scand 2007;116:226‑32.
836
+ 42. Tekur P, Chametcha S, Hongasandra RN, Raghuram N. Effect of yoga on
837
+ quality of life of CLBP patients: A randomized control study. Int J Yoga
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+ 2010;3:10‑7.
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+ 43. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N.
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+ Development and first validation of the COPD Assessment Test. Eur Respir
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+ J 2009;34:648‑54.
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+ 44. Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML, et al.
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+ Properties of the COPD assessment test in a cross‑sectional European study.
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+ Eur Respir J 2011;38:29‑35.
845
+ 45. Ringbaek T, Martinez G, Lange P. A comparison of the assessment of quality of
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+ life with CAT, CCQ, and SGRQ in COPD patients participating in pulmonary
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+ rehabilitation. COPD 2012;9:12‑5.
848
+ 46. Mackay AJ, Donaldson GC, Patel AR, Jones PW, Hurst JR, Wedzicha JA.
849
+ Usefulness of the chronic obstructive pulmonary disease assessment test
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+ to evaluate severity of COPD exacerbations. Am J Respir Crit Care Med
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+ 2012;185:1218‑24.
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+ 47. Dodd JW, Hogg L, Nolan J, Jefford H, Grant A, Lord VM, et al. The COPD
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+ assessment test (CAT): Response to pulmonary rehabilitation. A multicentre,
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+ prospective study. Thorax 2011;66:425‑9.
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+ 48. Beck AT, Steer RA, Brown GK. Manual for the beck depression inventory-II.
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+ San Antonio, TX: Psychological Corporation; 1996.
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+ 49. Dozois DJ, Covin R. The Beck Depression Inventory‑II (BDI‑II), Beck
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+ Hopelessness Scale (BHS), and Beck Scale for Suicide Ideation (BSS). In:
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+ Hersen M, Hilsenroth MJ, Segal DL, editors. Comprehensive Handbook of
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+ Psychological Assessment. Personality Assessment and Psychopathology.
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+ New York: John Wiley & Sons Inc.; 2004. p. 50‑69.
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+ 50. Spielberger CD, Gorsuch RL, Lushene RE. The State‑Trait Anxiety Inventory
863
+ (Test Manual). Palo Alto, CA: Consulting Psychologists; 1970.
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+ 51. Vitasari P, Wahab MN, Herawan T, Othman A, Sinnadurai SK. Re‑test of State
865
+ Trait Anxiety Inventory (STAI) among engineering students in Malaysia:
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+ Reliability and validity tests. Procedia Soc Behav Sci 2011;15:3843‑8.
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+ 52. Rao RM, Raghuram N, Nagendra HR, Usharani MR, Gopinath KS, Diwakar
868
+ RB, et al. Effects of an integrated yoga program on self‑reported depression
869
+ scores in breast cancer patients undergoing conventional treatment: A
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+ randomized controlled trial. Indian J Palliat Care 2015;21:174‑81.
871
+ 53. Raghuram N, Parachuri VR, Swarnagowri MV, Babu S, Chaku R, Kulkarni R,
872
+ et al. Yoga based cardiac rehabilitation after coronary artery bypass surgery:
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+ One-year results on LVEF, lipid profile and psychological states – A
874
+ randomized controlled study. Indian Heart J 2014;66:490-502.
875
+ 54. Tekur P, Nagarathna R, Chametcha S, Hankey A, Nagendra HR. A
876
+ comprehensive yoga programs improves pain, anxiety and depression in
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+ chronic low back pain patients more than exercise: An RCT. Complement
878
+ Ther Med 2012;20:107‑18.
879
+ 55. Ebnezar J, Nagarathna R, Yogitha B, Nagendra HR. Effect of integrated yoga
880
+ therapy on pain, morning stiffness and anxiety in osteoarthritis of the knee
881
+ joint: A randomized control study. Int J Yoga 2012;5:28‑36.
882
+ 56. Satyapriya M, Nagarathna R, Padmalatha V, Nagendra HR. Effect of integrated
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+ yoga on anxiety, depression & well being in normal pregnancy. Complement
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+ Ther Clin Pract 2013;19:230‑6.
885
+ 57. Newham JJ, Wittkowski A, Hurley J, Aplin JD, Westwood M. Effects of
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+ antenatal yoga on maternal anxiety and depression: A randomized controlled
887
+ trial. Depress Anxiety 2014;31:631‑40.
888
+ 58. Descilo T, Vedamurtachar A, Gerbarg PL, Nagaraja D, Gangadhar BN,
889
+ Damodaran B, et al. Effects of a yoga breath intervention alone and in
890
+ combination with an exposure therapy for post‑traumatic stress disorder and
891
+ depression in survivors of the 2004 South‑East Asia tsunami. Acta Psychiatr
892
+ Scand 2010;121:289‑300.
893
+ 59. de Godoy DV, de Godoy RF. A randomized controlled trial of the effect of
894
+ psychotherapy on anxiety and depression in chronic obstructive pulmonary
895
+ disease. Arch Phys Med Rehabil 2003;84:1154‑7.
896
+ 60. Chan W, Immink MA, Hillier S. Yoga and exercise for symptoms of depression
897
+ and anxiety in people with poststroke disability: A randomized, controlled
898
+ pilot trial. Altern Ther Health Med 2012;18:34‑43.
899
+ 61. Kirkwood G, Rampes H, Tuffrey V, Richardson J, Pilkington K. Yoga for
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+ anxiety: A systematic review of the research evidence. Br J Sports Med
901
+ 2005;39:884‑91.
902
+ 62. van Eck M, Berkhof H, Nicolson N, Sulon J. The effects of perceived stress,
903
+ traits, mood states, and stressful daily events on salivary cortisol. Psychosom
904
+ Med 1996;58:447‑58.
905
+ 63. Vempati RP, Telles S. Yoga‑based guided relaxation reduces sympathetic
906
+ activity judged from baseline levels. Psychol Rep 2002;90:487‑94.
907
+ 64. Ray US, Mukhopadhyaya S, Purkayastha SS, Asnani V, Tomer OS, Prashad R,
908
+ et al. Effect of yogic exercises on physical and mental health of young
909
+ fellowship course trainees. Indian J Physiol Pharmacol 2001;45:37‑53.
910
+ 65. Telles S, Nagarathna R, Nagendra HR, Desiraju T. Physiological changes
911
+ in sports teachers following 3 months of training in Yoga. Indian J Med Sci
912
+ 1993;47:235‑8.
913
+ 66. Harte JL, Eifert GH, Smith R. The effects of running and meditation on
914
+ beta‑endorphin, corticotropin‑releasing hormone and cortisol in plasma, and
915
+ on mood. Biol Psychol 1995;40:251‑65.
916
+ 67. West J, Otte C, Geher K, Johnson J, Mohr DC. Effects of Hatha yoga and
917
+ African dance on perceived stress, affect, and salivary cortisol. Ann Behav
918
+ Med 2004;28:114‑8.
919
+ 68. Pascoe MC, Bauer IE. A systematic review of randomised control trials on the
920
+ effects of yoga on stress measures and mood. J Psychiatr Res 2015;68:270‑82.
921
+ 69. Manzoni GM, Pagnini F, Castelnuovo G, Molinari E. Relaxation training for
922
+ anxiety: A ten‑years systematic review with meta‑analysis. BMC Psychiatry
923
+ 2008;8:41.
924
+ 70. Deberry S, Davis S, Reinhard KE. A comparison of meditation‑relaxation
925
+ and cognitive/behavioral techniques for reducing anxiety and depression in
926
+ a geriatric population. J Geriatr Psychiatry 1989;22:231‑47.
927
+ 71. Telles S, Nagarathna R, Nagendra HR. Autonomic changes while mentally
928
+ repeating two syllables – One meaningful and the other neutral. Indian J
929
+ Physiol Pharmacol 1998;42:57‑63.
930
+ 72. Streeter CC, Gerbarg PL, Saper RB, Ciraulo DA, Brown RP. Effects of yoga
931
+ on the autonomic nervous system, gamma‑aminobutyric‑acid, and allostasis
932
+ in epilepsy, depression, and post‑traumatic stress disorder. Med Hypotheses
933
+ 2012;78:571‑9.
934
+ 73. Raghuraj P, Ramakrishnan AG, Nagendra HR, Telles S Effect of two selected
935
+ yogic breathing techniques of heart rate variability. Indian J Physiol Pharmacol
936
+ 1998;42:467‑72.
937
+ 74. Nagendra HR, Nagarathna R. An integrated approach of yoga therapy
938
+ for bronchial asthma: A 3‑54‑month prospective study. J Asthma
939
+ 1986;23:123‑37.
940
+ [Downloaded from http://www.ijoy.org.in on Wednesday, July 27, 2016, IP: 14.139.155.82]
subfolder_0/A review of the scientific studies on cyclic meditation.txt ADDED
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1
+ IJOY
2
+ Online full text at
3
+ http://www.ijoy.org.in
4
+ Published by Medknow Publications
5
+ International
6
+ Journal of Yoga
7
+ 0973-6131
8
+ Volume 2 | Issue 2 | Jul-Dec 2009
9
+ C o n t e n t s
10
+ }
11
+ The power of Prana
12
+ }
13
+ A review of the scientific studies on cyclic meditation
14
+ }
15
+ Cardiovascular and metabolic effects of intensive Hatha Yoga training in middle-aged and older women from
16
+ northern Mexico
17
+ }
18
+ Effect of yogic education system and modern education system on memory
19
+ }
20
+ Motion analysis of sun salutation using magnetometer and accelerometer
21
+ }
22
+ Normative data for the digit-letter substitution task in school children
23
+ }
24
+ Effects of yoga on symptom management in breast cancer patients: A randomized controlled trial
25
+ International Journal of Yoga
26
+ y
27
+ Vol. 2:
28
+ y
29
+ Jul-Dec-2009
30
+ 46
31
+ A review of the scientifi
32
+ c studies on cyclic meditation
33
+ Pailoor Subramanya, Shirley Telles
34
+ Indian Council of Medical Research, Center for Advanced Research in Yoga and Neurophysiology, SVYASA, Bangalore, India
35
+ Address for correspondence: Dr. Shirley Telles,
36
+ Patanjali Yogpeeth, Maharishi Dayanand Gram, Bahadrabad,
37
+ Haridwar-249 402, Uttarakhand, India.
38
+ E-mail: [email protected]
39
+ DOI: 10.4103/0973-6131.60043
40
+ Review Article
41
+ GENERAL
42
+ Yoga is an ancient science, originating in India, which
43
+ has components of physical activity, instructed relaxation
44
+ and interoception.[1] Yoga includes diverse practices,
45
+ such as physical postures (asanas), regulated breathing
46
+ (pranayama), meditation and lectures on philosophical
47
+ aspects of yoga.[2-3] Meditation is the seventh of eight
48
+ steps prescribed to reach an ultimate stage of spiritual
49
+ emancipation (Patanjali, circa 900 B.C.).[4] While many
50
+ practitioners do learn meditation directly, others find it
51
+ easier to first pass through the other stages - learn yoga
52
+ postures (asanas) and regulated breathing (pranayamas).
53
+ It is postulated that when a novïce attempts to meditate
54
+ directly, there could be two responses based on the quality
55
+ of the mind viz., (i) a rajasic – active (personality) mind
56
+ would be restless all through the session and (ii) a tamasic
57
+ – a mind with inertia could fall asleep. This problem
58
+ of the mind is addressed in the Mandukya Upanishad.
59
+ Based on this a technique of ‘moving meditation’, which
60
+ combines the practice of yoga postures with guided
61
+ meditation was evolved, called cyclic meditation (CM), by
62
+ H.R. Nagendra, Ph.D., which has its’ origin in an ancient
63
+ Indian text, Mandukya Upanishad.[5] It is interesting to
64
+ note that CM does induce a quiet state of mind, which is
65
+ compatible with the description of meditation (dhyana
66
+ or effortless expansion), according to Patanjali. The
67
+ description states: ‘Tatra pratyayaikatanata dhyanam’
68
+ (Patanjali’s Yoga Sutras, Chapter 3: Verse 2). This means
69
+ that the uninterrupted flow of the mind towards the object
70
+ chosen for meditation is dhyana.[4] Indeed, all meditations,
71
+ irrespective of the strategies involved are believed to help
72
+ reach this state. There are several strategies in meditation
73
+ which include breath awareness, awareness of internal
74
+ sensations, directing the attention to a mantra or a koan,
75
+ and keeping the eyes open with the gaze fixed on the object
76
+ of meditation.
77
+ The verse on which CM is based, states: ‘In a state of mental
78
+ inactivity awaken the mind; when agitated, calm it; between
79
+ these two states realize the possible abilities of the mind.
80
+ If the mind has reached states of perfect equilibrium do
81
+ not disturb it again’. The underlying idea is that, for most
82
+ persons, the mental state is routinely somewhere between
83
+ the extremes of being ‘inactive’ or of being ‘agitated’ and
84
+ hence to reach a balanced/relaxed state the most suitable
85
+ technique would be one which combines ‘awakening’ and
86
+ ‘calming’ practices.
87
+ In CM, the period of practicing yoga postures constitutes
88
+ the ‘awakening’ practices, while periods of supine rest
89
+ comprise ‘calming practices’. An essential part of the
90
+ practice of CM is being aware of sensations arising in
91
+ the body.[6] This supports the idea that a combination
92
+ of stimulating and calming techniques practiced with
93
+ a background of relaxation and awareness (during CM)
94
+ may reduce psycho physiological arousal more than
95
+ resting in a supine posture for the same duration. The
96
+ practice of CM, includes yoga postures (asanas) which
97
+ involve muscle stretching and this has diverse benefits.
98
+ The effects, benefits and possible mechanisms underlying
99
+ CM are given below.
100
+ SCIENTIFIC STUDIES ON CM
101
+ The studies described below were all carried out at the
102
+ Swami Vivekananda Yoga Research Foundation, Bangalore,
103
+ India, where the technique was devised.
104
+ Studies on autonomic and respiratory variables
105
+ In a previous study, heart rate variability (HRV) was
106
+ studied in 42 male volunteers in CM and supine rest
107
+ (SR) sessions. The high frequency (HF) power of the
108
+ HRV increased during both CM and SR practice, which
109
+ is considered to suggest increased vagal tone.[7] However,
110
+ there was a marginally greater increase during CM (4.4
111
+ %) compared to during SR (1.0 %). In the same study the
112
+ low frequency (LF) power which is believed to correlate
113
+ with sympathetic activity was significantly less during
114
+ both CM (1.8 % decrease) and SR (0.3 % decrease). The
115
+ study showed parasympathetic dominance. The exact
116
+ mechanism underlying the effect of CM on the autonomic
117
+ nervous system is difficult to determine. The effect may be
118
+ 47
119
+ International Journal of Yoga
120
+ y
121
+ Vol. 2:
122
+ y
123
+ Jul-Dec-2009
124
+ brought about by reduced cortical activity, which in turn
125
+ may modify the activity at the level of the hypothalamus.
126
+ An earlier study on 35 male volunteers (between 20-
127
+ 46 yrs of age) showed a significant decrease in oxygen
128
+ consumption and increase in breath volume were
129
+ recorded after guided relaxation practiced for 10 minutes
130
+ compared to the equal duration of supine rest. During
131
+ guided relaxation the power of the LF component of the
132
+ heart-rate variability spectrum reduced, whereas the
133
+ power of the HF component increased, suggesting reduced
134
+ sympathetic activity.[8] However, another study on 40 male
135
+ volunteers (16 to 46 yrs) showed that Isometric relaxation
136
+ technique practiced for a minute showed a reduction in
137
+ the physiological signs of anxiety and stress.[9]
138
+ More recently, a study on 30 male volunteers (20 to 33 years)
139
+ showed a decrease in heart rate (HR), low frequency power
140
+ (LF power), LF/HF ratio, and an increase in the number of
141
+ pairs of Normal to Normal RR intervals differing by more
142
+ than 50 ms divided by total number of all NN intervals
143
+ (pNN50) following the practice of cyclic meditation (CM)
144
+ suggestive of a shift towards sympatho-vagal balance in
145
+ favor of parasympathetic dominance during sleep.[10]
146
+ Studies on applications in reducing occupational stress
147
+ levels
148
+ In a subsequent study correlating CM and heart
149
+ rate variability, a two-day CM program decreased
150
+ occupational stress levels and baseline autonomic
151
+ arousal in 26 asymptomatic, male, middle managers,[11]
152
+ suggesting significant reduction in sympathetic activity.
153
+ The mechanisms underlying the decrease in occupational
154
+ stress levels may be related to decreased autonomic arousal
155
+ (sympathetic activation) as well as psychological factors,
156
+ though this remains a speculation.
157
+ Studies on metabolism and oxygen consumed
158
+ An earlier study on oxygen consumption showed that a
159
+ period of CM significantly reduced oxygen consumption
160
+ to a greater degree (32.1%) than a comparable period of
161
+ supine rest.[12] A recent study also showed that after the
162
+ practice of CM oxygen consumption decreased (19.3 %)
163
+ compared to following SR (4.8 %). Also, the change in
164
+ oxygen consumption suggested that after the practices (but
165
+ not during) there was a period of physiological relaxation
166
+ which was more after CM compared to SR.[13]
167
+ The energy expenditure (EE), respiratory exchange ratio
168
+ (RER) and heart rate (HR) of 50 male volunteers were
169
+ assessed before, during, and after the sessions of CM and
170
+ sessions of supine rest. CM reduced the energy expenditure
171
+ more than supine rest alone.[14] The studies cited above
172
+ were conducted using the self-as-control design. Reduction
173
+ in oxygen consumption due to CM practice could be related
174
+ to decreased oxygen consumption of the brain and the
175
+ skeletal muscles (which are probably more relaxed with
176
+ the practice of CM).
177
+ Studies on attention and electrophysiology
178
+ Earlier studies showed that despite the changes suggestive
179
+ of parasympathetic dominance following CM, there was a
180
+ decrease in the P300 peak latency and an increase in the
181
+ P300 peak amplitude when the P300 was obtained using
182
+ an auditory oddball paradigm.[15] The P300 component of
183
+ event-related brain potentials (ERPs) is generated when
184
+ persons attend to and discriminate stimuli which differ
185
+ in a single aspect. More recently, middle latency auditory
186
+ evoked potentials (0-100ms range) were examined in 47
187
+ male volunteers before and after the practice of CM which
188
+ has resulted in prolonged latencies of evoked potentials
189
+ generated within the cerebral cortex, supporting the idea
190
+ of cortical inhibition after CM.[16] The studies cited above
191
+ were conducted using the self-as-control design. The
192
+ mechanism by which CM may improve attention while
193
+ reducing sympathetic tone may be related to increased
194
+ proprioceptive input (during the practice of asanas) to the
195
+ Reticular Activating System (RAS), which in turn keeps
196
+ cortical areas receptive and active.[17] This is difficult to
197
+ understand as generally increased alertness and vigilance
198
+ is associated with an increase in sympathetic tone.
199
+ Studies on performance in cancellation task
200
+ In a previous study, the effect of CM practice on
201
+ performance in a letter cancellation task, was assessed
202
+ in 69 male volunteers (whose ages ranged from 18 to
203
+ 48 years).[18] There was improved performance in the
204
+ task which required selective attention, concentration,
205
+ visual scanning abilities, and a repetitive motor response
206
+ following CM. The results were interpreted to suggest
207
+ that the improved performance after CM suggests that the
208
+ practice not only globally enhances performance but also
209
+ selectively reduces the probability of being distracted.
210
+ Again, it is difficult to understand how CM practice,
211
+ associated with reduced sympathetic activity, increases the
212
+ performance in an attention task. As described above this
213
+ may be via increased proprioceptive input to the reticular
214
+ activating system.
215
+ Study on memory and anxiety
216
+ In a recent study 57 male volunteers (group average age
217
+ ± S.D., 26.6 ± 4.5 years) the immediate effect of CM
218
+ and SR were studied on memory and state anxiety. A
219
+ cyclical combination of yoga postures and supine rest
220
+ in CM improved memory scores immediately after the
221
+ practice and decreased state anxiety more than rest in a
222
+ classical yoga relaxation posture (shavasana).[19] Like the
223
+ Scientifi
224
+ c studies on CM
225
+ International Journal of Yoga
226
+ y
227
+ Vol. 2:
228
+ y
229
+ Jul-Dec-2009
230
+ 48
231
+ P300 event-related potential and the letter cancellation
232
+ task, performance in the memory task requires increased
233
+ alertness. The mechanism (as described above) remains
234
+ speculative.
235
+ Study on polysomnography
236
+ In a recent study, whole night polysomnography measures
237
+ and the self-rating of sleep were assessed on the night
238
+ following a day in which 30 male volunteers practiced
239
+ CM twice (approximately 22:30 minutes each time). This
240
+ was compared to another night when they had two, equal
241
+ duration sessions of supine rest (SR) on the preceding day.
242
+ The percentage of slow wave sleep (SWS) was significantly
243
+ more in the night following CM practice than the night
244
+ following SR; percentage of rapid eye movement (REM)
245
+ sleep and the number of awakenings per hour were less.
246
+ The practice of CM during day time has been shown
247
+ to increase the percentage of slow wave sleep in the
248
+ subsequent night.[20] CM has a number of components
249
+ which may facilitate sleep such as increased physical
250
+ activity, muscle stretching, interoception, and guided
251
+ relaxation.
252
+ CONCLUSION
253
+ The practice of CM in general appears to bring about a
254
+ state of low physiological activation, as described above,
255
+ with reduced oxygen consumption and a shift in the
256
+ sympathovagal balance towards vagal dominance. A period
257
+ of CM practice significantly reduces oxygen consumption
258
+ and energy expenditure to a greater degree (32.1%) than
259
+ a comparable period of supine rest. The CM program has
260
+ also been shown to decrease occupational stress levels and
261
+ baseline autonomic arousal. There is also an improved
262
+ performance in a letter cancellation task which requires
263
+ selective attention, concentration, visual scanning abilities,
264
+ and a repetitive motor response following CM. Moreover, a
265
+ study of the P300 following CM suggested that participants
266
+ showed a better ability to discriminate auditory stimuli
267
+ of different pitches in a P300 auditory oddball task. The
268
+ prolonged latencies of evoked potentials, generated within
269
+ the cerebral cortex after the practice of CM, supported the
270
+ idea of cortical inhibition after CM. The practice of CM
271
+ during day time has been shown to increase the percentage
272
+ of slow wave sleep in the subsequent night. This
273
+ suggests that CM practice (i) reduces autonomic arousal,
274
+ (ii) improves attention, and (iii) improves quality of sleep.
275
+ ACKNOWLEDGMENT
276
+ The authors gratefully acknowledge H.R. Nagendra, Ph.D. who
277
+ derived the cyclic meditation technique from ancient yoga texts.
278
+ REFERENCES
279
+ 1.
280
+ Vivekananda Kendra. Yoga the science of holistic living. Chennai:
281
+ Vivekananda Kendra Prakashan Trust; 2005.
282
+ 2.
283
+ Nagendra HR. Yoga its’ basis and applications. Bangalore: Swami
284
+ Vivekananda Yoga Prakashana; 2004.
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+ 3.
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+ Saraswati Niranjanananda Swami. Prana, Pranayama, Pranavidya. Munger,
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+ Bihar: Yoga publication trust, Bihar School of yoga; 1994.
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+ Taimini IK. The science of yoga. Madras, India: The Theosophical Publishing
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+ House; 1986.
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+ 5.
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+ Chinmayanada Swami. Mandukya Upanishad. Bombay, India: Sachin
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+ Publishers; 1984.
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+ 6.
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+ Nagendra HR, Nagarathna R. New perspectives in stress management.
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+ Bangalore, India: Swami Vivekananda Yoga Prakashana; 1997.
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+ 7.
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+ Sarang P, Telles S. Effects of two yoga based relaxation techniques on heart
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+ rate variability. Int J Stress Manag 2006;13:460-75.
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+ 8.
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+ Vempati RP, Telles S. Yoga based guided relaxation reduces sympathetic
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+ activity in subjects based on baseline levels. Psychol Rep 2002;90:487-94.
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+ 9.
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+ Vempati RP, Telles S. Yoga based relaxation versus supine rest: A study of
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+ oxygen consumption, breath rate and volume and autonomic measures. J
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+ Indian Psychol 1999;17:46-52.
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+ 10. Patra S, Telles S. Heart rate variability during sleep following the practice
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+ of cyclic meditation and supine rest. Appl Psychophysiol Biofeedback 2009;
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+ 11.
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+ Vempati RP, Telles S. Baseline occupational stress levels and physiological
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+ responses to a two day stress management program. J Indian Psychol
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+ 2000;18:33-7.
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+ 12. Telles S, Reddy SK, Nagendra HR. Oxygen consumption and respiration
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+ following two yoga relaxation techniques. Appl Psychophysiol Biofeedback
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+ 2000;25:221-7.
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+ 13. Sarang PS, Telles S. Oxygen consumption and respiration during and
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+ after two yoga relaxation techniques. Appl Psychophysiol Biofeedback
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+ 2006;31:143-53.
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+ 14. Sarang, SP, Telles S. Cyclic meditation: A moving meditation-reduces energy
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+ expenditure more than supine rest. J Indian Psychol 2006;24:17-25.
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+ 15. Sarang SP, Telles S. Changes in P300 following two yoga-based relaxation
323
+ techniques. Int J Neurosci 2006;116:1419-30.
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+ 16. Subramanya P, Telles S. Changes in midlatency auditory evoked potentials
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+ following two yoga-based relaxation techniques. Clin EEG Neurosci
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+ 2009;40:190-5.
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+ 17. Kandel ER, Schwartz JH, Jessell TM. Principles of neural science. 4th ed.
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+ New York, USA: McGraw- Hill; 2000.
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+ 18. Sarang SP, Telles S. Immediate effect of two yoga based relaxation
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+ techniques on performance in a letter-cancellation task. Percept Mot Skills
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+ 2007;105:379-85.
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+ 19. Subramanya P, Telles S. Effect of two yoga-based relaxation techniques on
333
+ memory scores and state anxiety. Biopsychosoc Med 2009;3:8.
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+ 20. Patra S, Telles S. Positive impact of cyclic meditation on sleep. Med Sci
335
+ Monit 2009;15:CR375-81.
336
+ Subramanya and Telles
subfolder_0/A self-rating scale to measure tridos.as in_unlocked.txt ADDED
@@ -0,0 +1,1111 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Original Article
2
+
3
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
4
+ 85
5
+ A self-rating scale to measure tridos
6
+ .as in
7
+ children
8
+ S.P. Suchitra, H.R. Nagendra1
9
+ Life Sciences, 1Vice Chancellor, Swami Vivekananda Yoga Anusandhana Samsthana, Yoga University, Bangalore
10
+ INTRODUCTION
11
+ A
12
+ yurveda, the ancient life science is an aspect of Vedic lore
13
+ is broadly based on the principles of tridoṣas‑ vāta, pitta
14
+ and kapha. Tridoṣas are fundamental principles which maintain
15
+ bodily function (just as the sun, moon and air maintain the
16
+ universe, somatic functions are maintained by the dos
17
+ .as).[1‑9]
18
+ Western psychologists propose type and trait theories
19
+ for personality. Father of modern medicine, Hippocrates
20
+ ABSTRACT
21
+ Background: Self  –  rating inventories to assess the
22
+ Prakr
23
+ .ti (constitution) and personality have been developed
24
+ and validated for adults. To analyze the effect of personality
25
+ development programs on Prakr
26
+ .ti of the children, standardized
27
+ scale is not available. Hence, present study was carried out to
28
+ develop and standardize Caraka Child Personality inventory (CCPI).
29
+ Materials and Methods: The 77‑ item CCPI scale was developed
30
+ on the basis of translation of Sanskrit verses describing va
31
+ -taja (a),
32
+ pittaja (b) and kaphaja prakr
33
+ .ti (c) characteristics described in
34
+ Ayurveda texts and by taking the opinions of 5 Ayurveda experts
35
+ and psychologists. The scale was administered on children of the
36
+ age group 8-12 years in New Generation National public school,
37
+ Bangalore.
38
+ Results: This inventory was named CCPI and showed excellent
39
+ internal consistency. The Cronbach’s alpha for A, B and C scales
40
+ were 0.54, 0.64 and 0.64 respectively. The Split ‑ Half reliability
41
+ scores for A, B and C subscales were 0.64. 0.60 and 0.66
42
+ respectively. Factor validity coefficient Scores on each item was
43
+ above 0.4. Scores on va
44
+ -taja, pittaja and kaphaja scales were
45
+ inversely correlated. Test-retest reliability scores for A,B and C
46
+ scales were 0.87,0.88 and 0.89 respectively. The result of CCPI was
47
+ compared with a parent rating scale Ayurveda Child Personality
48
+ Inventory (ACPI). Subscales of CCPI correlated significantly
49
+ highly (above 0.80) with subscales of ACPI which was done for
50
+ the purpose of cross‑validation with respect to ACPI.
51
+ Conclusions: The prakr
52
+ .ti of the children can be measured
53
+ consistently by this scale. Correlations with ACPI pointed toward
54
+ concurrent validity.
55
+ KEY WORDS: Tridosha, prakriti, va
56
+ -ta, pitta, kapha, Ayurveda
57
+ classifies individuals as choleric, melancholic, sanguine, and
58
+ phlegmatic based on the predominance of bodily humors.
59
+ This comes close to Ayurveda’s description of personalities
60
+ except for the description of vāta in the latter. Sheldon’s
61
+ Somato‑type classification ectomorphic, endomorphic,
62
+ mesomorphic types of personalities have been correlated
63
+ with Ayurveda prakṛti.[12] Other psychologists do not
64
+ consider wide‑ranging aspects of the personality.[10]
65
+ Ayurveda classics[1‑9] propose a comprehensive analysis of
66
+ personality, encompassing physical‑physiological aspects
67
+ like color of the eyeball, texture of hair, appetite, sleep,
68
+ behavior, attitudes and interests, memory, intelligence,
69
+ mental stamina of an individual to come to a conclusion
70
+ about the tridoṣa state of the individual. The biological
71
+ qualities of tridoṣas also influence mental and behavioral
72
+ qualities. The texts suggest seven types of personality (vāta,
73
+ pitta, kapha, vāta–pitta, vāta–kapha, pitta–kapha, sama)
74
+ determined by predominance of a single, a pair, or all of
75
+ the doṣas.
76
+ Ayurveda considers the balanced state (sama) of Tridoṣa
77
+ as health. Person with predominance of single and
78
+ double doṣas will certainly be vulnerable to diseases, as
79
+ vitiation of tridoṣas is the cause for the manifestation of
80
+ disease.[3] Accordingly, Ayurveda recommends specific
81
+ diet and daily regimen for different types of personalities
82
+ to maintain health.Studies have discussed the importance
83
+ of Ayurveda[11], tridoṣas.[12] A Statistical model of doṣa prakṛti
84
+ based on analysis of a questionnaire has been developed.[13]
85
+ An analysis of the tridoṣa physiology, linking it to processes
86
+ of cellular physiology has been carried out. These studies
87
+ postulate the correspondence of functions of Vāta with
88
+ input/output  (homeostasis); Functions of Pitta with
89
+ Access this article online
90
+ Quick Response Code:
91
+ Website:
92
+ www.ancientscienceoflife.org
93
+ DOI:
94
+ 10.4103/0257-7941.139042
95
+ [Downloaded free from http://www.ancientscienceoflife.org on Wednesday, July 27, 2016, IP: 14.139.155.82]
96
+ 86
97
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
98
+ Suchitra and Nagendra: Self rating scale to asses prakr
99
+ .ti
100
+ turnover (negative entropy production); and functions of
101
+ kapha with storage of the cellular functions.[14‑16] Similarly, a
102
+ genetic basis of tridoṣa constitution has been postulated.[17‑20]
103
+ A study comparing the Ayurveda personality concepts and
104
+ western psychology concepts is available.[21‑22] Ayurveda
105
+ tridoṣa theory and four elements of Buddhist medicine,
106
+ Chinese humorolgy has been compared.[23,24] Importance
107
+ of prakṛti in ageing has been discussed.[25] Effect of
108
+ isotonic exercise on different types of prakṛti has been
109
+ observed.[26] A difference in metabolism of different prakṛti
110
+ has been explained.[27] Left and right hemisphere chemical,
111
+ dominance has been observed with predominance of
112
+ doṣas.[28] Another study postulated  ADP‑induced maximal
113
+ platelet aggregation was highest among the vāta‑pitta
114
+ prakṛti individuals.[29] Relationship between vāta prakṛti
115
+ and Parkinson’s disease has been studied.[30] A scale to
116
+ measure tridoṣas in psychotic patients has been developed.[31]
117
+ Ayurveda Child Personality Inventory (ACPI), a parent
118
+ rating scale to measure tridoṣas in children has been
119
+ standardized.[32] Chinese humorology and cosmology have
120
+ been compared showing that as humors control all the
121
+ activities of the body similarly in other form they control the
122
+ universe. [33] Scale to measure tridoṣas in psychotic patients
123
+ has been developed and standardized.[34] Ayurveda guṇa
124
+ inventory has been developed and standardized.[35]
125
+ The scale has been developed based on Sanskrit verses
126
+ quoted in nine texts and content validitation of 10
127
+ Ayurveda experts and three psychologists had three
128
+ subscales ‑ vāta (number of items in scale‑46), pitta (number
129
+ of items in scale‑44), kapha (number of items in scale‑47). It
130
+ was associated with good Cronbach’s alpha (above 0.5) and
131
+ the Split‑Half scores for all subscales (above 0.6 except pitta
132
+ scale which was 0.39). Factor validity coefficient Scores on
133
+ each items was above 0.5.
134
+ However, a simple self ‑ rating scale to assess the personality
135
+ of children, (as parents are often not available during
136
+ personality development camps etc) according to Āyurvedic
137
+ comprehensive concepts is not available.
138
+ Aims of the present study were
139
+ (i)
140
+ 
141
+ To develop a self‑rating scale Caraka child personality
142
+ inventory (CCPI)
143
+ (ii) 
144
+ To measure tridoṣas in children and to compare with
145
+ criterion ACPI, parent rating scale to establish of
146
+ validity of the scale.
147
+ MATERIALS AND METHODS
148
+ Ethical clearance was approved by research board of
149
+ SVYASA  (Yoga University). The CCPI was developed
150
+ based on 522 characteristics from nine authoritative ancient
151
+ Ayurveda texts in Sanskrit describing characteristics typical
152
+ of vātaja, pittaja and kaphaja prakṛti. Item reduction was
153
+ carried out by deleting the repeated items, ambiguous
154
+ items, and by selecting those items specifically suitable for
155
+ children [Table 1].
156
+ 155 items were shortlisted out of 522 in the texts and,
157
+ translation in English, were presented to ten Ayurveda
158
+ experts. They were asked to judge the correctness of each
159
+ statement and to check (1) whether any of the item was
160
+ repeated or if any item should be added? (2) Whether the
161
+ features of vātaja, pittaja and kaphaja prakṛti selected for the
162
+ scale are correct and (3) if the items constructed represented
163
+ acceptable translation of the Sanskrit in the original texts.
164
+ 147 items were retained. Out of which, some of items were
165
+ changed and refined [Table 2].[36]
166
+ Based on the final list of statements from the Sanskrit texts,
167
+ 77 questions of CCPI were framed by the researcher. The
168
+ scale was again presented to five Ayurveda experts and
169
+ one psychologist, who reviewed the format of this scale
170
+ and recommended a two point scoring (zero and one),
171
+ this was adopted in the final CCPI. Suggestions about the
172
+ Table 1: Texts and number of items
173
+ Text
174
+ Vāta prakr
175
+ . ti
176
+ Pitta prakr
177
+ . ti
178
+ Kapha prakr
179
+ . ti
180
+ a
181
+ b
182
+ c d a
183
+ b
184
+ c d a
185
+ b
186
+ c d
187
+ Caraka Sam
188
+ . hitā
189
+ 28 1 (27) 1 2 21
190
+ 0
191
+ 2 5 21 0 (21) 6 1
192
+ Suśruta sam
193
+ . hitā
194
+ 25 13 (12) 2 0 21 8 (14) 3 0 28 7 (21) 3 1
195
+ As
196
+ .t
197
+ .ān
198
+ . ga samgraha
199
+ 25 16 (9) 3 0 26 19 (7) 0 0 40 19 (21) 3 0
200
+ As
201
+ .t
202
+ .ān
203
+ . ga hṛdaya
204
+ 24 20 (4) 2 1 31 26 (5) 1 1 43 38 (5) 4 0
205
+ Bhela Sam
206
+ . hitā
207
+ 16 11 (5) 3 0 18 10 (8) 1 0 24 14 (0) 8 0
208
+ Bhāvaprakāśa
209
+ 8
210
+ 7 (1)
211
+ 0 0 8
212
+ 8 (0) 0 0 6
213
+ 6 (0)
214
+ 0 0
215
+ Harita Sam
216
+ . hitā
217
+ 16
218
+ 7 (9)
219
+ 2 0 16 9 (7) 0 0 16
220
+ 9 (7)
221
+ 4 0
222
+ Śārangadhara Sam
223
+ . hitā
224
+ 6
225
+ 6 (0)
226
+ 0 0 5
227
+ 5 (0) 0 0 5
228
+ 4 (1)
229
+ 1 0
230
+ Kāśyapa Sam
231
+ . hitā
232
+ 28 28 (0) 0 0 21 21 (0) 0 0 21 21 (0) 0 0
233
+ Number of initial items (Sanskrit) collected from Nine Ayurveda texts with number
234
+ of repeated, ambiguous items and items not concerned with children. a: Initial
235
+ number of items, b: Repeated (retained) number if items, c: Ambiguous items,
236
+ d: Items not concerned with children
237
+ Table 2: Content validity by experts
238
+ Experts
239
+ Comment
240
+ 1 (RH)
241
+ Agreed all questions except 3,4,5 questions
242
+ 2 (AH)
243
+ Agreed all questions
244
+ 3 (SUG)
245
+ Agreed all questions 4,5 questions
246
+ 4 (RA)
247
+ Agreed for all items except 10,11 questions
248
+ 5 (SHK)
249
+ Agreed for all items except 11,12 questions
250
+ 6 (AAJ)
251
+ Suggested changes in the format of questions
252
+ RH: Raju H, AH: Ahalya, SUG: Suguna, RA: Ramesh A, SHK: Shekahr K, AAJ:
253
+ Arati Jaggannath
254
+ [Downloaded free from http://www.ancientscienceoflife.org on Wednesday, July 27, 2016, IP: 14.139.155.82]
255
+
256
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
257
+ 87
258
+ Suchitra and Nagendra: Self rating scale to asses prakr
259
+ .ti
260
+ phrasing of questions were incorporated. All questions
261
+ which were agreed upon by three to four Ayurveda experts
262
+ and psychologist, were retained.
263
+ The final CCPI had 77 items ‑ 26 items for vātaja prakṛti
264
+ (A‑scale) 24 items for pittaja prakṛti (B‑scale) and 27 items
265
+ for kaphaja prakṛti (C‑scale) subscales. The questionnaire was
266
+ to be answered by the children (Appendix 2).
267
+ Data collection and analysis
268
+ Item difficulty level was analyzed by administering the
269
+ scale on 30 children on the age group 8‑12 years. Informed
270
+ consent of the children and parents was taken in prescribed
271
+ format (See Appendix‑3). For testing the internal consistency
272
+ and validity, the scale was administered on children who
273
+ were the students of New generation National Public school
274
+ in Bangalore, of both sexes between the age of 8 to 12 years
275
+ [Table 3].
276
+ The final 77 item CCPI was administered on 200 children.
277
+ Ayurveda child personality inventory (ACPI), a parent
278
+ rating scale was administered on 30 parents of the children.
279
+ Comparison was done for the purpose of cross‑validation.
280
+ To assess Test‑retest reliability, CCPI was administered on
281
+ 30 children, after an interval of 15 days.
282
+ The Statistical Package for Social Sciences (SPSS‑16.0) was
283
+ used for data analysis. The data was analyzed for reliability.
284
+ The split‑half and Cronbach’s alpha tests were applied for
285
+ internal consistency analysis. Pearson’s correlation analysis
286
+ was done to check the degree of association between
287
+ vāta, pitta and kapha scores and Test and Retest reliability.
288
+ Principal component analysis (factor analysis) was done to
289
+ check the validity.
290
+ RESULTS
291
+ Content validity
292
+ Amongst six experts, who served as judges all 77 questions
293
+ were agreed upon by four to five experts.[38]
294
+ Item difficulty level
295
+ This is defined as the presence of a said symptom expressed
296
+ as the percentage of children who score positive to that
297
+ item.[20‑22] The results obtained from the administration of
298
+ ACPI on parents of 60 children showed 136 items that had
299
+ a coefficient less than 0.9 (answered yes by the most) and
300
+ more than 0.3 (answered yes by the least number of subjects)
301
+ were retained.
302
+ Internal consistency
303
+ An analysis of the data collected from 200 children showed
304
+ the Cronbach’s alpha for V, P and K scales were 0.54, 0.64
305
+ and 0.64 respectively. The Split‑Half reliability for V, P and K
306
+ scale were 0.64, 0.60 and 0.66 respectively. This shows that
307
+ the three scales have acceptable internal consistency.[37,39]
308
+ Test‑Retest reliability
309
+ Scores on 30 Children revealed V, P and K scales have good
310
+ correlation, 0.87,0.88 and 0.89 respectively before and after
311
+ 15 days of assessment.
312
+ Correlations
313
+ The subscales (Vāta, Pitta, Kapha) correlated significantly
314
+ (negatively) with each other [Table 4].
315
+ Factor analysis
316
+ Factor analytic co‑efficient obtained for each items in
317
+ the V‑scale, P‑scale, and K‑scale for total score was
318
+ more than 0.3. [Table 3].
319
+ Correlation with ACPI –parent rating scale
320
+ V, P, K subscales correlated significantly positively with V,
321
+ P, K scales of parent rating scale [Table 5].
322
+ Table 3: Demographic data
323
+ Sample
324
+ Boys
325
+ Girls
326
+ Total
327
+ Gender (boys)
328
+ 104
329
+ 96
330
+ 200
331
+ Age range
332
+ 8‑12 years
333
+ 8‑12 years
334
+ 8‑12 years
335
+ Mean±SD
336
+ 10.13±1.23
337
+ 10.0±1.18
338
+ 10.27±1.28
339
+ Mean and standard deviation of demographics. Out of 200, children 104 were
340
+ boys, 96 were girls, aged around 8‑12 years. Mean age being 10.27. Studying in
341
+ 3rd standard to 7th standard, mean education being 4.65. SD: Standard deviation
342
+ Table 4: Correlation among subscales
343
+ Scales
344
+ Correlation
345
+ Significance
346
+ Vāta vs Pitta
347
+ −0.31**
348
+ P<0.01
349
+ Vāta vs Kapha
350
+ −0.49**
351
+ P<0.01
352
+ Pitta vs Kapha
353
+ −0.66**
354
+ P<0.01
355
+ (**) r‑Pearson correlation values and significance of correlation between subscales
356
+ which is at 99% confidence level. Pitta highly negatively correlating with Kapha,
357
+ Vāta having less correlation with Pitta
358
+ Table 5: Correlation with ACPI
359
+ Vp vs Vc
360
+ r=0.89**
361
+ Pp vs Pc
362
+ r=0.85**
363
+ Kp vs Kc
364
+ r=0.90**
365
+ Pearson correlation (r) of each subscales of CCPI with subscales of parent rating
366
+ scale ACPI (**P<0.01). Vāta, Pitta, Kapha subscales of CCPI correlated highly
367
+ positively with Vāta, Pitta, Kapha subscales of ACPI (Parent rating scale)
368
+ [Downloaded free from http://www.ancientscienceoflife.org on Wednesday, July 27, 2016, IP: 14.139.155.82]
369
+ 88
370
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
371
+ Suchitra and Nagendra: Self rating scale to asses prakr
372
+ .ti
373
+ DISCUSSION
374
+ The present study has described the development and
375
+ initial standardization of 77 items, self‑ rating, the CCPI
376
+ as an instrument to assess the personality (prakṛti) of the
377
+ children.
378
+ The reliability of subscales was substantiated by Cronbach’s
379
+ Alpha co‑efficient ranged from 0.54 to 0.64 and Split‑half
380
+ analysis ranging from 0.60 to 0.66. This provided the
381
+ evidence of homogeneity of items.[40]
382
+ For the ACPI (a parent rating scale to assess the prakṛti of
383
+ the children of the age group 6‑12 years), Cronach’s alpha
384
+ ranged from 0.55 to 0.84, spilt‑half coefficient ranged from
385
+ 0.39 to 0.84. The construct validity of items of subscales was
386
+ supported by Factor –analysis which was done to check the
387
+ association of the items with subscales. Factor loadings for
388
+ Vāta scale ranged from 0.41‑0.7, for pitta scale 0.47 ‑0.72, for
389
+ kapha scale 0.41‑0.76 Appendix‑1.While of ACPI, 0.55‑0.86,
390
+ 0.55‑0.78, 0.46‑0.77 respectively for vāta, pitta and kapha
391
+ scales. This proved to be a good correlation of items with
392
+ respective subscales.
393
+ Correlation between vātaja, pittaja and kaphaja scale
394
+ scores was negative, suggesting discriminative validity.
395
+ Values ranging from 0.31 to 0.66, significance at 99%
396
+ confidence for all correlations. Although of ACPI was
397
+ 0.16 to 0.82, significance for vāta‑ pitta correlation was at
398
+ 95% confidence.
399
+ Correlation with parent rating scale provided evidence
400
+ of concurrent validity. Classical texts of Ayurveda state
401
+ that when vāta and kapha (cold) increases, pitta decreases.,
402
+ similarly when vāta decreases kapha increases.
403
+ Applying the inventory to children, further helped to
404
+ measure the prakṛti of the children. Among selected
405
+ sample 27% were vāta‑pitta, 27%were pitta‑kapha,
406
+ 33% were vāta‑kapha, 9% were kapha, 2%were sama, 2% were
407
+ pitta [Table 6].
408
+ Changes in scores were observed between boys and
409
+ girls [Table 7]. Most girls scored high in kapha, vāta‑kapha
410
+ and pitta‑kapha prakṛti scales. Similarly Boys scored high in
411
+ pitta, vāta‑pitta prakṛti scales. Boys score was high in Pitta
412
+ indicating high aggressiveness and Girls scores were high
413
+ in Kapha indicating higher patience.
414
+ Subscales of CCPI correlated highly (‘r’above 0.8), positively
415
+ with subscales of ACPI, parent rating scale  [Table  5],
416
+ suggesting criterion related validity.
417
+ The difference in the results of self‑rating and parent‑rating
418
+ scales, may be because of discrepancy in types of prakṛti
419
+ of children, which was different in parent rating scale
420
+ study and self‑rating study, as both inventories were
421
+ administered in different schools, and variance in
422
+
423
+ race was observed [Ayurveda texts claim that prakṛti can be
424
+ influenced by race/ethnicity].[3]
425
+ The Strength of the study is that it is the first attempt to
426
+ develop a consistent, self –rating scale to measure prakṛti of
427
+ the children. Knowing one’s prakṛti is the first step towards
428
+ maintaining one’s health.[1‑9] A  balanced state of three
429
+ doṣas is considered as health.[4] A tool as developed in this
430
+ study will be useful in assessing the clinical significance of
431
+ prakṛti based regimen in prevention of somatic and mental
432
+ illnesses.
433
+ Though published scales are available to assess the
434
+ prakṛti of an individual,[11] they have been designed
435
+ for adultswhereas children require a different mode of
436
+ questioning. Hence, CCPI can be potentially used to
437
+ identify the predominant doṣas in children, and thus will
438
+ help to plan suitable regimens at an early age to maintain
439
+ health of the children.
440
+ A study has revealed significant effect of Yoga on
441
+ tridoṣas.[32] And treatment modalities are different for
442
+ Table 7: Mean differences between Boys and Girls
443
+ Sample
444
+ Vāta
445
+ Pitta
446
+ Kapha
447
+ Boys
448
+ 11.3
449
+ 11.8*
450
+ 11.8
451
+ Girls
452
+ 11.2
453
+ 10.0
454
+ 13.6*
455
+ Mean scores of Boys and Girls in each subscales. Showing high scores on kapha
456
+ in girls (13.6, for boys it is 11.8), high scores on pitta in Boys (11.8, for girls it is
457
+ 10.0). Changes were significant P<0.05 (One sample t‑test). *P<0.001
458
+ Table 6: Mean dos
459
+ .a scores for three different diagnostic groups
460
+ Doṣa→
461
+ Diagnosis↓
462
+ Vātaja
463
+ Pittaja
464
+ kaphaja
465
+ Vāta‑pitta (n=17)
466
+ 14.3
467
+ 13.8
468
+ 7.0
469
+ Pitta‑kapha
470
+ 7.1
471
+ 13.5
472
+ 14.9
473
+ Vāta‑Kapha
474
+ 13.6
475
+ 7.0
476
+ 14.4
477
+ Kapha
478
+ 7.0
479
+ 7.1
480
+ 20.8
481
+ Pitta
482
+ 7.0
483
+ 20.7
484
+ 7.2
485
+ Sama
486
+ 11.4
487
+ 11.5
488
+ 12
489
+ Distribution of different categories of prakṛti children (who particularly scored high
490
+ in one or two subscales) sample scores in each subscales.Children scoring high
491
+ in Vāta‑Pitta scored 14.3 and 13.8 in respective Vāta‑Pitta scales., who scored
492
+ high in Pitta‑Kapha scored 13.5 amd 14.9 in respective scales and who scored
493
+ high in Vāta‑kapha scored 13.6 and 14.4 in respective scales. And who were
494
+ predominant in single dosahs, scored 20.8 (kapha prakṛti) ,20.7 (Pitta prakṛti) in
495
+ respective scales. Who were of sama prakṛti scored 11.4,11.5,12 in vāta, pitta,
496
+ kapha scales respectively
497
+ [Downloaded free from http://www.ancientscienceoflife.org on Wednesday, July 27, 2016, IP: 14.139.155.82]
498
+
499
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
500
+ 89
501
+ Suchitra and Nagendra: Self rating scale to asses prakr
502
+ .ti
503
+ different prakṛti.[1‑9] Thus, the study is a initial step towards
504
+ positive health.
505
+ Limitations of the study: Though CCPI is a consistent,
506
+ valid instrument, it has not addressed the  norms of the
507
+ scale. Further studies are needed to confirm whether the
508
+ items used in the inventory are sensitive enough to assess
509
+ prakr
510
+ .ti with predominance of a particular doṣa. Studies
511
+ should be done on more number of samples and norms
512
+ should be established.
513
+ CONCLUSIONS
514
+ A CCPI is a consistent and valid instrument. Its reliability
515
+ to assess the prakṛti should be further studied. Tridoṣa
516
+ measure may point out to diet and regimen plans
517
+ management to prevent the disease and maintain the
518
+ health of the children.
519
+ ACKNOWLEDGMENT
520
+ We thank, Dr.Kishore, Dr. Aarti Jagannathan, Dr.Uma and
521
+ Āyurveda experts in Hubli, Bengaluru Ayurveda College, for their
522
+ support and participation in the study.
523
+ REFERENCES
524
+ 1.
525
+ Tripati R. Ashtanga sangraha: Hindi commentary. Second edition.
526
+ New Delhi: Choukamba publications; 2001.
527
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528
+ Tripati B. Ashtanga Hradaya: Hindi commentary. Second edition.
529
+ New Delhi: Choukamba publications; 1997.
530
+ 3.
531
+ Panday  GS. Caraka samhita: Hindi commentary. Fifth edition.
532
+ New Delhi: Choukamba publications; 1997.
533
+ 4.
534
+ Shastry KA. Sushruta Samhita: Hindi vyakhya. Fifteenth edition.
535
+ New Delhi: Choukamba publications; 2002.
536
+ 5.
537
+ Brahmashankaramishra. Bhavaprakash: Hindi Vyakhya. Tenth
538
+ edition. Varanasi: Chaukamba smaskrita bhavan; 2002.
539
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540
+ Pandit Parashram shastri. Sharangadhara samhita: Samskrita vyakhya.
541
+ Sixth edition. Varanasi: Chaukamba Orientalia; 2005.
542
+ 7.
543
+ Krishnamurthy KH. Bhavaprakasha: English commentary. First edition.
544
+ Varanasi: Chaukamba Vishwabharati; 2000.
545
+ 8.
546
+ Pandit Hariprasad Tripati. Harita samhita: Hindi vyakhya. First edition.
547
+ Varanasi: Chaukamba Krishnadas Academy; 2005.
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+ 9
549
+ Vidya Lakshmipati Shastri. Yogaratnakara: Hindi commentary. Re print
550
+ edition. Varanasi: Chaukamba Prakashana; 2007.
551
+ 10. Walter Misched. Introduction to Personality. New York: Holt. Rinehart
552
+ and Winston Inc.; 1971
553
+ 11. Concon AA.Tridosha and Three Original Energies; Am J Chin Med
554
+ 1980 Winter;8:391.
555
+ 12. Rizzo‑Sierra CV. Ayurvedic genomics, constitutional psychology, and
556
+ endocrinology: The missing connection. J Altern Complement Med
557
+ 2011 May;17:465‑8. Epub 2011 May 12.
558
+ 13. Joshi RR. A biostatistical approach to Ayurveda: Quantifying the
559
+ tridosa. Journal of Alternative and Complementary Medicine
560
+ 2005;11:221‑225.
561
+ 14. Hankey A. The scientific value of Ayurveda. J Altern Complement Med
562
+ 2005 Apr;11:221‑5.
563
+ 15. Hankey A. A test of the systems analysis underlying the scientific
564
+ theory of Ayurveda Tridosa. Journal of Alternative and Complementary
565
+ Medicine 2005;11:385‑390.
566
+ 16. Hankey  A. Establishing the Scientific Validity of Tridosha
567
+ part  1: Doshas, Subdoshas and Dosha Prakritis. Anc Sci Life.
568
+ 2010 Jan;29:6‑18.
569
+ 17. Patwardhan B., Joshi K., Chopra A. Classification of Human Population
570
+ Based on HLA Gene Polymorphism and the Concept of Prakriti in
571
+ Ayurveda. Journal of Alternative and Complementary Medicine
572
+ 2005;11:349 ‑353.
573
+ 18. Patwardhan B., Bodeker G. Ayurvedic genomics: Establishing a genetic
574
+ basis for mind‑body typologies. J Altern Complement Med 2008 Jun;
575
+ 14:571‑6.
576
+ 19. Prasher B, Negi S, Aggarwal S, Mandal AK, Sethi TP, Deshmukh SR,
577
+ et al. Whole genome expression and biochemical correlates of
578
+ extreme constitutional types defined in Ayurveda. J Transl Med
579
+ 2008 Sep 9;6:48.
580
+ 20. Mishra L, Singh BB, Dagenais S: Healthcare and disease management
581
+ in Ayurveda. Altern Ther Health Med 2001 Mar;7:44‑50.
582
+ 21. Aggarwal  S, Negi  S, Jha  P, Singh  PK, Stobdan  T, Pasha  MA, et
583
+ al. EGLN1 involvement in high‑altitude adaptation revealed
584
+ through genetic analysis of extreme constitution types defined
585
+ in Ayurveda. Proc Natl Acad Sci U S A 2010 Nov 2;107:18961‑6.
586
+ Epub 2010 Oct 18.
587
+ 22. Dube KC, Kumar A, Dube S: Personality types in Ayurveda. Am J Chin
588
+ Med 1983;11:25‑34.
589
+ 23. Dube KC: Nosology and therapy of mental illness in Ayurveda. Comp
590
+ Med East West 1979 Fall; 6:209‑28.
591
+ 24. Scharfetter C: Ayurveda; Schweiz Med Wochenschr. 1976 Apr
592
+ 24;106:565‑72.
593
+ 25. Tripathi  PK, Patwardhan  K, Singh G: The basic cardiovascular
594
+ responses to postural changes, exercise, and cold pressor test: Do they
595
+ vary in accordance with the dual constitutional types of ayurveda?
596
+ Evid Based Complement Alternat Med 2011;2011:251850. Epub
597
+ 2010 Aug 30.
598
+ 26. Ghodke Y, Joshi K, Patwardhan B: Traditional Medicine to Modern
599
+ Pharmacogenomics: Ayurveda Prakriti Type and CYP2C19 Gene
600
+ Polymorphism Associated with the Metabolic Variability. Evid Based
601
+ Complement Alternat Med 2009 Dec 16. [Epub ahead of print].
602
+ 27. Kurup  RK, Kurup PA: Hypothalamic digoxin, hemispheric
603
+ chemical dominance, and the tridosha theory. Int J Neurosci
604
+ 2003 May;113:657‑81.
605
+ 28. Trawick  M. An Ayurvedic theory of cancer. Med Anthropol
606
+ 1991 Jun;13:121‑36.
607
+ 29. Purvya MC, Meena MS. A review on role of prakriti in aging. Ayu
608
+ 2011 Jan;32:20‑4.
609
+ 30. Manyam  BV,  Kumar  A. Ayurvedic constitution  (prakruti)
610
+ identifies risk factor of developing Parkinson’s disease. J Altern
611
+ Complement Med  2013 Jul;19:644‑9. doi: 10.1089/acm. 2011.0809.
612
+ Epub 2013 Mar 07.
613
+ 31. Supriya Bhalerao,  Tejashree Deshpande,  Urmila Thatte. Prakriti
614
+ (Ayurvedic concept of constitution) and variations in platelet
615
+ aggregation: BMC Complementary and Alternative Medicine 2012.
616
+ 32. Endo J, Nakamura T. Comparative studies of the tridosha theory in
617
+ Ayurveda and the theory of the four deranged elements in Buddhist
618
+ medicine. Kagakushi Kenkyu 1995;34:1‑9.
619
+ 33. Mahdihassan  S. A  comparative study of Chinese cosmology
620
+ cum‑humorology with eight elements. Am J Chin Med
621
+ 1990;18:181‑4.
622
+ 34. Suchitra SP, Devika HS, Gangadhar BN, Nagarathna R, Nagendra HR,
623
+ Kulkarni  R. Measuring the tridosha symptoms of unmāda
624
+ (psychosis): A preliminary study; J Altern Complement Med.
625
+ 2010 Apr;16:457‑62.
626
+ 35. Suchitra SP, Nagendra HR. Development and initial standardization
627
+ of Ayurveda Child Personality Inventory: International Conference on
628
+ Non‑communicable diseases. 2012 Februvary.
629
+ 36. Frank S. Freeman.Theory and Practice of Psychological Testing. Third
630
+ edition. New Delhi: Surjeet publications; 2006.
631
+ 37. Rutherford B. Cattell R.Hand book for the children’s personality
632
+ questionnaire (CPQ). Illinois. Indian economy edition; Institute of
633
+ Personality and Ability testing. 1999.
634
+ 38. AK Singh. Tests, Measurements and Research methods in Behavioral
635
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+ 90
637
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
638
+ Suchitra and Nagendra: Self rating scale to asses prakr
639
+ .ti
640
+ sciences. Fifth edition. Patna: Bharati Bhavan publishers and
641
+ distributers; 2006.
642
+ 39. Anastasi A., Urbina S. Psychological testing. 7th Edition. Pearson
643
+ Education; 2005.
644
+ 40. Nunnaly JC. Psychometric theory. (2nd ed.). New York: Mc‑grow‑hill;
645
+ 1978.
646
+ Address for correspondence:
647
+ S.P
648
+ . Suchitra,
649
+ Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA), Eknath
650
+ Bhavan, No.19, Gavipuram Circle, Kempegowda Nagar,
651
+ Bangalore - 560 019, India.
652
+ E-mail: [email protected]
653
+ How to cite this article: Suchitra SP, Nagendra HR. A self-rating scale
654
+ to measure tridos
655
+ .as in children. Ancient Sci Life 2013;33:85-91.
656
+ Source of Support: Nil. Conflict of Interest: None declared.
657
+ Table 1: Factor analytic coefficients of each item
658
+ Vāta
659
+ Loadings
660
+ Pitta
661
+ Loadings
662
+ Kapha
663
+ Loadings
664
+ v1
665
+ 0.665
666
+ p1
667
+ 0.698
668
+ k1
669
+ 0.616
670
+ v2
671
+ 0.575
672
+ p2
673
+ 0.727
674
+ k2
675
+ 0.618
676
+ v3
677
+ 0.566
678
+ p3
679
+ 0.574
680
+ k3
681
+ 0.679
682
+ v4
683
+ 0.553
684
+ p4
685
+ 0.607
686
+ k4
687
+ 0.646
688
+ v5
689
+ 0.580
690
+ p5
691
+ 0.837
692
+ k5
693
+ 0.510
694
+ v6
695
+ 0.608
696
+ p6
697
+ 0.673
698
+ k6
699
+ 0.567
700
+ v7
701
+ 0.614
702
+ p7
703
+ 0.520
704
+ k7
705
+ 0.414
706
+ v8
707
+ 0.417
708
+ p8
709
+ 0.447
710
+ k8
711
+ 0.612
712
+ v9
713
+ 0.490
714
+ p9
715
+ 0.528
716
+ k9
717
+ 0.764
718
+ v10
719
+ 0.578
720
+ p10
721
+ 0.423
722
+ k10
723
+ 0.693
724
+ v11
725
+ 0.443
726
+ p11
727
+ 0.617
728
+ k11
729
+ 0.536
730
+ v12
731
+ 0.631
732
+ p12
733
+ 0.555
734
+ k12
735
+ 0.628
736
+ v13
737
+ 0.540
738
+ p13
739
+ 0.590
740
+ k13
741
+ 0.521
742
+ v14
743
+ 0.550
744
+ p14
745
+ 0.565
746
+ k14
747
+ 0.625
748
+ v15
749
+ 0.453
750
+ p15
751
+ 0.559
752
+ k15
753
+ 0.529
754
+ v16
755
+ 0.589
756
+ p16
757
+ 0.586
758
+ k16
759
+ 0.764
760
+ v17
761
+ 0.548
762
+ p17
763
+ 0.615
764
+ k17
765
+ 0.600
766
+ v18
767
+ 0.569
768
+ p18
769
+ 0.740
770
+ k18
771
+ 0.602
772
+ v19
773
+ 0.580
774
+ p19
775
+ 0.704
776
+ k19
777
+ 0.646
778
+ v20
779
+ 0.476
780
+ p20
781
+ 0.781
782
+ k20
783
+ 0.605
784
+ v21
785
+ 0.651
786
+ p21
787
+ 0.644
788
+ k21
789
+ 0.581
790
+ v22
791
+ 0.573
792
+ p22
793
+ 0.638
794
+ k22
795
+ 0.582
796
+ v23
797
+ 0.713
798
+ p23
799
+ 0.471
800
+ k23
801
+ 0.608
802
+ v24
803
+ 0.587
804
+ p24
805
+ 0.491
806
+ k24
807
+ 0.596
808
+ v25
809
+ 0.540
810
+ k25
811
+ 0.680
812
+ v26
813
+ 0.635
814
+ k26
815
+ 0.421
816
+ k27
817
+ 0.579
818
+ Factor loadings‑correlations of each item with respective subsales
819
+ APPENDIX‑1
820
+ APPENDIX ‑2
821
+ Caraka child personality inventory
822
+ For children
823
+ Instructions: There is no right or wrong answer. Select the
824
+ appropriate answer suitable to you and give explanation where
825
+ necessary
826
+ A‑scale
827
+ 1
828
+ I get skin problems easily
829
+ Yes/No
830
+ 2
831
+ I am thin
832
+ Yes/No
833
+ 3
834
+ Green lines (veins) are visible over
835
+ my arm than others
836
+ Yes/No
837
+ 4
838
+ My hair is rough and split
839
+ Yes/No
840
+ 5
841
+ Usually I hear some sound in my
842
+ knee while walking
843
+ Yes/No
844
+ 6
845
+ My nails grow faster than others
846
+ Yes/No
847
+ 7
848
+ Time taken by me to button my
849
+ cloth usually is
850
+ _____
851
+ 8
852
+ I eat food fast
853
+ Yes/No
854
+ 9
855
+ I eat _____ and _____ for
856
+ my breakfast (tell how much
857
+ also) (e.g.: 2 idlis, 2 dosa etc.)
858
+ 10
859
+ I get tired easily during exercise
860
+ Yes/No
861
+ 11
862
+ I usually wake‑up in between sleep
863
+ Yes/No
864
+ 12
865
+ I usually talk in low pitch
866
+ Yes/No
867
+ 13
868
+ I can understand, what teacher
869
+ teaches faster than others
870
+ Yes/No
871
+ 14
872
+ I usually forget the issues faster
873
+ than others
874
+ Yes/No
875
+ 15
876
+ I have some plans for this year
877
+ Yes/No
878
+ 16
879
+ Sometimes I like my relatives,
880
+ sometimes not
881
+ Yes/No
882
+ 17
883
+ If a classmate doesn’t behave
884
+ properly with me
885
+ I will be silent/I will also
886
+ behave badly with him
887
+ 18
888
+ When my parents ask me to stop
889
+ watching television do, I do it
890
+ immediately
891
+ Yes/No
892
+ 19
893
+ If my brother/sister/friend are
894
+ praised in front of me
895
+ I beat them/I will
896
+ become concerned
897
+ unhappy/I am not much
898
+ 20
899
+ I usually finish my home‑work,
900
+ before playing
901
+ Yes/No
902
+ contd...
903
+ [Downloaded free from http://www.ancientscienceoflife.org on Wednesday, July 27, 2016, IP: 14.139.155.82]
904
+
905
+ Ancient Science of Life / Oct-Dec 2013 / Vol 33 / Issue 2
906
+ 91
907
+ Suchitra and Nagendra: Self rating scale to asses prakr
908
+ .ti
909
+ APPENDIX ‑3
910
+ Format of Informed consent
911
+ I have been informed completely about the scale which is
912
+ about to measure the personality of My Son/Daughter……
913
+ ………………….I am agreeing completely for the analysis
914
+ of His/Her personality.
915
+ Signature of the parent/Guardian
916
+ Appendix ‑2: Contd...
917
+ 21
918
+ I usually don’t think much about
919
+ person who have helped me
920
+ Yes/No
921
+ 22
922
+ I usually don’t like to make new
923
+ friends
924
+ Yes/No
925
+ 23
926
+ I like hard chapatti, bread much
927
+ Yes/No
928
+ 24
929
+ I like hot drinks much
930
+ Yes/No
931
+ 25
932
+ I can give stage performance easily
933
+ Yes/No
934
+ 26
935
+ I bite my teeth when not allowed
936
+ to do what I like to do
937
+ Yes/No
938
+ B‑scale
939
+ 1
940
+ I get body pain after heavy exercise
941
+ Yes/No
942
+ 2
943
+ My body color is‑brown
944
+ Yes/No
945
+ 3
946
+ I usually have bad – breath
947
+ Yes/No
948
+ 4
949
+ Color of my eyes is brown
950
+ Yes/No
951
+ 5
952
+ Color of my nails is pink
953
+ Yes/No
954
+ 6
955
+ Color of my lips is pink
956
+ Yes/No
957
+ 7
958
+ I have small, brown eye‑lashes
959
+ Yes/No
960
+ 8
961
+ Color of my hair is brown
962
+ Yes/No
963
+ 9
964
+ I feel hungry in every
965
+ ______hours
966
+ 10
967
+ Time taken for taking bath by me is
968
+ ______
969
+ 11
970
+ I eat _____ and _____ for
971
+ lunch (tell how much also)
972
+ (e.g.,‑2 chapatis, one bowl rice etc.)
973
+ 12
974
+ I drinks more water than others
975
+ Yes/No
976
+ 13
977
+ I sweat a lot compared to others
978
+ Yes/No
979
+ 14
980
+ I go for urine often
981
+ Yes/No
982
+ 15
983
+ I usually get prizes in sports
984
+ Yes/No
985
+ 16
986
+ I usually get head‑ache, eye‑pain if
987
+ I read for longer duration
988
+ Yes/No
989
+ 17
990
+ I change my decisions easily
991
+ Yes/No
992
+ 18
993
+ I can learn new subjects easily
994
+ Yes/No
995
+ 19
996
+ I usually get ______ grade in tests
997
+ Yes/No
998
+ 20
999
+ I usually admit my mistakes
1000
+ Yes/No
1001
+ 21
1002
+ When my sister/brother/friend are
1003
+ paid more attention in front of me
1004
+ I get angry/I want to
1005
+ behave such a way,
1006
+ parents pay attention
1007
+ to me
1008
+ 22
1009
+ My health gets upset when I eat
1010
+ excessive sour taste foods
1011
+ Yes/No
1012
+ 23
1013
+ I like cold drinks a lot
1014
+ Yes/No
1015
+ 24
1016
+ My anger comes down quickly
1017
+ Yes/No
1018
+ C‑scale
1019
+ 1
1020
+ I get leg and arm pain often
1021
+ Yes/No
1022
+ 2
1023
+ I am liked by some friends/all friends
1024
+ 3
1025
+ My body color is bright white
1026
+ Yes/No
1027
+ Appendix ‑2: Contd...
1028
+ 4
1029
+ My eyes are big
1030
+ Yes/No
1031
+ 5
1032
+ My hair is curly and thick
1033
+ Yes/No
1034
+ 6
1035
+ My chest is wider comparatively
1036
+ Yes/No
1037
+ 7
1038
+ My forehead is bigger
1039
+ Yes/No
1040
+ 8
1041
+ My eye‑brows are big
1042
+ Yes/No
1043
+ 9
1044
+ I usually take _____ minutes to
1045
+ wear a dress
1046
+ 10
1047
+ I eat food slowly
1048
+ Yes/No
1049
+ 11
1050
+ I sweat less than others
1051
+ Yes/No
1052
+ 12
1053
+ I will not get tired after exercise
1054
+ for longer time
1055
+ Yes/No
1056
+ 13
1057
+ I can wait, if food is delayed
1058
+ sometimes
1059
+ Yes/No
1060
+ 14
1061
+ I usually sleep good for longer time
1062
+ Yes/No
1063
+ 15
1064
+ When my brother/sister/cousin
1065
+ quarrels with me
1066
+ I also want to quarrel/I
1067
+ want to keep quite
1068
+ 16
1069
+ I usually talk in loud voice
1070
+ Yes/No
1071
+ 17
1072
+ I usually get adjusted to new
1073
+ school easily
1074
+ Yes/No
1075
+ 18
1076
+ I usually can remember issues
1077
+ happened years back as it is
1078
+ Yes/No
1079
+ 19
1080
+ When my friend/classmate helps me
1081
+ I feel very thankful/I
1082
+ want to remember for
1083
+ always
1084
+ 20
1085
+ I remember the scolding of my
1086
+ parents a lot
1087
+ Yes/No
1088
+ 21
1089
+ I want to give money to the beggars
1090
+ Yes/N
1091
+ 22
1092
+ I like spicy foods
1093
+ Yes/No
1094
+ 23
1095
+ I like to share my things with my
1096
+ brother/sister
1097
+ Yes/No
1098
+ 24
1099
+ I can withstand/tolerate pain
1100
+ Yes/No
1101
+ 25
1102
+ I want to become ______ in my life
1103
+ 26
1104
+ I like to serve my guests
1105
+ Yes/No
1106
+ 27
1107
+ If my parents give money to me I
1108
+ want to spend on:
1109
+ ____
1110
+ contd...
1111
+ [Downloaded free from http://www.ancientscienceoflife.org on Wednesday, July 27, 2016, IP: 14.139.155.82]
subfolder_0/AUTONOMIC CHANGES WHILE MENTALLY REPEATING TWO SYLLABLES.txt ADDED
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+
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+
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+
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+
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+
6
+
7
+
8
+
9
+
10
+
11
+
12
+
13
+
14
+
15
+
16
+
17
+
18
+
19
+
20
+
21
+
subfolder_0/AWARENESS OF COMPUTER¬USE RELATED HEALTH RISKS IN SOFTWARE COMPANIES IN BANGALORE.txt ADDED
@@ -0,0 +1,71 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+
2
+ Indian J Med Sci Vol. 58 No.5, May 2004
3
+
4
+ AWARENESS OF COMPUTERUSE RELATED HEALTH RISKS IN SOFTWARE
5
+ COMPANIES IN BANGALORE
6
+
7
+ SHIRLEY TELLES, RAJENDRA DEGINAL & LOKESH HUTCHAPPA
8
+
9
+ Sir,
10
+ There are important physiological, biochemical, somatic and psychological indicators of stress
11
+ related to work where human computer interaction occurs '. Prevention is the best management
12
+ of computer-related ailments since it is more effective, lasts longer, and costs less." Among
13
+ software development organizations worldwide, several are in India, in Bangalore city." Hence
14
+ this study evaluated the awareness of computer-use related health risks in software companies in
15
+ Bangalore.
16
+
17
+ Forty-three software companies in Bangalore were contacted. Twenty companies participated
18
+ and the manager for human resource development (HRD) filled in a questionnaire.
19
+
20
+ The questions were: (1) Are you aware that using a computer for over 5 hours a day can cause
21
+ health problems (yes/no)?; (2) If your answer was 'yes', what was the source of your
22
+ information? (books/ newspapers/ television/ experience of yourself or others/ other source
23
+ (specify)); (3) Name three health problems which you think are the most likely to occur; (4) In
24
+ your company are you using any lifestyle modification strategy? (yes/no); (5) If your answer was
25
+ 'yes', what strategy does the company use? (6) If your answer to Question (4) was 'no', which of
26
+ the following was the most important reason for not using any strategy? (time constraints/ lack of
27
+ belief in such strategies/ poor response/ financial constraints/ lack of infrastructure/ no access to
28
+ a trained person/ any other reason (specify)).
29
+
30
+ In fifteen companies the number of software engineers was between 100 and 500 and five
31
+ companies had between 500 and 1000 employees. Seventeen out of twenty HRD managers were
32
+ aware of the health risks. Eleven had got the information from newspapers, five from the
33
+ employees' experience, and one from a television program. When asked about the three most
34
+ likely complaints, fifteen out of seventeen mentioned (i) visual strain, (ii) back pain, and (iii)
35
+ other musculoskeletal pains. Two mentioned 'psychological strain' and 'weight gain' as other
36
+ likely hazards. Two others did not know the likely problems. Ten out of seventeen were using
37
+ some lifestyle modification strategy, while seven were not. The following strategies were used:
38
+ indoor and outdoor games, yoga including meditation, health checkups, health advice,
39
+ recreational facilities, and a 'rooftop cafeteria'. The use of these strategies was optional. In the
40
+ case of the seven companies where no strategy was used, five of them gave the reason that they
41
+ had 'no access to a trained person to administer the strategy' and for two of them 'time
42
+ constraints' were the limiting factor.
43
+
44
+ Hence HRD managers in most software companies are aware of health risks of prolonged
45
+ computer use and which complaints are most probable. However the management strategies did
46
+ not seem adequate. In view of the increasing number of software companies across India this
47
+ topic requires attention.
48
+
49
+
50
+
51
+
52
+
53
+ ACKNOWLEDGMENT
54
+
55
+ The project was funded by a grant from the Central Council of Research in Yoga and
56
+ Naturopathy (CCRYN), Ministry of Health & Family Welfare, Govt. of India.
57
+
58
+ SHIRLEY TELLES, RAJENDRA DEGINAL & LOKESH HUTCHAPPA
59
+ Vivekananda Yoga Research Foundation, Bangalore, India E-mail: [email protected]
60
+
61
+ REFERENCES
62
+
63
+ 1. Smith MJ, Conway FT, Karsh B10 Occupational stress in human computer interaction. Ind
64
+ Health. 1999;37:157-73.
65
+ 2. Bawa J. Computers and your health. 1996.
66
+ Celestial Arts: Berkeley,CA.
67
+ 3. Killcrece G., Kossakowski K-P, Ruefle R. et al.
68
+ Organizational models for computer security incident response teams (CSIRTs). Handbook
69
+ Carnegie-Mellon University(CMU)/Software Engineering Institute-2003-HB-001-15213-
70
+ 3890. 2003. SEI: Pittsburgh, PA.
71
+
subfolder_0/Add-on Effect of Hot Sand Fomentation to Yoga on Pain, Disability, and Quality of Life in Chronic Neck Pain Patients.txt ADDED
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1
+
2
+ Current Problems in Diagnostic RadiologyIIMB Management ReviewJournal of Cardiac FailureJournal of Exotic Pet MedicineBiology of
3
+ Blood and Marrow TransplantationSeminars in Spine SurgerySeminars in Arthritis & RheumatismCurrent Problems in Pediatric and
4
+ Adolescent Helath CareSolid State Electronics Letters
5
+ Accepted Manuscript
6
+ Add-on effect of hot sand fomentation to yoga on pain, disability, and
7
+ quality of life in chronic neck pain patients
8
+ B. Nandini , A. Mooventhan Senior Medical Officer ,
9
+ NK. Manjunath Professor
10
+ PII:
11
+ S1550-8307(17)30363-4
12
+ DOI:
13
+ 10.1016/j.explore.2018.01.002
14
+ Reference:
15
+ JSCH 2294
16
+ To appear in:
17
+ The End-to-end Journal
18
+ Received date:
19
+ 11 October 2017
20
+ Revised date:
21
+ 5 January 2018
22
+ Accepted date:
23
+ 5 January 2018
24
+ Please
25
+ cite
26
+ this
27
+ article
28
+ as:
29
+ B. Nandini ,
30
+ A. Mooventhan Senior Medical Officer ,
31
+ NK. Manjunath Professor , Add-on effect of hot sand fomentation to yoga on pain, disability, and quality
32
+ of life in chronic neck pain patients , The End-to-end Journal (2018), doi: 10.1016/j.explore.2018.01.002
33
+ This is a PDF file of an unedited manuscript that has been accepted for publication. As a service
34
+ to our customers we are providing this early version of the manuscript. The manuscript will undergo
35
+ copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please
36
+ note that during the production process errors may be discovered which could affect the content, and
37
+ all legal disclaimers that apply to the journal pertain.
38
+ ACCEPTED MANUSCRIPT
39
+ ACCEPTED MANUSCRIPT
40
+ Highlights:
41
+  Addition of hot sand fomentation (HSF) to yoga provides a better reduction in pain
42
+ and disability in patients with non-specific neck pain than yoga alone.
43
+  All the subjects were actively participated in intervention
44
+  No adverse effects were reported throughout the study period.
45
+  Intervention is feasible, easy, safe and cost-effective
46
+
47
+
48
+
49
+
50
+ ACCEPTED MANUSCRIPT
51
+ ACCEPTED MANUSCRIPT
52
+ Add-on effect of hot sand fomentation to yoga on pain, disability, and quality of life in
53
+ chronic neck pain patients
54
+ Running Title: Hot sand fomentation for neck pain
55
+ B. Nandini,1 A. Mooventhan,2 NK. Manjunath3
56
+
57
+ 1Department of Yoga and Naturopathy, The School of Yoga and Naturopathic medicine, S-
58
+ VYASA University, Bengaluru, Karnataka, India
59
+ 2Senior Medical Officer, Department of Yoga, Center for Integrative Medicine and Research
60
+ (CIMR), All India Institute of Medical Sciences (AIIMS), New Delhi, India
61
+ 3Professor, Division of Yoga and Life Sciences, & Head, Department of Research and
62
+ Development, S-VYASA University, Bengaluru, Karnataka, India
63
+ Number of Tables: 03
64
+ Number of Figures: 0
65
+ Word Count:
66
+ Abstract
67
+ : 250
68
+ Manuscript
69
+ : 2895
70
+ Corresponding contributor:
71
+ Dr. A. Mooventhan,
72
+ Senior Medical Officer, Department of Yoga, Center for Integrative Medicine and Research
73
+ (CIMR), All India Institute of Medical Sciences (AIIMS), New Delhi, India.
74
+ Mobile: +91 9844457496
75
+ E-mail: [email protected]
76
+ ACCEPTED MANUSCRIPT
77
+ ACCEPTED MANUSCRIPT
78
+ Add-on effect of hot sand fomentation to yoga on pain, disability and quality of life in
79
+ chronic neck pain patients
80
+ ABSTRACT:
81
+ Background: Neck pain is one of the commonest complaints and an important public health
82
+ problem across the globe. Yoga has reported to be useful for neck pain and hot sand has
83
+ reported to be useful for chronic rheumatism. The present study was conducted to evaluate
84
+ the add-on effect of hot sand fomentation (HSF) to yoga on pain, disability, quality of sleep
85
+ (QOS) and quality of life (QOL) of the patients with non-specific neck pain.
86
+ Materials and Methods: A total of 60 subjects with non-specific or common neck pain were
87
+ recruited and randomly divided into either study group or control group. Both the groups
88
+ have received yoga and sesame seed oil (Sesamum Indicum L.) application. In addition to
89
+ yoga and sesame seed oil, study group received HSF for 15-minutes per day for 5-days.
90
+ Assessments were taken prior to and after the intervention.
91
+ Results: Results of the study showed a significant reduction in the scores of visual analogue
92
+ scale for pain, neck disability index (NDI), The Pittsburgh Sleep Quality Index (PSQI), and a
93
+ significant increase in physical function, physical health, emotional problem, pain, and
94
+ general health both in study and control groups. However, reductions in pain and NDI along
95
+ with improvement in social functions were better in the study group as compared with control
96
+ group.
97
+ Conclusion: Results of this study suggest that addition of HSF to yoga provides a better
98
+ reduction in pain and disability along with improvement in the social functioning of the
99
+ patients with non-specific neck pain than yoga alone.
100
+ Keywords: Chronic pain; Fomentation; Naturopathy; Neck pain; Yoga
101
+ ACCEPTED MANUSCRIPT
102
+ ACCEPTED MANUSCRIPT
103
+ BACKGROUND:
104
+ Back pain and neck pain are the major musculoskeletal problems in modern society causing
105
+ considerable costs in health care.[1] Non-specific[2] or common neck pain[3] is defined as the
106
+ pain with a postural or mechanical basis[2] caused by altered neck mechanics, advanced age-
107
+ related changes, additional load on the neck, occupational hazards as in computer
108
+ professionals or call center workers, faulty sleeping habits and sudden violent jerking injuries
109
+ to the neck as in whiplash injury and not due to any organic lesions.[3] It is an important public
110
+ health problem across the globe.[4] About two-thirds of people will experience neck pain at
111
+ some time with women being affected more than men.[2] The prevalence of neck pain has been
112
+ reported to be up-to 20% of the working populations worldwide[4] in which common neck pain
113
+ accounts for more than 80%.[3] It is often associated with marked disability[5] and sickness
114
+ absenteeism[3,5] that could disrupt a nation’s economy apart from disrupting the personal and
115
+ professional life of a patient.[3] Most patients with chronic neck pain were reported to use
116
+ alternative or complementary methods for their pain relief. Yoga (physical postures, breathing
117
+ exercises, meditation, and relaxation) was reported to be a safe and effective complementary
118
+ therapy for pain relief including chronic neck pain.[4] In a hydrotherapy textbook, the sand bath
119
+ was reported to be useful in cases of chronic rheumatism. It also reported that the local
120
+ applications of the sand bath may be made by heating the sand in an oven and heaping it about
121
+ the desired part as a hot sand application or fomentation.[6] Hot sand fomentation (HSF) is
122
+ commonly employed in various naturopathic hospitals for pain management. There are
123
+ various studies reporting the effect of a combination of exercise plus infrared, exercise plus
124
+ pillow; exercises plus manipulation; hot or cold packs plus massage; and heat combined with
125
+ other physical treatment for chronic neck pain management.[2] Though yoga was reported to
126
+ be useful for neck pain[4] and hot sand is reported to be useful for chronic rheumatism,[6] to the
127
+ best of our knowledge there is no known study reporting the combined effect of yoga and HSF
128
+ ACCEPTED MANUSCRIPT
129
+ ACCEPTED MANUSCRIPT
130
+ in patients with non-specific neck pain. Thus, the present study was conducted to evaluate the
131
+ add-on effect of HSF to yoga on pain, disability, quality of sleep (QOS) and quality of life
132
+ (QOL) in patients with non-specific neck pain.
133
+ MATERIALS AND METHODS
134
+ Study Design:
135
+ This is a parallel group randomized controlled study. All the subjects were randomly (1:1
136
+ ratio) divided into either study group (n=30) or control group (n=30). The study group
137
+ received HSF for 15-minutes a day for the period of 5-days along with yoga and sesame seed
138
+ oil application while the control group received yoga and sesame seed oil application alone
139
+ for the same period. Assessments were taken prior to and after the intervention.
140
+ Subjects:
141
+ A total of 60 subjects with non-specific or common neck pain age range from 24 to 56 years
142
+ were recruited from a holistic health centre in South India, based on the following inclusion
143
+ and exclusion criteria. Inclusion criteria: Subjects with the age range of 20-60 years with
144
+ non-specific or common neck pain due to ligament strain, sprain of the neck muscles or
145
+ spasm (myalgia), cervical spondylosis without any neurological impairment and who were
146
+ willing to participate in the study were included in the study. Exclusion criteria: Subjects
147
+ with uncommon neck pains due to organic causes such as congenital conditions like wry neck
148
+ also known as torticollis (a twisted and tilted neck), inflammatory conditions like rheumatoid
149
+ arthritis, metabolic disorders like osteoporosis, neoplastic conditions, infective conditions like
150
+ tuberculosis, and posttraumatic conditions with ligament or bone injuries; subjects with the
151
+ history of mental illness; and those who underwent yoga and other naturopathy treatments for
152
+ the past 1 month were excluded from the study. The study was conducted in Anvesana
153
+ research laboratories that include an inpatient holistic healthcare centre, S-VYASA
154
+ ACCEPTED MANUSCRIPT
155
+ ACCEPTED MANUSCRIPT
156
+ University, Bengaluru, India. The study protocol was approved by the institutional ethics
157
+ committee (RES/IEC-SVYASA/106/2017) and a written informed consent was obtained
158
+ from each subject.
159
+ Interventions:
160
+ Both Study and Control Groups: Practice of Yoga (Loosening practices, asanas, pranayama,
161
+ relaxation and meditation techniques and lecture on yoga philosophy), low fat and low salt
162
+ vegetarian diet and application of sesame seed oil (also called as Gingelly oil) [the oil that is
163
+ derived from the seeds of plant species Sesamum Indicum L., a herbaceous annual belonging
164
+ to the Pedaliaceae family. It has been reported to have anti-inflammatory effect. The main
165
+ constituents of sesame seed oil include fatty acids (palmitic acid, palmitoleic acid, stearic
166
+ acid, oleic acid, linoleic acid, linolenic acid, and eicosanoic acid), lignans, and antioxidants,
167
+ such as ??-tocopherol.][7] were common for both study group and control group (Table 1).
168
+ Study Group: Along with yoga and sesame seed oil application, study group subjects have
169
+ received HSF that consists of approximately 250 gm. of sand devoid of thorns, shells and
170
+ pebbles heated up to tolerable temperature (39-40oC) using a pan placed on the stove. The
171
+ procedure of the preparation of HSF is as follows: As soon as the sand in the vessel was
172
+ properly heated it was poured at the centre of the double layer cotton cloth of dimensions 15 x
173
+ 15 cm to tie it as a bolus. A strong thick thread was used to tie up the upper portion of the
174
+ bolus to avoid the outflow of the sand from small openings during the treatment procedure.
175
+ The free end of the cloth is then folded and tied to form a handle. Then the fomentation was
176
+ given by means of keeping it over (5 seconds) and taking it away from the painful region (2
177
+ seconds) which was continued for the duration of 15 minutes a day in the evening between
178
+ 5:00 pm and 6:00 pm for the period of 5 consecutive days. In order to maintain the
179
+ temperature, the HSF bag was replaced by a new HSF bag every 5 minutes. Thus, we used 3
180
+ ACCEPTED MANUSCRIPT
181
+ ACCEPTED MANUSCRIPT
182
+ HSF bags to complete one session. The intervention was given by two (1 male and 1 female)
183
+ institutionally qualified therapists.
184
+ Control Group: Control group subjects were under their normal routine and did not receive
185
+ HSF for the same period.
186
+ Assessments:
187
+ The primary (visual analog scale for pain and neck disability index) and secondary outcome
188
+ [quality of sleep (QOS), and quality of life (QOL)] measures were taken before and after the
189
+ intervention as mentioned below:
190
+ Visual analog scale (VAS) for pain: It was used to evaluate subject’s intensity of pain on a
191
+ scale of 0 to 10, where 0 indicates no pain and 10 indicates worst pain. Subjects were advised
192
+ to mark on the scale to indicate their pain intensity before and after the intervention.[8]
193
+ Cronbach’s alpha = 0.95[9]
194
+ Neck Disability Index (NDI): It is a measurement tool used to measure 10 dimensions of
195
+ neck-specific disability, namely pain intensity, personal care, lifting, reading, headache,
196
+ concentration, work, driving, sleeping, and recreation. Each dimension is assessed with 1
197
+ item, measured on a 6-point scale from 0 (no disability) to 5 (full disability). The sum score
198
+ out of all 10 items is multiplied by 2 to obtain a score out of 100%. The score 0-20, 21-40,
199
+ 41-60, 61-80, and 80-100 represents the normal, mild, moderate, severe and complete or
200
+ exaggerated disability. Cronbach’s alpha = 0.864. [10,11]
201
+ The Pittsburgh Sleep Quality Index (PSQI): It consists of seven components in 9-items
202
+ sleep questionnaire, which was used to evaluate subject’s QOS. The total score 0-4 indicates
203
+ good sleep quality, 5-10 indicate poor sleep quality, and >10 indicates the sleep disorder.
204
+ Cronbach’s alpha = 0.83.[12,13]
205
+ ACCEPTED MANUSCRIPT
206
+ ACCEPTED MANUSCRIPT
207
+ Short Form-36 Version 2 (SF-36 V2) Health Survey:
208
+ It consists of 36-items questionnaire, which measures the health in eight dimensions. For
209
+ each dimension, item scores were noted, averaged, and transformed into a scale of 0-100
210
+ where 0 indicates worst possible health and 100 indicates best possible health.[13,14]
211
+ Cronbach’s alpha = 0.85[15]
212
+ Sample size:
213
+ A total of 60 subjects with non-specific or common neck pain age range from 24 to 56 years
214
+ were recruited. The sample size was not calculated based on any previous study or pilot study
215
+ which is one of the limitations of the study.
216
+ Randomization:
217
+ All the subjects were randomly divided into either study group or control group using
218
+ computerized randomization available at http://www.randomization.com/. A simple
219
+ randomization procedure was performed for 60 subjects with 1:1 ratio to get a sample size of
220
+ (n=30) in each group. Random allocation of the intervention was kept in opaque sealed
221
+ envelopes until interventions were assigned. The randomization was performed by one of the
222
+ authors who did not involve in any part of the investigation.
223
+ Blinding:
224
+ It was not possible for us to blind the subjects from the intervention. However, the
225
+ investigator was kept blind to the study group and control group.
226
+ Data Analysis: Statistical analysis of within-group was performed using Wilcoxon signed
227
+ rank test and between groups analysis was performed using Mann Whitney-U-test with the use
228
+ of Statistical Package for the Social Sciences (SPSS) for Windows, Version 16.0. Chicago,
229
+ SPSS Inc.
230
+ ACCEPTED MANUSCRIPT
231
+ ACCEPTED MANUSCRIPT
232
+ RESULT
233
+ The details of the demographic variables of the study and control groups have been given in
234
+ table 2. Baseline characteristics were comparable and no significant differences were observed
235
+ between the groups in all the variables except pain and SF-36 health survey’s physical health
236
+ and energy scales. Results of the study showed a significant reduction in the scores of pain,
237
+ NDI, and social function in the study group compared to the control group. Within-group
238
+ analysis showed a significant reduction in VAS score for pain, NDI, PSQI and a significant
239
+ increase in physical function, physical health, emotional problem, pain, and general health
240
+ both in study and control groups, while a significant increase in energy level and social
241
+ functioning was observed only in study group unlike control group and no such significant
242
+ change was observed in emotional well being both in study and control groups (Table 3). The
243
+ compliance of the participants to the therapies was good due to voluntary participation and
244
+ there were no dropouts and none of the subjects reported any adverse effects during the study
245
+ period.
246
+ DISCUSSION
247
+ Research shows that spinal pain has become the largest category of medical claims, placing a
248
+ major burden on individuals and health care system. Yoga is quite commonly used as a
249
+ complementary therapy for spinal pain including neck pain.[1] Self-assessment questionnaires
250
+ are widely used to assess the outcome of medical management and interventions.[11] In the
251
+ present study, we used self-assessment questionnaires such as VAS for pain, NDI, PSQI and
252
+ SF-36 Healthy survey to assess the add-on effect of HSF on neck pain and disability, QOS and
253
+ QOL of patients with non-specific neck pain.
254
+ Results of this study showed a significant increase in the energy level and social functioning
255
+ only in the study group while no such significant changes were observed in the control group.
256
+ ACCEPTED MANUSCRIPT
257
+ ACCEPTED MANUSCRIPT
258
+ Moreover, the significant reduction in VAS score for pain and NDI score and the significant
259
+ increase in social functions were better in the study group compared with control group. It
260
+ suggests that the improvement in pain, neck disability, general energy level and the social
261
+ functioning of the people with the neck pain were better in the subjects who received HSF
262
+ along with yoga rather than the subjects who received yoga alone. It should be noted that
263
+ there was a significant baseline difference in pain between the groups and that might have
264
+ influenced the significant difference in the post-test analysis as well. However, the reduction
265
+ in the pain (mean score) was better in the study group (from 7.81 to 2.63; Difference = 5.18)
266
+ compared with control group (from 7.33 to 5.79; Difference = 1.54). Similarly, though there
267
+ was a significant baseline difference in SF-36 health survey’s energy level scale in between
268
+ groups, within group analysis showed a significant improvement in energy level in the
269
+ subjects those who received yoga plus HSF rather than the subjects those who received yoga
270
+ alone. This suggests that HSF might have additional effect in reducing pain and in improving
271
+ energy level of the patients with neck pain.
272
+ The better reduction in pain and neck disability in the study group compared with the control
273
+ group might attribute to the pain reducing and muscle relaxing effect of HSF. Improvement
274
+ in the energy level and social functioning of the study group unlike the control group might
275
+ attribute to the better reduction of pain and neck disability in the study group compared with
276
+ the control group. As mentioned in a previous study,[3] the tension that is associated with
277
+ stress is stored mainly in the neck muscles, diaphragm and the nervous system. Stress is
278
+ reported to produce spasm by interfering with coordination of different muscle groups
279
+ involved in the functioning of the neck. Thus, if these areas are relaxed, stress can get
280
+ reduced or if the stress reduced, these areas can be relaxed and these help in minimizing the
281
+ impact of stress in people with neck pain. In a previous study, yoga has been found to be an
282
+ effective tool in reducing stress levels that might have helped in reducing the pain and
283
+ ACCEPTED MANUSCRIPT
284
+ ACCEPTED MANUSCRIPT
285
+ disability by reducing the tension over the neck muscles indirectly.[3] According to a
286
+ hydrotherapy text, hot applications were reported to be effective in reducing pain and muscle
287
+ tension directly.[6] This explains the reason, why there was a better reduction in pain and
288
+ disability in the study group compared with control group.
289
+ Within group analysis of the present study showed a significant reduction in the scores of
290
+ VAS for pain, NDI, and PSQI and a significant increase SF-36 health survey especially in
291
+ physical function, physical health, emotional problem, pain, and general health both in study
292
+ and control groups. It suggests that practice of yoga with or without HSF was effective in
293
+ improving the problems that are associated with chronic neck pain such as neck pain,
294
+ disability, QOS and QOL.
295
+ The previous study on one of the advanced guided yoga relaxation techniques called “mind
296
+ sound resonance technique (MSRT)” was reported to add significant complimentary benefits
297
+ to conventional physiotherapy by reducing pain, tenderness, disability and providing
298
+ improved flexibility in patients with common neck pain.[3] Regular yoga practice has shown
299
+ to produce a significant reduction in time to fall asleep, decreased sleep disturbance during
300
+ night time, better sleep quality, decreased use of medications for sleep and improve overall
301
+ QOS[16] and also felt more rested and energetic in the morning.[17] Previous studies on yoga
302
+ practices showed improvement in pain, neck-related disabilities and health-related QOL in
303
+ patients with chronic non-specific neck pain.[18-20] And, sustained yoga practice seems to be
304
+ the most important predictor of long-term effectiveness in neck patients. A systematic review
305
+ has reported that the yoga can decrease pain and increase functional ability in patients with
306
+ spinal pain including neck pain.[1] Thus, the findings of the present study are consistent with
307
+ the reports of the previous studies.
308
+ Non-specific neck pain has reported to be associated with anxiety, depression[2] stress and
309
+ tension.[3] Yoga is fast advancing as an effective therapeutic tool in physical, psychological
310
+ ACCEPTED MANUSCRIPT
311
+ ACCEPTED MANUSCRIPT
312
+ and psychosomatic disorders. And the practice of yoga was found to be effective in reducing
313
+ stress, anxiety, pain[3] (by down regulating the hypothalamic pituitary adrenal axis and the
314
+ sympathetic nervous system)[4] and disability.[3,4] Moreover, yoga has shown to influence the
315
+ functional status of neck muscles of patients with neck pain[19] and reported to be an effective
316
+ method for treating neck pain by improving strength, flexibility and endurance that is a basic
317
+ goal of most rehabilitation programs for neck pain.[1] Thus, the reduction in pain and
318
+ disability and the improvement in QOS and QOL after yoga with or without HSF might
319
+ attribute to the effect of yoga on stress, anxiety, modulation of the hypothalamic pituitary
320
+ adrenal axis and the sympathetic nervous activity.
321
+ A qualitative study reported that the chronic neck pain patients those who have participated in
322
+ yoga intervention have changed on five dimensions of human experience: 1) Physically, most
323
+ participants cited renewed body awareness, both during yoga practice and in daily lives, 2)
324
+ Cognitively, participants reported increased perceived control over their health, 3)
325
+ Emotionally, they noted greater acceptance of their pain and life burdens, 4) Behaviourally,
326
+ they described enhanced use of active coping strategies, and 5) Socially, they reported
327
+ renewed participation in an active life.[21] In a previous study, intake of the vegetarian diet
328
+ has shown to be effective in reducing pain, tenderness, inflammatory markers and in
329
+ improving physical functioning of patients with rheumatoid arthritis.[22] Thus, the vegetarian
330
+ diet provided in the present study might also have attributed to the reduction in pain and
331
+ improvement in the health-related problems of neck pain.
332
+ Strength of the study: This is the first study evaluating the add-on effects of HSF to yoga in
333
+ patients with non-specific neck pain, the standard study design was adopted, and no adverse
334
+ effects were reported by the subjects throughout the study period. Limitations of the study:
335
+ Small sample size, short-term intervention, and lack of objective variables and assessments
336
+ such as stress, anxiety, muscle tension, flexibility, sleep architecture. Hence, long-term
337
+ ACCEPTED MANUSCRIPT
338
+ ACCEPTED MANUSCRIPT
339
+ studies are required with larger sample size and above-mentioned variables for the better
340
+ understanding of the effect and its underlying mechanisms.
341
+ CONCLUSION
342
+ Result of this study suggests that yoga with or without HSF is effective in reducing pain,
343
+ disability, and in improving QOS and QOL of patients with non-specific neck pain. However,
344
+ an addition of HSF to yoga provides a better reduction in pain and disability along with
345
+ improvement in the social functioning of the patients with non-specific neck pain than yoga
346
+ alone.
347
+ SOURCE OF FUNDING: Nil,
348
+ CONFLICT OF INTEREST: None declared
349
+
350
+
351
+
352
+
353
+
354
+
355
+
356
+
357
+
358
+
359
+ ACCEPTED MANUSCRIPT
360
+ ACCEPTED MANUSCRIPT
361
+ REFERENCES:
362
+ 1. Crow EM, Jeannot E, Trewhela A. Effectiveness of Iyengar yoga in treating spinal
363
+ (back and neck) pain: A systematic review. Int J Yoga. 2015;8(1):3-14. doi:
364
+ 10.4103/0973-6131.146046.
365
+ 2. Binder AI. Neck pain. BMJ Clin Evid. 2008;2008. pii: 1103.
366
+ 3. Yogitha B, Nagarathna R, John E, Nagendra H. Complimentary effect of yogic sound
367
+ resonance relaxation technique in patients with common neck pain. Int J Yoga.
368
+ 2010;3(1):18-25. doi: 10.4103/0973-6131.66774.
369
+ 4. Kim SD. Effects of yoga on chronic neck pain: a systematic review of randomized
370
+ controlled trials. J Phys Ther Sci. 2016;28(7):2171-4. doi: 10.1589/jpts.28.2171.
371
+ 5. Cramer H, Lauche R, Langhorst J, Dobos GJ, Michalsen A. Validation of the German
372
+ version of the Neck Disability Index (NDI). BMC Musculoskelet Disord. 2014;15:91.
373
+ doi: 10.1186/1471-2474-15-91.
374
+ 6. Kellogg JH. Rational Hydrotherapy. 2nd ed. Pune: National Institute of Naturopathy;
375
+ 2005.
376
+ 7. Hsu DZ, Liu CT, Chu PY, Li YH, Periasamy S, Liu MY. Sesame oil attenuates
377
+ ovalbumin-induced pulmonary edema and bronchial neutrophilic inflammation in
378
+ mice. Biomed Res Int. 2013;2013:905670. doi: 10.1155/2013/905670.
379
+ 8. Scott J, Huskisson EC. Graphic representation of pain. Pain 1976;2:175-84.
380
+ 9. Knop C, Oeser M, Bastian L, Lange U, Zdichavsky M, Blauth M. Development and
381
+ validation of the Visual Analogue Scale (VAS) Spine Score. Unfallchirurg.
382
+ 2001;104(6):488-97.
383
+ 10. Vernon H, Mior S. The Neck Disability Index: A study of reliability and validity. J
384
+ Manipulative Physiol Ther. 1991;14:409-415
385
+ ACCEPTED MANUSCRIPT
386
+ ACCEPTED MANUSCRIPT
387
+ 11. McCarthy MJ, Grevitt MP, Silcocks P, Hobbs G. The reliability of the Vernon and
388
+ Mior neck disability index, and its validity compared with the short form-36 health
389
+ survey questionnaire. Eur Spine J. 2007;16:2111-7.
390
+ 12. Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh
391
+ Sleep Quality Index: A new instrument for psychiatric practice and research.
392
+ Psychiatry Res 1989;28:193-213.
393
+ 13. Mooventhan A, Nivethitha L. Effects of acupuncture and massage on pain, quality of
394
+ sleep and health related quality of life in patient with systemic lupus erythematosus. J
395
+ Ayurveda Integr Med 2014;5:186-9. doi: 10.4103/0975-9476.140484.
396
+ 14. Jenkinson C, Stewart-Brown S, Petersen S, Paice C. Assessment of the SF-36 version
397
+ 2 in the United Kingdom. J Epidemiol Community Health 1999;53:46-50.
398
+ 15. Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, et al.
399
+ Validating the SF-36 health survey questionnaire: new outcome measure for primary
400
+ care. BMJ. 1992;305(6846):160-4.
401
+ 16. Manjunath NK, Telles S. Influence of Yoga and Ayurveda on self-rated sleep in a
402
+ geriatric population. Indian J Med Res. 2005;121:683-90.
403
+ 17. Bankar MA, Chaudhari SK, Chaudhari KD. Impact of long term Yoga practice on
404
+ sleep quality and quality of life in the elderly. J Ayurveda Integr Med. 2013;4:28-32.
405
+ doi: 10.4103/0975-9476.109548.
406
+ 18. Cramer H, Lauche R, Hohmann C, Langhorst J, Dobos G. Yoga for chronic neck
407
+ pain: a 12-month follow-up. Pain Med. 2013;14:541-8. doi: 10.1111/pme.12053.
408
+ 19. Cramer H, Lauche R, Hohmann C, Lüdtke R, Haller H, Michalsen A, et al.
409
+ Randomized-controlled trial comparing yoga and home-based exercise for chronic
410
+ neck pain. Clin J Pain. 2013;29:216-23. doi: 10.1097/AJP.0b013e318251026c.
411
+ ACCEPTED MANUSCRIPT
412
+ ACCEPTED MANUSCRIPT
413
+ 20. Michalsen A, Traitteur H, Lüdtke R, Brunnhuber S, Meier L, Jeitler M, et al. Yoga for
414
+ chronic neck pain: a pilot randomized controlled clinical trial. J Pain. 2012;13:1122-
415
+ 30. doi: 10.1016/j.jpain.2012.08.004.
416
+ 21. Cramer H, Lauche R, Haller H, Langhorst J, Dobos G, Berger B. "I'm more in
417
+ balance": a qualitative study of yoga for patients with chronic neck pain. J Altern
418
+ Complement Med. 2013;19:536-42. doi: 10.1089/acm.2011.0885.
419
+ 22. Kjeldsen-Kragh J, Haugen M, Borchgrevink CF, Laerum E, Eek M, Mowinkel P, et
420
+ al. Controlled trial of fasting and one-year vegetarian diet in rheumatoid arthritis.
421
+ Lancet. 1991;338:899-902.
422
+
423
+
424
+ ACCEPTED MANUSCRIPT
425
+ ACCEPTED MANUSCRIPT
426
+ TABLES:
427
+ Table 1: Detailed daily activities to study group and control group
428
+ Time
429
+ Schedule
430
+ 5:30 am
431
+ OM meditation
432
+ 6:00 am
433
+ Practice of asana (postures)
434
+ 7:30 am
435
+ Breakfast
436
+ 8:00 am
437
+ Bhagavat Geetha chanting followed by lecture on Yoga
438
+ 9:00 am
439
+ Discussion with the ward doctors and assessment of vitals
440
+ 10:00 am
441
+ Pranayama (breathing exercise) practices
442
+ 11:00 am
443
+ Sukshma Vyayama (loosening exercise)
444
+ 12:00 pm
445
+ Lecture on Yoga philosophy
446
+ 1:00 pm
447
+ Lunch break
448
+ 3:00 pm
449
+ Cyclic meditation
450
+ 4:00 pm
451
+ Loosening exercise followed by asana
452
+ 5:00 pm
453
+ Sesame oil application (for both the groups) followed by hot sand
454
+ fomentation (only for study group)
455
+ 6:00 pm
456
+ Bhajan (Singing of sacred scriptures)
457
+ 6:30 pm
458
+ Relaxation techniques
459
+ 7:30 pm
460
+ Dinner
461
+ 8:30-9:00 pm
462
+ Happy Assembly (interactions among the patients)
463
+
464
+
465
+ ACCEPTED MANUSCRIPT
466
+ ACCEPTED MANUSCRIPT
467
+ Table 2: Demographic variables of the study group (n = 30) and control group (n = 30)
468
+ Variable
469
+ Study group (n = 30)
470
+ Control group (n = 30)
471
+ p value
472
+ Age (Years)
473
+ 32.70±6.04
474
+ 35.27±8.28
475
+ 0.202¶
476
+ Gender
477
+ Female 14/Male 16
478
+ Female 13/Male 17
479
+ -
480
+ Height (cm)
481
+ 159.53±3.56
482
+ 160.52±4.57
483
+ 0.395¶
484
+ Weight (kg)
485
+ 62.77±6.72
486
+ 64.27±8.22
487
+ 0.327¶
488
+ BMI (kg/m2)
489
+ 24.66±2.40
490
+ 24.66±2.38
491
+ 0.842¶
492
+ Note: BMI = Body mass index. ¶ = Mann-Whitney U Test.
493
+
494
+
495
+
496
+ ACCEPTED MANUSCRIPT
497
+ ACCEPTED MANUSCRIPT
498
+ 19
499
+
500
+ Table 3: Baseline and post-test assessments of study group and control group
501
+ Variables Assessment Sample
502
+ size (n)
503
+ Study group with
504
+ within group
505
+ analysis
506
+ (Wilcoxon signed
507
+ ranks test)
508
+ Control group
509
+ with within
510
+ group analysis
511
+ (Wilcoxon
512
+ signed ranks test)
513
+ Between
514
+ groups
515
+ analysis
516
+ (Mann-
517
+ Whitney
518
+ U
519
+ Test)
520
+ p value
521
+ VAS
522
+ Baseline
523
+ 29
524
+ 7.81±1.08
525
+ 7.33±0.83
526
+ 0.019
527
+ Post test
528
+ 29
529
+ 2.63±0.98
530
+ 5.79±1.18
531
+ <0.001
532
+
533
+ p<0.001
534
+ p<0.001
535
+
536
+ NDI
537
+ Baseline
538
+ 30
539
+ 34.47±7.31
540
+ 34.80±6.34
541
+ 0.846
542
+ Post test
543
+ 30
544
+ 11.20±5.37
545
+ 23.73±7.10
546
+ <0.001
547
+
548
+ p<0.001
549
+ p<0.001
550
+
551
+ PSQI
552
+ Baseline
553
+ 30
554
+ 14.90±7.53
555
+ 11.93±6.41
556
+ 0.84
557
+ Post test
558
+ 30
559
+ 6.97±3.00
560
+ 8.93±5.33
561
+ 0.268
562
+
563
+ p<0.001
564
+ p<0.001
565
+
566
+ SF-36 Health Survey
567
+ PF
568
+ Baseline
569
+ 30
570
+ 45.00±20.97
571
+ 54.17±18.29
572
+ 0.154
573
+ Post test
574
+ 30
575
+ 71.00±20.02
576
+ 66.17±18.08
577
+ 0.201
578
+
579
+ p<0.001
580
+ p<0.001
581
+
582
+ PH
583
+ Baseline
584
+ 30
585
+ 20.00±27.39
586
+ 35.83±31.27
587
+ 0.023
588
+ Post test
589
+ 30
590
+ 59.17±41.25
591
+ 59.17±34.42
592
+ 0.819
593
+
594
+ p<0.001
595
+ p=0.002
596
+
597
+ ACCEPTED MANUSCRIPT
598
+ ACCEPTED MANUSCRIPT
599
+ 20
600
+
601
+ EP
602
+ Baseline
603
+ 30
604
+ 27.78±30.43
605
+ 27.78±31.66
606
+ 0.826
607
+ Post test
608
+ 30
609
+ 64.44±43.71
610
+ 51.67 ±35.11
611
+ 0.204
612
+
613
+ p=0.001
614
+ p=0.003
615
+
616
+ Energy
617
+ Baseline
618
+ 30
619
+ 44.58±10.42
620
+ 53.17±10.54
621
+ 0.004
622
+ Post test
623
+ 30
624
+ 58.25±12.85
625
+ 56.50±11.38
626
+ 0.581
627
+
628
+ p<0.001
629
+ p=0.188
630
+
631
+ EW
632
+ Baseline
633
+ 30
634
+ 65.33±12.66
635
+ 64.53±11.49
636
+ 0.840
637
+ Post test
638
+ 30
639
+ 66.33±12.66
640
+ 67.87±12.32
641
+ 0.800
642
+
643
+ p=0.628
644
+ p=0.091
645
+
646
+ SF
647
+ Baseline
648
+ 30
649
+ 42.50±17.47
650
+ 40.00±12.88
651
+ 0.742
652
+ Post test
653
+ 30
654
+ 64.08±13.20
655
+ 55.25±17.58
656
+ 0.035
657
+
658
+ p<0.001
659
+ p=0.091
660
+
661
+ Pain
662
+ Baseline
663
+ 30
664
+ 40.75±17.47
665
+ 39.83±16.58
666
+ 0.745
667
+ Post test
668
+ 30
669
+ 69.00±16.95
670
+ 49.92±17.09
671
+ <0.001
672
+
673
+ p<0.001
674
+ p=0.011
675
+
676
+ GH
677
+ Baseline
678
+ 30
679
+ 48.58±13.39
680
+ 43.58±14.35
681
+ 0.399
682
+ Post test
683
+ 30
684
+ 62.17 ±12.30
685
+ 56.17±12.01
686
+ 0.054
687
+
688
+ p<0.001
689
+ p<0.001
690
+
691
+ Note: All the values are in Mean ± Standard deviation. VAS= Visual analogue scale; NDI=
692
+ Neck disability index; PSQI= Pittsburgh sleep quality index; SF = Short form; PH= Physical
693
+ functioning; PH= Physical Health; EP= Emotional problem; EW= Emotional wellbeing; SF=
694
+ Social functioning; GH= General Health
695
+
696
+
subfolder_0/Anxiolytic effects of a yoga program in early breast cancer patients undergoing conventional treatment_a randomized controlled trial..txt ADDED
@@ -0,0 +1,944 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Complementary Therapies in Medicine (2009) 17, 1—8
2
+ available at www.sciencedirect.com
3
+ journal homepage: www.elsevierhealth.com/journals/ctim
4
+ Anxiolytic effects of a yoga program in early breast
5
+ cancer patients undergoing conventional treatment:
6
+ A randomized controlled trial
7
+ M. Raghavendra Rao a,∗, Nagarathna Raghuram b, H.R. Nagendra b,
8
+ K.S. Gopinath a, B.S. Srinath a, Ravi B. Diwakar a, Shekar Patil a,
9
+ S. Ramesh Bilimagga a, Nalini Rao a, S. Varambally c
10
+ a Departments of CAM, Surgical Oncology, Medical Oncology and Radiation Oncology,
11
+ Bangalore Institute of Oncology, Bangalore, India
12
+ b Department of Yoga Research, Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore, India
13
+ c Department of Psychiatry, NIMHANS, Bangalore, India
14
+ Available online 14 October 2008
15
+ KEYWORDS
16
+ Yoga;
17
+ Anxiety;
18
+ Cancer;
19
+ STAI;
20
+ CAM;
21
+ Relaxation
22
+ Summary
23
+ Objectives: This study compares the anxiolytic effects of a yoga program and supportive therapy
24
+ in breast cancer outpatients undergoing conventional treatment at a cancer centre.
25
+ Methods: Ninety-eight stage II and III breast cancer outpatients were randomly assigned to
26
+ receive yoga (n = 45) or brief supportive therapy (n = 53) prior to their primary treatment i.e.,
27
+ surgery. Only those subjects who received surgery followed by adjuvant radiotherapy and six
28
+ cycles of chemotherapy were chosen for analysis following intervention (yoga, n = 18, control,
29
+ n = 20). Intervention consisted of yoga sessions lasting 60 min daily while the control group was
30
+ imparted supportive therapy during their hospital visits as a part of routine care. Assessments
31
+ included Speilberger’s State Trait Anxiety Inventory and symptom checklist. Assessments were
32
+ done at baseline, after surgery, before, during, and after radiotherapy and chemotherapy.
33
+ Results: A GLM-repeated measures ANOVA showed overall decrease in both self-reported state
34
+ anxiety (p < 0.001) and trait anxiety (p = 0.005) in yoga group as compared to controls. There
35
+ was a positive correlation between anxiety states and traits with symptom severity and distress
36
+ during conventional treatment intervals.
37
+ Conclusion: The results suggest that yoga can be used for managing treatment-related symptoms
38
+ and anxiety in breast cancer outpatients.
39
+ © 2008 Published by Elsevier Ltd.
40
+  Sources of support: Central Council for Research in Yoga and Naturopathy, Ministry of Health and Family Welfare, Govt. of India.
41
+ ∗Corresponding author at: Departments of CAM, Bangalore Institute of Oncology, No8, P Kalinga Rao Rd, Sampangiramnagar, Bangalore,
42
+ India. Tel.: +91 80 40206000; fax: +91 80 22222146.
43
+ E-mail address: [email protected] (M.R. Rao).
44
+ 0965-2299/$ — see front matter © 2008 Published by Elsevier Ltd.
45
+ doi:10.1016/j.ctim.2008.05.005
46
+ 2
47
+ M.R. Rao et al.
48
+ Background
49
+ Anxiety and depression are the commonest psychiatric prob-
50
+ lems encountered in cancer patients. Fear and anxiety
51
+ associated with diagnosis of cancer, invasive treatment
52
+ procedures, sexual dysfunction secondary to surgery and
53
+ radiation, and aversive reactions to chemotherapy are
54
+ among the common treatment-related side effects observed
55
+ in cancer patients. Clinical descriptions have noted can-
56
+ cer patient’s fears of the treatment (e.g., being ‘‘burned’’
57
+ or ‘‘equating radiotherapy with electric current’’), causing
58
+ sterility, sickness or vomiting and vast individual differences
59
+ in their psychological reactions, which usually predisposes to
60
+ anxiety.1—5 Apart from treatment-related anxiety the diag-
61
+ nosis of cancer itself is anxiety provoking.
62
+ Psychiatric disorders in cancer patients are often missed
63
+ or untreated.6 Patients with breast cancer undergoing radi-
64
+ ation treatment also report anxiety and depression before,
65
+ during and after the treatment.7 The prevalence of anxi-
66
+ ety and depression in cancer patients undergoing radiation
67
+ treatment was 64% and 50%, respectively.1
68
+ Earlier studies have shown that anxiety increases psy-
69
+ chological distress and side effects following conventional
70
+ treatment.8,9 This treatment-related distress is predictive
71
+ of poorer treatment outcome, poor treatment compliance,
72
+ greater pain, longer hospital stays, more postoperative
73
+ complications and immune suppression.10,11 This has been
74
+ attributed in part to subjects increased attentiveness to
75
+ their somatic symptoms12 and development of aversive con-
76
+ ditioned responses induced by anxiety.13 Therefore, there is
77
+ a need to reduce anxiety in these patients.
78
+ The literature on psychosocial treatment for breast can-
79
+ cer patients provides uniform evidence for an improvement
80
+ in mood, coping, adjustment, vigour, and decrease in dis-
81
+ tressful symptoms using a variety of behavioural approaches
82
+ including alternative medicine approaches such as yoga.14—21
83
+ Yoga as a complementary and mind body therapy is being
84
+ practiced increasingly across the world. It is an ancient
85
+ Indian science that has been used for therapeutic ben-
86
+ efit in numerous health care concerns in which mental
87
+ stress was believed to play a role.22 This could be partic-
88
+ ularly useful in cancer patients who perceive cancer as a
89
+ threat.
90
+ Results from earlier studies provide preliminary sup-
91
+ port for anxiolytic effects of yoga interventions in cancer
92
+ patients. Positive effects have been seen on a variety of out-
93
+ comes, including sleep quality, mood, stress, cancer-related
94
+ distress, cancer-related symptoms, and overall quality of
95
+ life, as well as functional and physiological measures.23
96
+ Further, results from cancer trials are bolstered by stud-
97
+ ies conducted with non-cancer populations, which have
98
+ demonstrated positive effects on similar outcomes (e.g.,
99
+ improvements in mood and fatigue). These studies were
100
+ typically more methodologically rigorous than those con-
101
+ ducted with cancer populations and often included active
102
+ control groups (e.g., relaxation,24 exercise,25 and wait listed
103
+ controls26) lending further support to the results.27
104
+ An earlier uncontrolled study with cancer patients in
105
+ India also reported mood-enhancing effects with yoga
106
+ intervention.28 Being diagnosed with cancer is in itself
107
+ anxiety-provoking, and we hypothesize that yoga inter-
108
+ vention may be effective for reducing general anxiety
109
+ associated with the having cancer and those related to can-
110
+ cer treatment.
111
+ In this study, we compared the effects of a 24-week
112
+ ‘‘Integrated yoga program’’ with ‘‘Brief supportive ther-
113
+ apy’’ control intervention in early operable breast cancer
114
+ patients undergoing surgery, radiotherapy, and chemother-
115
+ apy.
116
+ Methods
117
+ This is a single centre randomized controlled trial which
118
+ recruited 98 recently diagnosed women with stage II and III
119
+ operable breast cancers. The institutional ethics committee
120
+ of the recruiting cancer centre approved the study. Patients
121
+ were included if they met the following criteria: (i) women
122
+ with recently diagnosed operable breast cancer, (ii) age
123
+ between 30 and 70 years, (iii) Zubrod’s performance status
124
+ 0—2 (ambulatory >50% of time), (iv) high school education,
125
+ (v) willingness to participate, and (vi) treatment plan with
126
+ surgery followed by adjuvant radiotherapy and chemother-
127
+ apy. Patients were excluded if they had (i) a concurrent
128
+ medical condition likely to interfere with the treatment, (ii)
129
+ any major psychiatric, neurological illness or autoimmune
130
+ disorders, and (iii) secondary malignancy. The details of the
131
+ study were explained to the participants and their informed
132
+ consent was obtained in writing.
133
+ Assessments were done prior to their surgery, fol-
134
+ lowing surgery, during and following radiotherapy and
135
+ chemotherapy.
136
+ All
137
+ participants
138
+ in
139
+ the
140
+ study
141
+ received
142
+ the same dose of radiation (50 cGy over 6 weeks) and
143
+ prescribed standard chemotherapy schedules (cyclophos-
144
+ phamide, methotrexate, fluorouracil or fluorouracil, adri-
145
+ amycin and cyclophosphamide—
146
+ –six cycles). Subjects in both
147
+ groups (control 45%, yoga 39%) received anxiolytic med-
148
+ ications during their chemotherapy to prevent aversive
149
+ responses (alprazolam 0.5 mg once daily for 1 week following
150
+ chemotherapy infusion). The subjects received anxiolytics
151
+ as a co-medication for only one to two cycles of chemother-
152
+ apy. However, co-medication was given only to prevent
153
+ aversive responses such as chemotherapy induced nausea
154
+ and vomiting following chemotherapy.
155
+ Measures
156
+ Before randomization demographic information, medical
157
+ history, clinical data, intake of medications, investigative
158
+ notes and conventional treatment regimen were ascertained
159
+ from all consenting participants. Participants completed the
160
+ state trait anxiety inventory (STAI) that consists of a sep-
161
+ arate self-report scale for measuring two distinct anxiety
162
+ concepts: state anxiety and trait anxiety.29
163
+ The A trait scale asks subjects to describe how they
164
+ generally feel, an attempt to tap individual differences in
165
+ ‘‘anxiety proneness’’ where as the A-state scale asks the
166
+ subjects to indicate how they feel at a particular moment in
167
+ time. Subjects are asked to rate on a 4-point scale (almost
168
+ never/not at all to almost always/very much) whether or
169
+ not each statement best describes their feelings. Because
170
+ the state measure is regarded similar to mood measures that
171
+ have expectedly low test—retest reliabilities, comparison of
172
+ internal consistencies between the state and trait measure
173
+ Anxiolytic effects of a yoga program in early breast cancer patients
174
+ 3
175
+ is more appropriate. Coefficient alpha values for the state
176
+ measure range from 0.86 to 0.92 and those for trait measure
177
+ are equally high.
178
+ The subjective symptom checklist was developed dur-
179
+ ing the pilot phase to assess treatment-related side effects,
180
+ problems with sexuality and image, and relevant psycho-
181
+ logical and somatic symptoms related to breast cancer.
182
+ The checklist consisted of 31 such items each evaluated
183
+ on two dimensions; severity graded from no to very severe
184
+ (0—4) and distress from not at all to very much (0—4).
185
+ These scales measured the total number of symptoms expe-
186
+ rienced, total/mean severity and distress scores and were
187
+ evaluated previously in a similar breast cancer population.30
188
+ The patients from both groups were briefed together by
189
+ investigators on filling the questionnaire. These self-report
190
+ questionnaires were filled by patients themselves at assess-
191
+ ment intervals.
192
+ Randomization
193
+ A person who had no part in the trial randomly allocated
194
+ consenting participants (n = 98) to either yoga (n = 45) or
195
+ supportive therapy groups (n = 53). Participants were ran-
196
+ domized at the initial visit before starting any conventional
197
+ treatment. Following randomization participants underwent
198
+ surgery followed by radiotherapy (RT) and chemotherapy
199
+ (CT) or any other treatment schedule as shown in Table 1.
200
+ There were 12 dropouts in yoga and 17 dropouts in control
201
+ group, respectively following surgery. Another 15 subjects
202
+ and 13 subjects in yoga and control arm who did not receive
203
+ the above treatment sequence were not considered for anal-
204
+ ysis (see Fig. 1: trial profile).
205
+ Sample size
206
+ Earlier studies have reported very large effect size (>1) for
207
+ anxiety scores with yoga intervention.31 We therefore used
208
+ a conservative estimate of effect size/standardised differ-
209
+ ence = 1 for our study. The sample size needed in our study
210
+ based on formula32 is 17 subjects in each arm with p at
211
+ 0.05 and 80% power. There were 18 subjects in yoga and
212
+ 20 subjects in control group who contributed data to the
213
+ study.
214
+ Interventions
215
+ The intervention group received an integrated yoga program
216
+ and the control group received supportive therapy sessions,
217
+ both imparted individually. Yoga practices consisted of a set
218
+ of asanas (postures), breathing exercises, pranayama (vol-
219
+ untarily regulated nostril breathing), meditation and yogic
220
+ relaxation techniques with imagery. The details of these
221
+ practices are described elsewhere.33 These practices were
222
+ based on principles of attention diversion, awareness and
223
+ relaxation to cope with stressful experiences. The subjects
224
+ were given booklets, audiotapes with instructions on these
225
+ practices for home practice using the instructors voice so
226
+ that a familiar voice could be heard on the cassette.
227
+ The subjects underwent four in-person sessions during
228
+ their pre- and postoperative period and were asked to
229
+ undergo three in-person sessions/week for 6 weeks dur-
230
+ Figure 1
231
+ Trial profile.
232
+ ing their adjuvant radiotherapy treatment in the hospital
233
+ with self-practice as homework on the remaining days. Dur-
234
+ ing chemotherapy, subjects underwent in person sessions
235
+ during their hospital visits for chemotherapy administration
236
+ (once in 21 days) and were imparted in-person sessions by
237
+ their trainer once in 10 days. The instructor monitored their
238
+ homework on a day-to-day basis through telephone calls and
239
+ house visits. Participants were also encouraged to maintain a
240
+ daily log listing the yoga practices done, use of audiovisual
241
+ aids, duration of practice, experience of distressful symp-
242
+ toms, intake of medication and diet history. There were two
243
+ instructors, one being a physician in naturopathy and yoga
244
+ and the other a trained and certified therapist in yoga from
245
+ the yoga institute. They together supervised and imparted
246
+ the yoga and supportive therapy intervention with help from
247
+ trained social workers and counsellors at the hospital.
248
+ The control intervention consisted of brief supportive
249
+ therapy with education as a component that is routinely
250
+ offered to patients as a part of their care in this centre.
251
+ We chose to have this as a control intervention mainly to
252
+ control for the non-specific effects of the yoga program
253
+ that may be associated with factors such as attention, sup-
254
+ port and a sense of control. Subjects and their caretakers
255
+ underwent counselling by a trained social worker (once in
256
+ 10 days, 15 min sessions) during their hospital visits for
257
+ adjuvant radiotherapy/chemotherapy. Subjects in the sup-
258
+ portive therapy group also completed daily logs or dairies
259
+ on treatment-related symptoms, medication and diet dur-
260
+ ing their chemotherapy cycles. The subjects were also given
261
+ homework based on education component and were also
262
+ 4
263
+ M.R. Rao et al.
264
+ Table 1
265
+ Demographic characteristics of the initially randomized sample (n = 98)
266
+ All subjects
267
+ Yoga group
268
+ Control group
269
+ n
270
+ (%)
271
+ n
272
+ (%)
273
+ n
274
+ (%)
275
+ Stage of breast cancer
276
+ II
277
+ 47
278
+ 47.9
279
+ 24
280
+ 53.3
281
+ 23
282
+ 43.4
283
+ III
284
+ 51
285
+ 52.1
286
+ 21
287
+ 46.7
288
+ 30
289
+ Grade of breast cancer
290
+ I
291
+ 1
292
+ 1
293
+ 1
294
+ 2.2
295
+ 0
296
+ 0
297
+ II
298
+ 11
299
+ 11.2
300
+ 6
301
+ 13.3
302
+ 5
303
+ 9.4
304
+ III
305
+ 86
306
+ 87.8
307
+ 38
308
+ 84.4
309
+ 48
310
+ 90.6
311
+ Menopausal status
312
+ Pre
313
+ 44
314
+ 44.9
315
+ 27
316
+ 60
317
+ 17
318
+ 32.1
319
+ Post
320
+ 50
321
+ 51.1
322
+ 15
323
+ 33.3
324
+ 35
325
+ 66
326
+ Peri
327
+ 2
328
+ 2
329
+ 2
330
+ 4.4
331
+ 0
332
+ 0
333
+ Post-hysterectomy
334
+ 2
335
+ 2
336
+ 1
337
+ 2.2
338
+ 1
339
+ 1.9
340
+ Histopathology type
341
+ IDC
342
+ 75
343
+ 76.5
344
+ 38
345
+ 84.4
346
+ 37
347
+ 69.8
348
+ ILC
349
+ 14
350
+ 14.3
351
+ 5
352
+ 11.2
353
+ 9
354
+ 17
355
+ IPC
356
+ 6
357
+ 6.1
358
+ 2
359
+ 4.4
360
+ 4
361
+ 7.5
362
+ IDC-P
363
+ 3
364
+ 3.1
365
+ 0
366
+ 0
367
+ 3
368
+ 5.6
369
+ Treatment regimen
370
+ S + RT + CT6
371
+ 49
372
+ 50
373
+ 22
374
+ 48.9
375
+ 27
376
+ 50.9
377
+ S + CT6
378
+ 7
379
+ 7.1
380
+ 4
381
+ 8.9
382
+ 3
383
+ 5.6
384
+ S + CT3 + RT + CT3
385
+ 28
386
+ 28.6
387
+ 12
388
+ 26.7
389
+ 16
390
+ 30.2
391
+ S + RT
392
+ 10
393
+ 10.2
394
+ 5
395
+ 11.1
396
+ 5
397
+ 9.4
398
+ S + CT6 + RT
399
+ 4
400
+ 4.1
401
+ 2
402
+ 4.4
403
+ 2
404
+ 3.8
405
+ Stressful life events past 2 years
406
+ Yes
407
+ 27
408
+ 28
409
+ 10
410
+ 22.2
411
+ 17
412
+ 32.1
413
+ No
414
+ 71
415
+ 72
416
+ 35
417
+ 77.8
418
+ 36
419
+ 67.9
420
+ Control group = Supportive Therapy, IDC—Infiltrating Ductal Carcinoma, ILC��Infiltarting Lobular Carcinoma, IPC—Infiltrating Papillary
421
+ Carcinoma, IDC-P—Infiltrating Ductal Carcinoma-Papillary type, S—Surgery, RT—Radiotherapy, CT—Chemotherapy.
422
+ followed up with telephone calls and house visits. While
423
+ the goals of yoga intervention were stress reduction and
424
+ appraisal changes, the goals of supportive therapy were edu-
425
+ cation, reinforcing social support and coping preparation.
426
+ Statistical methods
427
+ Data were analyzed using Statistical Package for Social Sci-
428
+ ences version 10.0. We used a per protocol analysis in this
429
+ study analyzing only those subjects who underwent surgery
430
+ followed by radiotherapy and six cycles of chemotherapy
431
+ (in this order) for the study as heterogeneity in treat-
432
+ ment modalities and sequence could have confounded the
433
+ results. A GLM-repeated measures ANOVA was done with
434
+ the within-subjects factor being time/assessments at six
435
+ levels and between-subjects factor being groups at two
436
+ levels (yoga and supportive therapy). Both within-subjects
437
+ and between-subjects effect and group by time interac-
438
+ tion effects were assessed. Post hoc tests were done using
439
+ Bonferroni correction for changes at different time points
440
+ between groups. Intention to treat analysis was also done on
441
+ the initially randomized sample (n = 98) with baseline mea-
442
+ sure and post-measure (post-CT) for all subjects. Baseline
443
+ value was carried forward for subjects who did not have
444
+ a post-measure (including those who received other treat-
445
+ ment schedules and study drop outs). Pearson correlation
446
+ analysis was used to study the bivariate relationships of
447
+ anxiety state and trait scores with treatment-related symp-
448
+ tom severity and distress at various conventional treatment
449
+ intervals (post-surgery/mid-RT/mid-CT).
450
+ Results
451
+ The subjects in our study were recruited and followed-up
452
+ between January 1999 and June 2004. The groups were
453
+ comparable with respect to socio-demographic and medical
454
+ characteristics (see Table 1). Subjects in both groups (con-
455
+ trol 45%, yoga 39%) received anxiolytic medications during
456
+ their chemotherapy to prevent aversive responses (alprazo-
457
+ lam 0.5 mg once daily for 1 week following chemotherapy
458
+ infusion). The subjects received anxiolytics as a comedica-
459
+ tion for only one to two cycles of chemotherapy.
460
+ Anxiety state
461
+ A repeated measures analysis of variance was done on
462
+ anxiety state scores. Sphericity was assumed with Hyun
463
+ Anxiolytic effects of a yoga program in early breast cancer patients
464
+ 5
465
+ feldt э at 0.6. Though group by time interaction effects
466
+ were not significant, the between-subjects effect was sig-
467
+ nificant F (1, 35) = 10.8, p = 0.002. Post hoc tests using
468
+ Bonferroni correction showed significant decrease in anxiety
469
+ states in yoga group as compared to control at post-surgery
470
+ (mean change ± S.E., p value, 95% CI), (4.3 ± 1.96, p = 0.04,
471
+ 0.2—8.3), mid-RT (5.7 ± 2.2, p = 0.01, 1.3—10.2), post-RT
472
+ (5.5 ± 2.1, p = 0.01, 1.3—9.7), mid-CT (8.9 ± 2.2, p < 0.001,
473
+ 4.3—13.3), and post-CT (8.9 ± 2.6, p = 0.002, 3.6—14.2) (see
474
+ Table 2). However, intention to treat analysis done on the
475
+ initially randomized sample showed a significant change
476
+ between groups on state measure following intervention
477
+ (4.7 ± 2.1, p = 0.05, 1.1—6.4) (Table 3).
478
+ Anxiety trait
479
+ A repeated measures analysis of variance was done on anx-
480
+ iety trait scores. Sphericity was assumed with Hyun feldt
481
+ э at 0.75. Though group by time interaction effects was
482
+ not significant, the between-subjects effect was significant
483
+ F (1, 35) = 8.2, p = 0.007. Post hoc tests using Bonferroni
484
+ correction showed significant decrease in anxiety trait in
485
+ the yoga group as compared to controls at post-surgery
486
+ (mean change ± S.E., p value, 95% CI), (6.9 ± 2.4, p = 0.007,
487
+ 2—11.8), post-RT (5.8 ± 2.1, p = 0.01, 1.5—10.1), and post-
488
+ CT (8.2 ± 2.8, p = 0.005, 2.6—13.8) (see Table 2). However,
489
+ intention to treat analysis done on the initially randomized
490
+ sample did not show any significant change between groups
491
+ on trait measure following intervention (Table 3).
492
+ Symptom distress
493
+ A repeated measures analysis of variance was done on
494
+ symptom distress scores. Sphericity was assumed with Hyun
495
+ feldt э at 1. Group by time interaction effects was sig-
496
+ nificant and between subjects effect was significant F (1,
497
+ 35) = 14.5, p = 0.001. Post hoc tests using Bonferroni cor-
498
+ rection showed significant decrease in symptom distress
499
+ in yoga group as compared to controls at post-surgery
500
+ (mean change ± S.E., p value, 95% CI), (6.4 ± 2.3, p = 0.009,
501
+ 1.7—11.1), mid-RT (10.1 ± 2.8, p = 0.001, 4.3—15.8), post-
502
+ RT (4.8 ± 1.7, p = 0.009, 1.4—8.2), mid-CT (16.3 ± 3.5,
503
+ p < 0.001,
504
+ 9.3—23.3),
505
+ and
506
+ post-CT
507
+ (7.7 ± 2.9,
508
+ p = 0.01,
509
+ 1.6—13.7) (Table 2).
510
+ There was a significant bivariate relationship between
511
+ anxiety states and traits with severity and distress of
512
+ treatment-related symptoms during various stages of con-
513
+ ventional treatment (see Table 4).
514
+ Discussion
515
+ We compared the effects of a 24-week yoga program
516
+ with supportive therapy in 38 recently diagnosed breast
517
+ cancer outpatients undergoing surgery, radiotherapy, and
518
+ chemotherapy. The results suggest an overall decrease in
519
+ both anxiety state (reactive anxiety) and trait with time in
520
+ both the groups. Yoga intervention reduced anxiety state
521
+ scores by 0.5% following surgery, 4.9% and 6% during and fol-
522
+ lowing radiotherapy and 8.5% and 11.6% during and following
523
+ chemotherapy from their respective baseline means than
524
+ Table 2
525
+ Comparison of scores for anxiety state, trait and symptom distress at various stages of conventional treatment using GLM-repeated measures ANOVA
526
+ Outcome measures
527
+ Pre-surgerya
528
+ Post-surgerya
529
+ During radiotherapya
530
+ Post-RT
531
+ During chemotherapya
532
+ Post-CT
533
+ Pre-RT
534
+ Mid-RT
535
+ Pre-CT
536
+ Mid-CT
537
+ STAI-anxiety state
538
+ Yoga, mean (S.D.)
539
+ 43.9 ± 11
540
+ 34 ± 3.2*
541
+ 34 ± 3.2
542
+ 29.3 ± 3.6*
543
+ 29.1 ± 3.6*
544
+ 29.1 ± 3.6
545
+ 29.3 ± 3.3***
546
+ 24.1 ± 3.1***
547
+ Control, mean (S.D.)
548
+ 48.7 ± 11.6
549
+ 38.3 ± 7.4
550
+ 38.3 ± 7.4
551
+ 35.3 ± 8.2
552
+ 34.3 ± 8.2
553
+ 34.3 ± 7.8
554
+ 38.2 ± 8.5
555
+ 33.1 ± 10.5
556
+ STAI-anxiety trait
557
+ Yoga, mean (S.D.)
558
+ 42.1 ± 8.8
559
+ 33.4 ± 3.9***
560
+ 33.4 ± 3.9
561
+
562
+ 30.1 ± 3.9**
563
+ 35.7 ± 7.8
564
+
565
+ 26.7 ± 3.9***
566
+ Control, mean (S.D.)
567
+ 46.8 ± 10.9
568
+ 40.6 ± 9.2
569
+ 40.6 ± 9.2
570
+
571
+ 35.7 ± 7.8
572
+ 35.7 ± 7.8
573
+
574
+ 34.9 ± 10.8
575
+ Symptom distress
576
+ Yoga, mean (S.D.)
577
+ 13.9 ± 9.5
578
+ 9.2 ± 8.3***
579
+ 9.2 ± 8.3
580
+ 10.1 ± 6.5***
581
+ 5.4 ± 5.6***
582
+ 31.8 ± 4.7
583
+ 15.3 ± 9.7***
584
+ 5.1 ± 6.5*
585
+ Control, mean (S.D.)
586
+ 15.8 ± 8.5
587
+ 15.3 ± 5.7
588
+ 34.4 ± 8.7
589
+ 19.8 ± 10.1
590
+ 10.1 ± 4.7
591
+ 37.6 ± 7.8
592
+ 31.6 ± 11.1
593
+ 12.8 ± 10.7
594
+ *p values < 0.05, **p values < 0.01, ***p values < 0.001, for post hoc tests comparing groups at different time points using Bonferroni correction. y = yoga, c = control/supportive therapy
595
+ group.
596
+ a Y (n = 18), C (n = 20).
597
+ 6
598
+ M.R. Rao et al.
599
+ Table 3
600
+ Comparison of scores between yoga and control
601
+ groups at baseline and following intervention on intention
602
+ to treat analysis using RMANOVA in the initially randomized
603
+ sample (n = 98)
604
+ Measures
605
+ Baseline
606
+ (mean ± S.D.)
607
+ Post-intervention
608
+ (mean ± S.D.)
609
+ Anxiety state
610
+ Yoga (n = 45)
611
+ 47.7 ± 11.1
612
+ 37.8 ± 11.6*
613
+ Control (n = 53)
614
+ 51.1 ± 10.9
615
+ 45.9 ± 14.2
616
+ Anxiety trait
617
+ Yoga (n = 45)
618
+ 45.7 ± 10.8
619
+ 37.9 ± 13.8
620
+ Control (n = 53)
621
+ 48.5 ± 10.3
622
+ 41.5 ± 12.3
623
+ y = yoga, c = control/supportive therapy group.
624
+ * p < 0.05 for post hoc tests comparing groups at different time
625
+ points using Bonferroni correction.
626
+ the control group. There was also a corresponding decrease
627
+ in anxiety trait scores by 7% following surgery, 8.1% follow-
628
+ ing radiotherapy, and 10.4% following chemotherapy from
629
+ their baseline means as compared to controls. However,
630
+ the decrease was less on intention to treat analysis. Our
631
+ results are bolstered by other studies in non-cancer popula-
632
+ tions using yoga intervention that have clearly demonstrated
633
+ both change in state and trait anxiety following 10 days to
634
+ 6 months of intervention.31,34—38
635
+ In all these studies the effect size for reduction in anxiety
636
+ by yoga were large (>0.8), where as in our study the effect
637
+ size (Cohen’s f) for anxiety state was 0.33 and trait was
638
+ 0.24. Another randomized controlled trial in cancer patients
639
+ using the anxiety subscale of the Profile of Moods Scale
640
+ also reported large effect size with MBSR intervention.39,40
641
+ High effect sizes seen with the above intervention could be
642
+ due to absence of an effective control intervention. It can
643
+ be argued that a modest effect size (<0.5) seen with our
644
+ intervention could be due to the fact that we controlled
645
+ for education, support and attention in these subjects that
646
+ could have reduced the effects of our intervention. Another
647
+ reason could also be for the fact that patients were followed
648
+ over a long period and repeat measurements could have
649
+ reduced the effect size of our intervention. Nevertheless,
650
+ our finding that yoga helped reduce treatment-related dis-
651
+ Table 4
652
+ Pearson correlation (r values) between anxiety
653
+ scores and treatment-related symptoms (severity and dis-
654
+ tress) at various conventional treatment intervals
655
+ Symptom severity
656
+ Symptom distress
657
+ r (95% CI)
658
+ r (95% CI)
659
+ Post-surgery
660
+ Anxiety state
661
+ 0.66 (0.62—1.1)
662
+ 0.65 (0.34—0.84)
663
+ Anxiety trait
664
+ 0.68 (0.77—1.3)
665
+ 0.69 (0.66—1.2)
666
+ During radiotherapy
667
+ Anxiety state
668
+ 0.73 (0.62—0.98)
669
+ 0.73 (0.5—0.79)
670
+ Anxiety trait
671
+ 0.60 (0.62—1.15)
672
+ 0.58 (0.67—1.15)
673
+ During chemotherapy
674
+ Anxiety state
675
+ 0.58 (0.27—0.57)
676
+ 0.64 (0.26—0.70)
677
+ Anxiety trait
678
+ 0.49 (0.31—1.1)
679
+ 0.50 (0.41—1.1)
680
+ tress and severity at various treatment follow-up intervals
681
+ support the anxiolytic effects of our intervention.
682
+ Overall, the results suggest that anxiolytic effects of
683
+ yoga program could be attributed to stress reduction rather
684
+ than mere social support and education in conformity with
685
+ earlier studies.41,42 Scores on anxiety state and trait corre-
686
+ lated directly with symptom severity and distress at various
687
+ stages of conventional treatment further supporting the
688
+ idea that reductions in anxiety could contribute to decre-
689
+ ments in treatment-related distress and outcomes.43 Earlier
690
+ studies also show that state and distressful symptoms can
691
+ also change an individual’s personality trait44 and hence
692
+ trait changes can also be seen with our intervention. Ear-
693
+ lier studies have shown that though distressful symptoms
694
+ do influence traits, they are independent of each other and
695
+ changes could be actually related to test retest issues and
696
+ the inadequacy of the trait scale itself and not related to
697
+ change in distressful symptoms. However, trait changes were
698
+ not significant on intention to treat analysis and the results
699
+ must therefore be viewed with caution. We have shown ear-
700
+ lier that yoga has been helpful in reducing aversive reactions
701
+ to chemotherapy such as nausea and vomiting.33 A reduction
702
+ in symptom distress and subjective severity is an important
703
+ benefit to be gained via stress reduction techniques such as
704
+ yoga.
705
+ We chose to have individual yoga therapy and supportive
706
+ counselling sessions as compared to group therapy as being
707
+ in a group could have confounded the benefits conferred
708
+ by our interventions.45 Moreover, these individual sessions
709
+ also helped to understand the specific needs and concerns
710
+ of participants and monitor individual progress in practice.
711
+ Finally, none of the patients in our study reported any mus-
712
+ culoskeletal complaints or any other adverse event that may
713
+ be related to yoga practice indicating that the yoga module
714
+ developed for cancer patients was safe.
715
+ We have also demonstrated that this yoga intervention
716
+ package could be used in a cancer centre along with the
717
+ routine treatment without any need for additional expen-
718
+ sive infrastructure. This would be feasible and cost effective
719
+ especially in a developing country where supportive services
720
+ for cancer patients are rarely available and access to care
721
+ is not affordable for the majority of the cancer population.
722
+ One of the major limitations in our study is the inequality
723
+ in contact duration of interventions. Supportive therapy
724
+ interventions were used only with an intention of negating
725
+ the confounding variables such as instructor—patient inter-
726
+ action, education, and attention.46 However, inequality in
727
+ contact duration of this intervention could have affected
728
+ its effectiveness as successes of such interventions depend
729
+ mainly on contact duration and content. Similar support-
730
+ ive sessions have been used successfully as a control
731
+ comparison
732
+ group
733
+ to
734
+ evaluate
735
+ psychotherapeutic
736
+ interventions46,47
737
+ and have been effective in control-
738
+ ling chemotherapy related side effects.48 Secondly; it was
739
+ not possible to mask the yoga intervention from the study
740
+ participants. Blinding in yoga studies is a topic of intense
741
+ discussion in yoga research. As yet there has been no perfect
742
+ method for blinding yoga therapy from the participants
743
+ because of the nature of the therapy itself, which involves
744
+ the patients being asked to perform asanas as well as a
745
+ spiritual component that includes the knowledge that they
746
+ are performing yoga.
747
+ Anxiolytic effects of a yoga program in early breast cancer patients
748
+ 7
749
+ Conclusions
750
+ In summary, our yoga-based intervention was effective in
751
+ reducing reactive anxiety and trait anxiety in early breast
752
+ cancer patients undergoing conventional cancer treatment.
753
+ This was probably facilitated through stress reduction and
754
+ helping the cancer patients to cope better with their illness
755
+ at various stages of their conventional treatment. Future
756
+ studies should explore the putative neurophysiologic mech-
757
+ anisms underlying the anxiolytic effects conferred by yoga
758
+ intervention.
759
+ Acknowledgements
760
+ We are thankful to Dr Jayashree, Mrs. Anupama for imparting
761
+ the yoga intervention. We are thankful to Dr. B.N. Gangad-
762
+ har, Prof and Head, Department of Psychiatry for editing this
763
+ manuscript. We are thankful to Central Council for Research
764
+ in Yoga and Naturopathy, Ministry of Health and Family Wel-
765
+ fare, Govt. of India for funding this study.
766
+ References
767
+ 1. Chaturvedi SK, Prabha Chandra S, Channabasavanna SM, Anan-
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+ tha N, Reddy BKM, Sharma Sanjeev. Levels of anxiety and
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+ 4. Welch DA. Assessment of nausea and vomiting in cancer
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subfolder_0/Application of integrated yoga therapy to increase imitation skills in children with autism.txt ADDED
@@ -0,0 +1,552 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ International Journal of Yoga  Vol. 3  Jan-Jun-2010
2
+ 26
3
+ Motor imitation is a complex developmental phenomenon
4
+ that serves important cognitive and social functions. At
5
+ a social level, it represents earliest forms of reciprocal
6
+ interactions between infant and the mother.
7
+ There is a growing body of literature demonstrating that
8
+ children with autism have specific deficits in imitating
9
+ action on objects, body movements, vocalization,
10
+ gesture, functional objectives and facial expression. Most
11
+ researchers recognize imitation as a central deficit in
12
+ children with autism[3,4] and a lack of imitative play is one
13
+ of the diagnostic criteria for the disability.[5]
14
+ Imitation is defined as the reproduction of a model’s
15
+ action in topography and function for the new actions
16
+ only. Charmil and Baren-Cohen,[6] Dawson and Adams[7]
17
+ and De Myer[8] were among the first to investigate
18
+ imitation skills in autism. In their experiment, 12 children
19
+ with autism and early childhood schizophrenia were
20
+ intROductiOn
21
+ The ability to understand another person’s action and, if
22
+ needed, imitate that action is a core component of human
23
+ social behavior. Imitation skills can be observed as early
24
+ as infancy. In typical infants, imitation emerges early in
25
+ development and plays a crucial role in the development
26
+ of cognitive, social, communication and other behaviors
27
+ such as language, play and joint attention.[1]
28
+ Early imitation is a non-verbal means of information
29
+ processing. In normal development, the baby is not taught
30
+ imitation as such; only in the second half of the year
31
+ parents begin to teach imitation like waving bye-bye, etc.
32
+ Typical children with autism spectrum disorder (ASD) fail
33
+ to demonstrate these skills. The more social the imitation
34
+ is, the harder it is to master. In the order of difficulty,
35
+ spontaneous object use is least difficult, motor object
36
+ imitation difficult and body imitation most difficult.[2]
37
+ Background/Aim: Children with autism exhibit significant deficits in imitation skills, which impede the acquisition of more complex
38
+ behavior and socialization. Imitation is often targeted early in intervention plans and continues to be addressed throughout the
39
+ child’s treatment. The use of integrated approach to yoga therapy (IAYT) as a complementary therapy for children diagnosed
40
+ with autism spectrum disorder (ASD) is rarely reported and little is known on the effectiveness of such therapies. This study
41
+ investigated IAYT as a treatment method with children with ASD to increase imitative skills.
42
+ Materials and Methods: Parents and six children with ASD participated in a 10-month program of 5-weekly sessions and
43
+ regular practice at home. Pre, mid and post treatment assessments included observers and parent ratings of children’s imitation
44
+ skills in tasks related to imitation skills such as gross motor actions, vocalization, complex imitation, oral facial movements
45
+ and imitating breathing exercises.
46
+ Results: Improvement in children’s imitation skills especially pointing to body, postural and oral facial movements. Parents
47
+ reported change in the play pattern of these children with toys, peers and objects at home.
48
+ Conclusions: This study indicates that IAYT may offer benefits as an effective tool to increase imitation, cognitive skills and
49
+ social-communicative behaviors in children with ASD. In addition, children exhibited increased skills in eye contact, sitting
50
+ tolerance, non-verbal communication and receptive skills to verbal commands related to spatial relationship.
51
+ Key words: Autism, Yoga, Imitation
52
+ ABSTRACT
53
+ Application of integrated yoga therapy to increase imitation
54
+ skills in children with autism spectrum disorder
55
+ Shantha Radhakrishna
56
+ Sri. Ganapathi Sachchidananda (SGS) Vagdevi Centre for the Rehabilitation of Communication Impaired, Bangalore, Karnataka, India
57
+ Address for correspondence: Shantha Radhakrishna,
58
+ Sri. Ganapathi Sachchidananda (SGS) Vagdevi Centre for the Rehabilitation of Communication Impaired,
59
+
60
+ 3rd C Main, 7th Cross, Girinagar II Phase, Bangalore - 560 085, Karnataka, India.
61
+ E-mail: [email protected]
62
+ DOI: 10.4103/0973-6131.66775
63
+ Original Article
64
+ www.ijoy.org.in
65
+ 27
66
+ International Journal of Yoga  Vol. 3  Jan-Jun-2010
67
+ compared to a controlled group of children with mental
68
+ retardation. The groups were evaluated on a variety of
69
+ body movements and object manipulation. Children with
70
+ autism exhibited significantly less imitation skill and
71
+ had particular difficulty with gestural imitation. Many
72
+ studies supported these findings. Heimann, Ullstadius,
73
+ Danigren and Gilberg[9] also found that motor tasks were
74
+ the least frequently imitated categories in children with
75
+ autism. Many more studies confirmed the above findings
76
+ of a relative deficit in motor imitation in children with
77
+ autism.[10]
78
+ Imitation research on children with autism has focused
79
+ primarily on the form of imitation (i.e. gestural, object, facial,
80
+ vocal). Cognitive developmental research on imitation
81
+ in autism generally used Piagetian models of sensory
82
+ motor development and compared children with autism
83
+ to mental age matched peers on a series of sensory motor
84
+ tasks. In behavioral research of imitation in children with
85
+ autism, emphasis is often placed on factors influencing skill
86
+ acquisition including teaching factors such as presentation
87
+ mode and model type. Independent variables evaluated in
88
+ behavioral analytic literature typically include response
89
+ class generalization and peer modeling. De Myer’s[8]
90
+ initial research generated many studies supportive of the
91
+ general findings of imitation deficits in autism. Findings
92
+ of deficits in imitation skills have significant implications
93
+ for the intervention approaches given the critical nature of
94
+ imitation to one’s ability to learn from the environment.
95
+ Treatment for autism based on either behavioral or
96
+ cognitive developmental models emphasizes on developing
97
+ imitation skills in young children with autism. The
98
+ methods and treatments used remain to be empirically
99
+ validated.
100
+ Many behavioral treatment approaches focusing on
101
+ imitation are in use in treating children with autism. In
102
+ discrete trial training (DTT), a target behavior or skill is
103
+ broken into component parts and repeatedly practiced
104
+ with prompting and fading the prompting until the skills
105
+ are mastered.
106
+ The applied behavioral analysis (ABA) also includes
107
+ teaching imitation skills in a “command/prompt method”
108
+ where a teacher provides a prompt or command for the
109
+ autistic student to initiate and if the student achieves
110
+ the desired behavior, there are rewards and if not, there
111
+ are repeats of the command/prompt and a repeat for the
112
+ student to produce the expected behavior. The desired
113
+ behavior is then reinforced and the student can repeat the
114
+ expected behavior in the classroom.
115
+ There are many behavioral treatment approaches such as
116
+ language training behavior, natural language procedure,
117
+ incidental teaching, pivotal learning and errorless
118
+ learning. All these basic procedures use ABA principles
119
+ such as stimulus control, prompts, modeling, shaping
120
+ and reinforcement to teach imitation skills. All these
121
+ procedures consider imitation skills to be essential to new
122
+ learning. Imitation skills are typically among the first to
123
+ be taught in many of these programs because they are
124
+ often considered being pre-requisite abilities for learning
125
+ other skills, e.g. motor imitation (clapping, running,
126
+ walking on toes and jumping). Once basic imitation skills
127
+ are established, they can be used as building blocks for
128
+ complex tasks.
129
+ A pilot study by Radhakrishna[11] suggests that integrated
130
+ approach to yoga therapy (IAYT) can specifically increase
131
+ imitation skills, an essential pre-requisite for learning. It
132
+ also demonstrated changes in non-verbal communication,
133
+ self-esteem, emotional bonding, focus, tolerance to touch,
134
+ proximity and sharing of attention.
135
+ The study reported here started with the premise that as
136
+ clinicians, we need to develop intervention approaches that
137
+ are derived from a number of theoretical understandings
138
+ of autism.
139
+ The IAYT approach is based on the philosophy that the
140
+ child is perfect and whole, and that the child and therapist
141
+ are both unlimited in their abilities to teach. Supporting
142
+ these beliefs is empirically sound therapy based on yoga
143
+ philosophy and practice to help the child to reach his/her
144
+ highest potential for a quality life.
145
+ mateRials and methOds
146
+ subject selection
147
+ This study adopted a case study approach. The IAYT
148
+ program was publicized through workshops conducted at
149
+ various national institutes and centers and schools for ASD
150
+ children. Six children admitted to SGS Vagdevi Integrated
151
+ School were matched for age, sex, IQ and socioeconomic/
152
+ educational background of parents. Children who were
153
+ already diagnosed with ASD by leading institutions of
154
+ Bangalore, India, were selected for the study. Diagnosis
155
+ was cross-validated by the author using DSM-IV-TR[5]
156
+ criteria. The Childhood Rating Scale[12] was also used to
157
+ determine autism severity. All the children demonstrated
158
+ mild to moderate range of autism.
159
+ Data are given in Table 1.
160
+ Table 1: Demographic data
161
+ No.
162
+ Age
163
+ Sex
164
+ IQ
165
+ SEB
166
+ EB
167
+ 6
168
+ 8–14 years
169
+ M/F = 5/1
170
+ 70 and above
171
+ Middle class
172
+ Graduates
173
+ SEB = Socio-economic background (minimum Rs. 8000); EB = Educational
174
+ background (graduate mothers)
175
+ ASDIM
176
+ International Journal of Yoga  Vol. 3  Jan-Jun-2010
177
+ 28
178
+ Written consent to participate in the study was obtained
179
+ from the parents.
180
+ imitation test battery
181
+ The tasks given in Table 2 were developed for this study
182
+ based on previous pilot study experience by the researcher
183
+ who is a speech-language/yoga therapist by profession.
184
+ assessment procedure
185
+ Special educators and parents contributed to a range of
186
+ data collection procedure through questionnaire and
187
+ observers’ comments and interviews. Assessment was
188
+ conducted at 3 points. Pre (1–12 sessions), mid (60th, 80th
189
+ and 100th sessions) and post (180th, 181st and 182nd
190
+ sessions).
191
+ child assessment measures
192
+ Perceived outcomes of IAYT for the child were measured
193
+ at the mid and end points of the program. Parents
194
+ completed a short questionnaire to see whether IAYT
195
+ has made any change on the five targeted areas of
196
+ behavior. A simple 3-point rating scale was used (based
197
+ on researcher’s pilot study[11]) to obtain information on
198
+ the level of benefit (0 = rarely imitates, 1 = occasionally
199
+ imitates, 2 = consistently imitates). Three trained
200
+ observers completed the assessment. Responses were
201
+ scored on a 3-point scale; a “2” was recorded if the child
202
+ produced exact imitation, a “1” was recorded if the child
203
+ produced an occasional imitation and a “0” was recorded
204
+ if the child rarely imitates or imitation absent. Inter-rater
205
+ reliability was established prior to scoring and maintained
206
+ throughout the study.
207
+ yoga intervention
208
+ Yoga therapy was then introduced five times a week 45
209
+ minutes daily for 10 months. Mother accompanied the
210
+ child during all these sessions. These sessions took place
211
+ in an open green, serene spiritual atmosphere overlooking
212
+ an ashram and temple. Children used their own mats and
213
+ marked their own boundary of operation. Yoga asanas
214
+ (postures) and pranayama (breathing exercises) adopted in
215
+ this study were specially selected to address issues related
216
+ to imitation difficulties with ASDs.
217
+ Exercises adopted during IAYT are listed in Table 3.
218
+ The sequence consisted of “warm-up asanas, strengthening
219
+ asanas, release of tension asanas, calming asanas and
220
+ breathing asanas”. Yogasanas selected initially were
221
+ physically less demanding. During warm-up asanas, if
222
+ the child did not imitate the therapist, the attending adult
223
+ physically guided the child to complete the task. The child
224
+ slowly learned that she/he is expected to imitate the model.
225
+ It also provided a motor plan to complete more asanas.
226
+ Results and discussiOn
227
+ First the children’s baseline data are described in
228
+ relation to imitation skills. Second, changes in various
229
+ parameters at mid and post therapy phase are discussed.
230
+ In the third section, changes in the related behavior,
231
+ namely communication, social relationships and
232
+ behavioral perseveration, are elaborated. The initial
233
+ interviews with parents and staff carried out to gain
234
+ an insight into the current imitation behavior are
235
+ summarized.
236
+ Relative absence of imitation was not of immediate
237
+ concern to parents as their knowledge of the importance of
238
+ imitation and its impact on development was limited. From
239
+ the parents’ perceptive, lack of any form of communication,
240
+ not playing with other children, hyperactivity was
241
+ something they found particularly difficult to cope with.
242
+ The baseline, mid and post therapy data are summarized
243
+ in Figure 1.
244
+ summary of imitation behaviors
245
+ At the start of the study, children in this sample
246
+ • never imitate gross motor actions (could not imitate
247
+ the model’s actions of pointing to body parts)
248
+ • rarely imitate vocalization
249
+ • never imitate two phase complex movements
250
+ • rarely imitate oral facial movements
251
+ • never imitate adult breathing in and out model
252
+ Table 2: Target imitation skills
253
+ Imitating
254
+ gross motor
255
+ actions
256
+ Imitating
257
+ vocalization
258
+ Complex
259
+ imitation
260
+ Imitating
261
+ oral facial
262
+ movements
263
+ Breathing
264
+ exercises
265
+ Running
266
+ Walking
267
+ Jumping
268
+ Walking on
269
+ toes
270
+ Imitating
271
+ sounds (A, E,
272
+ U, OM)
273
+ Imitating words
274
+ Imitating
275
+ phrases
276
+ Simple
277
+ asanas
278
+ Imitating
279
+ sequence
280
+ actions
281
+ Lips, tongue
282
+ and jaw
283
+ exercises
284
+ Blowing
285
+ exercises
286
+ In and out
287
+ breathing
288
+ Sectional
289
+ breathing
290
+ Table 3: Yoga intervention
291
+ Warm-up
292
+ asanas
293
+ Strengthening
294
+ asanas
295
+ Release
296
+ of tension
297
+ asanas
298
+ Calming
299
+ asanas
300
+ Breathing
301
+ asanas
302
+ Jogging
303
+ Bending
304
+ exercises
305
+ Twisting
306
+ Trikonasana
307
+ Parshavakonasana
308
+ Veerabhadrasana
309
+ Neck
310
+ exercises
311
+ Back
312
+ bending
313
+ exercises
314
+ Relaxation
315
+ exercises
316
+ Sukhasana
317
+ Shavasana
318
+ Blowing
319
+ exercises
320
+ in and out
321
+ breathing
322
+ sectional
323
+ breathing
324
+ Radhakrishna
325
+ 29
326
+ International Journal of Yoga  Vol. 3  Jan-Jun-2010
327
+ All the six children performed poorly in imitating
328
+ breathing exercises. They could not perform even simple
329
+ blowing exercises. This may be directly related to their
330
+ poor vocalization and expressive speech. They had
331
+ difficulty imitating two or more sequence imitations,
332
+ initiate vocalization and imitating gross motor actions.
333
+ Children were clumsy with their movements, were poorly
334
+ coordinated and could not run, jump, hop and walk
335
+ on toes. Four out of six children occasionally imitated
336
+ oral facial movements like protruding, elevating tongue
337
+ and puckering lips. Generally, this supports previous
338
+ research findings that children underperformed on various
339
+ imitation tasks such as gross motor actions, vocalization,
340
+ complex imitation, oral facial imitation and imitating
341
+ breathing exercises.[10] Complex motor tasks were the
342
+ least frequently imitated category compared to oral facial
343
+ movement imitation. Children had more difficulty on
344
+ tasks with multiple components than task involving one
345
+ action. Attempts by the therapist to involve the child to
346
+ sit in vajrasana (folding both legs backward and sitting
347
+ on the heel) initially resulted in the child losing interest
348
+ in therapy program and running away. No attempts were
349
+ made to force the children on the therapy mat, but slowly
350
+ they joined the group voluntarily.
351
+ During the mid assessment period, there was a significant
352
+ change in imitating gross motor actions, oral facial movements
353
+ and performing breathing exercises, but little change was seen
354
+ in imitating complex imitation and vocalization.
355
+ During last few sessions, significant changes in the
356
+ imitation skills related to all the five parameters and
357
+ also changes in communication, functional object use,
358
+ language, play and joint attention were seen. Pattern of
359
+ eye contacts steadily improved. Children started focusing
360
+ on the yoga therapist as she gave counts with drumbeat.
361
+ Initially, mothers manually guided the children to imitate
362
+ the movement. Slowly, manual manipulation decreased
363
+ and children started imitating complex motor movements
364
+ spontaneously. It is possible that a gentle touch or
365
+ pressure gave them a different experience and they started
366
+ perceiving changing dynamics and became interested in
367
+ therapy. Consequently, children started to display early
368
+ shared attention behaviors such as looking at the peers,
369
+ making eye contact with the therapist and offering no
370
+ resistance to the therapist.
371
+ In addition to these behaviors, an increase in facial
372
+ expression (pain and pleasure), vocalizations and gazing
373
+ at peers suggested an emerging understanding that sharing
374
+ an activity could be an enjoyable experience.
375
+ As the therapy progressed, increase in imitation skills
376
+ was noticed in imitating familiar and learnt movement.
377
+ Children started looking at peer model, resulting in
378
+ higher levels of generalization and maintenance of learnt
379
+ imitation behavior. This supports the study by Carr and
380
+ Darey[13] using different types of models (peer and adult)
381
+ and suggesting that peer model would help in better
382
+ generalization and maintenance of the learnt skill. Close
383
+ physical proximity of the mother and prompting of a
384
+ specific behavior by the mother may be a contributing
385
+ factor for higher generalization.
386
+ All the six children started to indicate their preferences
387
+ for asana, e.g. Shavasana, Parvathasana. They progressed
388
+ from the early resistance to passive tolerance to active
389
+ participation and enjoying the therapy sessions. Over
390
+ the course of yoga therapy, children started to trust,
391
+ share, initiate and reciprocate and thus the barrier to
392
+ communication of carrying the label of being “autistic”
393
+ is broken. By the end of 183rd session, all six children
394
+ engaged in 30–45 minutes of yoga therapy. During this
395
+ period, they all displayed increased intention to remain
396
+ in close proximity with the therapist and participated in
397
+ performing most of the asanas and breathing exercises.
398
+ ASDIM
399
+ Figure 1: Graphic representation of observed improvement in selected imitation behavioral traits
400
+ 0.18
401
+ 0.17
402
+ 0.17
403
+ 0.5
404
+ 0.15
405
+ 0.9
406
+ 0.7
407
+ 0.6
408
+ 1
409
+ 0.8
410
+ 1.8
411
+ 1.6
412
+ 1.4
413
+ 1.9
414
+ 1.5
415
+ 0
416
+ 0.2
417
+ 0.4
418
+ 0.6
419
+ 0.8
420
+ 1
421
+ 1.2
422
+ 1.4
423
+ 1.6
424
+ 1.8
425
+ 2
426
+ Parameter used for Imitation behavioural assessment
427
+ Average rating of responsiveness
428
+ on a scale 0 to 2
429
+ Imitating gross
430
+ motor actions
431
+ Imitating
432
+ vocalization
433
+ Complex imitation
434
+ Imitating oral facial
435
+ movements
436
+ Imitating breathing
437
+ exercises
438
+ Pre
439
+ Post
440
+ Mid
441
+ International Journal of Yoga  Vol. 3  Jan-Jun-2010
442
+ 30
443
+ All the six children showed increased vocal imitation skills
444
+ by imitating vowels “a, e, i, o, u” and “OM”. This increased
445
+ vocal imitation may be due to the verbal behavior approach
446
+ adopted by the yoga therapist who is also a Speech-
447
+ Language-Pathologist (SLP). Verbal behavior approach to
448
+ teaching language to children with autism emphasizes
449
+ teaching language units in its functional components
450
+ such as manding (to alter one’s environment), tacting
451
+ (to respond to sensory stimuli) and intraverbals (verbal
452
+ behavior in response to another person’s verbal behavior).
453
+ Imitation was used throughout the teaching of mands, tacts
454
+ and intraverbals. Changes in social interaction were seen.
455
+ Children started greeting the therapist with “namasthe”
456
+ (with folded hands) and verbalized “om shanthi” (let there
457
+ be peace) at the end of the therapy session.
458
+ Children engaged in increased play interaction during yoga
459
+ therapy sessions. Children who display increased imitation
460
+ skills during yoga therapy transferred these responses into
461
+ play situation whenever they engaged in symbolic play.
462
+ Final interviews with parents and staff were carried out
463
+ to assess whether the child’s imitation skill has changed
464
+ over the course of the study. Parents reported that their
465
+ children indicated basic needs using gestures, interacting
466
+ with other children during play situation and increased
467
+ sitting tolerance for an activity.
468
+ To conclude, this is the first scientific study in India
469
+ investigating the effect of IAYT to increase imitation skills
470
+ and also related language, social and cognitive skills.
471
+ This study aimed to investigate IAYT as a family-oriented
472
+ treatment alongside any conventional treatment received
473
+ by the children. The pilot study provides initial evidence
474
+ of the benefits of IAYT in alleviating the behavioral
475
+ symptoms of children diagnosed with ASD, confirmed
476
+ through parents’ and teachers’ report and children’s own
477
+ behavior. Future directions in IAYT research would be
478
+ well served by larger studies that involve teachers as well
479
+ as parents, followed by follow-up studies. Rigorously
480
+ controlled clinical trials on larger and more homogeneous
481
+ population would be needed to provide the necessary
482
+ rigor to assess the relative effect of IAYT as an alternative
483
+ or complementary treatment to increase imitation skills
484
+ in children with ASD. However, the indications are that
485
+ IAYT may offer families an effective management tool for
486
+ family-oriented treatment of childhood ASD.
487
+ acknOWledGments
488
+ The author gratefully acknowledges the contribution of parents of the
489
+ participants of the study and staff of Sri Ganapathi Sachchidananda
490
+ (SGS) Vagdevi Centre for the Rehabilitation of Communication
491
+ Impaired. The author also thanks Dr. Nagendra and Dr. Nagarathna
492
+ of Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)
493
+ for their input on Integrated Yoga Therapy (IYT).
494
+ RefeRences
495
+ 1.
496
+ Rogers S, Pennington B. A theoretical approach to the deficits in infantile
497
+ autism. Dev Psychol 1991;3:137-62.
498
+ 2.
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+ Siegel B. The world of the autistic child, Oxford; Oxford University
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+
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+ Press: 1991.
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+ 3.
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+ Smith IM, Bryson SE. Imitation and action in autism: A critical review.
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+ Psychol Bull 1994;116:259-73.
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+ 4.
506
+ Williams JH, Whiten A, Suddendorf T, Perrett DI. Imitation, mirror neurons
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+ and autism. Neurosci Biobehav Rev 2001;25:287-95.
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+ 5.
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+ American Psychiatric Association, Diagnostic and statistical manual of
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+ mental disorders. 4, text revision. Washington, DC: American Psychiatric
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+
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+ Association 2000.
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+ 6.
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+ Charman T, Swettenham J, Baron-Cohen S, Cox A, Baird G, Drew A. Infants
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+ with autism: An investigation of empathy, pretend play, joint attention, and
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+ imitation. Dev Psychol 1994;33:781-9.
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+ Dawson G, Adams A. Imitation and social responsiveness in autistic children.
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+ J Abnorm Child Psychol 1984;12:209-26.
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+ 8.
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+ DeMeyer MK, Alpern GD, Barton S, DeMyer WE, Churchill DW, Hingtgen
522
+ JN, et al. Imitation in autistic, early schizophrenic, and non-psychotic
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+ subnormal children. J Autism Child Schizophr 1972;2:264-87.
524
+ 9.
525
+ Heimann M, Ullstadius E, Danigren SO, Gilberg C. Imitation in autism. A
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+ preliminary research ote. Behav Neurol 1992;5:219-27.
527
+ 10. Stone WL, Ousley OY, Littleford CD. Motor imitation in young children with
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+ autism: What’s the object? J Abnorm Child Psychol 1994;25:475-85.
529
+ 11.
530
+ Radhakrishna S. Using Yoga Therapy (YT) to increase communication,
531
+ social and cognitive skills in children with autistic spectrum disorders.
532
+ Available from: http://www.integralpsychology.in/texts/nsip/nsip-abstracts/
533
+ shantharadhakrishna.html. [Last cited on 2007].
534
+ 12. Schopler E, Reichler RJ, DeVellis RF, Daly K. Toward objective classification
535
+ of childhood autism: Childhood Autism Rating Scale (CARS). J Autism Dev
536
+ Disord 1980;10:91-103.
537
+ 13. Carr EG, Darcy M. Setting generality of peer modeling in children with
538
+ autism. J Autism Dev Disord 1990;20:45-59.
539
+ Radhakrishna
540
+ Staying in touch with the journal
541
+ 1)
542
+ Table of Contents (TOC) email alert
543
+
544
+ Receive an email alert containing the TOC when a new complete issue of the journal is made available online. To register for TOC alerts go to
545
+ www.ijoy.org.in/signup.asp.
546
+ 2)
547
+ RSS feeds
548
+
549
+ Really Simple Syndication (RSS) helps you to get alerts on new publication right on your desktop without going to the journal’s website.
550
+ You need a software (e.g. RSSReader, Feed Demon, FeedReader, My Yahoo!, NewsGator and NewzCrawler) to get advantage of this tool.
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+ RSS feeds can also be read through FireFox or Microsoft Outlook 2007. Once any of these small (and mostly free) software is installed, add
552
+ www.ijoy.org.in/rssfeed.asp as one of the feeds.
subfolder_0/Association between a guided meditation practice, sleep and psychological well-being in type 2 diabetes mellitus patients.txt ADDED
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1
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
2
+ DE GRUYTER
3
+ Journal of Complementary and Integrative Medicine. 2018; 20150026
4
+ Short Communication
5
+ Mathew P Varghese1 / RagavendrasamyBalakrishnan1 / SubramanyaPailoor1,2
6
+ Association between a guided meditation
7
+ practice,sleep and psychological well-being in
8
+ type2 diabetes mellitus patients
9
+ 1 S-VYASA University, 19, Gavipuram Circle, K G Nagar, Bangalore, India, E-mail: [email protected],
10
11
+ 2 Department of Yoga, Central University of Kerala, Kasaragod, Kerala, India, E-mail: [email protected]
12
+ Abstract:
13
+ Background: Type 2 diabetes mellitus [T2DM] is one of the leading causes for mortality. This study examined
14
+ the role of an self-awareness based guided meditation practice, Cyclic Meditation [CM] on perceived stress,
15
+ anxiety, depression, sleep and quality of life in T2DM patients.
16
+ Design: A single arm pre-post design was used for the study.
17
+ Setting: The study was conducted in an auditorium for general public diagnosed with T2DM in Ernakulam,
18
+ Kerala, India.
19
+ Subjects: Subjects were 30 T2DM patients, both male and female of age 50.12 ± 11.15 years and BMI 25.14
20
+ ± 4.37 Kg/m2 and not having a history of hospitalisation were randomly recruited for the study following
21
+ advertisements in national dailies.
22
+ Intervention: Participants completed a supervised CM programs in the evenings, 5 days a week for 4 weeks,
23
+ in addition to their regular medication.
24
+ Measures: Perceived stress, anxiety and depression were assessed with Perceived Stress Scale, State Anxiety
25
+ Inventory and Beck’s depression inventory, respectively. Sleep and quality of life were assessed with Pittsburgh
26
+ Sleep Quality Index and WHO-Quality of Life – BREF respectively.
27
+ Analysis: Changes in the outcome measures from baseline to 4 weeks were compared using paired “t” test.
28
+ Results: After 4 weeks, the quality of life and sleep scores increased 7.1% [p = 0.001] and 32.7% [p = 0.001],
29
+ respectively. The perceived stress, anxiety and depression reduced 26.1% [p = 0.001], 16.01% [p = 0.003] and
30
+ 37.63% [p = 0.006] as compared to their baseline reports. The CM practice also reduced daytime dysfunction.
31
+ Conclusions: A guided self-awareness based meditation program was safe and effective in improving depres-
32
+ sion, anxiety, perceived stress and enhance sleep and quality of life in T2DM patients, which could be helpful
33
+ in reducing the future complications of T2DM. Mind management is essential along with medical management
34
+ to achieve better clinical results.
35
+ Keywords: cyclic meditation, depression, quality of life, sleep, type 2 diabetes mellitus
36
+ DOI: 10.1515/jcim-2015-0026
37
+ Received: May 7, 2015; Accepted: May 11, 2018
38
+ Introduction
39
+ India with a type 2 diabetes mellitus (T2DM) prevalence rate of 7.1% [1], is increasing proportionately to de-
40
+ clare it an epidemic [2]. Psychological stress plays a vital role in the incidence and development of T2DM [3].
41
+ Persistent stress causes release of stress hormones leading to loss of immune specificity, and a state of chronic
42
+ low grade inflammation resulting in metabolic disorders and aging [4, 5]. T2DM is understood to be a state
43
+ of chronic low grade inflammation, which over a period of time causes complications like atherosclerosis [6],
44
+ coronary artery disease [7], nephropathy [8] and obesity [9]. It has been noted that complications cause more
45
+ mortality than T2DM itself [10], demanding huge financial burden over the individual and also over the nation
46
+ [11].
47
+ Recent studies have given immense importance to understand the significance of relaxation. The role of
48
+ introspection and self-awareness has been given considerable importance in classical yoga literatures. To facil-
49
+ itate this process, a technique called cyclic meditation (CM) was evolved. CM, is a “moving meditation” which
50
+ RagavendrasamyBalakrishnan is the corresponding author.
51
+ © 2018 Walter de Gruyter GmbH, Berlin/Boston.
52
+ 1
53
+ Brought to you by | Göteborg University - University of Gothenburg
54
+ Authenticated
55
+ Download Date | 7/20/18 1:14 PM
56
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
57
+ Varghese et al.
58
+ DE GRUYTER
59
+ integrates the yoga practices along with guided meditation technique derived from Mandukya Upanishad [12],
60
+ developed by Nagendra HR. The verse on which the CM is based states that “awaken the mind in states of
61
+ mental inactivity; calm it when agitated; realise the possibilities of the mind in between these two mental states
62
+ and when the mind reaches the state of equilibrium do not disturb it”. The idea of the technique is to achieve
63
+ a state of equilibrium/relaxation through combination of alternating phases of stimulation and relaxation [13]
64
+ (refer to supplement material 1). Unlike other meditation practices, whose practice involves either focussing
65
+ or defocussing [14], CM involves a judicial combination of focussing followed by defocussing encouraging an
66
+ individuals’ attention and enhancing autonomic balance [15]. Earlier studies have shown CM to enhance sleep
67
+ quality, quality of life, and attention with better heart rate variability [15]. The present study was designed
68
+ to understand the role of awareness based meditation practices, CM - in addressing depression, anxiety and
69
+ quality of life in T2DM population.
70
+ The pilot work was carried out following the approval from the Institutional Ethical Committee. Thirty pa-
71
+ tients both male and female, diagnosed with T2DM since 6.97 ± 1.2 years, with mean 50.12 ± 11.15 years of
72
+ age, and BMI 25.14 ± 4.37 Kg/m [2] and not having a history of hospitalisation in the past 6 months were re-
73
+ cruited following advertisements issued in national dailies. A total of 70 patients were screened, and 33 patients
74
+ matching the inclusion criteria were recruited for the study. A written informed consent was obtained from the
75
+ recruits following their expression of interest to participate in the study. The study did not attract any financial
76
+ binding with the subjects. The practice involved 23 min of pre-recorded cyclic meditation practice every day for
77
+ 5 days in a week for 1 month practiced under supervision of experts. Recorded tapes containing instructions
78
+ were given to avoid the instructor bias.
79
+ Observations were made during the start and end of the month long intervention. Paired samples “t” test
80
+ was performed following normal distribution of data. Pittsburgh Sleep Quality Index revealed a significant
81
+ improvement in the global score (p ≤0.001), subjective sleep quality (p = 0.05), sleep latency (p = 0.001), sleep
82
+ duration (p = 0.017), sleep disturbance (p = 0.032), and daytime dysfunction (p = 0.029) suggestive of overall
83
+ improvement in quality of sleep. Quality of life as measured through WHO – Quality of Life had shown sig-
84
+ nificant improvements (p = 0.001). Also, a significant reduction was observed in state anxiety (p = 0.003), and
85
+ depression scores (p = 0.006) as reported by the state trait anxiety inventory and beck’s depression inventory-
86
+ II, respectively. Interestingly the subjective perception of stress was observed to be significantly reduced (p =
87
+ 0.001) as understood from the perceived stress scale [Table 1].
88
+ Table 1: ap ≤0.05, bp ≤0.01, cp ≤0.001, Paired Sample “t” test. Comparing day 30 values with respective day 1 values
89
+ (Mean ± SD) following cyclic meditation intervention.
90
+ Assessments
91
+ Pre
92
+ Post
93
+ p Value
94
+ (Mean ± SD)
95
+ (Mean ± SD)
96
+ BDI-II
97
+ 11.96 ± 8.96
98
+ 7.46 ± 5.12b
99
+ p ≤0.01
100
+ PSS
101
+ 17.85 ± 6.39
102
+ 13.19 ± 5.42c
103
+ p ≤0.001
104
+ STAI (state)
105
+ 40.58 ± 8.84
106
+ 34.08 ± 9.04b
107
+ p ≤0.01
108
+ WHOQOL domains
109
+ Physical health
110
+ 24.92 ± 3.16
111
+ 26.88 ± 3.80c
112
+ p ≤0.001
113
+ Psychological
114
+ 20.08 ± 3.11
115
+ 22.12 ± 3.23c
116
+ p ≤0.001
117
+ Social & personal
118
+ relationships
119
+ 11.00 ± 1.98
120
+ 11.35 ± 2.17
121
+ Environment
122
+ 27.85 ± 4.65
123
+ 29.88 ± 3.09a
124
+ p ≤0.05
125
+ Global score
126
+ 83.85 ± 10.34
127
+ 90.23 ± 9.88c
128
+ p ≤0.001
129
+ PSQI
130
+ Subjective sleep
131
+ quality
132
+ 0.88 ± 0.65
133
+ 0.62 ± 0.70a
134
+ p ≤0.05
135
+ Sleep latency
136
+ 0.92 ± 1.05
137
+ 0.35 ± 0.75c
138
+ p ≤0.001
139
+ Sleep duration
140
+ 1.92 ± 0.89
141
+ 1.58 ± 0.90a
142
+ p ≤0.05
143
+ Habitual sleep
144
+ efficiency
145
+ 0.85 ± 1.19
146
+ 0.50 ± 0.99
147
+ p = 0.059
148
+ Sleep disturbance
149
+ 1.08 ± 0.69
150
+ 0.81 ± 0.57a
151
+ p ≤0.05
152
+ Use of sleep
153
+ medication
154
+ 0.23 ± 0.82
155
+ 0.31 ± 0.88
156
+ p = 0.538
157
+ Daytime dysfunction
158
+ 0.81 ± 0.63
159
+ 0.50 ± 0.58a
160
+ p ≤0.05
161
+ Global score
162
+ 6.69 ± 3.83
163
+ 4.50 ± 3.23c
164
+ p ≤0.001
165
+ Earlier study on CM conducted on healthy volunteers showed a 32.1% reduction in Oxygen consumption
166
+ inducing a state of enhanced physiological rest [16]. And, evoked potentials recorded from the cerebral cortex
167
+ of healthy volunteers following CM showed prolonged latencies [17]. Whereas, cognitive evoked potentials
168
+ 2
169
+ Brought to you by | Göteborg University - University of Gothenburg
170
+ Authenticated
171
+ Download Date | 7/20/18 1:14 PM
172
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
173
+ DE GRUYTER
174
+ Varghese et al.
175
+ suggested reduced latency and enhanced amplitude [18] suggesting a possible cortical inhibition following
176
+ CM. Hence, we speculate from the study that, CM practice reduces the perception of stress and thereby it
177
+ reduces state anxiety; enhances quality of sleep and quality of life in T2DM patients.
178
+ The strength of the study is that we have demonstrated that CM improves the quality of sleep, life, and
179
+ reduces the risk for depression in patients with T2DM which can be incorporated into clinical setting along
180
+ with routine treatments. However, the limitation of this study is that the results needs to be validated with an
181
+ identical group of patients who are under conventional treatment. Further studies are warranted to understand
182
+ the probable mechanisms towards alleviation of associated complications and determining the effectiveness of
183
+ using CM in the prevention of T2DM in the high risk group.
184
+ Summarising the findings, CM in general appears to promote vagal predominance, decrease perceived
185
+ stress and promotes sleep, mental well-being and quality of life. These findings suggest the necessity for mind
186
+ management apart from the medical management in T2DM.
187
+ Author contributions: All the authors have accepted responsibility for the entire content of this submitted
188
+ manuscript and approved submission.
189
+ Research funding: None declared.
190
+ Employment or leadership: None declared.
191
+ Honorarium: None declared.
192
+ Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis,
193
+ and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
194
+ References
195
+ [1] Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010;87:4–14.
196
+ [2] Seidell JC. Obesity, insulin resistance and diabetes-a worldwide epidemic. Br J Nutr. 2000;83.
197
+ [3] McEwen BS. Protective and damaging effects of stress mediators. New Eng J Med. 1998;338:171–9.
198
+ [4] Bauer ME. Chronic stress and immunosenescence: a review. Neuroimmunomodulation. 2008;15:241–50.
199
+ [5] Cannizzo ES, Clement CC, Sahu R, Follo C, Santambrogio L. Oxidative stress, inflamm-aging and immunosenescence. J Proteomics.
200
+ 2011;74:2313–23.
201
+ [6] Duncan BB, Schmidt MI, Pankow JS, Ballantyne CM, Couper D, Vigo A, et al. Low-grade systemic inflammation and the development of
202
+ type 2 diabetes the atherosclerosis risk in communities study. Diabetes. 2003;52:1799–805.
203
+ [7] Danesh J, Whincup P
204
+ , Walker M, Lennon L, Thomson A, Appleby P
205
+ , et al. Low grade inflammation and coronary heart disease: prospective
206
+ study and updated meta-analyses. Br Med J. 2000;321:199–204.
207
+ [8] Sela S, Shurtz-Swirski R, Cohen-Mazor M, Mazor R, Chezar J, Shapiro G, et al. Primed peripheral polymorphonuclear leukocyte: a culprit
208
+ underlying chronic low-grade inflammation and systemic oxidative stress in chronic kidney disease. J Am Soc Nephrol. 2005;16:2431–38.
209
+ [9] Bastard JP
210
+ , Maachi M, Lagathu C, Kim MJ, Caron M, Vidal H, et al. Recent advances in the relationship between obesity, inflammation, and
211
+ insulin resistance. Eur Cytokine Netw. 2006;17:4–12.
212
+ [10] Garcia MJ, McNamara PM, Gordon T, Kannell WB. Morbidity and mortality in diabetics in the Framingham population: sixteen year
213
+ follow-up study. Diabetes. 1974;23:105–11.
214
+ [11] Stratton IM, Amanda IA, Andrew WN, David RM, Susan EM, Carole AC, et al. Association of glycaemia with macrovascular and microvas-
215
+ cular complications of type 2 diabetes (UKPDS 35): prospective observational study. Br Med J. 2000;321:405–12.
216
+ [12] Chinmayanada S. Mandukya Upanishad. Bombay, India: Sachin Publishers; 1984.
217
+ [13] Nagendra HR, Nagarathna R. New perspectives in stress management. Bangalore, India: Swami Vivekananda Yoga Prakashana; 1997.
218
+ [14] Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008;12:163–9.
219
+ [15] Subramanya P
220
+ , Telles S. A review of the scientific studies on cyclic meditation. Int J Yoga. 2009;2:46.
221
+ [16] Telles S, Reddy SK, Nagendra HR. Oxygen consumption and respiration following two yoga relaxation techniques. Appl Psychophysiol-
222
+ ogy Biofeedback. 2000;25:221–7.
223
+ [17] Subramanya P
224
+ , Telles S. Changes in midlatency auditory evoked potentials following two yoga-based relaxation techniques. Clin EEG
225
+ Neurosci. 2009;40:190–5.
226
+ [18] Sarang SP
227
+ , Telles S. Changes in P300 following two yoga-based relaxation techniques. Int J Neurosci. 2006;116:1419–30.
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+ 3
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+ Brought to you by | Göteborg University - University of Gothenburg
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+ Authenticated
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+ Download Date | 7/20/18 1:14 PM
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1
+ 37
2
+ International Journal of Yoga  Vol. 3  Jul-Dec-2010
3
+ have been studies of short and midlatency auditory-evoked
4
+ potentials during meditation. The studies on midlatency
5
+ auditory-evoked potentials have most often shown changes
6
+ in a component called the Na-wave, a negative wave
7
+ occurring between 14 and 19 msec. The changes have been
8
+ in the form of an increase in amplitude,[8] suggesting the
9
+ requirement of more neurons. A decrease in latency has
10
+ also been reported,[9] suggesting a decrease in time taken
11
+ to transmit sensory information.
12
+ Studies on short latency auditory-evoked potentials have
13
+ not shown such clear changes.[2] In that study, brainstem
14
+ auditory evoked potentials (BAEP) were measured in five
15
+ advanced practitioners of transcendental meditation (TM)
16
+ to determine whether such responses would reflect an
17
+ increase in perceptual acuity to auditory stimuli following
18
+ meditation. The BAEP provide an objective physiological
19
+ index of auditory function at a subcortical level. Repeated
20
+ INTRODUCTION
21
+ The functions of the brain in meditation have been
22
+ studied using different techniques. These include the
23
+ electroencephalogram (EEG),[1] evoked potentials,[2]
24
+ regional cerebral glucose utilization as well as, more
25
+ recently, functional magnetic resonance imaging.[3] Among
26
+ these methods, a specific technique is selected for each
27
+ experiment as each of them have different spatial and
28
+ temporal resolutions.[4]
29
+ Evoked potentials are used in meditation studies because a
30
+ correlation between different evoked potential components
31
+ and underlying neural generators is reasonably well
32
+ worked out.[5] Apart from this, it appears that the cerebral
33
+ cortex is actively involved in meditation.[6] Hence, one
34
+ may expect corticoefferent gating with changes occurring
35
+ at the subcortical relay centers.[7] For these reasons, there
36
+ Context: Practicing mental repetition of “OM” has been shown to cause significant changes in the middle latency auditory-
37
+ evoked potentials, which suggests that it facilitates the neural activity at the mesencephalic or diencephalic levels.
38
+ Aims: The aim of the study was to study the brainstem auditory-evoked potentials (BAEP) in two meditation states based on
39
+ consciousness, viz. dharana, and dhyana.
40
+ Materials and Methods: Thirty subjects were selected, with ages ranging from 20 to 55 years (M=29.1; ±SD=6.5 years) who
41
+ had a minimum of 6 months experience in meditating “OM”. Each subject was assessed in four sessions, i.e. two meditation
42
+ and two control sessions. The two control sessions were: (i) ekagrata, i.e. single-topic lecture on meditation and (ii) cancalata,
43
+ i.e. non-targeted thinking. The two meditation sessions were: (i) dharana, i.e. focusing on the symbol “OM” and (ii) dhyana,
44
+ i.e. effortless single-thought state “OM”. All four sessions were recorded on four different days and consisted of three states,
45
+ i.e. pre, during and post.
46
+ Results: The present results showed that the wave V peak latency significantly increased in cancalata, ekagrata and dharana,
47
+ but no change occurred during the dhyana session.
48
+ Conclusions: These results suggested that information transmission along the auditory pathway is delayed during cancalata,
49
+ ekagrata and dharana, but there is no change during dhyana. It may be said that auditory information transmission was delayed
50
+ at the inferior collicular level as the wave V corresponds to the tectum.
51
+ Key words: Brainstem auditory-evoked potential; cancalata; dharana; dhyana; ekagrata.
52
+ ABSTRACT
53
+ Brainstem auditory-evoked potentials in two meditative
54
+ mental states
55
+ Sanjay Kumar, Nagendra HR, Naveen KV, Manjunath NK, Shirley Telles
56
+ Department of Yoga Research, Indian Council of Medical Research Center for Advanced Research in Yoga and Neurophysiology, SVYASA,
57
+ Bangalore, India
58
+ Address for correspondence: Dr. Shirley Telles,
59
+ Patanjali Yogpeeth, Maharishi Dayanand Gram, Bahadrabad,
60
+ Haridwar - 249 402, Uttarakhand, India.
61
+ E-mail: [email protected]
62
+ DOI: 10.4103/0973-6131.72628
63
+ Original Article
64
+ www.ijoy.org.in
65
+ [Downloaded from http://www.ijoy.org.in on Friday, March 04, 2011, IP: 117.211.90.10]
66
+ International Journal of Yoga  Vol. 3  Jul-Dec-2010
67
+ 38
68
+ measures of the BAEP of TM practitioners were taken
69
+ before and after a period of meditation and were compared
70
+ with those of age-matched controls. Peak latencies as well
71
+ as interwave latencies between major BAEP components
72
+ were evaluated. No pre–post meditation differences for
73
+ experimental subjects were observed at low-stimulus
74
+ intensities (0–35 dB). At moderate intensities (40–50
75
+ dB), the latency of the inferior collicular wave (wave
76
+ V) increased following meditation. However, at higher
77
+ stimulus intensities (55–70 dB), the latency of this wave
78
+ was slightly decreased. Comparison of the slopes and
79
+ intercepts of stimulus intensity–latency functions indicate
80
+ a possible effect of meditation on brainstem activity.[2]
81
+ This study on short latency auditory-evoked potentials
82
+ in TM meditation practitioners demonstrated that short
83
+ latency auditory-evoked potential varies with stimulus
84
+ characteristics.
85
+ More recently, we have attempted to understand meditation
86
+ based on descriptions from an ancient yoga text. This is
87
+ Patanjali’s yoga sutras (circa 900 BC).[10] Based on this
88
+ description, meditation has been considered as two states,
89
+ namely dharana, which is characterized by focusing on
90
+ the object of meditation and dhyana, which is a defocused
91
+ state of mental expansiveness. With this background,
92
+ the present study was undertaken to determine whether
93
+ short latency auditory-evoked potentials would change in
94
+ normal subjects in meditation considered as both dharana
95
+ and dhyana sessions on separate days.
96
+ MATERIALS AND METHODS
97
+ Subjects
98
+ Thirty subjects were selected in the age range between 20
99
+ and 55 years (group mean±SD, 29.1±6.5 years) recruited
100
+ from a residential setup, Swami Vivekananda Yoga
101
+ Research Foundation, Bangalore, in south India. This age
102
+ range was selected as short latency does not vary within
103
+ this age range in healthy individuals.[11] Only male subjects
104
+ were selected because it has been demonstrated that short
105
+ latency auditory-evoked potentials vary with the phases of
106
+ the menstrual cycle.[12] All of them had normal health based
107
+ on a routine case history and a clinical examination. Also,
108
+ all of them had experience of practicing meditation for at
109
+ least 30 min per day, 4 days in a week, for a minimum of 1
110
+ year. Their meditation practice was based on self-reporting
111
+ of the meditators as well as (where possible) consultations
112
+ with the meditation teacher (guru).
113
+ To assess the quality of the practice, visual analogue scale
114
+ (VAS) was used at the end of each session.
115
+ All of them expressed their willingness to participate in the
116
+ experiment. The project was approved by the Institution’s
117
+ Ethics Committee. The study protocol was explained to the
118
+ subjects and their signed informed consent was obtained.
119
+ Apart from their prior experience of “OM” meditation,
120
+ they had undergone a 2-month orientation program in
121
+ “OM” meditation under the guidance of an experienced
122
+ meditation teacher.
123
+ The condition to exclude subjects were any health disorder,
124
+ especially psychiatric or neurological disorders, auditory
125
+ deficits assessed by checking the auditory threshold of
126
+ each ear separately and any medication that alters the
127
+ functions of the nervous system. None of the subjects had
128
+ to be excluded for these reasons.
129
+ The order of the four sessions (i.e. two meditation sessions
130
+ and two non-meditation control sessions) was randomized
131
+ for each subject using a standard random number table.[13]
132
+ This was done to prevent the influence of being exposed
133
+ to the laboratory for the first time for example, from
134
+ influencing the results among other reasons.
135
+ Design
136
+ Each subject was assessed in four sessions, i.e. two
137
+ meditation and two control sessions, to record BAEP
138
+ . The
139
+ two control sessions were: (i) ekagrata, i.e. single-topic
140
+ lecture on meditation and (ii) cancalata, i.e. non-targeted
141
+ thinking. The two meditation sessions were: (i) dharana,
142
+ i.e. focusing on the symbol “OM” and (ii) dhyana, i.e.
143
+ effortless single-thought state “OM.” All four sessions
144
+ consisted of three states, i.e. “pre” (5 min), “during” (20
145
+ min) and “post” (5 min).
146
+ The assessments were made on four different days, not
147
+ necessarily on consecutive days, but at the same time of
148
+ the day (i.e., the self-as-control design). The allocation of
149
+ the subjects to the four sessions was randomized using a
150
+ standard random number table.[13] This was done to prevent
151
+ the influence of being exposed to the laboratory for the
152
+ first time from influencing the results.
153
+ Assessments
154
+ BAEP were recorded using the Nicolet Bravo system
155
+ (Nicolet Biomedicals, Madison, WI, USA). The amplifier
156
+ settings were as follows: low-frequency filter 100 Hz,
157
+ high-frequency filter 3 KHz, sensitivity 50 µV
158
+ , number of
159
+ sweeps averaged 1,500, sweep width 10 ms, delay 0 ms.
160
+ Binaural click stimuli, of alternating polarity, with 11.1 Hz
161
+ frequency and 100 µS duration, were delivered through
162
+ acoustically shielded earphones (Amplivox, Oxfordshire,
163
+ UK). The stimulus intensity was kept at 80 dB nHL. The
164
+ rejection level was expressed as a percentage of the full-
165
+ scale range of the analog-to-digital converter. This level
166
+ was set at 90%. Silver chloride (Ag/AgCl) disc electrodes
167
+ were placed on the scalp using a conductive water-soluble
168
+ Kumar, et al.
169
+ [Downloaded from http://www.ijoy.org.in on Friday, March 04, 2011, IP: 117.211.90.10]
170
+ 39
171
+ International Journal of Yoga  Vol. 3  Jul-Dec-2010
172
+ paste. The active electrode was at Cz according to the
173
+ International 10–20 system[14] referenced to linked ear
174
+ lobes, with the ground electrode on the forehead (FPz). All
175
+ electrode impedances were kept below 5 KΩ throughout
176
+ the session.
177
+ Interventions
178
+ Throughout all sessions, the subjects kept their eyes closed
179
+ and followed pre-recorded instructions. The instructions
180
+ emphasized carrying out the practice slowly, with
181
+ awareness and relaxation. The meditators who participated
182
+ in the study underwent 1 month of orientation sessions,
183
+ where they practiced two phases that formed a continuum
184
+ in meditation (dharana and dhyana) as two separate states
185
+ and two control states, i.e. cancalata or non-focused
186
+ thinking and ekagrata or focusing without meditation and
187
+ on more than one thought.
188
+ These states are described in the traditional texts, i.e. the
189
+ Patanjali’s Yoga Sutras and Bhagavad Gita, stating that
190
+ when awake and in the absence of a specific task, the mind
191
+ is very distractible (cancalata), and has to be taken through
192
+ the stages of “streamlining the thoughts” (concentration
193
+ or ekagrata) before moving on to the states of meditation.
194
+ These are: one-pointed concentration or dharana and a
195
+ defocused, effortless single-thought state or dhyana.
196
+ In the cancalata session, the 20-min period consisted of
197
+ “non-targeted thinking,” during which the subjects were
198
+ asked to allow their thoughts to wander freely as they
199
+ listened to a compiled audio CD consisting of brief periods
200
+ of conversation and talks on multiple topics recorded from
201
+ a local radio station transmission. In the ekagrata session,
202
+ the 20-min period consisted of focusing on a single topic,
203
+ which was listening to a lecture on meditation, with
204
+ multiple, yet associated, thoughts. In the dharana session,
205
+ the 20-min period consisted of focusing on the symbol
206
+ “OM.” During this session, they were asked to focus on the
207
+ meaning of the syllable, OM, which is used as a symbol for
208
+ the entire universe because OM is considered to represent
209
+ “that which sustains everything.”[15] In the dhyana session,
210
+ the 20 min of the practice consisted of meditation with
211
+ effortless absorption in the single-thought state of the
212
+ object of meditation, i.e. “OM.”
213
+ For the two meditation sessions and the two control
214
+ sessions, subjects were given guided instructions through
215
+ separate recorded instructions for each session.
216
+ Data extraction
217
+ For the BAEP
218
+ , the peak latencies and peak amplitudes of
219
+ all seven waves were calculated. Peak latency (msec) is
220
+ defined as the time from stimulus onset to the point of
221
+ maximum positive amplitude within the latency window.
222
+ Peak amplitude (V) is defined as the voltage difference
223
+ between a pre-stimulus baseline and the largest positive
224
+ going peak within a given latency window.
225
+ Data analysis
226
+ Statistical analysis was performed using SPSS (Version
227
+ 10.0). The peak latencies and peak amplitudes of all seven
228
+ waves were analyzed using repeated-measures analyses of
229
+ variance (ANOVAs) and post hoc analyses with Bonferroni
230
+ adjustment were performed to compare “pre” data with
231
+ “during” and “post.”
232
+ The repeated measures ANOVAs were performed with two
233
+ “within–subject” factors, i.e. Factor 1: Sessions; with four
234
+ levels, viz. cancalata, ekagrata, dharana and dhyana, and
235
+ Factor 2: States; with six levels, viz. pre, during (D1 to D4)
236
+ and post. These repeated measures ANOVAs were carried
237
+ out for the peak latency and peak amplitude of all levels.
238
+ This was followed by a post hoc analysis with Bonferroni
239
+ adjustment for multiple comparisons between the mean
240
+ values of different states (pre, during 1 to during 4 and post).
241
+ RESULTS
242
+ The peak latency of wave V showed a significant difference
243
+ between Sessions (F=3.894, for df=2.678, 77.651,
244
+ P<0.015, Huynh-Feldt epsilon=0.893) and between States
245
+ (F=11.713, for df=4.181, 121.256, P<0.001, Huynh-Feldt
246
+ epsilon=0.836).
247
+ Post hoc analysis with Bonferroni adjustment for each
248
+ session (cancalata, ekagrata, dharana and dhyana)
249
+ separately showed a significant increase in the latency of
250
+ wave V during the cancalata session (pre versus during, i.e.
251
+ D2; P=0.042), ekagrata session (pre versus during, i.e. D2;
252
+ P=0.009, pre versus during, i.e. D3; P=0.026, pre versus
253
+ during, i.e. D4; P=0.005 and pre versus post P=0.001) and
254
+ following the dharana session (pre versus post; P=0.018).
255
+ The amplitude of wave V also showed a significant
256
+ difference between Sessions (F=6.515, for df=2.692,
257
+ 78.060, P<0.001, Huynh-Feldt epsilon=0.897) and
258
+ between States (F=8.574, for df=4.292, 124.456, P<0.001,
259
+ Huynh-Feldt epsilon=0.858).
260
+ Post hoc analysis with Bonferroni adjustment for each
261
+ session (cancalata, ekagrata, dharana and dhyana)
262
+ separately showed no significant change in the peak
263
+ amplitude of wave V (P>0.05). Also, there were no
264
+ significant change in the other waves (P>0.05).
265
+ Hence, the changes in wave V peak latency alone are
266
+ presented in Table 1.
267
+ Evoked potentials in meditation
268
+ [Downloaded from http://www.ijoy.org.in on Friday, March 04, 2011, IP: 117.211.90.10]
269
+ International Journal of Yoga  Vol. 3  Jul-Dec-2010
270
+ 40
271
+ Kumar, et al.
272
+ DISCUSSION
273
+ In the present study, normal healthy volunteers who
274
+ were experienced in practicing meditation on the syllable
275
+ “OM” were assessed in two meditation (i.e., dharana
276
+ and dhyana) and two control sessions (i.e., cancalata
277
+ and ekagrata sessions). BAEP were recorded throughout
278
+ all four sessions. There was a significant increase in the
279
+ wave V peak latency during the cancalata, ekagrata and
280
+ dharana sessions but there was no change during the
281
+ dhyana session.
282
+ In the literature, there is only one previous study of short
283
+ latency auditory-evoked potentials in TM practitioners.
284
+ In this study, at moderate stimulus intensities (40–50 dB),
285
+ the wave V latency increased following meditation.[2] In
286
+ contrast, at higher stimulus intensities, the wave V latency
287
+ was slightly decreased by a comparison of the slopes and
288
+ intercepts of stimulus intensity–latency functions. The
289
+ authors suggested a possible effect of TM on brainstem
290
+ activity. In the present study, there was no attempt to
291
+ vary the stimulus intensity, which was kept at the 80 dB
292
+ normal hearing level. This would fit in the category of a
293
+ higher-intensity stimulus based on the categorization in
294
+ the study.[2] In contrast to that study, even at this high-
295
+ stimulus intensity, the latency of wave V did not decrease
296
+ during either of the two meditation sessions (dharana and
297
+ dhyana). In contrast, an increase in wave V peak latency
298
+ was found in the cancalata, ekagrata and dharana sessions.
299
+ No such increase was obtained in the dhyana session. An
300
+ increase in the latency of an evoked potential component
301
+ is taken to suggest that sensory information processing at
302
+ the level of the underlying neural generator is delayed.[16]
303
+ This suggests that in the cancalata, ekagrata and dharana
304
+ mental states, sensory processing at the midbrain level
305
+ was delayed. Another feature of the present study is that
306
+ a difference is seen in the nature of the results in the two
307
+ meditation sessions.
308
+ In the introduction, it was already mentioned that dharana
309
+ and dhyana states have been described in an ancient yoga
310
+ text, namely Patanjali’s yoga sutras. In this text, dharana
311
+ literary means “fixing the mind on a specific object”
312
+ (Patanjali’s yoga sutras Chapter 3 verse 1). The mind
313
+ could be fixed on any point and. as long as disturbances
314
+ from any corner are warded off, this mental state is called
315
+ dharana. When dharana becomes effortless, it takes the
316
+ form of dhyana, which is defined as the uninterrupted
317
+ spontaneous flow of the mind toward the chosen object.
318
+ In contrast to this, the two control sessions, i.e. cancalata
319
+ and ekagrata are described in another ancient text, the
320
+ Bhagavad Gita.[17] The cancalata state is characterized by
321
+ constant shifting of thoughts from one object to another.
322
+ The ekagrata state is quite different from this and is
323
+ similar to concentration. When haphazard thoughts are
324
+ streamlined in a single direction, it is called ekagrata.
325
+ Hence, irrespective of whether meditators were in a state
326
+ of random thinking (cancalata), channelized thought
327
+ in concentration (ekagrata) or in a state of channelized
328
+ thought as in meditation (dharana), there was a delay in
329
+ sensory information processing, as mentioned above at
330
+ the mid-brain (possibly the inferior colliculus) level. In
331
+ contrast, when the mental state was characterized by a
332
+ lack of effort in dhyana, no such change occurred.
333
+ Further studies are required to understand whether neural
334
+ relay centers further along the auditory pathway would
335
+ also change differently in dharana and dhyana states. The
336
+ limitations of the present study are: (i) the fact that there
337
+ was no attempt to vary stimulus intensities and hence the
338
+ earlier findings of McEvoy, Frumkin and Harkins,[2] could
339
+ not be examined, (ii) ekagrata, dharana and cancalata
340
+ sessions were not different and cannot be ruled out as
341
+ the VAS is essentially a subjective measure; no objective
342
+ measure was taken. Only those subjects who achieved 75%
343
+ of their ideal practice based of their subjective rating were
344
+ included in the study. Again, the possibility that the sound
345
+ stimulus influences all four practices cannot be ruled out.
346
+ This is another limitation of the study.
347
+ Despite these limitations, the present study does
348
+ demonstrate a difference between the dharana and dhyana
349
+ states of meditation based on BAEP
350
+ .[15,17,18]
351
+ REFERENCES
352
+ 1.
353
+ Banquet JP. Spectral analysis of the EEG in meditation. Electroencephalogr
354
+ Clin Neurophysiol 1973;35:143-51.
355
+ 2.
356
+ McEvoy TM, Frumkin LR, Harkins SW. Effects of meditation on brainstem
357
+ auditory evoked potentials. Int J Neurosci 1980;10:165-70.
358
+ 3.
359
+ Lazar SW, Kerr CE, Wasserman RH, Gray JR, Greve DN, Treadway MT,
360
+ Table 1: Latency of wave V brainstem auditory-evoked potentials (BAEP) in four sessions
361
+ Sessions
362
+ States
363
+ Pre
364
+ During 1
365
+ During 2
366
+ During 3
367
+ During 4
368
+ Post
369
+ Cancalata
370
+ 5.78±0.18
371
+ 5.82±0.18
372
+ 5.84**±0.17
373
+ 5.84±0.20
374
+ 5.84±0.18
375
+ 5.82±0.17
376
+ Ekagrata
377
+ 5.76±0.19
378
+ 5.83±0.18
379
+ 5.83**±0.18
380
+ 5.83*±0.17
381
+ 5.87±0.19
382
+ 5.85***±0.18
383
+ Dharana
384
+ 5.75±0.20
385
+ 5.80±0.19
386
+ 5.80±0.19
387
+ 5.78±0.21
388
+ 5.80±0.21
389
+ 5.82**±0.18
390
+ Dhyana
391
+ 5.79±0.18
392
+ 5.81±0.19
393
+ 5.82±0.19
394
+ 5.81±0.18
395
+ 5.81±0.20
396
+ 5.82±0.18
397
+ *P<0.05, **P<0.01, ***P<0.001; RM ANOVA with Bonferroni adjustment compared state with pre.
398
+ [Downloaded from http://www.ijoy.org.in on Friday, March 04, 2011, IP: 117.211.90.10]
399
+ 41
400
+ International Journal of Yoga  Vol. 3  Jul-Dec-2010
401
+ et al. Meditation experience is associated with increased cortical thickness.
402
+ Neuroreport 2005;28:1893-7.
403
+ 4.
404
+ Mishra UK, Kalita J. Clinical neurophysiology. New Delhi: B.I. Churchill
405
+ Livingstore; 2001.
406
+ 5.
407
+ Woods DL, Clayworth CC. Click spatial position influences middle latency
408
+ auditory evoked potentials (MAEPs) in humans. Clin Electroencephalogr
409
+ 1985;60:122-9.
410
+ 6.
411
+ Lazar SW, Kerr CE, Wasserman RH, Gray JR, Greve DN, Treadway MT,
412
+ et al. Meditation experience is associated with increased cortical thickness.
413
+ Neuroreport 2005;28:1893-7.
414
+ 7.
415
+ Napadow V, Dhond R, Conti G, Makris N, Brown EN, Barbieri R. Brain
416
+ correlates of autonomic modulation: Combining heart rate variability with
417
+ fMRI. Neuroimage 2008;42:169-77.
418
+ 8.
419
+ Telles S, Nagarathna R, Nagendra HR. Alterations in auditory middle latency
420
+ evoked potentials during meditation on a meaningful symbol–“OM”. Int J
421
+ Neurosci 1994;76:87-93.
422
+ 9.
423
+ Telles S, Naveen KV. Changes in middle latency auditory evoked potentials
424
+ during meditation. Psychol Rep 2004;94:398-400.
425
+ 10. Taimini IK. The Science of Yoga. Madras, India: The Theosophical
426
+ Publishing House; 1961.
427
+ 11.
428
+ Lauter JL, Oyler RF, Lord-Maes J. Amplitude stability of auditory brainstem
429
+ responses in two groups of children compared with adults. Br J Audiol
430
+ 1993;27:263-71.
431
+ 12. Yadav A, Tandon OP, Vaney N. Auditory evoked responses during different
432
+ phases of menstrual cycle. Indian J Physiol Pharmacol 2002;46:449-56.
433
+ 13. ZAR JH. Biostatistical analysis. 4th ed. Delhi, India: Person Education
434
+ (Singapore) Pvt. Ltd; 2005.
435
+ 14. Jasper HH. The ten-twenty electrode system of the International federation.
436
+ Electroencephalogr Clin Neurophysiol 1958;10:371-5.
437
+ 15. Chinmayananda S. Mandukya Upanisad. Bombay: Sachin publishers; 1984.
438
+ 16. Subramanya P, Telles S. Changes in middle latency auditory evoked
439
+ potentials following two yoga based relaxation techniques. Clinical
440
+ EEG and Neuroscience 2009;40:190-95.
441
+ 17. Bhakttivedanta Swami Prabhupada AC. Bhagavad Gita: as it is. Mumbai:
442
+ The Bhaktivedanta Book Trust; 1998.
443
+ 18. Telles S, Desiraju T. Recording of auditory middle latency evoked potentials
444
+ during the practice of meditation with the syllable ‘OM’. Indian J Med Res
445
+ 1993;98:237-9.
446
+ Evoked potentials in meditation
447
+ Author Help: Online submission of the manuscripts
448
+ Articles can be submitted online from http://www.journalonweb.com. For online submission, the articles should be prepared in two files (first
449
+ page file and article file). Images should be submitted separately.
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452
+ Prepare the title page, covering letter, acknowledgement etc. using a word processor program. All information related to your identity
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+ should be included here. Use text/rtf/doc/pdf files. Do not zip the files.
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+ 2)
455
+ Article File:
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+
457
+ The main text of the article, beginning with the Abstract to References (including tables) should be in this file. Do not include any information
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+ [Downloaded from http://www.ijoy.org.in on Friday, March 04, 2011, IP: 117.211.90.10]
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subfolder_0/Cancer Prevention and rehabilitation through yoga.txt ADDED
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1
+ © 2018 International Journal of Yoga | Published by Wolters Kluwer ‑ Medknow
2
+ 1
3
+ Cancer is one of the leading causes of death worldwide,
4
+ with an incidence of 14 million new cases per year, with
5
+ about 1 million diagnosed in India. The prevalence of
6
+ cancer has increased over the past decade and is expected
7
+ to rise by 8% in the next 5  years. Regular screening,
8
+ early detection, and improved therapies have increased
9
+ the 10‑year survival from 61% to 77% in the past decade.
10
+ However, advancements in cancer treatment have not
11
+ changed mortality rates.
12
+ While cancer prevention is being debated and developed
13
+ in many health‑care facilities, there is no doubt a
14
+ strong component is in following some basic lifestyle
15
+ modifications.
16
+ Cancer cells are not powerful invaders as viruses from
17
+ outside. They are born in our own bodies, say a thousand
18
+ in a billion cells which are created every day in our
19
+ bodies. However, our immune system takes care of them
20
+ recognizing them as enemies as it does with outside germs.
21
+ It is well known that stress is an immune suppression
22
+ factor and highly stressed lifestyle can bring confusion in
23
+ the immune system to recognize cancer as an enemy. On
24
+ the contrary, it thinks that they are good friends and does
25
+ not destroy them. This aspect is known as Viparyaya, a
26
+ state of mind in which reality is perceived wrongly  (an
27
+ example of perceiving a rope as snake or a post as
28
+ ghost). Unless this Viparyaya is corrected, the root cause
29
+ of cancer will not be vanquished. This is possible by
30
+ de‑stressing mind‑body through the practice of relaxation
31
+ techniques such as asanas, breath slowing Pranayama, and
32
+ mind‑calming meditation methods. Furthermore, proper
33
+ diet, exercise, avoiding smoking, use of tobacco in various
34
+ forms, psychedelic drug addictions, and uncontrolled
35
+ consumption of alcohol surely will help in the prevention
36
+ of cancer. This is where the role of Yoga practices take
37
+ importance. It is said in the Gita that he who eats sparingly,
38
+ who sleeps just adequately and who is skillful in action, for
39
+ such a person Yoga becomes a “killer of duhkha  (distress
40
+ or misery)”  (Bhagavad Gita 6:17).[1] A positive attitude in
41
+ work arena and to act stress‑free is an important factor in
42
+ maintaining high level of immunity. We know, for example,
43
+ many students report sick during examination time. This is
44
+ because of the stress that is experienced by them and their
45
+ inappropriate response to stress.
46
+ It is presently recommended that overeating and eating
47
+ too often in a day could be causes of reduced immunity.
48
+ There are a few individuals who eat only twice a day
49
+ and skip all solid foods 1  day a month. Cancer cells are
50
+ known to proliferate deriving energy from the food we
51
+ eat; by skipping solid foods once a month, we could
52
+ arrest the proliferation and even eliminate production of
53
+ Cancer: Prevention and Rehabilitation through Yoga
54
+ Editorial
55
+ cancerous cells. More work is needed to substantiate these
56
+ statements; however, there is some basic understanding
57
+ of cancer cell activity which is important in cancer
58
+ prevention.
59
+ We at Vivekananda Yoga Anusandhana Samsthana have
60
+ developed yoga module for cancer‑based on traditional
61
+ Yoga texts and research evidence. We have carried out
62
+ collaborative research studies on Breast Cancer with
63
+ MD Anderson Cancer Centre in Texas, USA. Consistent
64
+ improvements have been reported in anxiety, symptom
65
+ severity, distress, nausea and vomiting, and affect and
66
+ global QOL14 as well as beneficial effects on natural
67
+ killer cell counts and radiation‑induced DNA damage.[2‑5]
68
+ However, safety and efficacy of yoga has to considered
69
+ carefully in cancer care. Yoga should be practiced under
70
+ the guidance of trained yoga therapist.
71
+ Addressing the root cause and using holistic healing
72
+ methods along with conventional methods would be the
73
+ best solution for cancer prevention and management.
74
+ Along with yoga, other Indian systems of medicines have
75
+ also shown beneficial effects in cancer care. Hence there
76
+ is a need for Integrating AYUSH in Palliative Care. Every
77
+ alternate year, we conduct an international conference on
78
+ Frontiers in Yoga Research and its Applications. This
79
+ year we have selected a theme “Integrative Oncology:
80
+ Future of Cancer Care.” The 22nd  INCOFYRA  –  2018
81
+ will make an effort to integrate Ayurveda, Naturopathy,
82
+ Yoga, Unani, Siddha, Homeopathy, and Modern Medicine
83
+ by bringing prominent researchers and doctors from all
84
+ these fields under one platform to evolve better cancer
85
+ care.
86
+ HR Nagendra
87
+ Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru,
88
+ Karnataka, India
89
+ E‑mail: [email protected]
90
+ References
91
+ 1.
92
+ Swarupananda 
93
+ S.
94
+ Srimad
95
+ Bhagavad
96
+ Gita.
97
+ Kolkatta:
98
+ Advitashrama; 2016.
99
+ 2.
100
+ Rao MR, Raghuram N, Nagendra HR, Gopinath KS, Srinath BS,
101
+ Diwakar  RB, et  al. Anxiolytic effects of a yoga program in
102
+ early breast cancer patients undergoing conventional treatment:
103
+
104
+ randomized
105
+ controlled
106
+ trial.
107
+ Complement
108
+ Ther
109
+ Med
110
+ 2009;17:1‑8.
111
+ 3.
112
+ Vadiraja  HS, Raghavendra  RM, Nagarathna  R, Nagendra  HR,
113
+ Rekha  M, Vanitha  N, et  al. Effects of a yoga program on
114
+ cortisol rhythm and mood states in early breast cancer patients
115
+ undergoing adjuvant radiotherapy: A randomized controlled trial.
116
+ Integr Cancer Ther 2009;8:37‑46.
117
+ 4.
118
+ Raghavendra RM, Nagarathna R, Nagendra HR, Gopinath KS,
119
+ Srinath  BS, Ravi  BD, et  al. Effects of an integrated
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+ yoga
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+ programme
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+ on
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+ chemotherapy‑induced
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+ nausea
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+ and
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+ Nagendra: Yoga and Cancer
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+ 2
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+ International Journal of Yoga | Volume 11 | Issue 1 | January‑April 2018
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+ emesis in breast cancer patients. Eur J Cancer Care  (Engl)
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+ 2007;16:462‑74.
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+ 5.
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+ Chandwani  KD, Perkins  G, Nagendra  HR, Raghuram  NV,
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+ Spelman  A, Nagarathna  R, et  al. Randomized, controlled trial
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+ of yoga in women with breast cancer undergoing radiotherapy.
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+ J Clin Oncol 2014;32:1058‑65.
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+ How to cite this article: Nagendra HR. Cancer: Prevention and
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+ rehabilitation through yoga. Int J Yoga 2018;11:1-2.
138
+ Received: December, 2017. Accepted: December, 2017.
139
+ This is an open access article distributed under the terms of the Creative Commons
140
+ Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows others to remix, tweak,
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+ and build upon the work non‑commercially, as long as the author is credited and the new
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+ creations are licensed under the identical terms.
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+ Access this article online
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+ Quick Response Code:
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+ Website:
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+ www.ijoy.org.in
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+ DOI:
148
+ 10.4103/ijoy.IJOY_71_17
149
+ © 2018. This work is published under
150
+ https://creativecommons.org/licenses/by-nc-sa/4.0/ (the “License”).
151
+ Notwithstanding the ProQuest Terms and Conditions, you may use this content
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+ in accordance with the terms of the License.
subfolder_0/Challenges faced in diabetes risk prediction among an indigenous South Asian population in India using the Indian Diabetes Risk Score.txt ADDED
@@ -0,0 +1,363 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Themed Paper e Original Research
2
+ Challenges faced in diabetes risk prediction among
3
+ an indigenous South Asian population in India
4
+ using the Indian Diabetes Risk Score
5
+ V. Vijayakumar*, M. Balakundi, K.G. Metri
6
+ Department of Yoga and Lifesciences, Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA University),
7
+ Bengaluru, India
8
+ a r t i c l e i n f o
9
+ Article history:
10
+ Received 16 November 2017
11
+ Received in revised form
12
+ 14 June 2018
13
+ Accepted 7 September 2018
14
+ Available online xxx
15
+ Keywords:
16
+ Diabetes risk
17
+ Diabetes prevalence
18
+ IDRS
19
+ Indigenous
20
+ South Asian ethnicity
21
+ a b s t r a c t
22
+ Objectives: Indigenous populations around the world have a higher health disparity and an
23
+ increased risk of diabetes. Scientific literature on the prevalence of diabetes in India is not
24
+ available, and the current work is a pilot study to explore the risk of diabetes in one such
25
+ indigenous population in India.
26
+ Study design: This is a cross-sectional survey and screening study.
27
+ Methods: The study took place in a remote tribal hamlet of Machuru in South India. A door-
28
+ to-door survey was conducted in the hamlet with a population of 555. The Indian Diabetes
29
+ Risk Score (IDRS) questionnaire was completed by 160 individuals older than 25 years.
30
+ Capillary blood glucose levels were measured to compare the glycaemic status with the
31
+ predicted IDRS.
32
+ Results: Of 160 adults who completed the questionnaire, 37 were at high risk (23.13%) as per
33
+ the IDRS, 52 at medium risk (32.5%) and 71 at low risk (44.38%). None of the respondents
34
+ knew their family history of diabetes owing to the lack of awareness about the condition.
35
+ Interestingly, the villagers had a sedentary lifestyle owing to their unique family dynamics
36
+ but a healthy diet. Five participants were diagnosed with diabetes, and 18 were diagnosed
37
+ with impaired fasting glucose or prediabetes.
38
+ Conclusions: The IDRS might not be an accurate measure to understand the risk of diabetes
39
+ in this particular population owing to their unique family dynamics and a lack of aware-
40
+ ness about diabetes. The best possible way to assess the diabetes risk might be through
41
+ blood examination.
42
+ © 2018 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.
43
+ * Corresponding author.
44
+ E-mail address: [email protected] (V. Vijayakumar).
45
+ Available online at www.sciencedirect.com
46
+ Public Health
47
+ journal homepage: www.elsevier.com/puhe
48
+ p u b l i c h e a l t h x x x ( 2 0 1 8 ) 1 e4
49
+ https://doi.org/10.1016/j.puhe.2018.09.012
50
+ 0033-3506/© 2018 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.
51
+ Please cite this article in press as: Vijayakumar V, et al., Challenges faced in diabetes risk prediction among an indigenous South Asian
52
+ population in India using the Indian Diabetes Risk Score, Public Health (2018), https://doi.org/10.1016/j.puhe.2018.09.012
53
+ Introduction
54
+ The prevalence of diabetes is increasing worldwide, especially
55
+ in the South Asian ethnic population.1 An increase in the
56
+ prevalence of diabetes is observed both in rural and urban
57
+ India.2 Indigenous populations are the natives of a country,
58
+ with ‘defined territory and ethnic distinctiveness’ as the two
59
+ distinguishing features.3 In India, indigenous groups are
60
+ classified by the government as ‘scheduled tribes’.4 Health
61
+ disparities between indigenous and non-indigenous pop-
62
+ ulations are universal.5 In the case of diabetes, the prevalence
63
+ and related mortality are 3e4 times higher in indigenous
64
+ populations than in non-indigenous populations, and this has
65
+ been extensively studied in various countries.6 Most of the
66
+ accessible information, such as the scientific articles or pub-
67
+ lished reports, on indigenous populations is from Western
68
+ countries, particularly the US, Canada, New Zealand, the UK
69
+ and Australia.6,7 With more than 705 individual ethnic groups
70
+ and an indigenous population of more than 104 million in
71
+ India,8 such structured published scientific literature on the
72
+ tribal or indigenous population is very limited;7 in particular,
73
+ there are no available scientific literature on the prevalence of
74
+ diabetes.
75
+ Diabetes risk assessment questionnaires are cost-effective
76
+ tools for assessing the risk of diabetes. Several risk assess-
77
+ ment tools have been developed using a combination of de-
78
+ mographic, clinical and biochemical information.9 Every
79
+ country has tailor-made questionnaires constructed based on
80
+ the sociocultural factors and risk factors associated with the
81
+ particular population. The Indian Diabetes Risk Score (IDRS) is
82
+ one such tool to assess the risk of diabetes in the Indian
83
+ population.10 IDRS consists of four questions, namely, on age,
84
+ family history, physical activity and waist circumference. In
85
+ general, indigenous populations are at an increased risk of
86
+ diabetes when compared with non-indigenous populations.
87
+ The present study aims at assessing the risk of diabetes in a
88
+ remote tribal population in a southern state of India, using the
89
+ IDRS questionnaire and evaluating the suitability of the IDRS
90
+ questionnaire as an appropriate risk assessment tool.
91
+ Methods
92
+ Study design
93
+ The present study is a cross-sectional study, assessing the
94
+ current diabetes risk of the given population through survey
95
+ and capillary blood screening. The presented data were
96
+ collected as part of a health camp.
97
+ Door-to-door surveys were conducted in a remote tribal
98
+ hamlet of Machuru in South India as part of a health camp.
99
+ The team went to every individual house to get the details of
100
+ the family members. The total population of the hamlet was
101
+ 555. The IDRS questionnaire was completed by 160 individuals
102
+ who were older than 25 years. The research team included
103
+ members who could speak the local language, in addition to a
104
+ member of the local community. Capillary blood glucose
105
+ levels were measured using a standardised digital glucometer
106
+ (Accu-Chek, Roche Diagnostics, Germany) after 8e12 h of
107
+ overnight fasting to compare the current glycaemic status
108
+ with their IDRS.
109
+ Results
110
+ The population of the hamlet was 555. In total, 160 adults
111
+ older than 25 years were surveyed initially using the IDRS, and
112
+ capillary glucose levels were measured in 103 individuals. The
113
+ remaining 57 individuals did not give consent for the finger
114
+ prick test.
115
+ Among 160 adults, 37 were at high risk (23.13%) as per the
116
+ IDRS, 52 at medium risk (32.5%) and 71 at low risk (44.38%; see
117
+ Table 1). Five participants were diagnosed with diabetes, and
118
+ 18 were diagnosed with impaired fasting glucose (IFG) or
119
+ prediabetes, according to the American Diabetes Association
120
+ criteria (see Table 2). There was no significant difference in
121
+ mean glucose levels or IDRS between the genders (P > 0.05).
122
+ The risk prediction of the IDRS was not substantial in the
123
+ current population. Amongst the 18 individuals with IFG, the
124
+ IDRS recognised 12 to be at moderate risk and six at low risk of
125
+ diabetes. Among the five individuals with diabetes, IDRS recog-
126
+ nised four to be at moderate risk and one at high risk of diabetes.
127
+ Discussion
128
+ Exploring the lifestyle of a remote tribal indigenous popula-
129
+ tion was a unique experience for the research team. The
130
+ family dynamics of the population are very unique, in that
131
+ there is only one earning member of the family (predomi-
132
+ nantly a man younger than 30 years) and the rest of the family
133
+ members who are older than 30 years become dependants
134
+ and subsequently lead sedentary lives.
135
+ None of the 160 adults who answered the IDRS question-
136
+ naire knew whether their parents had diabetes. And, for the
137
+ question on the ‘family history’ of diabetes, every single
138
+ participant said that their parents were not diagnosed with
139
+ diabetes as they had never checked their blood glucose levels
140
+ before. It is noteworthy that the awareness about diabetes as a
141
+ health condition is very minimal in the current population,
142
+ let alone the previous generations. Family history scored ‘0’
143
+ for all the subjects as none of them knew the diabetic status of
144
+ their parents as no blood test was carried out to detect dia-
145
+ betes. This indicates that diabetes awareness and screening
146
+ programmes should also be conducted in the remote areas of
147
+ Table 1 e Indian Diabetes Risk Score (IDRS) across both
148
+ genders.
149
+ Male (n ¼ 68)
150
+ Female (n ¼ 92)
151
+ Age in years (mean ± SD)
152
+ 34 ± 2.83
153
+ 46 ± 4.24
154
+ IDRS risk (n)
155
+ High risk
156
+ 10
157
+ 27
158
+ Medium risk
159
+ 24
160
+ 28
161
+ Low risk
162
+ 34
163
+ 37
164
+ IDRS
165
+ High risk
166
+ 55 ± 13
167
+ 56 ± 12
168
+ (Mean ± SD)
169
+ Medium risk
170
+ 40 ± 4.7
171
+ 38 ± 4.4
172
+ Low risk
173
+ 29 ± 7.1
174
+ 32 ± 12
175
+ SD, standard deviation.
176
+ p u b l i c h e a l t h x x x ( 2 0 1 8 ) 1 e4
177
+ 2
178
+ Please cite this article in press as: Vijayakumar V, et al., Challenges faced in diabetes risk prediction among an indigenous South Asian
179
+ population in India using the Indian Diabetes Risk Score, Public Health (2018), https://doi.org/10.1016/j.puhe.2018.09.012
180
+ the country to curb the increasing prevalence of diabetes in
181
+ India.
182
+ Age was found to be the major risk factor for diabetes in
183
+ this study, followed by the lack of physical activity and
184
+ abdominal obesity. In the current indigenous population,
185
+ abdominal obesity was not prevalent and contributed only
186
+ minimally to the risk score.
187
+ The prevalence of diabetes and prediabetes in this particular
188
+ indigenous population is much lower at 3.24% and 3.42% when
189
+ compared with the national prevalence of 8.7% and 4.6%,
190
+ respectively.11 This is contradictory to the findings from the
191
+ indigenous populations of other countries, where the preva-
192
+ lence of diabetes was 3e4 times higher, on average, than non-
193
+ indigenous populations.6 The possible reasons could be that
194
+ urbanisation has not reached this particular indigenous com-
195
+ munity as much as in the developed countries. Health disparity
196
+ in indigenous populations is attributed more to lifestyle factors
197
+ than genetic factors.3 Despite a sedentary lifestyle above the
198
+ age of 30 years, there are a few factors that are protective
199
+ against diabetes in this study population. For example, whole-
200
+ grain consumption helps to reduce the risk of diabetes,12,13 and
201
+ this particular indigenous population still consumes whole
202
+ grains and has not even heard about or used refined products
203
+ for cooking. Locally grown vegetables are used in abundance
204
+ and become a part of their daily diet which is possibly an added
205
+ advantage as fruit and vegetable consumption is inversely
206
+ associated with diabetes.14 Basic amenities such as electricity
207
+ have still not reached these indigenous community dwellings.
208
+ This could be seen as a blessing in disguise as they go to bed
209
+ early and get up before sunrise, maintaining an optimal circa-
210
+ dian rhythm, possibly keeping them healthy and protected
211
+ against a metabolic disorder such as diabetes.15,16 Similar to
212
+ most diabetes risk assessment questionnaires around the
213
+ world, lifestyle risk factors such as diet and sleep are not
214
+ included in the IDRS. The Finnish Diabetes Risk Score ques-
215
+ tionnaire, which includes a question on diet, is found to be
216
+ better than theIDRS in diagnostic accuracy and clinicalutility.17
217
+ The addition of questions on diet and sleep in the diabetes risk
218
+ assessment
219
+ questionnaire
220
+ might,
221
+ thus,
222
+ be
223
+ beneficial
224
+ in
225
+ increasing the diagnostic accuracy of type 2 diabetes.
226
+ The main strength of the study is that it has been con-
227
+ ducted on a remote indigenous tribal population whose dia-
228
+ betic status is not widely studied in India, as even accessibility
229
+ by road is still limited in these areas.
230
+ Limitations
231
+ Diagnosis of type 2 diabetes was performed using capillary
232
+ glucose levels and not venous blood glucose levels. Owing to
233
+ the funding constraints and lack of resources at the remote
234
+ tribal location, it was not possible to measure the plasma
235
+ glucose levels, and the capillary blood glucose tests were
236
+ performed using a glucometer. Screened individuals were
237
+ older than 25 years, and there are higher chances that other
238
+ types of diabetes such as type 1 diabetes or latent autoim-
239
+ mune diabetes of adulthood might have gone unnoticed. The
240
+ data reported were from a remote indigenous community in a
241
+ southern state of India. The data might not be considered as a
242
+ representative sample to explain the diabetic status of all the
243
+ indigenous populations across the country.
244
+ Conclusions
245
+ The best way to assess the diabetes risk in this population
246
+ might be through blood glucose measurements, rather than
247
+ analysing the diabetes risk scores. The IDRS might not be an
248
+ appropriate measure to detect the risk of diabetes in the given
249
+ tribal population. The IDRS has definitely been of great benefit
250
+ in the early type 2 diabetes risk prediction in a developing
251
+ country such as India, similar to all other risk prediction
252
+ questionnaires. Adding a few key lifestyle risk factors to the
253
+ current available risk prediction tools could make them more
254
+ precise. It might not be appropriate to generalise the findings
255
+ obtained from this particular population to all the indigenous
256
+ tribes in India, and further large-scale studies including other
257
+ parameters such as glycated haemoglobin A1c and the oral
258
+ glucose tolerance test would give a much better understand-
259
+ ing about the diabetes prevalence in the indigenous pop-
260
+ ulations of India.
261
+ Author statements
262
+ Ethical approval
263
+ Ethical approval was not applied for the study as the data
264
+ presented here are a part of a health camp, and this was not
265
+ performed exclusively as a research study.
266
+ Funding
267
+ This research is funded by the JagMohan Maheswari trust, a
268
+ not-for-profit organisation working on the welfare of indige-
269
+ nous tribal populations. However, they did not have any in-
270
+ fluence on the outcome of the study or designing the
271
+ methodology.
272
+ Competing interests
273
+ The authors declare no conflict of interest.
274
+ r e f e r e n c e s
275
+ 1. Vijayakumar V, Mavathur R, Sharma MN. Ethnic disparity and
276
+ increased prevalence of type 2 diabetes among South Asians:
277
+ aetiology and future implications for diabetes prevention and
278
+ management. Curr Diabetes Rev 2017;14(6):518e22.
279
+ Table 2 e Fasting capillary blood glucose measurement
280
+ (n ¼ 103).
281
+ Range
282
+ Fasting glucose (mg/dL)
283
+ [mean ± SD]
284
+ Male
285
+ Female
286
+ Normal range
287
+ 88.79 ± 16.82
288
+ 87.69 ± 19.29
289
+ Prediabetes range
290
+ 107.17 ± 12.58
291
+ 110 ± 14.96
292
+ Diabetes range
293
+ 275 ± 19.52
294
+ 225.33 ± 18.31
295
+ SD, standard deviation.
296
+ p u b l i c h e a l t h x x x ( 2 0 1 8 ) 1 e4
297
+ 3
298
+ Please cite this article in press as: Vijayakumar V, et al., Challenges faced in diabetes risk prediction among an indigenous South Asian
299
+ population in India using the Indian Diabetes Risk Score, Public Health (2018), https://doi.org/10.1016/j.puhe.2018.09.012
300
+ 2. Anjana RM, Pradeepa R, Deepa M, Datta M, Sudha V,
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+ Unnikrishnan R, et al. Prevalence of diabetes and prediabetes
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+ (impaired fasting glucose and/or impaired glucose tolerance)
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+ in urban and rural India: phase I results of the Indian Council
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+ of Medical ResearcheIndia DIABetes (ICMReINDIAB) study.
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+ Diabetologia 2011;54(12):3022e7.
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+ 3. Durie MH. The health of Indigenous peoples: depends on
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+ genetics, politics, and socioeconomic factors. BMJ Br Med J
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+ 4. Subramanian SV, Smith GD, Subramanyam M. Indigenous
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+ health and socioeconomic status in India. PLoS Med
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+ 2006;3(10):e421.
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+ 5. Stephens C, Nettleton C, Porter J, Willis R, Clark S. Indigenous
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+ peoples' healthdwhy are they behind everyone, everywhere?
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+ Lancet 2005;366(9479):10e3.
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+ 6. Si D, Bailie R, Wang Z, Weeramanthri T. Comparison of
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+ diabetes management in five countries for general and
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+ indigenous populations: an internet-based review. BMC Health
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+ Serv Res 2010;10(1):169.
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+ 7. Valeggia CR, Snodgrass JJ. Health of indigenous peoples. Annu
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+ Rev Anthropol 2015;44:117e35.
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+ 8. Ministry of Tribal Affairs. Scheduled tribes in India as revealed in
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+ census 2011 (RGI report). New Delhi: India Ministry of Tribal
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+ Affairs; 2017. Available: https://tribal.nic.in/writereaddata/
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+ AnnualReport/
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+ ScheduledTribesinIndiaasRevealedinCensus2011.pdf.
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+ 9. Glu
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+ ¨ mer C, Vistisen D, Borch-Johnsen K, Colagiuri S. Risk
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+ scores for type 2 diabetes can be applied in some populations
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+ but not all. Diabetes Care 2006;29(2):410e4.
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+ 10. Mohan V, Deepa R, Deepa M, Somannavar S, Datta M. A
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+ simplified Indian Diabetes Risk Score for screening for
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+ undiagnosed diabetic subjects. J Assoc Phys India
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+ 2005;53:759e63.
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+ 11. Ogurtsova K, da Rocha Fernandes JD, Huang Y,
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+ Linnenkamp U, Guariguata L, Cho NH, et al. IDF Diabetes
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+ and 2040. Diabetes Res Clin Pract 2017;128:40e50.
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+ 12. Aune D, Norat T, Romundstad P, Vatten LJ. Whole grain and
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+ refined grain consumption and the risk of type 2 diabetes: a
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+ systematic review and doseeresponse meta-analysis of
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+ cohort studies. Eur J Epidemiol 2013;28(11):845e58.
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+ 13. Cho SS, Qi L, Fahey GC, Klurfeld DM. Consumption of cereal
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+ fiber, mixtures of whole grains and bran, and whole grains
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+ and risk reduction in type 2 diabetes, obesity, and
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+ cardiovascular disease. Am J Clin Nutr 2013. ajcn-067629.
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+ 14. Jannasch F, Kr€
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+ oger J, Schulze MB. Dietary patterns and type 2
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+ diabetes: a systematic literature review and meta-analysis of
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+ prospective studies. J Nutr 2017;147(6):1174e82.
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+ 15. Sridhar GR, Gumpeny L. Sleep, obesity and diabetes: the
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+ circadian rhythm. Adv Diabetes Nov Insights 2016:197.
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+ 16. Tan E, Scott EM. Circadian rhythms, insulin action, and
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+ glucose homeostasis. Curr Opin Clin Nutr Metab Care
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+ 2014;17(4):343e8.
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+ 17. Pawar SD, Naik JD, Prabhu P, Jatti GM, Jadhav SB, Radhe BK.
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+ Comparative evaluation of Indian Diabetes Risk Score and
357
+ Finnish Diabetes Risk Score for predicting risk of diabetes
358
+ mellitus type II: a teaching hospital-based survey in
359
+ Maharashtra. J Fam Med Prim Care 2017;6(1):120.
360
+ p u b l i c h e a l t h x x x ( 2 0 1 8 ) 1 e4
361
+ 4
362
+ Please cite this article in press as: Vijayakumar V, et al., Challenges faced in diabetes risk prediction among an indigenous South Asian
363
+ population in India using the Indian Diabetes Risk Score, Public Health (2018), https://doi.org/10.1016/j.puhe.2018.09.012
subfolder_0/Changes in Heart Rate Variability Following Yogic Visual Concentration (Trataka)_unlocked.txt ADDED
@@ -0,0 +1,335 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ 15
2
+ Heart India, Vol 2 / Issue 1 / Jan-Mar 2014
3
+ Changes in Heart Rate Variability Following Yogic Visual
4
+ Concentration (Trataka)
5
+ B R Raghavendra, V Ramamurthy
6
+ Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India
7
+ The literal meaning of the Sanskrit word trataka is “to gaze steadily.”
8
+ Looking intently with an unwavering gaze at a small point until tears
9
+ are shed is known as trataka (Hatha Yoga Pradipika, Ch:2, V:31).
10
+ Hatha Yoga Pradipika mentions that, practice of trataka eradicates
11
+ all the eye diseases, fatigue and lethargy (Hatha Yoga Pradipika, Ch:2,
12
+ V:32). Though trataka is considered as cleansing technique, the final
13
+ stage of trataka leads to meditative mental state.[3]
14
+ Recently, a study has been conducted to assess the immediate effect
15
+ of trataka on critical flicker fusion (CFF).[4] The CFF is defined as the
16
+ frequency at which a flickering stimulus is perceived to be continuous.
17
+ There was a significant increase in CFF following trataka suggesting
18
+ changes at the cortical level in the processes that mediate fusion.
19
+ Meditation and autonomic changes are researched extensively and
20
+ shown a shift toward vagal tone during meditation.[5-7] However,
21
+ there was no study evaluating autonomic changes during trataka
22
+ which is similar to meditation. Hence, in the present study, we
23
+ used heart rate variability (HRV) which is a well-known and
24
+ extensively used method to evaluate autonomic modulation.
25
+ MATERIALS AND METHODS
26
+ Participants
27
+ A total of 30 male volunteers with ages ranging from 20 to 33
28
+ years (group mean age ± SD, 23.8 ± 3.5) were recruited for this
29
+ A b s t ra ct
30
+ Background: The yogic visual concentration technique, trataka is similar to meditation. Research studies have shown
31
+ a shift toward the vagal tone during meditation. However, autonomic changes in trataka were not studied. Objectives:
32
+ The present study was planned to assess the changes in heart rate variability (HRV) following trataka. Materials and
33
+ Methods: HRV and breath rate were assessed in thirty healthy male volunteers with ages ranging from 20 to 33 years
34
+ (group mean age ± SD, 23.8 ± 3.5) before and after yogic visual concentration (trataka) and control session on 2 separate
35
+ days. Repeated measures analysis of variance (ANOVA) were performed with two “within subjects” factors, i.e., Factor 1:
36
+ Sessions; trataka and control and Factor 2: States; “Pre”, and “Post”. This was followed by post-hoc analyses with Bonferroni
37
+ adjustment comparing “Post” with “Pre” values. Results: There was a significant decrease in LF (RM ANOVA with
38
+ Bonferroni adjustment P < 0.01) and increase in high frequency (P < 0.01) after trataka. Breath rate (P < 0.001) and heart rate
39
+ (P < 0.01) were significantly reduced after trataka compared to before. Control session showed no change. Conclusions: The
40
+ practice of trataka leads to increased vagal tone and reduced sympathetic arousal. Though trataka is known as cleansing
41
+ technique, it could induce calm state of mind which is similar to a mental state reached by the practice of meditation.
42
+ Key words: Heart rate variability, high frequency, low frequency, trataka
43
+ Address for correspondence:
44
+ Dr. B R Raghavendra,
45
+ Swami Vivekananda Yoga Anusandhana Samsthana,
46
+ # 19, Eknath Bhavan, Gavipuram Circle, K G Nagar,
47
+ Bengaluru - 560 019, Karnataka, India.
48
+ INTRODUCTION
49
+ Yoga is an ancient Indian science and the way of life. Sage
50
+ Patanjali (circa 900 B.C) explains the theoretical aspects yoga in
51
+ 196 aphorisms called Yoga Sutras.[1] Patanjali evolved Astanga
52
+ yoga (eight limbed) to reach the ultimate reality. Later around 10th
53
+ Century CE Sage Svatmarama wrote a text called Hatha Yoga
54
+ Pradipika in which he explains the method of yoga techniques.
55
+ He prescribes six cleansing techniques (kriyas) viz., dauti, basti,
56
+ neti, trataka, nauli and kapalabhati to purify the body. The goal of
57
+ Hatha Yoga is to prepare the body and mind for the practice of
58
+ Raja yoga or Astanga yoga.[2]
59
+ O riginal Article
60
+ Access this article online
61
+ Quick Response Code:
62
+ Website:
63
+ www.heartindia.net
64
+ DOI:
65
+ 10.4103/2321-449x.127975
66
+ [Downloaded free from http://www.heartindia.net on Thursday, July 28, 2016, IP: 14.139.155.82]
67
+ 16
68
+ Raghavendra and Ramamurthy: Trataka and HRV
69
+ Heart India, Vol 2 / Issue 1 / Jan-Mar 2014
70
+ study. They were all students of a yoga university in Southern
71
+ India. Their health status was evaluated by a routine clinical
72
+ examination and case history. They had normal health and
73
+ were not on any medication. The predetermined conditions to
74
+ exclude participants from the trial were any chronic illness. Male
75
+ volunteers alone were selected as autonomic and respiratory
76
+ variables are known to vary with the phases of the menstrual
77
+ cycle.[8] The project was approved by the institution’s ethics
78
+ committee. The study protocol was explained to the participants
79
+ and their signed consent was obtained.
80
+ Design
81
+ Self as control design was used. Each participant was assessed in
82
+ two sessions (trataka and control session) on 2 separate days. Half
83
+ the subjects practiced trataka on 1st day and control session on 2nd
84
+ day. The other half was having the order of the session reversed.
85
+ Duration of both the sessions were of 25 min. Participants were
86
+ assessed before and immediately after the sessions.
87
+ Assessment
88
+ Electrocardiogram (ECG) and respiration were recorded using
89
+ a four channel polygraph (Biopac MP 100, USA).
90
+ HRV and heart rate
91
+ The ECG was recorded using a standard bipolar limb lead II
92
+ configuration and an AC amplifier with 100 Hz high cut filter
93
+ and 1.5 Hz low cut filter settings. The EKG was digitized using
94
+ a 12-bit analog-to-digital converter at a sampling rate of 1024 Hz
95
+ and was analyzed off-line to obtain the HRV spectrum.
96
+ Breath rate
97
+ Respiration was be recorded using a volumetric pressure
98
+ transducer fixed around the trunk about 8 cm below the lower
99
+ costal margin as the participants sat erect.
100
+ Intervention
101
+ Trataka (a yogic visual concentration)
102
+ Fifteen days orientation program was conducted to train
103
+ participants in trataka. Theoretical aspects of trataka was
104
+ explained by a senior yoga teacher on day one. The pre-recorded
105
+ audio instructions for trataka was played during the session.
106
+ Trataka practice consists of two distinct stages. The first stage,
107
+ consisted of eye exercises, which is a preparatory practice for
108
+ trataka. The eye exercise includes eyeball movements in the
109
+ horizontal, vertical and diagonal direction directions and circular
110
+ movements. These was performed with eyes open, in a well-lit
111
+ room. This was followed by the practice of palming to relax the
112
+ eyes. Palming consisted of putting slightly cupped palms over
113
+ the eyes, so that the eyes perceive complete darkness. First stage
114
+ lasted for 10 min. The second stage, trataka, was practiced in a
115
+ dark room. Subjects were asked to fix the gaze on the flame of
116
+ the candle for about 2 to 3 min, suppressing the urge to blink
117
+ as far as possible. Then visualize the candle flame in between
118
+ the eyebrows. This process was repeated for 2-3 rounds. Finally,
119
+ subjects were asked to defocus and the practice ended with silence
120
+ and then prayer. The second stage lasted for 15 min. The duration
121
+ of the whole practice was 25 min.
122
+ Control session
123
+ During control session participants were asked to practice the
124
+ first stage (eye exercise) for 10 min and then for next 15 min
125
+ they sat quietly with closed eyes without doing any concentration
126
+ or meditation.
127
+ Data extraction
128
+ HRV
129
+ Frequency domain analysis of HRV were carried out. The energy
130
+ in the HRV spectrum in the following specific frequency bands
131
+ were studied. The low frequency (LF) (0.04-0.15 Hz) and high
132
+ frequency (HF) band (0.15-0.4 Hz). According to guidelines,
133
+ LF and HF band values will be expressed as normalized units.[9]
134
+ Herat rate
135
+ The heart rate in beats per minute was calculated by counting
136
+ the R waves of the QRS complex in the EKG in 60 s epochs,
137
+ continuously.
138
+ Breath rate
139
+ The breath rate in cycles per minute was calculated by counting
140
+ the breath cycles in 60 s epochs, continuously.
141
+ Data analysis
142
+ Statistical analysis was performed using SPSS (version 16.0).
143
+ Since the same individuals were assessed in repeat sessions on
144
+ separate days (i.e., trataka and control), repeated measures analysis
145
+ of variance was used (ANOVA). Repeated measures ANOVA
146
+ were performed with two “within subjects” factors, i.e., Factor
147
+ 1: Sessions; trataka and control and Factor 2: States; “Pre” and
148
+ “Post.” This was followed by post-hoc analyses with Bonferroni
149
+ adjustment comparing “Post” with “Pre” values.
150
+ RESULTS
151
+ The group mean values and standard deviation for frequency
152
+ domain measures of HRV, heart rate and breath rate are shown
153
+ in Table 1.
154
+ Repeated measures ANOVA
155
+ Repeated measures ANOVA were conducted where subjects
156
+ were measured before and after trataka as well as control session.
157
+ There was a significant difference between the states for
158
+ 1.
159
+ LF F(1, 29) = 7.58, P < 0.01;
160
+ 2.
161
+ HF F(1, 29) = 7.60, P < 0.01;
162
+ 3.
163
+ Hear rate F(1, 29) = 13.08, P < 0.01;
164
+ 4.
165
+ Breath rate F(1, 29) = 20.52, P < 0.001.
166
+ [Downloaded free from http://www.heartindia.net on Thursday, July 28, 2016, IP: 14.139.155.82]
167
+ 17
168
+ Raghavendra and Ramamurthy: Trataka and HRV
169
+ Heart India, Vol 2 / Issue 1 / Jan-Mar 2014
170
+ There was a significant difference between the sessions for
171
+ 1.
172
+ Heart rate F(1, 29) = 6.75, P < 0.05; and
173
+ 2.
174
+ Breath rate F(1, 29) = 9.38, P < 0.01.
175
+ There was also a significant interaction between Session and
176
+ State for
177
+ 1.
178
+ Breath rate F (1, 29) = 14.14, P < 0.001.
179
+ Post-hoc analyses with Bonferroni
180
+ adjustment
181
+ There was a significant decrease in LF (P < 0.01) and significant
182
+ increase in HF (P < 0.01) after trataka. Breath rate (P < 0.001)
183
+ and heart rate (P < 0.01) were significantly reduced after trataka
184
+ compared to before. Control session did not show any change.
185
+ DISCUSSION
186
+ In the current study, HRV and breath rate were assessed before
187
+ and after the practice of trataka and control session in thirty
188
+ healthy male volunteers. There was a significant decrease in LF
189
+ and increase in HF after trataka compared to before. Breath rate
190
+ and heart rate were significantly reduced after trataka compared
191
+ to before. Control session showed no change.
192
+ HRV refers to beat-to-beat alterations in the heart rate. In general
193
+ two type of HRV analysis are used. These are frequency domain
194
+ analysis and time domain analysis. In the preset study, we have
195
+ used only frequency domain analysis. Earlier it was believed
196
+ that the LF (LF, 0.04-0.15 Hz) band of the HRV is an index of
197
+ cardiac sympathetic activity and HF (HF, 0.15-0.4 Hz) band is
198
+ correlated with parasympathetic activity.[9] However this has been
199
+ questioned subsequently. Recent research findings says, neither
200
+ the LF band (LF) nor the HF, are considered exclusive markers of
201
+ sympathetic and parasympathetic tone respectively.[10] It is found
202
+ that, sympathetic activity can also regulate the HF component
203
+ of HRV, though to a lesser extent than the parasympathetic
204
+ influence on the LF power. The association between HF power
205
+ and cardiac parasympathetic activity is stronger. Hence the HRV
206
+ provides broad changes in cardiac parasympathetic regulation and
207
+ changes in the LF power and LF/HF ratio have to be considered
208
+ carefully. The decrease in LF power and increase in HF power
209
+ after trataka suggests increased vagal modulation after trataka.
210
+ The changes in hear rate are due to several factors. The heart rate
211
+ is under the control of sympathetic and parasympathetic nerves
212
+ as well as humeral factors.[11] Hence, it is difficult to conclude
213
+ that decrease in hear rate is only due to increased vagal tone or
214
+ due to sympathetic withdrawal.
215
+ Breath rate depends upon numerous factors ranging from the
216
+ level of physical activity to psychological stress.[12] In general,
217
+ a decrease in breath rate is correlated with relaxation. Though
218
+ trataka practice involves intense focusing, it ends with defocusing
219
+ and silence. This might induce relaxation after the practice which
220
+ can explain the decrease in breath rate.
221
+ The findings in the current study are similar to the earlier study on
222
+ autonomic change sand two meditative states described in yoga
223
+ texts, which showed reduced sympathetic arousal and increased
224
+ vagal tone during dhyana.[7] Hence, it is speculated that the practice
225
+ of trataka leads mental state which similar to meditation.
226
+ One of the main limitations of the study is that, assessments were
227
+ not performed during the practice of trataka. Changes in HRV
228
+ during trataka might have conveyed much more information. It
229
+ will be interesting to have a longer duration of “Post” session (10
230
+ or 15 min) by which we can understand how much time effect
231
+ of trataka sustains. In future, along with HRV other autonomic
232
+ variables can be studied before during and after trataka.
233
+ In summary, considering changes in HRV
234
+ , heart rate and breath rate,
235
+ the present results show that, practice of trataka leads to increased
236
+ vagal tone and reduced sympathetic arousal. Though trataka is known
237
+ as cleansing technique, it could induce calm state of mind which is
238
+ similar to a mental state reached by the practice of meditation.
239
+ REFERENCES
240
+ 1.
241
+ Taimni IK. The Science of YogaMadras: Theosophical Publishing
242
+ House; 1999.
243
+ 2.
244
+ Muktibodhananda S. Hatha Yoga Pradipika. Munger: Yoga
245
+ Publications Trust; 1993.
246
+ 3.
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+ Nagaratha R, Nagendra H. Yoga for Promotion of Positive Health.
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+ Bangalore: Swami Vivekananda Yoga Prakashana; 2000.
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+ 4.
250
+ Mallick T, Kulkarni R. The effect of trataka, a yogic visual concentration
251
+ practice, on critical flicker fusion. J Altern Complement Med
252
+ 2010;16:1265-7.
253
+ 5.
254
+ Orme-Johnson DW. Autonomic stability and transcendental
255
+ meditation. Psychosom Med 1973;35:341-9.
256
+ Table 1: Changes in heart rate variability and breath rate before and after trataka and control session
257
+ Variables
258
+ Control
259
+ Trataka
260
+ Pre
261
+ Post
262
+ Pre
263
+ Post
264
+ LF in n.u.(Hz)
265
+ 64.40±14.92
266
+ 62.21±16.17
267
+ 63.85±14.25
268
+ 53.58±15.41**↓
269
+ HF in n.u.(Hz)
270
+ 35.60±14.92
271
+ 37.79±16.14
272
+ 36.15±14.25
273
+ 46.42±15.41**↑
274
+ LF/HF ratio
275
+ 2.79±2.42
276
+ 2.54±2.64
277
+ 2.41±1.73
278
+ 2.24±1.96
279
+ Heart rate (bpm)
280
+ 72.87±6.61
281
+ 70.91±8.11
282
+ 71.20±8.83
283
+ 67.29±5.84**↓
284
+ Breath rate (cpm)
285
+ 15.20±1.34
286
+ 14.85±1.36
287
+ 15.13±0.96
288
+ 13.85±1.22***↓
289
+ **P<0.01, ***P<0.001. Repeated measures analysis of variance with Bonferroni adjustment comparing post values with pre values. ↑: Increase, ↓: Decrease, LF: Low
290
+ frequency, HF: High frequency
291
+ [Downloaded free from http://www.heartindia.net on Thursday, July 28, 2016, IP: 14.139.155.82]
292
+ 18
293
+ Raghavendra and Ramamurthy: Trataka and HRV
294
+ Heart India, Vol 2 / Issue 1 / Jan-Mar 2014
295
+ 6.
296
+ Wallace RK. Physiological effects of transcendental meditation. Science
297
+ 1970;167:1751-4.
298
+ 7.
299
+ Telles S, Raghavendra BR, Naveen KV, Manjunath NK, Kumar S,
300
+ Subramanya P. Changes in autonomic variables following two
301
+ meditative states described in yoga texts. J Altern Complement Med
302
+ 2013;19:35-42.
303
+ 8.
304
+ Yildirir A, Kabakci G, Akgul E, Tokgozoglu L, Oto A. Effects
305
+ of menstrual cycle on cardiac autonomic innervation as assessed
306
+ by heart rate variability. Ann Noninvasive Electrocardiol
307
+ 2002;7:60-3.
308
+ 9.
309
+ Heart rate variability. Standards of measurement, physiological
310
+ interpretation, and clinical use. Task Force of the European Society
311
+ of Cardiology and the North American Society of Pacing and
312
+ Electrophysiology. Eur Heart J 1996;17:354-81.
313
+ 10.
314
+ Lombardi F, Stein PK. Origin of heart rate variability and turbulence:
315
+ An appraisal of autonomic modulation of cardiovascular function.
316
+ Front Physiol 2011;2:95.
317
+ 11.
318
+ Andreassi JL. Psychophysiology: Human Behavior and Physiological
319
+ Response. Mahwah, NJ: Lawrence Earl Baum Associates; 2007.
320
+ 12.
321
+ Stevenson I, Ripley HS. Variations in respiration and in respiratory
322
+ symptoms during changes in emotion. Psychosom Med 1952;14:476-90.
323
+ How to cite this article: Raghavendra BR, Ramamurthy V. Changes
324
+ in heart rate variability following yogic visual concentration (Trataka).
325
+ Heart India 2014;2:15-8.
326
+ Source of Support: Nil Conflict of Interest: Nil.
327
+ Announcement
328
+ iPhone App
329
+ A free application to browse and search the journal’s content is now available for iPhone/iPad. The application
330
+ provides “Table of Contents” of the latest issues, which are stored on the device for future offline browsing.
331
+ Internet connection is required to access the back issues and search facility. The application is Compatible
332
+ with iPhone, iPod touch, and iPad and Requires iOS 3.1 or later. The application can be downloaded from http://
333
+ itunes.apple.com/us/app/medknow-journals/id458064375?ls=1&mt=8. For suggestions and comments do
334
+ write back to us.
335
+ [Downloaded free from http://www.heartindia.net on Thursday, July 28, 2016, IP: 14.139.155.82]
subfolder_0/Combination of Ayurveda and Yoga therapy reduces pain intensity and improves quality of life in patients with migraine headache.txt ADDED
@@ -0,0 +1,1390 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Accepted Manuscript
2
+ Combination of Ayurveda and Yoga therapy reduces pain intensity and improves
3
+ quality of life in patients with migraine headache
4
+ Vasudha M. Sharma, N.K. Manjunath, H.R. Nagendra, Csaba Ertsey
5
+ PII:
6
+ S1744-3881(18)30100-2
7
+ DOI:
8
+ 10.1016/j.ctcp.2018.05.010
9
+ Reference:
10
+ CTCP 876
11
+ To appear in:
12
+ Complementary Therapies in Clinical Practice
13
+ Received Date: 18 February 2018
14
+ Revised Date:
15
+ 8 May 2018
16
+ Accepted Date: 25 May 2018
17
+ Please cite this article as: Sharma VM, Manjunath NK, Nagendra HR, Ertsey C, Combination of
18
+ Ayurveda and Yoga therapy reduces pain intensity and improves quality of life in patients with migraine
19
+ headache, Complementary Therapies in Clinical Practice (2018), doi: 10.1016/j.ctcp.2018.05.010.
20
+ This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to
21
+ our customers we are providing this early version of the manuscript. The manuscript will undergo
22
+ copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please
23
+ note that during the production process errors may be discovered which could affect the content, and all
24
+ legal disclaimers that apply to the journal pertain.
25
+ MANUSCRIPT
26
+
27
+ ACCEPTED
28
+ ACCEPTED MANUSCRIPT
29
+ Combination of Ayurveda and Yoga therapy reduces pain intensity and
30
+ improves Quality of life in patients with Migraine Headache
31
+
32
+
33
+
34
+ Vasudha M. Sharma1*., Manjunath N. K1., Nagendra H.R1., and Ertsey
35
+ Csaba2
36
+
37
+
38
+ 1. Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) A
39
+ Deemed to be University, Bengaluru, Karnataka, India
40
+ 2. Department of Neurology, Faculty of Medicine, Semmelweis
41
+ University Budapest, 1083 Hungary
42
+
43
+
44
+
45
+
46
+
47
+
48
+ * Address for correspondence: Dr. Vasudha M. Sharma, Division of Yoga
49
+ and Life Sciences, S-VYASA University, Prashanthi Kutiram, Jigani
50
+ (Hobli), Anekal (Talluk), Bengaluru – 560106, Karnataka, India. E-mail:
51
52
+ MANUSCRIPT
53
+
54
+ ACCEPTED
55
+ ACCEPTED MANUSCRIPT
56
+ Objectives: To Understand the efficacy of Ayurveda and Yoga in the management of
57
+ Migraine Headache.
58
+ Methods: 30 subjects recruited to Ayurveda and Yoga (AY) group underwent traditional
59
+ Panchakarma (Bio-purificatory process) using therapeutic Purgation followed by Yoga
60
+ therapy, while 30 subjects of Control (CT) group continued on symptomatic treatment
61
+ (NSAID's) for 90 days. Body constitution questionnaire was administered to both groups.
62
+ The outcome measures included Symptom check list, Comprehensive Headache related
63
+ Quality of Life Questionnaire and Visual Analogue Scale.
64
+ Results: Forty-six (76.6%) out of 60 subjects belonging to both groups had Pitta based body
65
+ constitution. Following 90 days of intervention the AY group showed significant reduction in
66
+ Migraine symptoms including pain intensity (p<.001) and improvement in Headache related
67
+ Quality of Life (p<.001). The CT group showed no significant change (p>.05).
68
+ Conclusion: Traditional Ayurveda along with Yoga therapy reduces symptoms, intensity of
69
+ pain and improves Quality of life in Migraine patients.
70
+ MANUSCRIPT
71
+
72
+ ACCEPTED
73
+ ACCEPTED MANUSCRIPT
74
+ 1. Introduction
75
+ Migraine is a primary headache disorder which is vastly prevalent across the world. It contributes
76
+ extensively to the disease-related burden resulting in lowered Quality of life (1). Migraine is the
77
+ 10th most disabling disorder amongst both genders in the world (2), triggered by psychological and
78
+ physiological stressors (3). Stress as a risk factor attributes to the problem in 50% of the mi-
79
+ graineurs (4). Studies have shown that the adherence to prophylactic treatment is low and more than
80
+ 50% of migraineurs discontinue such treatment, regardless of the class of medicine taken (5). Medi-
81
+ cation overuse is also an associated issue in Migraine patients owing to use of Non-Steroidal Anti
82
+ Inflammatory Drugs (NSAIDS) with or without doctor’s prescription (6).
83
+
84
+ The use of Complementary and Alternative medicine in migraine or in patients with severe head-
85
+ ache is popular as they feel it is congruent to their beliefs in health and lifestyle and has lesser-
86
+ known side effects with less dependency on medication (7). The idea of Integrative medicine is
87
+ gaining popularity and its use is increasing in the management of chronic conditions (8). In a study
88
+ on the prevalence of CAM use in Migraine patients, among several therapies acupuncture, massage
89
+ and chiropractice were found to be the most commonly used methods. 47.7% participants reported
90
+ potential improvement in headache (9).
91
+
92
+ Ayurveda is an ancient Indian system of medicine, which considers health as a state of wellbeing
93
+ resulting from a synergistic balance in Doshas (Principal systems functions - Vata, Pitta, and
94
+ Kapha), Agni (Digestive fire), Dhatu (Body tissues) and Mala (Excretory products). It also empha-
95
+ sizes on a blissful state of Atma (spirit), Indriya (sense organs) and Manas (mind) (10). Migraine
96
+ headache finds its mention as Ardhavabedhaka under the classification of Shiroroga (Diseases re-
97
+ lated to the Head region) in Ayurveda treatises (11). Acharya Sushruta, an ancient Indian Ayurveda
98
+ Physician opines Ardhavabhedaka to be a Tridoshaja vyadhi (a disease with involvement of Vata
99
+ Pitta and Kapha) (11) and Acharya Charaka mentions it as a Vata-kaphaja Vyadhi (Disease involv-
100
+ ing Vata and Kapha) (12). There are visible Pitta lakshana’s (signs of Pitta) and involvement of
101
+ Rakta (blood) in the pathogenesis of Ardhavabhedaka (13). The line of treatment involves admin-
102
+ istration of Samshodhana (Panchakarma-Bio-purificatory techniques) with special mention of Kaya
103
+ virechana (Therapeutic Purgation) (12), diet and lifestyle regulation. Scientific literature also shows
104
+ that diet, lifestyle and stress can contribute to increased prevalence of Migraine Headache (14).
105
+
106
+ A study on five Ayurveda oral medicines administered for 90 days provided a preliminary evidence
107
+ for the effectiveness of an Ayurveda based treatment protocol in the management of Migraine
108
+ Headache (15).
109
+ MANUSCRIPT
110
+
111
+ ACCEPTED
112
+ ACCEPTED MANUSCRIPT
113
+
114
+ According to Yoga, Migraine is considered as an Adhija Vyadhi (mind-body disorder) where the
115
+ disturbances in the mind influence the flow of Prana (the vital force/breath) resulting in physical
116
+ problems and affecting the weakest system in the body (16).
117
+
118
+ Studies have shown the beneficial effects of Yoga not only in stress and lifestyle-related diseases
119
+ but also in the management of pain related conditions (17). In two different studies, Yoga therapy
120
+ for three months and the use of transcendental meditation have demonstrated a significant reduction
121
+ in frequency and severity of pain in migraine patients (18) (19). Therefore, Yoga therapy compli-
122
+ ments Ayurveda by adding physical activity, breath regulation, relaxation, and meditation.
123
+
124
+ Identifying the need for generating more scientific evidence for integrative treatment protocols, the
125
+ present study was designed to evaluate the use of traditional Ayurveda based Virechana (Therapeu-
126
+ tic purgation) followed by Yoga therapy in the management of Migraine in comparison to sympto-
127
+ matic conventional treatment.
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
140
+
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+
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+
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+
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+
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+
146
+
147
+ MANUSCRIPT
148
+
149
+ ACCEPTED
150
+ ACCEPTED MANUSCRIPT
151
+ 2. Methods
152
+ 2.1. Setting
153
+ The study was conducted as a prospective matched controlled trial comparing an Ayurveda-Yoga
154
+ group (AY) with a Control group (CT) on symptomatic conventional treatment. Participants for
155
+ both the groups were recruited at a Center for Integrative Medicine in South India. The participants
156
+ in both groups had consulted a neurologist or a physician. The study protocol was approved by the
157
+ Institutional Ethics Committee of S-VYASA (a Deemed to be University), Bengaluru, India. The
158
+ study was conducted between 2015-2017 and registered with the Clinical Trials Registry of India
159
+ (CTRI/2017/10/010074).
160
+
161
+ 2.2 Participants
162
+ Eighty-six individuals who were clinically diagnosed with Migraine Headache were screened pro-
163
+ spectively based on inclusion and exclusion criteria and sixty participants were selected for the
164
+ study.
165
+
166
+ The recruitment was based on self-selection by the participants to either Ayurveda and Yoga (AY)
167
+ or Control (CT) group. Participants were explained about the study protocol and an informed con-
168
+ sent was obtained before recruitment. They were also given the choice to withdraw from the study
169
+ at any stage.
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+
171
+ The sample size was calculated using the G Power software with the Mean values and Standard
172
+ deviations derived from a previous study (18) with an effect size of 1.31, α = 0.05 and power =
173
+ 0.95. The required sample size was 19 participants in each group. Considering the compliance-
174
+ related issues, and to improvise the statistical impact, a sample size of 30 participants in each group
175
+ was considered in the present study.
176
+ The diagnostic criteria were based on the International Classification of Headache Disorders (3rd
177
+ edition) of the International Headache Society, 2013 (20).
178
+
179
+ 2.2.1 Inclusion criteria: The participants included in the study were from both genders, between
180
+ 18-46 years of age with a headache history for more than one year, 5 or more attacks of headache in
181
+ 3 months and willingness to follow the dietary restrictions and complete the headache diary. The
182
+ Participants in Ayurveda and Yoga group had to be willing to take oral Ayurveda medicine for 75
183
+ days.
184
+
185
+ MANUSCRIPT
186
+
187
+ ACCEPTED
188
+ ACCEPTED MANUSCRIPT
189
+ 2.2.2 Exclusion criteria: The participants with primary Psychiatric disorders (Depression, Anxiety,
190
+ Psychosis), major medical illness (Renal, Hepatic, Neurological and Cardiac diseases), Pregnancy,
191
+ pure menstrual migraine, women who have attained Menopause, participants on Ayurveda or Yoga
192
+ intervention for the past six months and participants on conventional prophylactic treatment were
193
+ excluded from the study.
194
+
195
+ 2.3 Study Design
196
+ The present study was a prospective matched controlled trial, with a pre-post design. Participants
197
+ were recruited as and when they approached the physician who referred them to the investigator.
198
+ Those willing to undergo Ayurveda and Yoga intervention were allocated to AY group, while the
199
+ others who chose to continue with symptomatic treatment were recruited to the Control (CT) group.
200
+ The groups were matched for age and gender. Participants of AY group and CT group were as-
201
+ sessed on Day 1, Day 30 and Day 90.
202
+
203
+ 2.4 Assessment
204
+ After the participants volunteered for the study, the Sushruta Prakriti Inventory, Comprehensive
205
+ Headache-related Quality of life Questionnaire (CHQQ) and Visual analogue scale (VAS) were
206
+ administered to both the groups on day 1 and day 90 of the study. The symptom checklist was ad-
207
+ ministered on day 1, day 30 and day 90, since it was essential to closely monitor the response to
208
+ therapeutic purgation (Virechana) in the AY group. The assessments were carried out in headache-
209
+ free states.
210
+
211
+ 2.4.1 Prakriti Analysis: The Body constitution (Prakriti) was assessed using Sushruta Prakriti In-
212
+ ventory (SPI) which has two parts i.e., SPI-Q (Questions) with 90 items and SPI-C (Checklist) with
213
+ 60 items. Participants were asked to answer all 90 questions of SPI-Q, while an Ayurveda physician
214
+ evaluated the SPI-C. The scoring of SPI-Q and SPI-C were added to quantify the Tridosha domi-
215
+ nance of respective participants.
216
+ Sushrutha Prakriti Inventory (SPI) is a standardized tool for assessing body constitution (Prakriti)
217
+ and the combination of dosha of an individual. SPI has been assessed for reliability and validity in
218
+ the Indian population with a test-retest reliability for Vata, Pitta, and Kapha items as 0.994, 0.975
219
+ and 0.976 respectively based on Pearson Correlation coefficient. The Content and consensual valid-
220
+ ity based on Cronbach’s alpha was between 0.61 and 0.80 respectively (21).
221
+ As seen in other Ayurveda studies, the individuals were grouped as Vata-Pitta, Pitta-Kapha, and
222
+ Vata-Kapha based on the total score of the questionnaire (22).
223
+ MANUSCRIPT
224
+
225
+ ACCEPTED
226
+ ACCEPTED MANUSCRIPT
227
+ 2.4.2 Symptom Checklist: It was used to understand the influence of Ayurveda and Yoga on num-
228
+ ber and severity of symptoms. The symptom checklist had 10 questions based on the number of
229
+ attacks, duration of attack, intensity of pain, use of analgesics, associated with nausea and or vomit-
230
+ ing. The checklist was completed based on an individual’s experience of the above-mentioned
231
+ symptoms over the past three months. The intensity of being moderate or severe was assessed based
232
+ on the pointer which was set between 1-10, where 1-3 was considered as mild, 4-6 was considered
233
+ as moderate and 7-10 was considered severe.
234
+
235
+ 2.4.3 Comprehensive headache-related quality of life (CHQQ): CHQQ is a 23 item question-
236
+ naire, used to understand the subjective experience of an individual and to note the way in which
237
+ migraine headache affected their daily life. The questionnaire has been found to be reliable with
238
+ Cronbach’s alpha being 0.913 for the whole instrument when used in Migraine and Tension-Type
239
+ Headache patients. The questions have been categorized under physical, mental and social dimen-
240
+ sions with a total score of 0-100 (23). An earlier pilot study in an Indian population has demonstrat-
241
+ ed the possible correlations between Ayurveda based Prakriti (Body Constitution) on Headache
242
+ related Quality of Life (24).
243
+
244
+ 2.4.4 Visual Analogue Scale (VAS): The scale included a 10 cm long straight line, marked with
245
+ ‘No Pain’ on one side and ‘extreme pain’ on the other side. The VAS was used to assess the head-
246
+ ache intensity on Day 1and Day 90. Participants were asked to mark the pain level on the straight
247
+ line by drawing a perpendicular line. A measuring scale was used to identify the self-rated pain
248
+ intensity between 0 and 10 (25).
249
+
250
+ No Pain
251
+
252
+
253
+
254
+
255
+
256
+
257
+
258
+
259
+
260
+ Extreme Pain
261
+
262
+ 0
263
+ 1
264
+ 2
265
+ 3
266
+ 4
267
+ 5
268
+ 6
269
+ 7
270
+ 8
271
+ 9
272
+ 10
273
+
274
+
275
+
276
+
277
+
278
+
279
+
280
+
281
+
282
+
283
+
284
+
285
+
286
+
287
+
288
+
289
+ MANUSCRIPT
290
+
291
+ ACCEPTED
292
+ ACCEPTED MANUSCRIPT
293
+ 3. Intervention
294
+ Ayurveda treatment of Virechana (Therapeutic Purgation) followed by Yoga therapy was given to
295
+ the Participants of AY group for 90 days.
296
+
297
+ 3.1 Ayurveda: Following the assessment, on day 1 for Deepana - Pachana (Stomachic and Diges-
298
+ tive) 2.5 grams - 5 grams of Hinguvachadi churna (polyherbal powder) (26) was given twice a day
299
+ after food in the morning and evening with warm water for first 3 days. From Day 4, Abhyantara
300
+ Snehapana (Internal Oleation) with Kallyanaka Ghrita (polyherbal preparation made with Clarified
301
+ butter) (27) was administered on empty stomach between 7 am to 8 am in arohana pramana (in-
302
+ creasing dosage from 30-150 ml) for 3-5 days until Samyak Snighdha Lakshanas (adequacy of in-
303
+ ternal oleation) were seen (28). Following this, Sarvanga Abhyanga (external oil application) with
304
+ Shuddha Tila taila (Pure Sesame oil) and Swedana (steam bath) was administered for 3 days. The
305
+ next day (approximately day 9), Virechana (Therapeutic Purgation) was induced by administering
306
+ Trivrit lehyam (polyherbal paste) (29) based on their Prakriti (body constitution) and Koshta (na-
307
+ ture of the digestive tract). As documented in an earlier study, the process of Virechana was safe
308
+ and efficacious with no imbalance in serum electrolyte levels (30). Samsarjana krama (dietary reg-
309
+ imen) for 3-5 days (Day 7-9/12) was specified based on the Shuddhi (degrees of cleansing) (31).
310
+
311
+ Shamana Oushadhi (oral pacificatory medicines) were started between the Days 10-13 based on
312
+ individual response to purgation. The following medicine was used for oral administration for a
313
+ span of 75 days: Pathyakshadhatradi Kashaya (polyherbal decoction) (32) – 15 ml, 30 minutes be-
314
+ fore breakfast and dinner with 45 ml of warm water. Kachoradi churna (polyherbal powder) (33)
315
+ was used for topical application on the forehead, once a day as a paste mixed with milk (at room
316
+ temperature). There was special mention of Pathya and Apathya (Do’s and Don’ts regarding diet
317
+ and lifestyle).
318
+ The composition of each polyherbal formulation is mentioned in Table - 1.
319
+
320
+ The Participants were allowed to take an oral analgesic (NSAID) only on need, based on the inten-
321
+ sity of pain tolerable to the subject and the same was noted in their diary for medication use.
322
+
323
+ 3.2 Yoga therapy: The specially designed integrated Yoga therapy module for Migraine included
324
+ loosening exercises, breathing exercises, asana (postures), pranayama (regulated breathing), relaxa-
325
+ tion techniques and Chanting. This was practiced for a duration of 40 minutes daily. Yoga practices
326
+ were introduced on Day 10/11/12 of the treatment for 7 days as personalized sessions under the
327
+ MANUSCRIPT
328
+
329
+ ACCEPTED
330
+ ACCEPTED MANUSCRIPT
331
+ guidance and supervision of a trained Yoga therapist. The Participants were asked to practice the
332
+ same module at home, 5 days in a week till day 90.
333
+ The female Participants were advised not to practice yoga during the first three days of menstrual
334
+ cycle. The Yoga therapy module is detailed in Table 2.
335
+
336
+ 3.3 Control Group: The participants who agreed to participate in the trial but preferred to continue
337
+ on oral Analgesics (Non-Steroidal Anti Inflammatory Drug's) for symptomatic relief as per the pre-
338
+ scription of a general physician or neurologist were included under the control group. They were
339
+ asked not to practice Yoga or follow Ayurveda during the study period. They were given an option
340
+ to undergo the same therapy protocol as given for AY group after the study period.
341
+
342
+ Participants of AY and CT groups were asked to maintain a daily diary to record the regularity of
343
+ the practice of Yoga or Physical activity respectively along with medication use. They were moni-
344
+ tored once in two weeks over a telephonic call. The Participants were free to withdraw from the
345
+ study at any stage if they felt that the conditions weren’t conducive.
346
+
347
+
348
+ 4. Data Analysis
349
+ The data were analyzed using Statistical Package for Social Sciences, SPSS version 23. The nor-
350
+ mality and homogeneity were assessed using Kolmogorov-Smirnov test. Since the data were found
351
+ to be normally distributed, the CHQQ data and Visual analogue scale data collected on day 1 and
352
+ on day 90 in both AY and CT groups respectively were analyzed using paired sample t-test, while
353
+ the between-group comparisons were made using a one-way analysis of variance (ANOVA). The
354
+ values were considered significant if p<.05. The missing values of participants in AY and CT group
355
+ were replaced using intention to treat analysis.
356
+
357
+
358
+
359
+
360
+
361
+
362
+
363
+
364
+
365
+
366
+
367
+ MANUSCRIPT
368
+
369
+ ACCEPTED
370
+ ACCEPTED MANUSCRIPT
371
+ 5. Results
372
+ The Ayurveda and Yoga (AY) group had 30 participants with 8 male and 22 female participants
373
+ with an average age of 33.83 + 6.84 years. The CT Group had an equally matched number of Par-
374
+ ticipants (8male and 22 female) with an average age of 31.46 + 7.81years. There was one drop out
375
+ in AY group on Day 90 and one from the CT group on Day 30 and Day 90.
376
+
377
+ 5.1 Sushruta Prakriti Inventory: The Prakriti analysis showed that there were 15 participants
378
+ with Vata Pitta Prakriti, 31 with Pitta Kapha Prakriti and 14 with Vata Kapha Prakriti. This indi-
379
+ cated that Pitta dosha was predominantly seen (76.6%) in the Prakriti of 46 participants either as
380
+ pravara (primary) or madhayama (moderate) dosha. The details of the Prakriti are mentioned in
381
+ Table - 3.
382
+
383
+ 5.2 Comprehensive headache-related quality of life (CHQQ): The headache-related quality of
384
+ life included scores from physical, mental, social domains and their total score. The data of Day 1
385
+ compared to Day 90 in AY group showed significant improvement (p<.001, for all comparisons),
386
+ while the CT group did not show any change (p>.05). There was a significant difference between
387
+ the groups (AY and CT) when compared using a one-way ANOVA (p<.001). The group mean and
388
+ SD of AY and CT group is mentioned in Table - 4.
389
+ Participants with Pitta Kapha Prakriti had higher CHQQ scores (average score - 84.92) compared
390
+ to the Vata Pitta and Vata- Kapha Prakriti.
391
+
392
+ 5.3 The Symptom Checklist: The number of attacks and the average maximum duration of an at-
393
+ tack reduced in the AY group compared to the CT group when assessed on Day 30 and Day 90
394
+ compared to Day 1 of the study. The number of participants with severe headache, nausea and/or
395
+ vomiting reduced across Day 30 and day 90 in the AY group compared to the CT group. The anal-
396
+ gesic requirement on need basis which was noticed in all 30 participants of the AY group (100%)
397
+ on Day 1 reduced to 14 participants (46.6%) by Day 30 and was noticed in 6 participants (20%) on
398
+ Day 90 compared to the CT group. Table 5 represents the changes in symptom checklist.
399
+
400
+ 5.4 Visual Analogue Scale (VAS): The pain intensity as measured by visual analogue scale has
401
+ shown a significant reduction in AY group (p<.001) in comparison to CT group (p>.05) which
402
+ showed no change. The between-group comparison also showed a significant difference between
403
+ AY and CT groups (p<.001). Table 6 represents the changes in VAS.
404
+
405
+
406
+
407
+ MANUSCRIPT
408
+
409
+ ACCEPTED
410
+ ACCEPTED MANUSCRIPT
411
+ 6. Discussion
412
+
413
+ An Integrated approach of Ayurveda combined with Yoga therapy administered for 90 days in 30
414
+ patients with Migraine Headache showed a significant reduction in migraine-related symptoms and
415
+ improvement in the quality of life in comparison to Control group where there was no change.
416
+ Migraine is a disabling headache related disorder due to its impact on quality of life, affecting
417
+ 14.7% of the world population (34). Conventional line of treatment has focused on symptomatic
418
+ pain management and is associated with side effects due to long term use of drugs. Hence, the pre-
419
+ sent study was an attempt to understand the influence of an Ayurveda and Yoga-based intervention
420
+ in the treatment of Migraine.
421
+ Studies on Ayurveda provide scientific understanding to the Tridosha (Principal systems functions)
422
+ theory on which Ayurveda system of Medicine is developed. In a previous report, Prasher et al.
423
+ introduced Ayurveda based phenotyping with reference to body constitution as a method to under-
424
+ stand the predisposition of individuals to certain diseases (35). This supports the traditional descrip-
425
+ tion that a person is prone to a disease caused by the same dosha as his Prakriti (36). While at-
426
+ tempting to document and correlate body constitution with Migraine related symptoms, the present
427
+ study showed a clear involvement of Pitta in the body constitution (76.6 %) of individuals making
428
+ them prone to Migraine headache.
429
+
430
+ Similar correlations reported earlier, with respect to Rheumatoid Arthritis (37) demonstrated that
431
+ the concept of Prakriti specific disease susceptibility mentioned in Ayurveda is important in both
432
+ diagnosis and treatment of diseases.
433
+
434
+ The association of Pitta with inflammatory processes was speculated (38) and in Pitta individuals,
435
+ the genes related to Oxidative stress pathway were up-regulated (37). Oxidative stress is considered
436
+ a key for Migraine trigger (39) and the Phospholipase C in the Cerebrospinal fluid is increased in
437
+ migraineurs (40). Evidence on Panchakarma (mild virechana and nasya based) have shown a sig-
438
+ nificant reduction in certain plasma metabolites (41)
439
+ Perhaps, the choice of Virechana (Therapeutic purgation) as part of bio-purificatory treatment given
440
+ to AY group was customized based on the predominance of Pitta and the positive results observed
441
+ here are in line with the expected outcomes as mentioned in traditional Ayurveda texts (12).
442
+
443
+ The changes in symptom scores observed in the present study suggest reduced frequency, lowered
444
+ intensity, and the improved ability to recover from an attack. The changes observed can be attribut-
445
+ MANUSCRIPT
446
+
447
+ ACCEPTED
448
+ ACCEPTED MANUSCRIPT
449
+ ed to modifying pain perception both at physical and mental levels as pain is a complex sensory and
450
+ emotional experience that can vary widely between people and even within an individual. A simple
451
+ psychological manipulation, such as distraction, can modify perception of pain (42), and a negative
452
+ emotional state increases pain, whereas a positive state lowers the same (43). The neuroimaging
453
+ studies in chronic pain suggest that the activity in afferent pain pathways can be altered by the at-
454
+ tentional state, positive and negative emotions, empathy and administration of a placebo (44). It is
455
+ also understood that psychological factors activate intrinsic modulatory systems in the brain, includ-
456
+ ing those involved in opioid-related pain relief (45).
457
+ Using real-time Functional MRI (rtfMRI), attempts were made in healthy volunteers to modulate
458
+ the activation of their own anterior cingulate cortex (ACC) in order to alter their pain experience
459
+ (46). Several studies on Yoga and Meditation have demonstrated activation of areas which regulate
460
+ attentional process and emotions in the Brain. The association between increased cortical thickness
461
+ in pain-related brain regions (including ACC, bilateral parahippocampal gyrus) and lowered pain
462
+ sensitivity in Zen meditators compared to non-meditators has added the much needed supporting
463
+ evidence for the underlying mechanisms (47).
464
+
465
+ John et al, have reported that the practice of Yoga can reduce the levels of stress biomarkers such as
466
+ serum cortisol and Superoxide dismutase levels (48). Yoga in Migraineurs can bring in autonomic
467
+ modulation by improving vagal tone and also reduction of drug dosage when used along with con-
468
+ ventional care (49).
469
+
470
+ While there are few studies on Yoga and Migraine, the studies on Ayurveda are limited to poly-
471
+ herbal combinations (15). In this study, the emphasis was on the classical line of Ayurveda treat-
472
+ ment combined with Yoga for a better clinical outcome (50).
473
+
474
+ For the process of Virechana (therapeutic purgation) few poly herbal combinations were used in the
475
+ present study. Kallyanaka ghrita is one of the combinations mentioned in Bower manuscript and
476
+ traditional Ayurveda texts and its HPTLC has been studied for qualitative analysis (51).
477
+
478
+ The orally administered decoction (Pathyakshadhatyradi Kashaya) used in this study for 75 days
479
+ has 7 herbs. The herbs in the combination are Triphala (formula with 3 herbs) which has adap-
480
+ togenic, antimutagenic, chemoprotective, radioprotective effects (52), Neem which has anti-
481
+ inflammatory, apoptotic and antiproliferative properties (53), Turmeric with the active ingredient
482
+ Curcumin has potential therapeutic roles against many pro-inflammatory diseases such as cancer,
483
+ arthritis etc (54), Tinospora cordifolia has anti-oxidant, immunomodulatory and anti-inflammatory
484
+ MANUSCRIPT
485
+
486
+ ACCEPTED
487
+ ACCEPTED MANUSCRIPT
488
+ properties (55) and Andrographis paniculata which is studied for Hepatoprotective activity, Im-
489
+ munostimulant activity, antioxidant activity and anti-inflammatory activity. (56).
490
+
491
+ While Ayurveda believes that Yoga is a part of Swastha Vritha (Preventive medicine), Yoga thera-
492
+ py has grown as an independent system of complementary medicine. Ayurveda can primarily work
493
+ at a physical level to bring in balance in Dosha (body constituents) and Agni (digestive fire) while
494
+ Yoga therapy has contributed extensively to psychological well-being and mental relaxation.
495
+ Hence, a combination of Ayurveda and Yoga therapy given for 90 days has shown to complement
496
+ and augment the beneficial effects. This study adds much-needed evidence to demonstrate the
497
+ promising future of integrative medicine. The process also provides an opportunity to manage the
498
+ condition in a holistic perspective than a system-oriented, symptom-based approach.
499
+
500
+ However, a larger sample size and long-term follow up for a minimum period of 1 year is needed.
501
+ Further studies involving neuroimaging and biochemical measures are warranted for deeper scien-
502
+ tific understanding.
503
+
504
+ 7. Conclusion
505
+ Ayurveda and Yoga therapy as combined intervention reduces symptoms and improves quality of
506
+ life in patients with Migraine headache. The inference of this study is therefore, promising to look
507
+ at synergistic integration of two or more systems of Medicine for better clinical outcome.
508
+
509
+
510
+ MANUSCRIPT
511
+
512
+ ACCEPTED
513
+ ACCEPTED MANUSCRIPT
514
+ References
515
+ 1.
516
+ Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring
517
+ disability in headache disorders with WHO's classification of Functioning, Disability and
518
+ Health (ICF). J Headache Pain. 2005; 6:429-440
519
+ 2. Stovner LJ, Hagen K, Jensen R et al. The global burden of headache: a documentation of
520
+ headache prevalence and disability worldwide. Cephalalgia. 2007; 27(3):193-210
521
+ 3. Menken M, Munsat TL, Toole JF. The Global Burden of Disease Study Implications for
522
+ Neurology. Arch Neurol. 2000; 57(3):418-420
523
+ 4. Sevillano-Garcia MD, Manso-Calderón R, Cacabelos-Pérez P. Comorbidity in the migraine:
524
+ depression, anxiety, stress and insomnia. Rev Neurol. 2007;45(7):400-405
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+ 5.
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+ Berger A, Bloudek LM, Varon SF, Oster G. Adherence with migraine prophylaxis in clinical
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+ practice. Pain Pract. 2012; 12(7):541–549
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+ 6. Miller S, Matharu MS. Migraine is underdiagnosed and undertreated. Practitioner. 2014;
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+ 258(1774):19-24
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+ 7. Wells RE, Bertisch SM, Buettner C, Phillips RS, McCarthy EP. Complementary and alter-
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+ native medicine use among adults with migraines/severe headaches. Headache. 2011;
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+ 51(7):1087-97.
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+ 8. Millstone D, Chen CY, Bauer B. Complementary and integrative medicine in the manage-
534
+ ment of headache. BMJ. 2017; 357: j1805
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+ 9. Rossi P, Di Lorenzo G, Malpezzi MG et al. Prevalence, pattern and predictors of use of
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+ complementary and alternative medicine (CAM) in migraine patients attending a headache
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+ clinic in Italy. Cephalalgia. 2015; 25(7):493-506
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+ 10.
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+ Shastry AD, editor. Sushrutha Samhita of Maharshi Sushruta with Hindi commentary, Su-
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+ trasthana; Doshadhatumalakshayavriddhivigyaniyaadhyayam (Chap 15/48), 9th edn, Chau-
541
+ khambha Sanskrit Samsthan; Varanasi, India; 1995: pp 64
542
+ MANUSCRIPT
543
+
544
+ ACCEPTED
545
+ ACCEPTED MANUSCRIPT
546
+ 11.
547
+ Shastry AD, editor. Sushrutha Samhita of Maharshi Sushruta with Hindi commentary, Ut-
548
+ tara Tantra; Shirorogavigyaniyaadhyayaya (Chap 25/15), 11th ed, Chaukhambha Sanskrit
549
+ Samsthan: Varanasi, India;1997: pp128
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+ 12.
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+ Shastry K, Chaturvedi G. editors. Charaka Samhita of Agnivesha with Vidyotini Hindi
552
+ Commentary, Siddhi Sthana; Trimarmiyasiddhi (Chap 9/75-78), 22nd ed, Chaukhambha
553
+ Bharati Academy; Varanasi, India; 2001: pp1067
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+ 13.
555
+ Sharma RK, Vaidya BD. Charaka Samhita of Agnivesha with English translation, Su-
556
+ trasthana; Kiyantahashirasiyamadhyayam (Chap 17/11), 4th edn, Chaukhambha Sanskrit Se-
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+ ries Office; Varanasi, India,1995: pp 312
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+ 14.
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+ Fukui PT, Gonçalves TR, Strabelli CG et al. Trigger factors in migraine patients. Arq Neu-
560
+ ropsiquiatr. 2008; 66(3A):494-499
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+ 15.
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+ Vaidya PB, Vaidya BS, Vaidya SK. Response to Ayurvedic therapy in the treatment of mi-
563
+ graine without aura. Int J Ayurveda Res. 2010;1(1): 30–36
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+ 16.
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+ S. Venkatesananda. The Concise Yoga Vasistha. (Chap 2) 1st edn, State University of New
566
+ York, New York, USA, 1985: verses 709–723
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+ 17.
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+ Kim DH, Moon YS, Kim HS et al. Meditation and yoga reduce emotional stress of chronic
569
+ pain. Prog Neuropsychopharmacol Biol Psychiatry. 2005;29: 327- 331
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+ 18.
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+ John PJ, Sharma N, Sharma CM, Kankane A. Effectiveness of yoga therapy in the treat-
572
+ ment of migraine without aura: a randomized controlled trial. Headache. 2007; 47(5):654-
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+ 661
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575
+ Lovell-Smith HD. Transcendental meditation and three cases of migraine. N Z ed J.
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+ International Headache Society. International classification of headache disorders. Cepha-
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+ lalgia .2013; 33(9) 629–808
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+ MANUSCRIPT
581
+
582
+ ACCEPTED
583
+ ACCEPTED MANUSCRIPT
584
+ 21.
585
+ Ramakrishna BR, Kishore KR, Vaidya V, Nagaratna R, Nagendra HR. Standardization of
586
+ Sushruta Prakriti inventory- SPI an Ayurveda based personality assessment tool with scien-
587
+ tific methods. JAHM. 2014; 2(9):1-8
588
+ 22.
589
+ Mahalle NP, Kulkarni MV, Pendse NM, Naik SS. Association of constitutional type of
590
+ Ayurveda with cardiovascular risk factors, inflammatory markers and insulin resistance. J
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+ Ayurveda Integr Med. 2012; 3: 150-157
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+ 23.
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+ Manhalter N, Bozsik G, Palasti A, Csepany E, Ertsey C. The validation of a new compre-
594
+ hensive headache-specific quality of life questionnaire. Cephalalgia. 2012; 32(9): 668-682
595
+ 24.
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+ Ertsey C, Csepany E, Manjunath NK et al. The comprehensive headache-related quality of
597
+ life questionnaire: status report. Cephalalgia, 2015; vol. 35:181-182 (Meeting Abstract)
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+ 25.
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+ Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006;15(1): S17–S24
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+ Yadunandan U. editor of Ashtanga Hrudayam of Vagbhata with Vidyotini Hindi commen-
602
+ tary, Chikitsa sthana; Gulma chikitsitam (Chap 14/ 31-33), 12th edn, Chaukhambha Sanskrit
603
+ Sansthan; Varanasi: 1997; pp380
604
+ 27.
605
+ Yadunandan U. editor of Ashtanga Hrudayam of Vagbhata with Vidyotini Hindi commen-
606
+ tary, Uttarasthana; Unmada pratishedham (Chap 6/ 26-28), 12th ed, Chaukhambha Sanskrit
607
+ Sansthan; Varanasi: 1997; pp 474
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+ 28.
609
+ Shastry K, Chaturvedi G. editors. Charaka Samhita of Agnivesha with Vidyotini Hindi
610
+ Commentary, Siddhi Sthana; Kalpana Siddhi adhyaya (Chap 1/6), 22nd ed, Chaukhambha
611
+ Bharati Academy; Varanasi, India: 2001; pp 960
612
+ 29.
613
+ Yadunandan U.editor of Ashtanga Hrudayam of Vagbhata with Vidyotini Hindi commen-
614
+ tary, kalpasiddhisthana; Virechanakalpam (Chap 2/9), 12th ed, Chaukhambha Sanskrit
615
+ Sansthan; Varanasi: 1997; pp 432
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+ 30.
617
+ Rais A and Bhatted S. Clinical study to evaluate the effect of Virechanakarma on serum
618
+ electrolytes. Ayu. 2013; 34(4): 379–382
619
+ MANUSCRIPT
620
+
621
+ ACCEPTED
622
+ ACCEPTED MANUSCRIPT
623
+ 31.
624
+ Shastry K, Chaturvedi G. editors. Charaka Samhita of Agnivesha with Vidyotini Hindi
625
+ Commentary, Siddhi Sthana; Kalpana Siddhi adhyaya (Chap 1/11), 22nd ed, Chaukhambha
626
+ Bharati Academy; Varanasi, India: 2001; pp 961
627
+ 32.
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+ Shastri P, editor. Sharangadhara Samhita, Madhyama Khanda. Chapter 2/145-147, Oriental
629
+ Publishers & Distributors; Varanasi, India: 1985
630
+ 33.
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+ Niteshwar K, Vidayanath R. Sahasra yoga churnaprakarana 62, Chaukhambha Bharati
632
+ Academy; Varanasi, India: 2007
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+ 34.
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+ Steiner TJ, Stovner LJ, Birbeck GL. Migraine: The seventh disabler. The Journal of Head-
635
+ ache and Pain. 2013;14(1): 1
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+ 35.
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+ Prasher B, Negi S, Aggarwal S et al. Whole-genome expression and biochemical correlates
638
+ of extreme constitutional types defined in Ayurveda. J Transl Med. 2008;6:48
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+ 36.
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+ Acharya Y T. editor. Charaka Samhita of Agnivesha, Sutrasthana; (Chap 7/40), Chau-
641
+ khambha Orientalia Varanasi, India: 2016; pp 52
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+ 37.
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+ Juyal RC, Negi S, Wakhode P, Bhat S, Bhat B, Thelma BK. Potential of Ayurgenomics Ap-
644
+ proach in Complex Trait Research: Leads from a Pilot Study on Rheumatoid Arthritis.
645
+ PLOS. 2012; 7(9): e45752
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+ 38.
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+ Gokani T. Ayurveda - the science of healing. Headache. 2014; 54(6):1103-1106
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+ 39.
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+ Nassini R, Materazzi S, Benemei S, Geppetti P. The TRPA1 channel in inflammatory and
650
+ neuropathic pain and migraine. Rev Physiol Biochem Pharmacol. 2014; 167:1-43
651
+ 40.
652
+ Fonteh AN, Pogoda JM, Chung R, Cowan RP, Harrington MG. Phospholipase C activity
653
+ increases in cerebrospinal fluid from migraineurs in proportion to the number of comorbid
654
+ conditions: a case-control study. J Headache Pain. 2013; 14(1): 60
655
+ 41.
656
+ Peterson CT, Lucas J, St. John-Williams L et.al. Identification of Altered Metabolomic Pro-
657
+ files Following a Panchakarma-based Ayurvedic Intervention in Healthy Participants: The
658
+ Self-Directed Biological Transformation Initiative (SBTI). Sci Rep. 2016; 6: 32609
659
+ MANUSCRIPT
660
+
661
+ ACCEPTED
662
+ ACCEPTED MANUSCRIPT
663
+ 42.
664
+ Villemure C, Bushnell MC. Cognitive modulation of pain: how do attention and emotion
665
+ influence pain processing? Pain. 2002; 95:195-199
666
+ 43.
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+ Villemure C, Bushnell MC. Mood influences supraspinal pain processing separately from
668
+ attention. J Neurosci. 2009; 29: 705-715
669
+ 44.
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+ Schweinhardt P, Bushnell MC. Pain imaging in health and disease - how far have we
671
+ come? J Clin Invest. 2010;120: 3788-3797
672
+ 45.
673
+ Bushnell MC, Ceko M, Low LA. Cognitive and emotional control of pain and its disruption
674
+ in chronic pain. Nat Rev Neurosci. 2013;14(7): 502-511
675
+ 46.
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+ deCharms RC, Maeda F, Glover GH et al. Control over brain activation and pain learned by
677
+ using real-time functional MRI. Proc Natl Acad Sci USA. 2005;102: 18626-18631
678
+ 47.
679
+ Grant JA, Courtemanche J, Duerden EG, Duncan GH, Rainville P. Cortical thickness and
680
+ pain sensitivity in Zen meditators. Emotion. 2010;10: 43-53
681
+ 48.
682
+ John PJ, Sharma N, Sharma CM, Kankane A. Effectiveness of yoga therapy in the treat-
683
+ ment of migraine without aura: A randomized controlled trial. Headache. 2007; 47:654-661.
684
+ 49.
685
+ Kisan R, Sujan M, Adoor M et al. Effect of Yoga on migraine: A comprehensive study us-
686
+ ing clinical profile and cardiac autonomic functions. Int J Yoga. 2014; 7(2): 126-132
687
+ 50.
688
+ Wahbeh H, Elsas SM, Oken BS. Mind-body interventions, Applications in neurology. Neu-
689
+ rology. 2008; 70 (24): 2321-2328
690
+ 51.
691
+ Natsume Y, Neeraj K , Tripathi SM, Nose M, Bhutani KK. Kalyanaka ghrita: an example of
692
+ intertextuality among the Bower manuscript, Charak Samhita, Susruta Samhita, As-
693
+ tangahrdayam Samhita and Ayurvedic Formulary of India (AFI). Ind J Trad Knowl.
694
+ 2015;14(4): 519-524
695
+ 52.
696
+ Peterson CT, Denniston K, Chopra D. Therapeutic Uses of Triphala in Ayurvedic Medi-
697
+ cine. J Altern Complement Med. 2017; 23(8): 607–614
698
+ MANUSCRIPT
699
+
700
+ ACCEPTED
701
+ ACCEPTED MANUSCRIPT
702
+ 53.
703
+ Marc S, Claudia C, Simon R, Mario D and Marc D. Anti-inflammatory, pro-apoptotic, and
704
+ anti-proliferative effects of a methanolic neem (Azadirachta indica) leaf extract are mediated
705
+ via modulation of the nuclear factor-κB pathway. Genes Nutr. 2011; 6(2): 149-160
706
+ 54.
707
+ Gupta SC, Patchva S, and Aggarwal B. Therapeutic Roles of Curcumin: Lessons Learned
708
+ from Clinical Trials. AAPS J. 2013; 15(1): 195-218
709
+ 55.
710
+ Subramanian M, Chintalwar GJ, Chattopadhyay S. Antioxidant properties of a Tinospora
711
+ cordifolia polysaccharide against iron-mediated lipid damage and gamma-ray induced pro-
712
+ tein damage. Redox Rep. 2002; 7:137-143
713
+ 56.
714
+ Chua LS. Review on liver inflammation and anti-inflammatory activity of Androgra-
715
+ phis paniculata for hepatoprotection. Phytother Res. 2014;28(11):1589-1598
716
+
717
+
718
+
719
+
720
+
721
+
722
+
723
+
724
+
725
+ MANUSCRIPT
726
+
727
+ ACCEPTED
728
+ ACCEPTED MANUSCRIPT
729
+
730
+ Table1: List of polyherbal preparations (with their botanical names) used across Ayurveda
731
+ treatment period and their prescribed quantity in the formulation.
732
+
733
+ 1a-Hinguvachadi Churna (26)
734
+ It is prepared with one part of each of the ingredients mentioned below. They are powdered
735
+ separately and mixed together.
736
+ Dosage: 2.5grams - 5 grams, 30 minutes before food with warm water.
737
+
738
+
739
+ Sanskrit name
740
+ Botanical name
741
+ Shuddha
742
+ Hingu
743
+ (Processed with Ghee)
744
+ Ferula asafetida
745
+ Vacha
746
+ Acorus calamus
747
+ Vijaya
748
+ Terminalia chebula
749
+ Pashugandha
750
+ Cleome gynandra
751
+ Dadima
752
+ Punica granatum
753
+ Dipyaja(Ajwain)
754
+ Trachyspermum ammi
755
+ Dhanya
756
+ Coriandrum sativum
757
+ Pata
758
+ Cyclea peltata
759
+ Pushkaramoola
760
+ Inula racemosa
761
+ Shati
762
+ Hedychium spicatum
763
+ Hapusha
764
+ Sphaeranthus indicus
765
+ Agni
766
+ Plumbago zeylanica
767
+ Yavakshar
768
+ Alkali preparation made of
769
+ Hordeum vulgare
770
+ Svarjika kshara
771
+ Sarjika kshara
772
+ Saindava lavana
773
+ Rock salt
774
+ Sauvarchala lavana
775
+ Black salt
776
+ Vida lavana
777
+ Type of black salt
778
+ Shunti
779
+ Zingiber officinalis
780
+ Maricha
781
+ Piper nigrum
782
+ Pippali
783
+ Piper longum
784
+ Ajaji
785
+ Cuminum cyminum
786
+ Chavya
787
+ Piper chaba
788
+ Tintidika
789
+ Rhus parviflora
790
+ Vetasamla(Amlavetasa) Garcinia morella
791
+
792
+ Manufacturer -Arya Vaidya Pharmacy, GMP certified company
793
+
794
+
795
+ MANUSCRIPT
796
+
797
+ ACCEPTED
798
+ ACCEPTED MANUSCRIPT
799
+
800
+
801
+ Table 1b- Kallyanaka Ghrita (27)
802
+ 12g each of the below mentioned ingredients are used to make a medicated ghee (clarified butter)
803
+
804
+ Sanskrit name
805
+ Botanical name
806
+ Haritaki
807
+ Terminalia chebula
808
+ Vibhitaki
809
+ Terminalia bellirica
810
+ Amalaki
811
+ Emblica officinalis
812
+ Vishala
813
+ Citrulus cholocynthis
814
+ Bhadra ela
815
+ Amomum subulatum
816
+ Devadaru
817
+ Cedrus deodara
818
+ Elavaluka
819
+ Prunus avium
820
+ Sariva
821
+ Hemidesmus indicus
822
+ Haridra
823
+ Turmeric
824
+ Daruharidra
825
+ Berberis aristata
826
+ Shalaparni
827
+ Desmodium gangeticum
828
+ Prishnaparni
829
+ Uraria picta
830
+ Phalini
831
+ Callicarpa macrophylla
832
+ Nata
833
+ Valeriana wallichi
834
+ Brihati
835
+ Solanum indicum
836
+ Kushta
837
+ Saussurea lappa
838
+ Manjishta
839
+ Rubia cordifolia
840
+ Nagakeshara
841
+ Mesua ferrea
842
+ Dadimaphalatwak
843
+ Punica granatum
844
+ Vella
845
+ Embelia ribes
846
+ Talisapatra
847
+ Abbies webbiana
848
+ Ela
849
+ Elettaria cardamomum
850
+ Malati
851
+ Jasminum sambac
852
+ Utpala
853
+ Nymphea stellata
854
+ Danti
855
+ Baliospermum montanum
856
+ Padmaka
857
+ Prunus poddum
858
+ Hima
859
+ Sandalwood -Santalum album
860
+ Sarpi
861
+ ghee – 768 g
862
+
863
+ Manufacturer- Arya Vaidya Pharmacy, Coimbatore, India.
864
+
865
+
866
+
867
+
868
+ MANUSCRIPT
869
+
870
+ ACCEPTED
871
+ ACCEPTED MANUSCRIPT
872
+ Table 1c- Trivrit Lehyam (29)
873
+ Trivrit – Operculina turpethum
874
+ Preparation- 25 grams of the powder is added with 400 ml of water, boiled and reduced to 100 ml,
875
+ filtered. To this Trivrit Kashaya, 25 grams of Trivrit powder is again added, along with 50 grams of
876
+ sugar and mixed well. 25 ml of honey and 5 grams of each of cinnamon, cardamom and cinnamon
877
+ leaves fine powder is added to obtain the sweet paste.
878
+ Sl. No.
879
+ Ingredients
880
+ Quantity
881
+ 1
882
+ Trivrit Kashaya
883
+ 100 ml
884
+ 2
885
+ Trivrit Churna
886
+ 25 grams
887
+ 3
888
+ Sugar
889
+ 50 grams
890
+ 4
891
+ Honey
892
+ 25 ml
893
+ 5
894
+ Cinnamon
895
+ 5 grams
896
+ 6
897
+ Cardamom
898
+ 5 grams
899
+ 7
900
+ Cinnamon leaves powder
901
+ 5 grams
902
+
903
+ Manufacturer- Arya Vaidya Pharmacy, Coimbatore, India
904
+
905
+
906
+
907
+
908
+ Table 1d-Pathyakshadhatradi Kashaya (32)
909
+ Herbal decoction is prepared from 10 grams each of the following herbs
910
+
911
+ Sanskrit name
912
+ Botanical name
913
+ Pathya
914
+ Terminalia chebula
915
+ Aksha
916
+ Terminalia bellirica
917
+ Dhatri (Amla)
918
+ Emblica officinalis
919
+ Bhunimba
920
+ Andrographis paniculata
921
+ Nisha (Turmeric)
922
+ Curcuma longa
923
+ Nimba (Neem)
924
+ Azadirachta indica
925
+ Amruta
926
+ Tinospora cordifolia
927
+
928
+ Dosage-15 ml twice daily before breakfast and dinner mixed with 45 ml of warm water.
929
+ Manufacturer- Arya Vaidya Pharmacy
930
+
931
+
932
+
933
+ MANUSCRIPT
934
+
935
+ ACCEPTED
936
+ ACCEPTED MANUSCRIPT
937
+ Table 1e-Kachoradi churna (33).
938
+ Equal quantities of herbal powders mentioned below are used to make the powder.
939
+
940
+ Sanskrit name
941
+ Botanical name
942
+ Kachora
943
+ Curcuma zedoaria
944
+ Dhatri
945
+ Emblica officinalis
946
+ Manjishta
947
+ Rubia cordifolia
948
+ Yashti
949
+ Glycyrrhiza glabra
950
+ Daru
951
+ Cedrus deodara
952
+ Silajitu
953
+ Asphaltum
954
+ Vedhi
955
+ Ferula foetida
956
+ Rohini
957
+ Andrographis paniculata
958
+ Tintrinisira
959
+ Tamarindus indicus
960
+ Kumkuma
961
+ Crocus sativus
962
+ Indu
963
+ Camphor
964
+ Varivaha
965
+ Cyperus rotundus
966
+ Rochanam
967
+ Mallotus phillippenensis
968
+ Bala
969
+ Sida cordifolia
970
+ Laja
971
+ Oryza sativa
972
+ Jala
973
+ Coleus zeylanicus
974
+ Usira
975
+ Vetiveria zizanioides
976
+ Pushkaramoola
977
+ Innula racemosa
978
+
979
+ Dosage- ½ tsp to be mixed with milk and applied on the forehead.
980
+ Manufacturer- Arya Vaidya Pharmacy, Coimbatore, India
981
+
982
+
983
+
984
+
985
+
986
+ MANUSCRIPT
987
+
988
+ ACCEPTED
989
+ ACCEPTED MANUSCRIPT
990
+ Table 2: Details of Yoga program specially designed for the Migraine patients are listed below.
991
+ The description includes the category of practices, duration of each practice, number of repetitions,
992
+ and the sequence of practices.
993
+
994
+ Sl.No
995
+
996
+ Practices
997
+ Number
998
+ of
999
+ rounds
1000
+ Duration
1001
+ 1.
1002
+ Loosening practices (Shithilikarana vyayama)
1003
+ 5 rounds
1004
+ 5 minutes
1005
+
1006
+ Neck up and down movement
1007
+ Neck side to side movement
1008
+ Shoulder rotation- Clockwise and Anti clockwise
1009
+ Shoulder cuff rotation -Clockwise and Anti
1010
+ clockwise
1011
+ Head rolling - Clockwise and Anti clockwise, Up
1012
+ and Down movement
1013
+
1014
+
1015
+ 2.
1016
+ Instant Relaxation Technique
1017
+
1018
+ 1 Round
1019
+ 1 minute
1020
+ 3.
1021
+ Breathing Practices
1022
+ 5 rounds each
1023
+ 5 minutes
1024
+
1025
+ Ankle stretch breathing
1026
+ Shashankasana breathing
1027
+ Tiger stretch breathing
1028
+ Uttanapadasana breathing- Single leg
1029
+
1030
+
1031
+ 4.
1032
+ Quick Relaxation Technique
1033
+ 1 round
1034
+ 3 minutes
1035
+ 5.
1036
+ Postures (Asanas)
1037
+ 1 round each
1038
+ 12 minutes
1039
+ 5a
1040
+ Standing:
1041
+ Padahasthasana
1042
+ Ardha Chakrasana
1043
+ Ardhakati Chakrasana
1044
+ Trikonasana
1045
+ 30 seconds each
1046
+ approximately
1047
+ 2.5 minutes
1048
+
1049
+ Relaxation in standing posture
1050
+ 30 seconds
1051
+ 30 seconds
1052
+ 5b
1053
+ Sitting:
1054
+ Janushirasana
1055
+ Vajrasana
1056
+ Ushtrasana
1057
+ Shashankasana
1058
+ Suptavajrasana
1059
+ Vakrasana
1060
+ 30 seconds each
1061
+ approximately
1062
+ 4 minutes
1063
+
1064
+ Relaxation in sitting posture
1065
+ 30 seconds
1066
+ 30 seconds
1067
+ 5c
1068
+ Supine:
1069
+ Viparita karani/ Sarvangasana
1070
+ Matsyasana
1071
+ Pavanamukthasana
1072
+ Naukasana
1073
+ Setubandhasana
1074
+ 30 seconds each
1075
+ 2.5 minutes
1076
+
1077
+ Relaxation in supine position
1078
+ 30 seconds
1079
+ 30 seconds
1080
+ MANUSCRIPT
1081
+
1082
+ ACCEPTED
1083
+ ACCEPTED MANUSCRIPT
1084
+ 5d
1085
+ Prone:
1086
+ Bhujangasana
1087
+ Shalabhasana
1088
+ Dhanurasana
1089
+ 30 seconds each
1090
+ 1.5 minutes
1091
+ 6.
1092
+ Deep relaxation technique
1093
+
1094
+ 7 minutes
1095
+ 7.
1096
+ Kriyas
1097
+ Kapalabhati
1098
+
1099
+ 1 minute
1100
+ 8.
1101
+ Regulated breathing practices (Pranayama)
1102
+ 1 minute each
1103
+ 3 minutes
1104
+
1105
+ Nadishodhana Pranayama
1106
+ Bhramari Pranayama
1107
+ Ujjayi Pranayama
1108
+ 1 minute each
1109
+ 3 minutes
1110
+ 9.
1111
+ Nadanusandhana ( chanting )
1112
+
1113
+ 3 minutes
1114
+
1115
+
1116
+
1117
+
1118
+
1119
+ Table 3: The combination of the Prakriti seen in all 60 subjects
1120
+
1121
+ Prakriti
1122
+ Ayurveda and Yoga group
1123
+ Control group
1124
+ Total
1125
+ Vata- Pitta
1126
+ 3
1127
+ 5
1128
+ 8
1129
+ Pitta- Vata
1130
+ 4
1131
+ 3
1132
+ 7
1133
+ Pitta-Kapha
1134
+ 9
1135
+ 12
1136
+ 21
1137
+ Kapha-Pitta
1138
+ 6
1139
+ 4
1140
+ 10
1141
+ Vata-Kapha
1142
+ 4
1143
+ 4
1144
+ 8
1145
+ Kapha-Vata
1146
+ 4
1147
+ 2
1148
+ 6
1149
+
1150
+ Vata-Pitta Prakriti- 15
1151
+ Pitta-Kapha Prakriti- 31
1152
+ Vata –Kapha Prakriti- 14
1153
+
1154
+
1155
+
1156
+
1157
+
1158
+
1159
+
1160
+
1161
+ MANUSCRIPT
1162
+
1163
+ ACCEPTED
1164
+ ACCEPTED MANUSCRIPT
1165
+ Table 4: Comprehensive headache related quality of life questionnaire measuring quality of life at
1166
+ physical, mental and social domains recorded on Day 1 and Day 90 in Both AY as well as CT
1167
+ Groups. Values are Group mean ± SD.
1168
+
1169
+ Sl. No.
1170
+ Domains
1171
+ Ayurveda and Yoga group
1172
+ Control group
1173
+
1174
+
1175
+ Day 1
1176
+ Day 90
1177
+ Day 1
1178
+ Day 90
1179
+ 1
1180
+ Physical
1181
+ 50.93
1182
+ 86.63***
1183
+ 55.72
1184
+ 55.81
1185
+
1186
+
1187
+ ±13.41
1188
+ ±10.66
1189
+ ± 17.77
1190
+ ± 16.75
1191
+ 2
1192
+ Mental
1193
+ 50.06
1194
+ 80.04***
1195
+ 55.91
1196
+ 51.98
1197
+
1198
+
1199
+ ±15.18
1200
+ ±9.49
1201
+ ± 16.88
1202
+ ± 13.49
1203
+ 3
1204
+ Social
1205
+ 55.16
1206
+ 85.68***
1207
+ 59.00
1208
+ 59.31
1209
+
1210
+
1211
+ ±14.35
1212
+ ±10.06
1213
+ ±20.14
1214
+ ±17.60
1215
+ 4
1216
+ Total
1217
+ 51.47
1218
+ 83.56***$
1219
+ 56.52
1220
+ 54.91
1221
+
1222
+
1223
+ ±13.24
1224
+ ±9.12
1225
+ ±17.05
1226
+ ±14.19
1227
+
1228
+ *** p <.001, Paired Sample t-test comparing the Mean values of the groups on Day 90 compared to
1229
+ Day 1 values respectively. $ p<.001, Oneway ANOVA comparing the between group differences
1230
+
1231
+
1232
+ Table 5: Symptom checklist measuring the change in subjective symptoms recorded on Day 1 and
1233
+ Day 90 in Both AY Group as well as Control Group. Values are Number of subjects reporting a
1234
+ particular symptom for items 1,3,4 and 5, while values for item number 2 are group mean in hours.
1235
+
1236
+ Sl.
1237
+ No.
1238
+ Symptoms
1239
+ Ayurveda and Yoga group
1240
+
1241
+ Control group
1242
+
1243
+
1244
+ Day 1
1245
+ Day 30
1246
+ Day 90
1247
+ Day 1
1248
+ Day 30
1249
+ Day 90
1250
+ 1.
1251
+ Number of subjects
1252
+ with 5 or more
1253
+ migraine attacks in
1254
+ last 3 months
1255
+ 30
1256
+ 8
1257
+ 5
1258
+ 30
1259
+ 29
1260
+ 26
1261
+ (100%)
1262
+ (26.6%)
1263
+ (16.66%) (100%)
1264
+ (96.6%)
1265
+ (86.66%)
1266
+ 2.
1267
+ Average score of
1268
+ maximum duration
1269
+ of attack in hours
1270
+ 27.8
1271
+ 8.86
1272
+ 5.62
1273
+ 43.6
1274
+ 29.8
1275
+ 45
1276
+ 3.
1277
+ Number of subjects
1278
+ with severe
1279
+ headache
1280
+ 21
1281
+ 10
1282
+ 4
1283
+ 18
1284
+ 20
1285
+ 21
1286
+ (70%)
1287
+ (33.3%)
1288
+ (13.33%)
1289
+ (60%)
1290
+ (66.66%)
1291
+ (70%)
1292
+ 4.
1293
+ Number of subjects
1294
+ with nausea and/ or
1295
+ vomiting
1296
+ 30
1297
+ 17
1298
+ 4
1299
+ 30
1300
+ 27
1301
+ 28
1302
+ (100%)
1303
+ (56.6%)
1304
+ (13.33%) (100%)
1305
+ (90%)
1306
+ (93.33%)
1307
+ 5.
1308
+ Number of subjects
1309
+ with analgesic
1310
+ requirement on need
1311
+ 30
1312
+ 14
1313
+ 6
1314
+ 30
1315
+ 27
1316
+ 26
1317
+ (100%)
1318
+ (46.66%)
1319
+ (20%)
1320
+ (100%)
1321
+ (90%)
1322
+ (86.66%)
1323
+
1324
+
1325
+ MANUSCRIPT
1326
+
1327
+ ACCEPTED
1328
+ ACCEPTED MANUSCRIPT
1329
+ Table 6: Visual Analogue Scale (VAS) measuring pain intensity recorded on Day 1 and Day 90 in
1330
+ Both AY Group as well as Control Group. Values are Group mean ± SD.
1331
+
1332
+ Sl. No.
1333
+ Ayurveda and Yoga
1334
+ Control
1335
+
1336
+ Day 1
1337
+ Day 90
1338
+ Day 1
1339
+ Day 90
1340
+ VAS
1341
+ 7.30
1342
+ 2.20***$
1343
+ 7.13
1344
+ 7.37
1345
+
1346
+ ± 1.53
1347
+ ± 1.24
1348
+ ± 1.35
1349
+ ± 1.06
1350
+
1351
+ *** p <.001, Paired Sample t-test comparing the Mean values of both groups on Day 90 compared
1352
+ to Day 1 values respectively.
1353
+ $ p <.001, One-way ANOVA comparing the Mean values of both groups on Day 90 compared to
1354
+ Day 1 values respectively.
1355
+
1356
+
1357
+
1358
+
1359
+
1360
+
1361
+
1362
+ MANUSCRIPT
1363
+
1364
+ ACCEPTED
1365
+ ACCEPTED MANUSCRIPT
1366
+ Highlights
1367
+ • The present study is the first attempt to evaluate the influence of Ayurveda and Yoga
1368
+ on symptoms and quality of life in patients with Migraine Headache as a prospective
1369
+ matched controlled trial.
1370
+ • The AY group underwent Virechana (Therapeutic Purgation) for the first 15 days
1371
+ followed by Shamanaushadha (pacificatory oral medicines) and Yoga therapy for 75
1372
+ days. The CT group continued on symptomatic treatment using conventional
1373
+ medicine for 90 days.
1374
+ • Prakriti questionnaire (SPI-Q and SPI-C) was administered to both groups on Day 1
1375
+ to understand their body constitution. The outcome measures included Symptom
1376
+ checklist (recorded on Day 1, Day 30 and Day 90), Comprehensive Headache related
1377
+ Quality of Life Questionnaire (CHQQ) and Visual Analogue Scale (VAS) (both
1378
+ recorded on Day 1 and Day 90).
1379
+ • Out of the 60 subjects belonging to both groups, 46 (76.6%) had Pitta based Prakriti
1380
+ (either as pravara (primary) or as madhyama (secondary)).
1381
+ • The AY group showed a significant reduction in the Migraine related symptoms viz.,
1382
+ number of attacks, duration of each attack, associated with nausea and vomiting,
1383
+ severity of headache and analgesic requirements.
1384
+ • There was a significant improvement in the total score of Headache related Quality of
1385
+ Life along with a reduction in pain intensity.
1386
+ • The CT group showed no significant change.
1387
+ • An Integrated Ayurveda and Yoga-based intervention reduced symptoms, the intensity
1388
+ of pain and improved Quality of life in Migraine patients.
1389
+
1390
+
subfolder_0/Comments to Health realizationInnate health Can a quiet mind and a positive feeling state be accessible over the lifespan wit.txt ADDED
@@ -0,0 +1,734 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Health Realization/Innate Health: Can a quiet mind
2
+ and a positive feeling state be accessible over the
3
+ lifespan without stress-relief techniques?
4
+ Judith A. Sedgeman
5
+ Department of Community Medicine, West Virginia Initiative for Innate Health, West Virginia University,
6
+ Morgantown, WV, U.S.A.
7
+ Source of support: Departmental sources
8
+ Summary
9
+
10
+
11
+ Health Realization/Innate Health (HR/IH) questions long-held assumptions about chronic stress,
12
+ and challenges current defi
13
+ nitions of both stress and resiliency. HR/IH sets forth principles that
14
+ explain why the experience of psychological stress is not an effect of causal factors beyond peo-
15
+ ple’s control, but is an artifact of the energetic potential of the mind. HR/IH describes the “cog-
16
+ nitive factor” in stress not as the content of people’s thinking in response to stressors, but rather as
17
+ a quality of the way people hold and use their thinking, referred to as state of mind.
18
+
19
+
20
+ HR/IH hypothesizes that understanding principles that explain the nature and origin of thinking
21
+ and experience offers a means to access innate protective processes that are healing and antibi-
22
+ osenescent reliably and consistently, without techniques. HR/IH suggests that the primary effort
23
+ of mental health care could be to initiate life-long prevention of the state of chronic stress. In ad-
24
+ dition, HR/IH suggests that addressing mental well-being would have a broad impact on the inci-
25
+ dence and course of the many physical illnesses that are known to be stress-related.
26
+
27
+
28
+ The brief therapeutic interactions of HR/IH draw upon people’s innate wisdom and recognition
29
+ of the healthy perspective available to everyone. Anecdotal results suggest that people who gain
30
+ insight into the principles that explain the nature of thought and experience and who realize how
31
+ to re-access a natural, positive state of mind can and do experience sustained day-to-day peace of
32
+ mind, wisdom and well-being, regardless of circumstances. HR/IH deserves rigorous scientifi
33
+ c eval-
34
+ uation.
35
+
36
+ key words:
37
+ resiliency theory • resiliency application • stress • coping • health • innate •
38
+ Health Realization • Innate Health
39
+
40
+ Full-text PDF:
41
+ http://www.medscimonit.com/fulltxt.php?IDMAN=8224
42
+
43
+ Word count:
44
+ 3436
45
+
46
+ Tables:
47
+
48
+
49
+ Figures:
50
+
51
+
52
+ References:
53
+ 66
54
+ Author’s address:
55
+ Judith A. Sedgeman, Assistant Professor, Department of Community Medicine, West Virginia University Health
56
+ Sciences Center, P.O. Box 9147, Morgantown, WV 26506, U.S.A., e-mail: [email protected]
57
+ Received:
58
+ 2005.09.28
59
+ Accepted: 2005.11.02
60
+ Published: 2005.12.01
61
+ HY47
62
+ Hypothesis
63
+ WWW.MEDSCIMONIT.COM
64
+ © Med Sci Monit, 2005; 11(12): HY47-52
65
+ PMID: 16319796
66
+ HY
67
+ Current Contents/Clinical Medicine • SCI Expanded • ISI Alerting System • Index Medicus/MEDLINE • EMBASE/Excerpta Medica • Chemical Abstracts • Index Copernicus
68
+ BACKGROUND
69
+ The state of chronic stress underlies many disease states that
70
+ diminish quality of life and reduce life expectancy [1–5].
71
+ And the state of chronic stress is a major contributor to the
72
+ infl
73
+ ation of national health care costs [6].
74
+ Evidence has coalesced around the idea that the ultimate
75
+ answer to stress may not lie in addressing external stressors
76
+ but in exploring and enhancing internal human capacities.
77
+ The intent to develop means to comprehend, build and but-
78
+ tress human resiliency is predominant in both behavioral
79
+ [7–10] and biological [1,11–20] investigations.
80
+ This dual shift towards recognizing the experience of chron-
81
+ ic stress itself as an underlying contributor to many disease
82
+ states and towards seeing intrinsic human capacity as a heal-
83
+ ing mechanism has led to investigation of the biochemis-
84
+ try of a psychological immune system that addresses chron-
85
+ ic stress systemically.
86
+ Research has established the positive physiological and psy-
87
+ chological effects of resilience, as well as the extensive nega-
88
+ tive physiological and psychological effects of chronic stress
89
+ [1,8]. The persistent assumption that stress is a consequence
90
+ of factors outside of the control of the individual, howev-
91
+ er, has kept research attention on the relationship between
92
+ stressors and the individuals who are subject to them. As a
93
+ result, studies focus on how best to protect people from
94
+ stressors or equip them to respond to stressors as success-
95
+ fully as possible. A question for further study is how peo-
96
+ ple access their internal resiliency. What allows some peo-
97
+ ple to draw upon their internal strengths when they most
98
+ need them, while others are easily overwhelmed? What ex-
99
+ plains the power of the psychological immune system, and
100
+ why is it not consistently engaged or functioning?
101
+ The mechanisms of acute stress are readily apparent, and
102
+ have been for a century, since they were fi
103
+ rst described by
104
+ Walter Cannon [21]. But the mechanisms of chronic stress
105
+ are less clear. Hans Selye described the fi
106
+ nal, chronic stage
107
+ in his general adaptation response to stress as “exhaustion���
108
+ [22]. That remains a potent metaphor, although an inaccu-
109
+ rate scientifi
110
+ c description, of the effect of the state of stress
111
+ unrelieved over time, which has been shown to redirect the
112
+ body’s resources and thus leave the person vulnerable to dis-
113
+ ease [2]. But as Sapolsky points out [3], chronic stress does
114
+ not actually deplete hormonal resources, but keeps the body
115
+ in a constant, unrelieved state of hormonal imbalance, which
116
+ creates a “hormonal milieu” that fosters disease states [5].
117
+ But why are people vulnerable to chronic stress? Why doesn’t
118
+ the body return to homeostasis after every encounter with
119
+ “stressors”? Why are some people in good circumstances un-
120
+ able to keep their bearings, while others in the worst of cir-
121
+ cumstances are able to remain stable? What is the common
122
+ underlying explanation for the varied responses to the same
123
+ stressors among different individuals? Why does each person
124
+ respond differently to the same stressors at different times?
125
+ Assumptions of current research
126
+ Current investigations of chronic stress are governed by un-
127
+ challenged assumptions. From the outset, stress has been
128
+ studied as an inevitable result of pressures beyond the con-
129
+ trol of those experiencing the stress. Cannon and Selye, both
130
+ using animal studies, established the scientifi
131
+ c basis for the
132
+ study of stress. Their work focused on physiologic responses
133
+ of animals to stressful external pressures, such as heat and
134
+ cold, prolonged restraint, surgical procedures. Ideas about
135
+ psychological stress in human beings were extrapolated from
136
+ the study of physiological stress responses in animals. Then,
137
+ early studies of human stress by Richard Rahe and others
138
+ [23–26] established the prevailing view that there are distinct,
139
+ measurable life stressors that cause stress, and even that those
140
+ life stressors can be ranked according to their level of infl
141
+ u-
142
+ ence on the degree of stress people experience. The stres-
143
+ sors were ranked by median responses to various situations.
144
+ Thus the question was never raised why one person might
145
+ call “going to the dentist” a 20 on the stress scale, while an-
146
+ other called it an 85. The broad variations in responses to
147
+ the same stressors have never been addressed.
148
+ Psychologists now refer to “toxic” circumstances, relation-
149
+ ships, emotions and events when describing stress-related syn-
150
+ dromes. Stress-coping presentations address “noxious” events
151
+ or “insults” to the psyche. Psychiatrists document “allostatic
152
+ load,” the weight of stressful and negative circumstances in
153
+ a person’s life history [27]. It is assumed that some degree
154
+ of stress is inevitable for all people, given the life demands
155
+ and challenges everyone must face. It is assumed that “re-
156
+ lief” from stress is a desirable, if temporary, departure from
157
+ that normal expectation. Techniques and methods that pro-
158
+ vide a respite from stress are seen as the appropriate focus
159
+ of stress remediation. The premise is that people who prac-
160
+ tice such techniques or methods still must cope with a re-
161
+ lentlessly stress-inducing milieu but are better equipped to
162
+ withstand and recover from stress [28–36].
163
+ THE HEALTH REALIZATION/INNATE HEALTH CONCEPTUAL MODEL
164
+ Since the late 1970’s, a completely different way of under-
165
+ standing and addressing stress has been quietly spreading
166
+ through the helping professions. Known primarily as Health
167
+ Realization, or Innate Health, this work emerged from the
168
+ insights of Sydney Banks, a man who had spent much of his
169
+ life until the early 1970’s in a state of extreme stress and in-
170
+ security. The insights that set him free to transcend a life-
171
+ time of limitations came out of the blue, unsought, in a pro-
172
+ found experience. When he realized how much these simple,
173
+ but extraordinary, insights had changed him, he began to
174
+ share his knowledge with others, offering free public talks.
175
+ After a few psychologists and psychiatrists were exposed to
176
+ his insights and began to see and experience life different-
177
+ ly for themselves [37–40], they changed their minds about
178
+ what is possible in mental health and well-being, and de-
179
+ veloped a new approach to clients. The work ultimately be-
180
+ came a psychoeducational approach that is based on the
181
+ assumptions that (1) people have an innate wellspring of
182
+ psychological well-being from which to draw, and (2) any-
183
+ one can realize that and live from a healthy, wise, balanced
184
+ state of mind, regardless of the “stressors” and external cir-
185
+ cumstances encountered over time [38,40–42].
186
+ Principles underlying HR/IH
187
+ Health Realization/Innate Health (HR/IH) suggests that
188
+ the prevailing fundamental assumptions about chronic
189
+ Hypothesis
190
+ Med Sci Monit, 2005; 11(12): HY47-52
191
+ HY48
192
+ stress are inherently fl
193
+ awed [43–46]. It proposes to replace
194
+ the theories of how and why stressors induce and sustain
195
+ stress from the outside-in with principles that explain how
196
+ and why the experience of stress is created from the inside-
197
+ out, regardless of circumstances. HR/IH describes univer-
198
+ sal principles that explain how people arrive at so many dif-
199
+ ferent ideas about the world and so many strategies about
200
+ how to cope with it [43–47]. Current therapeutic methods
201
+ concern themselves with what people think and how peo-
202
+ ple deal with what they think, and what has caused them to
203
+ think the way they think, all of which exist in the realm of
204
+ already-created experience. HR/IH addresses the fact that
205
+ people think, which represents the fundamental source of
206
+ experience, experience inchoate [38,43,47–49].
207
+ The principles underlying HR/IH are Mind, Thought and
208
+ Consciousness [43,47]. The principle of Mind describes
209
+ the formless, infi
210
+ nite energy of all things. The principle of
211
+ Thought describes the capacity for the personal mind to
212
+ use that energy to form an infi
213
+ nitely variable personal real-
214
+ ity to express unique life. The principle of Consciousness
215
+ describes the capacity to be aware of the reality being cre-
216
+ ated, i.e. to perceive, recognize and experience ever-chang-
217
+ ing life [43,47]. These three principles combined refer to
218
+ a universal dynamic of creation that is constant. Each per-
219
+ son’s moment-to-moment thinking is variable, representing
220
+ the boundless array of potential forms energy can take. The
221
+ essential meaning of the principles is that thoughts are no
222
+ different from any other “forms” of life, always in motion,
223
+ ever-changing through an infi
224
+ nitude of possibilities, origi-
225
+ nating from the one formless, energetic source.
226
+ HR/IH operates at the emergent impetus for human in-
227
+ quiry and self-expression. There are ideas that point to it in
228
+ the current literature regarding the mind and the brain, for
229
+ example the defi
230
+ nition of the mind proposed by Stefano,
231
+ Fricchione, Slingsby & Benson [4, p6]:
232
+ “…in order for cognitive ability to develop and succeed, however,
233
+ there must fi
234
+ rst be a unifying consciousness to control or regulate
235
+ the many individual neural processes that potentially summate a
236
+ decision-making process. …That is, the brain represents only neu-
237
+ ral tissues organized into various neural patterns that can work
238
+ together or separately. Without a unifying component being able
239
+ to cope with a focus, the signifi
240
+ cance and uniqueness of this cop-
241
+ ing strategy would be lost. … Moreover, a unifi
242
+ ed entity, a ‘mind’,
243
+ would only be involved with experience-related phenomena (both
244
+ exteroceptive and interoceptive) since this is the realm in which cop-
245
+ ing strategies are designed.”
246
+ But HR/IH is a unique perspective because of its neutral
247
+ and non-specifi
248
+ c treatment of the creative power of thought
249
+ as evidence of the universal energy of Mind, rather than as
250
+ evidence of the strength of discrete external situations with
251
+ which the personal mind must interact. Most therapeutic
252
+ work focuses on the specifi
253
+ c content of people’s thinking as
254
+ though it were absolute, with no acknowledgement of the
255
+ subtle variations in thinking that arise from an ever-chang-
256
+ ing state of mind or feeling state. Once the process of think-
257
+ ing is realized, once people understand how their thinking
258
+ works to create reality and how powerful the transitory and
259
+ illusory images of thinking appear to be, they are set free
260
+ from living at the mercy of any thoughts they think. They
261
+ can see that the experience of stress and distress is actually
262
+ their own thought-consciousness manifesting negative, wor-
263
+ risome, distressing thoughts in the form of negative, worri-
264
+ some, distressing experience, and that those thoughts have
265
+ no life beyond the moment they are created and held in
266
+ their minds. They see the illusory, kaleidoscopic nature of
267
+ all formed thoughts.
268
+ THE HEALTH REALIZATION/INNATE HEALTH THERAPEUTIC
269
+ MODEL
270
+ HR/IH assumes that the state of stress is an occasional brief
271
+ and temporary interruption of life lived naturally in a heal-
272
+ ing, positive, antibiosenescent state. Moments of stress, reg-
273
+ istered as recognizable physical and psychological changes,
274
+ are regarded as valuable information about the temporari-
275
+ ly deteriorating quality of one’s state of mind (feeling state
276
+ and quality of thinking), rather than as upsetting informa-
277
+ tion about the negative reality of life circumstances. One
278
+ might say that the feeling of stress is a measure of the bar-
279
+ ometric pressure of the human mind, not the baromet-
280
+ ric pressure of life. If these assumptions hold under scruti-
281
+ ny, the need to develop and teach stress coping and stress
282
+ management strategies would be drastically reduced, if not
283
+ eliminated. People could recognize and access their own
284
+ natural resiliency to address life situations. By using their
285
+ feeling state as a guide to the quality of their thinking, with
286
+ the understanding that all thinking is illusory and fl
287
+ eeting
288
+ and will pass, they would naturally default to a quiet mind
289
+ and a positive feeling state.
290
+ HR/IH is innovative because it demands a departure from
291
+ prevailing assumptions. But because prevailing assumptions
292
+ are so strong, HR/IH is often linked with recognized ther-
293
+ apeutic models by people who try to explain it. For exam-
294
+ ple, it is often confused with, but is not related to, many
295
+ theories that draw on human spirituality and the ability
296
+ people consistently show to attain positive feeling states
297
+ and quietude under controlled or induced circumstanc-
298
+ es [9,12,34,50–54]. It is important to note that even spirit-
299
+ ually advanced and profound therapeutic approaches do
300
+ not depart from the notion that “stressors” are real and in-
301
+ evitable and must be dealt with by marshalling human re-
302
+ sources. Even when psychoneuroimmunology suggests that
303
+ “innate processes” are at work, it is taken for granted that
304
+ these arise from “remembered wellness” or primal learned
305
+ responses to external stressors [4,55]. The word “innate”
306
+ in that context appears to mean “internal to processes that
307
+ naturally occur within the body and brain.” But the word
308
+ “innate” in the context of HR/IH means the common, uni-
309
+ versal, infi
310
+ nite, intrinsic energy before the formation of the
311
+ body and the brain.
312
+ Comparison with current therapy models
313
+ Prevailing therapeutic assumptions, even those that are at the
314
+ leading edge of the discoveries of psychoneuroimmunology,
315
+ consistently seek to analyze, treat or stave off stressors that
316
+ are presumed to exist as factors separate from, and threat-
317
+ ening to, the people who must deal with them [1]. HR/IH
318
+ proposes that “stressors” are the moment-to-moment per-
319
+ ceptions of a mind innocently caught up in negative, up-
320
+ setting thinking without recognition and understanding of
321
+ the process that is driving the experience. HR/IH does not
322
+ question the existence of external life circumstances that
323
+ Med Sci Monit, 2005; 11(12): HY47-52
324
+ Sedgeman JA – Innate health theory
325
+ HY49
326
+ HY
327
+ affect people – physical discomfort or limitations, the up-
328
+ heavals of war and weather, unforeseen tragedies, etc. It
329
+ explains that there is an internal mediating factor between
330
+ such external factors and each individual’s experience of
331
+ them; the factors do not have the power to determine a per-
332
+ son’s reaction to them, the person has the power to deter-
333
+ mine how factors will affect him or her.
334
+ Because the principles of Mind, Consciousness and Thought
335
+ are linked to the idea of empowerment, they are often at-
336
+ tached by observers to familiar concepts of “reframing think-
337
+ ing” or “assertiveness” or “locus of control”. Yet the empow-
338
+ erment that arises from the principles in action is a much
339
+ different quality. It is not an experience of effort or willpow-
340
+ er. It is an experience of freedom before the thought of any
341
+ particular activity or frame of reference.
342
+ The power of the principles in action is seen as the very
343
+ ability to have and hold such ideas, i.e. the natural, intrin-
344
+ sic capacity of individual minds continually to make things
345
+ up and see them as real. Willpower, exercising personal
346
+ control, is thus a byproduct of that power, not an aspect of
347
+ it. It is a use of the personal mind – just as apathy is a use of
348
+ the mind, negativity is a use of the mind, positivity is a use
349
+ of the mind, anger is a use of the mind, good will is a use
350
+ of the mind, quietude is a use of the mind.
351
+ The principles distinguish Health Realization/Innate Health
352
+ from theories, such as cognitive-behavioral theory, or rational-
353
+ emotive theory, or behavior modifi
354
+ cation, or positive psychol-
355
+ ogy – or other conceptual frameworks – as means of “improv-
356
+ ing” thought or experience [38,44]. All theoretical teachings
357
+ are derived from the power of thought; they are thoughts or
358
+ thought systems made up by people using their own power
359
+ to see the world and make sense of what they see.
360
+ Therapeutic impact of HR/IH
361
+ The strength of HR/IH is that it opens hope and possibil-
362
+ ity even to those who have been caught in a certain way of
363
+ thinking for years because it allows them to pull back the
364
+ curtain and recognize themselves at the controls before the
365
+ thoughts they create. HR/IH practitioners do not try to talk
366
+ clients out of negative thoughts, or ask them to replace them
367
+ with other, more encouraging, thoughts or teach them how
368
+ to empty their mind of certain thoughts. HR/IH practition-
369
+ ers explain to clients that fundamental and powerful prin-
370
+ ciples are at work, and that they are experiencing the fact
371
+ of those principles as surely as a glass of water experiences
372
+ gravity when it slips out of someone’s hand and drops to the
373
+
374
+ oor. As long as they have not yet realized their own ability to
375
+ create experience via thinking, they’re bound to get caught
376
+ in little whirlwinds of upsetting experiences. They may fi
377
+ ght
378
+ the content of the thoughts that create them and thus keep
379
+ them spinning in their minds, rather than allowing them to
380
+ pass as new thoughts come to mind. When they begin to see
381
+ the nature of thought, they are able to use distress as a warn-
382
+ ing sign to stop ruminating. Then their natural, resilient fl
383
+ ow
384
+ of thinking can resume. Upsetting thoughts lose their power;
385
+ they are no more real, and just as real, as any other thoughts.
386
+ The person becomes an artist holding the paintbrush, able
387
+ to create a constantly changing reality, rather than a victim
388
+ painted into a frightening scenario by thoughts that seem
389
+ out of his control and seem to be coming from life.
390
+ People realize they can navigate life using their feeling state
391
+ as a reliable guide to the moment-to-moment quality of their
392
+ thinking, knowing that the thinking process naturally self-
393
+ corrects. Unattended thoughts pass, the mind clears, con-
394
+ sciousness lifts, and from a quieter mind and positive feeling
395
+ state, people get increasingly functional ideas. The natural
396
+ tendency of the human mind at peace is towards wisdom
397
+ and insight [8,43,46,47], which might be called psycholog-
398
+ ical homeostasis. Chronic stress is not an actual enemy of
399
+ human well-being with which one must do battle; chron-
400
+ ic stress is an artifact of the human imagination in a nega-
401
+ tive state of mind.
402
+ IMPLICATIONS FOR RESEARCH
403
+ For more than 20 years, psychiatrists, psychologists, coun-
404
+ selors and social workers who have shared the principles
405
+ underlying Health Realization with clients from all walks
406
+ of life and across all diagnoses have consistently reported
407
+ common results [40,45,46]. Clients come to see life from
408
+ a perspective that allows them to operate from wisdom,
409
+ peace of mind, insight and strength and to accept negative
410
+ states of mind as an indicator of the quality of their think-
411
+ ing. Common sense tells them to allow their thinking to
412
+ pass in such cases until more constructive thinking comes
413
+ to mind [46,56–59].
414
+ The logic of Health Realization indicates that research now
415
+ providing increasing evidence that a quiet mind, such as the
416
+ state of meditation, is a healing state that not only prevents
417
+ the effects of chronic stress [9,15,32,60–63] but may even re-
418
+ verse them [8,18,19,64,65] should be directed towards the
419
+ study of the unique and growing population [40,42,45,59]
420
+ of HR/IH clients. In that population are people who have
421
+ realized how to live day to day in a serene state of mind
422
+ regardless of past experiences, external challenges in the
423
+ present, or uncertainty about the future.
424
+ A study population could readily be identifi
425
+ ed. Over the
426
+ years, HR/IH has been a grassroots movement, spread
427
+ through demand from clients who saw others come to a
428
+ peace and sense of well-being they did not think possible,
429
+ and through word of mouth by practitioners and colleagues
430
+ who found hopefulness in working with clients that had elud-
431
+ ed them previously. There are thousands of practitioners
432
+ and many thousands of clients across the U.S. and in oth-
433
+ er countries. Many practitioners have gathered an exten-
434
+ sive array of qualitative and anecdotal results that fall out-
435
+ side current parameters for expected outcomes in mental
436
+ health [40,45,59]. Health Realization is now beginning to
437
+ be recognized by and incorporated into university programs
438
+ (e.g., San Jose State in California, UBC in British Columbia,
439
+ University of Minnesota, Portland State University in Oregon,
440
+ State University of West Georgia, West Virginia University)
441
+ and is appearing in curricula and textbooks in counseling,
442
+ education and prevention [66].
443
+ CONCLUSIONS
444
+ Health Realization/Innate Health represents a paradigm
445
+ shift in the understanding and study of chronic stress. It ex-
446
+ plains the experience of stress as an inside-out process, orig-
447
+ inating within the mind. It suggests that people can recog-
448
+ nize how to access their own innate health and resiliency
449
+ Hypothesis
450
+ Med Sci Monit, 2005; 11(12): HY47-52
451
+ HY50
452
+ to live in a quiet mind and a positive feeling state. It sug-
453
+ gests that the experience of stress can be temporary, regard-
454
+ less of circumstances, and should be seen as a warning sig-
455
+ nal to allow the mind to quiet, rather than to focus on the
456
+ content of the thinking that is creating the negative feel-
457
+ ing state. HR/IH sees the research demonstrating that qui-
458
+ etude fosters psychological and physiological benefi
459
+ ts that
460
+ can ameliorate, or even reverse, the effects of chronic stress
461
+ as evidence for the pressing need to investigate its effects.
462
+ HR/IH is a new prevention strategy in mental health which
463
+ may hold promise for a signifi
464
+ cant reduction in the problem
465
+ of chronic stress. Evidence to date is anecdotal but compel-
466
+ ling and warrants carefully designed clinical studies.
467
+ Acknowledgements
468
+ William F. Pettit, MD, Medical Director of the West Virginia
469
+ Initiative for Innate Health, and a long-time practitioner of
470
+ Innate Health, provided guidance and useful commentary.
471
+ Sarah S. Quesen, MPH, Statistics Lecturer at West Virginia
472
+ University, provided editing suggestions regarding organi-
473
+ zation and clarity of material. Robert M. D’Alessandri, MD,
474
+ Vice President for Health Sciences, West Virginia University,
475
+ provided input and has consistently provided support and
476
+ mentorship to the evolution of Innate Health in theory and
477
+ practice. Sydney Banks, author, philosopher and friend, con-
478
+ tinues to inspire all those who pursue the dream of higher
479
+ levels of well-being for all people.
480
+ REFERENCES:
481
+ 1. Stefano GB et al: The Stress Response: Always Good and When
482
+ It Is Bad. New York: Medical Science International Co., 2005, 152
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+ 2. Charney DS: Psychobiological mechanisms of resilience and vul-
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+ nerability: implications for successful adaptation to extreme stress. Am
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+ J Psychiatry, 2004. 161(2): 195–216
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+ 3. Sapolsky RM: Why Zebras Don’t Get Ulcers. Henry Holt & Co.,
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+ 4. Stefano GB et al: The placebo effect and relaxation response:
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+ Res Brain Res Rev, 2001; 35(1): 1–19
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+ Scientist, 2003; 91: 330–35
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+ 33. Richardson GE, Waite PJ: Mental health promotion through resilience
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+ 34. Salovey P, Rothman AJ, Detweiler JB, Steward WT: Emotional States and
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+ 35. Sapolsky RM: Organismal stress and telomeric aging: an unexpected
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+ 36. Taylor SE, Kemeny ME, Reed GM et al: Psychological Resources, Positive
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+ Illusions and Health. American Psychologist, 2000, 55(1): 99–109
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+ Publishing, Ltd., 1995; 207
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+ 38. Pransky G, Mills RC, Sedgeman J, Blevens K: An emerging paradigm
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+ for brief treatment and prevention. Innovations in Clinical Practice: A
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+ Sourcebook, 1995; 15: 401–20
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+ 39. Pransky G: Renaissance of Psychology. New York: Sulzburger & Graham,
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+ 1998; 268
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+ 40. Pransky J: Prevention from the Inside Out. Bloomington, IN: 1st Books,
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+ 2003
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+ 41. Howard M, Mansheim K: Myths & Realities: Questions and Answers
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+ about Health Realization. Santa Clara County Department of Alcohol
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+ and Drug Services, Health Realization Services Division, 2005; 1–17
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+ 42. Mills RC: Empowering Communities: Prevention from the Inside Out.
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+ in Creating a Dialogue Between Science and Spirituality. Morgantown,
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+ 43. Banks S: The Missing Link. Renton, WA: Lone Pine Publishing, 1998;
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+ 142
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+ 44. Kelley TM: Positive Psychology and Adolescent Mental Health: False
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+ Promise or True Breakthrough? Adolescence, 2004; 39(154): 257–77
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+ 45. Marshall KM: Resilience Research and Practice, in Educational Resiliency:
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+ Student, Teacher and School Perspectives, Waxman HC, Padron Y, Gray
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+ JP, editor. Information Age Publishing: Greenwich, CT, 2004; 63–84
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+ 46. Mills RC, Spittle E: The Wisdom Within. Renton, WA: Lone Pine
592
+ Publishing, 2001; 176
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+ Med Sci Monit, 2005; 11(12): HY47-52
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+ Sedgeman JA – Innate health theory
595
+ HY51
596
+ HY
597
+ 47. Banks S: The Enlightened Gardener. Renton, WA: Lone Pine Publishing,
598
+ 2001; 176
599
+ 48. Banks S: Second Chance. Tampa, FL: Duval-Bibb Publishing Co., 1989;
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+ 91
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+ 49. Banks S: In Quest of the Pearl. Tampa, FL: Duval-Bibb Publishing Co.,
602
+ 1989; 113
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+ 50. Benson H: The relaxation response: therapeutic effect. Science, 1997;
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+ 278(5344): 1694–95
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+ 51. Kabat-Zinn J: Full Catastrophe Living. New York: Dell Publishing,
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+ 1990
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+ 52. Lazar SW et al: Functional brain mapping of the relaxation response
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+ and meditation. Neuroreport, 2000; 11(7): 1581–85
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+ 53. Miller WR Thoresen CE: Spirituality, religion, and health. An emerg-
610
+ ing research fi
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+ eld. Am Psychol, 2003; 58(1): 24–35
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+ 54. Richmond LJ: Religion, spirituality, and health: a topic not so new. Am
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+ Psychol, 2004; 59(1): 52
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+ 55. Pert CB: The wisdom of the receptors: neuropeptides, the emotions,
615
+ and bodymind. 1986. Adv Mind Body Med, 2002; 18(1): 30–35
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+ 56. Pransky J: Modello: A Story of Hope for the Inner City and Beyond.
617
+ Cabot VT: NEHRI Publications, 1998; 280
618
+ 57. Bailey J: The Speed Trap. San Francisco: HarperSanFrancisco, 1999;
619
+ 188
620
+ 58. Carlson R, Bailey J: Slowing Down to the Speed of Life. San Francisco:
621
+ HarperSanFrancisco, 1997; 209
622
+ 59. Borg M: The Impact of Training in the Health Realization/Community
623
+ Empowerment Model on Affective States of Psychological Distress and
624
+ Well-Being, in Psychology. California School of Professional Psychology:
625
+ Los Angeles, CA, 1997
626
+ 60. Benson H et al: Decreased blood-pressure in pharmacologically treat-
627
+ ed hypertensive patients who regularly elicited the relaxation response.
628
+ Lancet, 1974; 1(7852): 289–91
629
+ 61. Benson H, Alexander S, Feldman CL: Decreased premature ventricu-
630
+ lar contractions through use of the relaxation response in patients with
631
+ stable ischaemic heart-disease. Lancet, 1975; 2(7931): 380–82
632
+ 62. Ray O: How the Mind Hurts and Heals the Body. American Psychologist,
633
+ 2004; 59(1): 29–40
634
+ 63. Sapolsky RM, Krey LC, McEwen BS: The neuroendocrinology of stress
635
+ and aging: the glucocorticoid cascade hypothesis. Endocr Rev, 1986;
636
+ 7(3): 284–301
637
+ 64. Niess JH et al: Review on the infl
638
+ uence of stress on immune mediators,
639
+ neuropeptides and hormones with relevance for infl
640
+ ammatory bowel
641
+ disease. Digestion, 2002; 65(3): 131–40
642
+ 65. Stefano GB et al: Morphine stimulates iNOS expression via a rebound
643
+ from inhibition in human macrophages: nitric oxide involvement. Int
644
+ J Immunopathol Pharmacol, 2001; 14(3): 129–38
645
+ 66. Capuzzi D, Gross DR: Counseling and Psychotherapy: Theories and
646
+ Interventions. 3rd ed. Upper Saddle River: Merrill Prentice Hall, 2003;
647
+ 500
648
+ Hypothesis
649
+ Med Sci Monit, 2005; 11(12): HY47-52
650
+ HY52
651
+ Index
652
+ Copernicus
653
+ integrates
654
+ www.IndexCopernicus.com
655
+ Index Copernicus
656
+ Global Scientific Information Systems
657
+ for Scientists by Scientists
658
+ Index
659
+ Copernicus
660
+ integrates
661
+ IC Virtual Research Groups [VRG]
662
+ Web-based complete research
663
+ environment which enables researchers
664
+ to work on one project from distant
665
+ locations. VRG provides:
666
+ 
667
+ customizable and individually
668
+ self-tailored electronic research
669
+ protocols and data capture tools,
670
+ 
671
+ statistical analysis and report
672
+ creation tools,
673
+ 
674
+ profiled information on literature,
675
+ publications, grants and patents
676
+ related to the research project,
677
+ 
678
+ administration tools.
679
+ IC Scientists
680
+ Effective search tool for
681
+ collaborators worldwide.
682
+ Provides easy global
683
+ networking for scientists.
684
+ C.V.'s and dossiers on selected
685
+ scientists available. Increase
686
+ your professional visibility.
687
+ IC Patents
688
+ Provides information on patent
689
+ registration process, patent offices
690
+ and other legal issues. Provides
691
+ links to companies that may want
692
+ to license or purchase a patent.
693
+ IC Lab & Clinical Trial Register
694
+ Provides list of on-going laboratory
695
+ or clinical trials, including
696
+ research summaries and calls for
697
+ co-investigators.
698
+ IC Grant Awareness
699
+ Need grant assistance?
700
+ Step-by-step information on
701
+ how to apply for a grant. Provides
702
+ a list of grant institutions and
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subfolder_0/Comparative study on effect of neutral spinal bath and neutral spinal spray on blood pressure, heart rate and heart rate variability in healthy vol.txt ADDED
@@ -0,0 +1,515 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
2
+ DE GRUYTER
3
+ Journal of Complementary and Integrative Medicine. 2018; 20180118
4
+ Arundhati Goley1 / A. Mooventhan2 / NK. Manjunath3
5
+ Comparativestudyon effect of neutral spinal
6
+ bathand neutralspinal spray on blood pressure,
7
+ heart rateand heart rate variability in healthy
8
+ volunteers
9
+ 1 Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA), A Deemed to be Univer-
10
+ sity, #19, Eknath Bhavan, Gavipuram Circle, Kepegowda Nagar, Bengaluru, Karnataka, India
11
+ 2 Division of Yoga and Life Sciences, Department of Research and Development, Swami Vivekananda Yoga Anusandhana Sam-
12
+ sthana (S-VYASA), A Deemed to be University, #19, Eknath Bhavan, Gavipuram Circle, Kepegowda Nagar, Bengaluru, Kar-
13
+ nataka, India, E-mail: [email protected]
14
+ 3 Division of Yoga and Life Sciences & Head, Department of Research and Development, Swami Vivekananda Yoga Anusand-
15
+ hana Samsthana (S-VYASA), A Deemed to be University, #19, Eknath Bhavan, Gavipuram Circle, Kepegowda Nagar, Ben-
16
+ galuru, Karnataka, India
17
+ Abstract:
18
+ Background: Hydrotherapeutic applications to the head and spine have shown to improve cardiovascular and
19
+ autonomic functions. There is lack of study reporting the effect of either neutral spinal bath (NSB) or neutral
20
+ spinal spray (NSS). Hence, the present study was conducted to evaluate and compare the effects of both NSB
21
+ and NSS in healthy volunteers.
22
+ Methods: Thirty healthy subjects were recruited and randomized into either neutral spinal bath group (NSBG)
23
+ or neutral spinal spray group (NSSG). A single session of NSB, NSS was given for 15 min to the NSBG and
24
+ NSSG, respectively. Assessments were taken before and after the interventions.
25
+ Results: Results of this study showed a significant reduction in low-frequency (LF) to high-frequency (HF)
26
+ (LF/HF) ratio of heart rate variability (HRV) spectrum in NSBG compared with NSSG (p=0.026). Within-group
27
+ analysis of both NSBG and NSSG showed a significant increase in the mean of the intervals between adjacent
28
+ QRS complexes or the instantaneous heart rate (HR) (RRI) (p=0.002; p=0.009, respectively), along with a signif-
29
+ icant reduction in HR (p=0.002; p=0.004, respectively). But, a significant reduction in systolic blood pressure
30
+ (SBP) (p=0.037) and pulse pressure (PP) (p=0.017) was observed in NSSG, while a significant reduction in dias-
31
+ tolic blood pressure (DBP) (p=0.008), mean arterial blood pressure (MAP) (p=0.008) and LF/HF ratio (p=0.041)
32
+ was observed in NSBG.
33
+ Conclusion: Results of the study suggest that 15 min of both NSB and NSS might be effective in reducing HR
34
+ and improving HRV. However, NSS is particularly effective in reducing SBP and PP, while NSB is particularly
35
+ effective in reducing DBP and MAP along with improving sympathovagal balance in healthy volunteers.
36
+ Keywords: autonomic functions, blood pressure, heart rate, hydrotherapy, naturopathy, spine
37
+ DOI: 10.1515/jcim-2018-0118
38
+ Received: July 31, 2018; Accepted: September 4, 2018
39
+ Introduction
40
+ Hydrotherapy uses water in its various forms (water, ice and steam) at various temperatures for health promo-
41
+ tion and disease prevention and management [1]. Spinal bath is a local, non-pressurized hydratic measure in
42
+ which the pre-spinal and para-spinal area is immersed in water of required temperature for a specific duration
43
+ to get the desired effects [2]. Spinal spray is a local, slightly pressurized hydratic measure in which the spinal
44
+ area is exposed to water of certain temperature for a specific duration to get the desired effects [3]. Cardiovas-
45
+ cular diseases (CVDs) are the main cause of mortality worldwide. CVD is associated with lifestyle, especially
46
+ physical inactivity, the use of tobacco, unhealthy diet habits, and psychosocial stress. The World Health Organi-
47
+ zation has stated that over three-quarters of CVD deaths could be prevented with lifestyle changes. Immersion
48
+ in thermo-neutral water and spa bathing were used to treat cardiovascular risk factors. Evidence suggests that
49
+ A. Mooventhan is the corresponding author.
50
+ © 2018 Walter de Gruyter GmbH, Berlin/Boston.
51
+ 1
52
+ Brought to you by | Université de Strasbourg
53
+ Authenticated
54
+ Download Date | 10/20/18 12:18 PM
55
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
56
+ Goley et al.
57
+ DE GRUYTER
58
+ the thermo-neutral water has antihypertensive effect, which is essential for the prevention as well as the man-
59
+ agement of lifestyle diseases like CVD [4].
60
+ Heart rate variability (HRV) is one of the most commonly used non-invasive tools that measures cardiac au-
61
+ tonomic nervous system and helps to distinguish sympathetic from the parasympathetic activity [5]. There are
62
+ various studies reporting the effect of either cold water [6, 7] or hot water applications [8–11] on cardiovascu-
63
+ lar variables. But, though neutral water is being widely used in many of the naturopathic hospitals in India for
64
+ general health promotion and treatment of various diseases including CVDs, there is a lack of studies reporting
65
+ its effect on cardiovascular [12] and autonomic functions [13]. Hydrotherapeutic applications to the head and
66
+ spine have shown to improve cardiovascular [14] and autonomic functions [1], However, there is lack of study
67
+ reporting the effect of either neutral spinal bath (NSB) or neutral spinal spray (NSS). Hence, the present study
68
+ was conducted with the objective to evaluate and compare the effects of NSB and NSS on BP, heart rate (HR)
69
+ and HRV in healthy volunteers.
70
+ Materials and methods
71
+ Study design
72
+ This is a parallel-group pilot randomized comparative trial. Recruited subjects were randomly (1:1 ratio) allo-
73
+ cated to either a neutral spinal bath group (NSBG) or a neutral spinal spray group (NSSG). The NSBG subjects
74
+ received one session of NSB, while the NSSG received one session of NSS for the duration of 15 min. Assess-
75
+ ments were taken prior to and after the respective intervention.
76
+ Subjects
77
+ Thirty healthy subjects of both the genders were recruited from a residential university located in South India.
78
+ Both male and female genders aged 18 years and above who are willing to participate in the study were included
79
+ in the study. Subjects with the history of any systemic and/or mental illness, chronic smoking and alcoholism
80
+ and females during menstruations were excluded from the study. The study protocol was approved by the
81
+ institutional ethics committee and informed consents were obtained from all the subjects.
82
+ Interventions
83
+ Neutralspinal bath group
84
+ Spinal bath tubs are made up of fibre material and are water proof and non-allergic. The water level in the tub
85
+ was one and half inches to two inches. The subjects were asked to lie down in a spinal bath tub [filled with water
86
+ (32–33 °C)] with minimum dress for 15 min, with the head on the side that was most slanted, while the buttock
87
+ was at the opposite side end. Upper and lower limbs were kept outside the tub and adjusted in such manner
88
+ that water should immerse the entire length of the spine, from the nape of the neck to the lowest portion of the
89
+ spine [2].
90
+ Neutral spinal spraygroup
91
+ A spinal spray tub consists of a fiber perforated tube at the center of the tub. This tube is connected with a pipe
92
+ to a 0.5 H.P. motor adjusted below the tub which is connected to water supply. The subjects were asked to be
93
+ in minimum dress and made to lie down in supine posture resting the entire back in a spinal spray tub filled
94
+ with water (32–33 °C) in such manner that the pores present in tub were occupied by the subject’s spine and
95
+ keeping the head and limbs outside the tub for the duration of 15 min [3].
96
+ Temperature of the water was measured using hydratic thermometer (water thermometer).
97
+ Assessments
98
+ The primary (BP) and secondary (HR and HRV) outcome measures were taken before and after the intervention
99
+ by one of the authors who was blind to NSBG and NSSG.
100
+ 2
101
+ Brought to you by | Université de Strasbourg
102
+ Authenticated
103
+ Download Date | 10/20/18 12:18 PM
104
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
105
+ DE GRUYTER
106
+ Goley et al.
107
+ Blood pressure (BP): Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before
108
+ and after the intervention using sphygmomanometer.
109
+ HR and HRV: HR and HRV were assessed (5 min at baseline and 5 min after intervention) using a four-
110
+ channel polygraph (Polyrite D, Recorders and Medicare Systems, Chandigarh, India). The Ag/AgCl pre-gelled
111
+ electrodes were placed according to the standard limb lead II configuration to record electrocardiogram. Data
112
+ were acquired at the sampling rate of 1,024 Hz [1].
113
+ Data extraction
114
+ Time domain and frequency domain analysis of baseline and post-intervention HRV data were performed
115
+ using HRV analysis software (Kubios-HRV version 2.0) developed by the Biomedical Signal Analysis Group
116
+ (University of Kuopio, Finland) [15]. The time domain HRV variables such as (1) the mean of the intervals
117
+ between adjacent QRS complexes or the instantaneous HR (RRI), (2) standard deviation of RR intervals (SDNN),
118
+ (3) HR, (4) the square root of the mean of the sum of the squares of differences between adjacent NN intervals
119
+ (RMSSD), (5) the number of interval differences of successive NN intervals greater than 50 ms (NN50) and
120
+ (6) the proportion derived by dividing NN50 by the total number of NN intervals (pNN50) were analysed [1].
121
+ Similarly, the frequency domain of HRV such as low-frequency (LF) band (0.04–0.15 Hz) and high-frequency
122
+ (HF) band (0.15–0.4 Hz) in normalized units and LF/HF ratio were also analysed [16]. Assessments such as
123
+ pulse pressure (PP) and mean arterial pressure (MAP) were derived using the following formulas. PP was
124
+ calculated by using (SBP −DBP) and MAP by using (DBP + ￿PP) [14]
125
+ Sample size
126
+ Thirty healthy subjects of both the genders with the age varying from 18 to 25 years were recruited from a
127
+ residential university located in South India. Sample size was not calculated based on any previous study.
128
+ Randomization
129
+ All the subjects were randomly allocated to either a NSBG or a NSSG using computerized randomization. A
130
+ simple randomization procedure with 1:1 ratio was done for 30 subjects to get a sample size of (n=15) in each
131
+ group. Until interventions were assigned, the random allocation of the intervention was kept in opaque sealed
132
+ envelopes. An author who did not involve in assessments performed the randomization.
133
+ Blinding
134
+ Subjects were not blinded to their intervention. However, the investigator was kept blind to the NSBG and
135
+ NSSG.
136
+ Data analysis
137
+ Data were checked for normality using Kolmogorov–Smirnov test. Statistical analysis of within group was
138
+ performed using Student’s paired samples t-test (data that assumed normal distribution) and Wilcoxon signed
139
+ ranks test (data that did not assume normal distribution) and between group was performed using independent
140
+ samples t-test (data that assumed normal distribution) and Mann–Whitney U test (data that did not assume
141
+ normal distribution) using Statistical Package for the Social Sciences (SPSS) for Windows, Version 16.0. Chicago,
142
+ SPSS Inc. p-value<0.05 was kept as significant.
143
+ Results
144
+ Recruited 30 subjects were randomly allocated to either a NSBG or a NSSG. The details of the demographic
145
+ variables of both NSBG and NSSG are given in Table 1. There were no significant differences in the baseline of
146
+ all the variables between NSBG and NSSG except PP. Results of this study showed a significant reduction in
147
+ 3
148
+ Brought to you by | Université de Strasbourg
149
+ Authenticated
150
+ Download Date | 10/20/18 12:18 PM
151
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
152
+ Goley et al.
153
+ DE GRUYTER
154
+ LF/HF ratio in NSBG compared with NSSG. Within-group analysis showed a significant increase in RRI and
155
+ insignificant increase in SDNN, RMSSD, NN50, pNN50 and HF spectrum of HRV with a significant reduction
156
+ in HR and insignificant reduction in LF spectrum of HRV both in NSBG and in NSSG. However, a significant
157
+ reduction in SBP and PP was observed in NSSG, while a significant reduction in DBP, MAP and LF/HF ratio
158
+ was observed in NSBG (Table 2).
159
+ Table 1: Demographic variables of the neutral spinal bath and neutral spinal spray groups.
160
+ Variables
161
+ Neutral spinal bath group (n=15)
162
+ Neutral spinal spray group (n=15)
163
+ Age, years
164
+ 20.53 ± 1.77
165
+ 21.27 ± 2.09
166
+ Gender
167
+ Males (n=4), females (n=11)
168
+ Males (n=6), females (n=9)
169
+ Height, m
170
+ 1.60 ± 0.07
171
+ 1.632 ± 0.07
172
+ Weight, kg
173
+ 52.33 ± 6.42
174
+ 54 ± 5.67
175
+ Body mass index, kg/m2
176
+ 20.35 ± 1.73
177
+ 20.32 ± 2.18
178
+ Table 2: Baseline and post-test assessments of neutral spinal bath group (n=15) and neutral spinal spray group (n=15).
179
+ Variables
180
+ Assessment
181
+ Neutral spinal bath group (n=15) with
182
+ within-group analysis
183
+ Neutral spinal spray
184
+ group (n=15) with within-
185
+ group analysis
186
+ Between-group
187
+ analysis
188
+ t/z
189
+ value
190
+ p-value
191
+ SBP,
192
+ mmHg
193
+ Baseline
194
+ 109.87 ± 10.10
195
+ 113.73 ± 11.41
196
+ 0.983
197
+ 0.334!
198
+ Post-test
199
+ 108.00 ± 10.14
200
+ 108.53 ± 11.70
201
+ 0.133
202
+ 0.895!
203
+ t=0.969
204
+ p=0.349*
205
+ t=2.312
206
+ p=0.037*
207
+ DBP,
208
+ mmHg
209
+ Baseline
210
+ 71.07 ± 9.47
211
+ 66.67 ± 11.18
212
+ 1.346
213
+ 0.178ˆ
214
+ Post-test
215
+ 63.60 ± 6.56
216
+ 68.80 ± 8.94
217
+ 1.817
218
+ 0.080!
219
+ z=2.661
220
+ p=0.008
221
+ z=0.911
222
+ p=0.362
223
+ PP,
224
+ mmHg
225
+ Baseline
226
+ 38.80 ± 11.00
227
+ 47.07 ± 9.88
228
+ 2.165
229
+ 0.039!
230
+ Post-test
231
+ 44.40 ± 10.37
232
+ 39.73 ± 12.98
233
+ 1.088
234
+ 0.286!
235
+ t=1.844
236
+ p=0.087*
237
+ t=2.700
238
+ p=0.017*
239
+ MAP,
240
+ mmHg
241
+ Baseline
242
+ 84.00 ± 8.18
243
+ 82.36 ± 10.25
244
+ 0.486
245
+ 0.631!
246
+ Post-test
247
+ 78.40 ± 6.25
248
+ 82.04 ± 7.84
249
+ 1.408
250
+ 0.170!
251
+ t=3.076
252
+ p=0.008*
253
+ t=0.139
254
+ p=0.891*
255
+ RRI, ms
256
+ Baseline
257
+ 745.40 ± 74.99
258
+ 745.47 ± 133.24
259
+ 0.002
260
+ 0.999!
261
+ Post-test
262
+ 789.65 ± 67.63
263
+ 791.39 ± 133.79
264
+ 0.768
265
+ 0.443ˆ
266
+ t=3.889
267
+ p=0.002*
268
+ z=2.613
269
+ p=0.009
270
+ SDNN,
271
+ ms
272
+ Baseline
273
+ 53.67 ± 14.41
274
+ 52.46 ± 15.92
275
+ 0.436
276
+ 0.663ˆ
277
+ Post-test
278
+ 54.12 ± 12.15
279
+ 60.64 ± 21.29
280
+ 1.030
281
+ 0.312!
282
+ t=−0.159
283
+ p=0.876*
284
+ z=1.108
285
+ p=0.268
286
+ HR,
287
+ beat-
288
+ s/mint
289
+ Baseline
290
+ 81.79 ± 8.88
291
+ 82.85 ± 11.91
292
+ 0.276
293
+ 0.784!
294
+ Post-test
295
+ 76.90 ± 6.86
296
+ 77.89 ± 10.16*
297
+ 0.312
298
+ 0.757!
299
+ t=3.838
300
+ p=0.002*
301
+ t=3.482
302
+ p=0.004*
303
+ RMSSD,
304
+ ms
305
+ Baseline
306
+ 34.92 ± 8.65
307
+ 38.17 ± 17.24
308
+ 0.652
309
+ 0.520!
310
+ Post-test
311
+ 42.82 ± 16.15
312
+ 47.70 ± 29.24
313
+ 0.394
314
+ 0.693ˆ
315
+ z=1.534
316
+ p=0.125
317
+ z=1.563
318
+ p=0.118
319
+ NN50,
320
+ count
321
+ Baseline
322
+ 60.53 ± 36.33
323
+ 55.87 ± 45.87
324
+ 0.312
325
+ 0.755ˆ
326
+ Post-test
327
+ 64.00 ± 32.02
328
+ 77.13 ± 59.91
329
+ 0.749
330
+ 0.460!
331
+ t=0.898
332
+ p=0.384*
333
+ z=1.449
334
+ p=0.147
335
+ pNN50,
336
+ %
337
+ Baseline
338
+ 15.57 ± 10.21
339
+ 15.49 ± 14.89
340
+ 1.038
341
+ 0.299ˆ
342
+ Post-test
343
+ 16.97 ± 8.63
344
+ 21.67 ± 19.18
345
+ 0.866
346
+ 0.394!
347
+ t=0.145
348
+ p=0.887*
349
+ z=1.761
350
+ p=0.078
351
+ 4
352
+ Brought to you by | Université de Strasbourg
353
+ Authenticated
354
+ Download Date | 10/20/18 12:18 PM
355
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
356
+ DE GRUYTER
357
+ Goley et al.
358
+ LF, n.u.
359
+ Baseline
360
+ 57.54 ± 14.44
361
+ 60.29 ± 16.73
362
+ 1.329
363
+ 0.184ˆ
364
+ Post-test
365
+ 49.99 ± 11.69
366
+ 59.91 ± 16.95
367
+ 1.867
368
+ 0.072!
369
+ t=1.973
370
+ p=0.069*
371
+ z=0.454
372
+ p=0.649
373
+ HF, n.u.
374
+ Baseline
375
+ 42.46 ± 14.44
376
+ 39.78 ± 16.71
377
+ 1.329
378
+ 0.184ˆ
379
+ Post-test
380
+ 50.04 ± 11.71
381
+ 40.09 ± 16.95
382
+ 1.871
383
+ 0.072!
384
+ t=1.980
385
+ p=0.068*
386
+ z=0.454
387
+ p=0.649
388
+ LF/HF
389
+ ratio
390
+ Baseline
391
+ 1.88 ± 2.03
392
+ 1.75 ± 1.73
393
+ 1.246
394
+ 0.213ˆ
395
+ Post-test
396
+ 1.18 ± 0.91
397
+ 2.05 ± 1.58
398
+ 2.220
399
+ 0.026ˆ
400
+ z=2.045
401
+ p=0.041
402
+ z=−0.114
403
+ p=0.910
404
+ Note: All values are in mean  ±  standard deviation. Values in bold=p-value <0.05. *=Paired samples t-test; ¶=Wilcoxon signed ranks test;
405
+ !=Independent samples t-test; ˆ=Mann-Whitney U test. SBP, systolic blood pressure; DBP, diastolic blood pressure; PP, pulse pressure;
406
+ MAP, mean arterial pressure; RRI, the intervals between adjacent QRS complexes or the instantaneous heart rate; standard deviation of
407
+ RR intervals (SDNN); HR, heart rate; the square root of the mean of the sum of the squares of differences between adjacent NN intervals
408
+ (RMSSD); NN50=the number of interval differences of successive NN intervals greater than 50 ms; pNN50=proportion derived by
409
+ dividing NN50 by the total number of NN intervals; LF, low frequency; HF, high frequency; n.u.=Normalized units; LF/HF ratio, ratio of
410
+ low frequency to high frequency.
411
+ Discussion
412
+ SBP, DBP, PP and MAP are the commonest and most important indicator of CVD risks [17]. Physical, mental,
413
+ cognitive and emotional activities modulate the HR. A beat-to-beat modulation in HR following physiologi-
414
+ cal variation is called HRV. Evidence suggests that HR and HRV are the most sensitive and easily accessible
415
+ indicators of parasympathetic and sympathetic activity and autonomic regulation [16].
416
+ Results of this study showed a significant reduction in DBP, MAP in NSBG and a significant reduction in
417
+ SBP and PP in NSSG. It suggests that application of 15 min of NSB was effective in reducing DBP and MAP,
418
+ while the application of 15 min of NSS was effective in reducing the SBP and PP in healthy volunteers.
419
+ The hydrostatic pressure created by the head-out water immersion shifts peripheral blood into the thoracic
420
+ vasculature, thereby increasing central blood volume, stroke volume, cardiac output (CO) and central venous
421
+ pressure. This increase in central venous pressure is likely to stimulate arterial pressure and lower cardiopul-
422
+ monary pressure. This process is known to augment parasympathetic activity and inhibit sympathetic activity,
423
+ leading to bradycardia [2]. Thus, in the present study, reduction in the blood pressure (BP) variables might
424
+ possibly attributed primarily to the effects on reduction of HR. Because BP is the outcome of both CO and
425
+ peripheral resistance, wherein CO is the outcome of HR and stroke volume and thus HR forms one of the de-
426
+ terminants of BP; hence the reduction of HR in this study might reduce the BP indices by decreasing CO [14].
427
+ Other possible reason for the reduction of BP might be due to humoral control mechanisms, because in a previ-
428
+ ous study on immersion at 32 °C it has shown to produce a significant reduction in HR, SBP and DBP along with
429
+ a significant reduction in plasma renin activity, plasma cortisol and aldosterone concentrations, and thus the
430
+ physiological changes induced by water immersion were reported to mediate by humoral control mechanisms
431
+ [12]. However, the reduction in DBP and MAP only in NSBG and a reduction in SBP and PP only in NSSG is
432
+ not clear and needs to be explored in future studies.
433
+ The time domain analysis of HRV mainly reflects parasympathetic activity, while the frequency domain
434
+ analysis reflects overall autonomic balance. Results of this study showed a significant reduction in HR and
435
+ a significant increase in RRI along with insignificant increase in all the other time domain variables such as
436
+ SDNN, RMSSD, NN50 and pNN50 both in NSBG and in NSSG compared to its respective baseline. Likewise,
437
+ there was a trend towards reduction (insignificant) in LF spectrum of HRV and increase (insignificant) in HF
438
+ spectrum of HRV both in NSBG and in NSSG. It suggests that 15 min of both NSB and NSS might have ef-
439
+ fect in reducing HR and in improving HRV towards parasympathetic dominance or sympathetic withdrawal.
440
+ Because the time domain measures of the HRV, i. e. mean RRI, HR, RMSSD and NN50, have been recognized
441
+ as stronger predictors of vagal modulation [1]. However, a significant reduction in LF/HF ratio in NSBG in
442
+ within- and between-group analysis, unlike NSSG, revealed the presence of better sympathovagal balance in
443
+ NSBG compared to NSSG. Previous studies on thermo-neutral water immersion [13] and NSS [3] also reported
444
+ the enhanced parasympathetic activity [3, 13], which is supporting the results of the present study.
445
+ Strength of the study: To the best of our knowledge, this is the first ever study evaluating the effect of NSB
446
+ and comparing the effect of NSB with NSS on HRV and BP in healthy subjects. None of the subjects reported
447
+ any adverse effect during intervention.
448
+ Limitations of the study: 1) Study was conducted in the healthy subjects that limit the scope of this study in
449
+ pathological conditions, 2) Small sample size and sample size calculation was not performed using any previ-
450
+ ous/pilot study, 3) Lack of control group to differentiate the effect of NSB and NSS from a simple supine lying,
451
+ 5
452
+ Brought to you by | Université de Strasbourg
453
+ Authenticated
454
+ Download Date | 10/20/18 12:18 PM
455
+ Automatically generated rough PDF by ProofCheck from River Valley Technologies Ltd
456
+ Goley et al.
457
+ DE GRUYTER
458
+ and 4) Long-term effect of NSB and NSS on HRV and BP was not assessed. Hence, further studies with a control
459
+ group are required in a large sample size for a better understanding of its precise cardiovascular effects.
460
+ Conclusions
461
+ Results of the study suggest that 15 min of both NSB and NSS might be effective in reducing HR and in improv-
462
+ ing HRV. However, NSS is particularly effective in reducing SBP and PP while NSB is particularly effective in
463
+ reducing DBP and MAP along with improving sympathovagal balance in healthy volunteers.
464
+ Author contributions: All the authors have accepted responsibility for the entire content of this submitted
465
+ manuscript and approved submission.
466
+ Research funding: None declared.
467
+ Employment or leadership: None declared.
468
+ Honorarium: None declared.
469
+ Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis
470
+ and interpretation of data; in the writing of the report or in the decision to submit the report for publication.
471
+ References
472
+ [1] Mooventhan A, Nivethitha L. Effects of ice massage of the head and spine on heart rate variability in healthy volunteers. J Integr Med.
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+ 2016;14:306–10.
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+ [2] Shetty GB, Shetty P
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+ , Shetty B. Immediate effect of cold spinal bath on autonomic and respiratory variables in hypertensives. World J
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+ Pharm Med Res. 2016;2:236–40.
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+ [3] Avanthika G, Sujatha KJ, Shetty P
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+ . Immediate effect of cold and neutral spinal spray on autonomic functions in healthy volunteers – A
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+ comparative study. IOSR J Dental Med Sci. 2017;16:18–24.
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+ [4] Naumann J, Sadaghiani C, Bureau N, Schmidt S, Huber R. Outcomes from a three-arm randomized controlled trial of frequent immersion
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+ in thermoneutral water on cardiovascular risk factors. BMC Complem Altern Med. 2016;16:250.
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+ [5] Muralikrishnan K, Balakrishnan B, Balasubramanian K, Visnegarawla F. Measurement of the effect of Isha Yoga on cardiac autonomic
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+ nervous system using short-term heart rate variability. J Ayurveda Integr Med. 2012;3:91–6.
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+ [6] Roberts LA, Muthalib M, Stanley J, Lichtwark G, Nosaka K, Coombes JS, et al. Effects of cold water immersion and active recovery on
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+ hemodynamics and recovery of muscle strength following resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2015;309:R389–
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+ 98.
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+ [7] Radtke T, Poerschke D, Wilhelm M, Trachsel LD, Tschanz H, Matter F, et al. Acute effects of Finnish sauna and cold-water immersion on
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+ haemodynamic variables and autonomic nervous system activity in patients with heart failure. Eur J Prev Cardiol. 2016;23:593–601.
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+ [8] Thomas KN, Van Rij AM, Lucas SJ, Gray AR, Cotter JD. Substantive hemodynamic and thermal strain upon completing lower-limb hot-
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+ water immersion; comparisons with treadmill running. Temp (Austin). 2016;3:286–97.
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+ [9] Thomas KN, Van Rij AM, Lucas SJ, Cotter JD. Lower-limb hot-water immersion acutely induces beneficial hemodynamic and cardiovascu-
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+ lar responses in peripheral arterial disease and healthy, elderly controls. Am J Physiol Regul Integr Comp Physiol. 2017;312:R281–91.
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+ [10] Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood
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+ pressure in sedentary humans. J Physiol. 2016;594:5329–42.
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+ [11] Findikoglu G, Cetin EN, Sarsan A, Senol H, Yildirim C, Ardic F. Arterial and intraocular pressure changes after a single-session hot-water
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+ immersion. Undersea Hyperb Med. 2015;42:65–73.
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+ [12] Srámek P
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+ , Simecková M, Janský L, Savlíková J, Vybíral S. Human physiological responses to immersion into water of different tempera-
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+ tures. Eur J Appl Physiol. 2000;81:436–42.
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+ [13] Florian JP
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+ , Simmons EE, Chon KH, Faes L, Shykoff BE. Cardiovascular and autonomic responses to physiological stressors before and after
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+ six hours of water immersion. J Appl Physiol (1985). 2013;115:1275–89.
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+ [14] Mooventhan A. Immediate effect of ice bag application to head and spine on cardiovascular changes in healthy volunteers. Int J Health
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+ Allied Sci. 2016;5:53–6.
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+ [15] Tarvainen MP
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+ , Niskanen JP
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+ , Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV-heart rate variability analysis software. Comput
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+ Methods Prog Biomed. 2014;113:210–20.
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+ [16] Tyagi A, Cohen M. Yoga and heart rate variability: A comprehensive review of the literature. Int J Yoga. 2016;9:97–113.
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+ [17] Nivethitha L, Mooventhan A, Manjunath NK. A pilot study on evaluating cardiovascular functions during the practice of Bahir Kumbhaka
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+ 6
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+ Authenticated
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+ Download Date | 10/20/18 12:18 PM
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1
+ ORIGINAL RESEARCH
2
+ published: 18 May 2022
3
+ doi: 10.3389/fpubh.2022.814328
4
+ Frontiers in Public Health | www.frontiersin.org
5
+ 1
6
+ May 2022 | Volume 10 | Article 814328
7
+ Edited by:
8
+ Larry K. Olsen,
9
+ Logan University, United States
10
+ Reviewed by:
11
+ Parmeshwar Satpathy,
12
+ Indian Institute of Technology
13
+ Kharagpur, India
14
+ Mujeeb Zafar Banday,
15
+ Government Medical College
16
+ (GMC), India
17
+ *Correspondence:
18
+ Raghuram Nagarathna
19
20
21
+ Akshay Anand
22
23
+ Specialty section:
24
+ This article was submitted to
25
+ Public Health Education and
26
+ Promotion,
27
+ a section of the journal
28
+ Frontiers in Public Health
29
+ Received: 13 November 2021
30
+ Accepted: 06 April 2022
31
+ Published: 18 May 2022
32
+ Citation:
33
+ Nagarathna R, Sharma MNK,
34
+ Ilavarasu J, Kulkarni R, Anand A,
35
+ Majumdar V, Singh A, Ram J, Rain M
36
+ and Nagendra HR (2022) Coping
37
+ Strategy, Life Style and Health Status
38
+ During Phase 3 of Indian National
39
+ Lockdown for COVID-19
40
+ Pandemic—A Pan-India Survey.
41
+ Front. Public Health 10:814328.
42
+ doi: 10.3389/fpubh.2022.814328
43
+ Coping Strategy, Life Style and
44
+ Health Status During Phase 3 of
45
+ Indian National Lockdown for
46
+ COVID-19 Pandemic—A Pan-India
47
+ Survey
48
+ Raghuram Nagarathna 1*, Manjunath N. K. Sharma 1, Judu Ilavarasu 1, Ravi Kulkarni 1,
49
+ Akshay Anand 2,3,4*, Vijaya Majumdar 1, Amit Singh 1, Jagat Ram 5, Manjari Rain 2 and
50
+ Hongasandra R. Nagendra 1
51
+ 1 Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India, 2 Neuroscience Research Lab, Department of
52
+ Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India, 3 CCYRN – Collaborative Centre for
53
+ Mind Body Intervention Through Yoga, Post Graduate Institute of Medical Education and Research, Chandigarh, India,
54
+ 4 Centre of Phenomenology and Cognitive Sciences, Panjab University, Chandigarh, India, 5 Department of Ophthalmology,
55
+ Postgraduate Institute of Medical Education and Research, Chandigarh, India
56
+ The implementation of timely COVID-19 pan-India lockdown posed challenges to the
57
+ lifestyle. We looked at the impact of lifestyle on health status during the lockdown in
58
+ India. A self-rated scale, COVID Health Assessment Scale (CHAS) was circulated to
59
+ evaluate the physical health or endurance, mental health i.e. anxiety and stress, and
60
+ coping ability of the individuals under lockdown. This is a pan-India cross-sectional
61
+ survey study. CHAS was designed by 11 experts in 3 Delphi rounds (CVR = 0.85)
62
+ and was circulated through various social media platforms, from 9th May to 31st May
63
+ 2020, across India by snowball circulation method. CHAS forms of 23,760 respondents
64
+ were downloaded from the Google forms. Logistic regression using R software was
65
+ used to compare vulnerable (>60 years and with chronic diseases) with non-vulnerable
66
+ groups. There were 23,317 viable respondents. Majority of respondents included males
67
+ (58·8%). Graduates/Postgraduates (72·5%), employed (33·0%), businessmen (6·0%),
68
+ and professionals (9·7%). The vulnerable group had significantly (OR 1.31, p < 0.001)
69
+ higher representation of overweight individuals as compared to non-vulnerable group.
70
+ Regular use of tobacco (OR 1.62, p = 0.006) and other addictive substances (OR
71
+ 1.80, p = 0.039) showed increased vulnerability. Respondents who consume junk food
72
+ (OR 2.19, p < 0.001) and frequently snack (OR 1.16, p < 0.001) were more likely to
73
+ be vulnerable. Respondents involved in fitness training (OR 0.57, p < 0.001) or did
74
+ physical works other than exercise, yoga, walk or household activity (OR 0.88, p =
75
+ 0.004) before lockdown were less likely to be vulnerable. Majority had a very good
76
+ lifestyle, 94.4% never smoked or used tobacco, 92.1% were non-alcoholic, 97.5% never
77
+ used addictive substances, 84.7% had good eating habits, 75.4% were vegetarians,
78
+ Nagarathna et al.
79
+ Lifestyle During Lockdown in India
80
+ 82.8% had “good” sleep, 71.7% did physical activities. Only 24.7% reported “poor”
81
+ coping ability. Depression with somewhat low feeling were more likely to be vulnerable
82
+ (OR 1.26, p < 0.001). A healthy lifestyle that includes healthy eating, proper sleep,
83
+ physical activeness and non-addictive habits supports better coping ability with lesser
84
+ psychological distress among Indian population during lockdown.
85
+ Keywords: COVID-19, public health, stress, coping strategy, lockdown
86
+ INTRODUCTION
87
+ The past two decades have witnessed three highly pathogenic,
88
+ novel zoonotic CoVs, first SARS-CoV-1 was recognized in 2002,
89
+ followed by MERS-CoV in 2012 and now as a more virulent
90
+ strain, the SARS-CoV-2 causing COVID-19 (1). Based on the
91
+ estimated report of the instantaneous reproduction number
92
+ (Rt) on the severity in China, several countries implemented
93
+ social distancing, hygiene etiquettes, contact tracing, wearing face
94
+ masks, temperature checks, and avoided premature relaxation of
95
+ the lockdown (2). The largest timely lockdown was enforced in
96
+ India after its first case on 30th Jan 2020 (3).
97
+ The
98
+ present
99
+ COVID-19
100
+ pandemic
101
+ affected
102
+ global
103
+ mental
104
+ health,
105
+ as
106
+ evidenced
107
+ initially
108
+ by
109
+ panic-buying,
110
+ worldwide.
111
+ Following
112
+ any
113
+ natural
114
+ disaster,
115
+ survivors
116
+ are
117
+ prone to develop post-traumatic stress disorder (PTSD).
118
+ For instance, survivors of the August 2008 floods in India
119
+ (Bihar) had shown higher scores for PTSD (4). Similarly,
120
+ studies in China showed high level of depression with low
121
+ health-related
122
+ quality
123
+ of
124
+ life
125
+ (HRQoL)
126
+ and
127
+ high
128
+ scores
129
+ on PTSD symptoms with no significant changes during
130
+ COVID-19 (5, 6).
131
+ The first large-scale community-based cohort study on
132
+ 387,109 adults in UK concluded that an unhealthy lifestyle
133
+ (smoking, physical inactivity, obesity, and excessive alcohol
134
+ intake) is a risk factor for hospital admission for COVID-
135
+ 19 (7). A study on Italian children observed increased screen
136
+ time and sleep time, increased consumption of potato chips,
137
+ red meat, and sugary drink and decrease in time spent in
138
+ sports activities, which may have lasting impact on adiposity
139
+ (8). The incidence, progression and death rate during this
140
+ pandemic in India seems to be much lesser than other
141
+ countries [COVID-19 Worldwide Dashboard | WHO Live
142
+ World Statistics]. The reasons being India’s relatively younger
143
+ population, early biggest national lockdown (9), and a unique
144
+ mutation in the spike surface glycoprotein [A930V (24351C
145
+ > T)] in the Indian SARS-CoV-2 (10). A recent survey in
146
+ Indian cohort showed that the level of psychological distress
147
+ was lesser than the Chinese population on IES-R (11). There
148
+ are unpublished observations that the traditional life style of
149
+ the Indian families may also be a contributory factor. As
150
+ there were no nationwide studies looking at the impact of
151
+ life style on vulnerability during first wave and lockdown, we
152
+ executed this pan-India on-line survey. The objective of the study
153
+ was to investigate physical and mental health, lifestyle and to
154
+ examine activities adapted by people to cope with COVID-19
155
+ and lockdown.
156
+ MATERIALS AND METHODS
157
+ CHAS Survey and Study Subjects
158
+ This was a nationwide survey on general Indian population
159
+ during the 3rd phase of lockdown for COVID-19 pandemic that
160
+ had respondents from all States/Union Territories except Ladakh
161
+ and Lakshadweep. COVID Health Assessment Scale (CHAS),
162
+ prepared in 10 languages by a committee of 11 experts through
163
+ 3 Delphi rounds [Content Valid Ratio (CVR) was 0.85], had
164
+ questions related to life style behavior (exercise, diet, additive
165
+ substances, and sleep), physical health (BMI, chronic diseases,
166
+ and endurance), mental health (fear, anxiety, depression, stress),
167
+ and coping ability [refer to CHAS questionnaire from reference
168
+ (12)]. Endurance under physical health signifies durability or
169
+ ability to perform physical work for longer duration of time
170
+ without feeling breathlessness. Further, coping ability is defined
171
+ as conscious and unconscious efforts and strategies acquired
172
+ by respondents such as reading, cooking and others to reduce
173
+ emotional impact of challenging situation created by pandemic
174
+ and lockdown.
175
+ Phone calls and special requests were sent to different
176
+ sections of the society (∼200 universities, corporate companies,
177
+ healthcare institutions, government organizations, wellness
178
+ centers, and their networks) to acquire data by snowball method.
179
+ Participants filled the online forms, if they were willing to answer
180
+ the subjected questions. Hence, there were no exclusion and
181
+ inclusion criteria for participants.
182
+ The responses were collected from May 9, 2020 to May 31,
183
+ 2020. Responses from non-Indians and aged <18 years were not
184
+ considered for analysis. After quality control, the participants
185
+ were divided into vulnerable and non-vulnerable groups based
186
+ on presence of co-morbidities and age >60 years. Respondents
187
+ were considered vulnerable when their age was above 60 years
188
+ and/or they have any chronic disease as these two conditions
189
+ increases the risk of getting infected with COVID-19 and risk of
190
+ severe outcome. For zone wise analyses, the 34 states/UTs were
191
+ divided into 3 zones based on the number of positive cases in
192
+ the state as on 31st May 2020 (source: Ministry of health and
193
+ Family Welfare, Government of India). The groups were red
194
+ zone (>10,000 cases including Maharashtra, Tamil Nadu, Delhi,
195
+ Gujarat), orange zone (5,000 to 10,000 cases including Rajasthan,
196
+ Madhya Pradesh, Uttar Pradesh), and green zone (<5,000 cases
197
+ including remaining states and UTs).
198
+ Statistical Analysis
199
+ The CHAS data received from the Google drive in ten
200
+ languages were combined into one dataset. R Statistical software,
201
+ Frontiers in Public Health | www.frontiersin.org
202
+ 2
203
+ May 2022 | Volume 10 | Article 814328
204
+ Nagarathna et al.
205
+ Lifestyle During Lockdown in India
206
+ version 4.0.0, was used for data cleaning, extraction, and
207
+ analyses. Incomplete and unreliable responses were excluded.
208
+ Logistic regression was used to compare respondents under two
209
+ categories viz. vulnerable and non-vulnerable. Arsenal package
210
+ was used to test significance on cross tabulations on categorical
211
+ variables. Reference for Odd’s ratio (OR) calculation was set to
212
+ sequential contrast for all ordinal variables and first row and first
213
+ column for nominal variables.
214
+ RESULTS
215
+ Of the 23,760 respondents, participants from other countries
216
+ (n = 401) and marked as other genders (n = 42) were excluded.
217
+ Data was analyzed for 23,317 respondents. Logistic regression
218
+ to compare 4,416 vulnerable participants with 18,901 non-
219
+ vulnerable participants showed that graduates (OR 0.77, p <
220
+ 0.001) were less likely to and postgraduates (OR 1.11, p =
221
+ 0.027) were more likely to be associated with vulnerability
222
+ than non-graduates (Table 1). Students were less likely to be
223
+ associated with vulnerability than agriculturists (OR 0.26, p <
224
+ 0.001). Businessmen (OR 1.87, p < 0.001), homemakers (OR
225
+ 2.91, p < 0.001), professionals (OR 1.72, p < 0.001) and those
226
+ in other occupations (OR 1.40, p = 0.005) were more likely
227
+ to be vulnerable as compared to agriculturists (Table 1). Of
228
+ note, only 3.2% were agriculturists and 48.7% were actively
229
+ working professionals (6.0% business, 9.7% professionals, 33.0%
230
+ employees) among the total respondents.
231
+ During the lockdown, those who were not working were more
232
+ vulnerable than who worked from home (OR 1.22, p < 0.001).
233
+ Those who had stayed away from home (OR 0.41, p < 0.001)
234
+ or with friends (OR 0.62, p = 0.017) or colleagues (OR 0.41, p
235
+ < 0.001) were less likely to be in the vulnerable group as they
236
+ were younger and did not have illnesses. Individuals experiencing
237
+ symptoms like cough (OR 2.08, p < 0.001), breathing difficulty
238
+ (OR 7.52, p < 0.001) and others (OR 1.74, p < 0.001), except
239
+ fever, were more likely to be vulnerable (Table 1).
240
+ Life Style
241
+ Table 2 summarizes the life style variables. Good eating habits
242
+ was reported by 84.7% and strict vegetarian diet was reported
243
+ by 75.4% of the total respondents. Vulnerable group had better
244
+ eating habit (0.89, p = 0.032) and more strict vegetarians (OR
245
+ 0.49, p < 0.001). However, consumption of junk food (OR 2.19,
246
+ p < 0.001) and frequent snacking (OR 1.16, p < 0.001) was
247
+ positively associated with vulnerability.
248
+ Substance users were minimal in this cohort as majority said
249
+ they “never” used tobacco (94.4%), or alcohol (92.1%) or other
250
+ substances (97.5%) before lockdown; only 1.1% “agreed” they
251
+ had increased the use of alcohol and tobacco during lockdown.
252
+ Regular consumers of tobacco (OR 1.62, p = 0.006) and other
253
+ substance users (very few in this cohort; OR 1.80, p = 0.039) were
254
+ more likely to be vulnerable.
255
+ Looking at the quality of sleep, 82.8% and 79.1% said
256
+ they had “good” sleep quality before and during lockdown,
257
+ respectively in total respondents. Those who had average
258
+ sleep before (OR 1.31, p < 0.001) or during (OR 1.22, p
259
+ < 0.001) lockdown were more likely to be vulnerable than
260
+ those who had good sleep. Individuals having bad sleep quality
261
+ had increased from 2.4% to 4.2% during lockdown among
262
+ total respondents.
263
+ Logistic regression further showed that those who went for
264
+ fitness training (OR 0.57, p < 0.001) or did works other than
265
+ exercise, yoga, walk or household activity (OR 0.88, p = 0.004)
266
+ before lockdown were less likely to be vulnerable. Walking before
267
+ lockdown did not reduce the risk of vulnerability (OR 1.28, p <
268
+ 0.001). Individual practicing fitness training during the lockdown
269
+ were less likely to be vulnerable (OR 0.56, p < 0.001). Very
270
+ few individuals never did any physical activity during lockdown.
271
+ Those who were involved in physical activity for <30 min (OR
272
+ 0.79, p = 0.004) or for 30 to 60 min (OR 1.15, p = 0.004)
273
+ were more in non-vulnerable group. Individuals involved in
274
+ physical activity for more than an hour were more in vulnerable
275
+ group (OR 1.12, p = 0.004). It is to be noted that 54.0% did
276
+ yoga during lockdown while 46.6% were already practicing yoga
277
+ (before lockdown).
278
+ Physical Health
279
+ Majority had “good/average” endurance as marked on a 3 point
280
+ scale (good, average, and bad). Respondents with average (OR
281
+ 1.72, p < 0.001) and bad (OR 1.55, p = 0.014) endurance were
282
+ more likely to be vulnerable than respondents who had good
283
+ endurance. BMI was high in vulnerable group at 25·49 ± 4·34
284
+ kg/m2 than non-vulnerable at 24·05 ± 4·31 kg/m2 group (p <
285
+ 0.001). The BMI between 23 and 24.9 kg/m2 (OR 1.63, p < 0.001)
286
+ and above 25 kg/m2 (OR 1.31, p < 0·001) were more likely to be
287
+ vulnerable (Table 3).
288
+ Mental Health
289
+ Majority did not feel depressed (low feeling) in vulnerable
290
+ group. Those with depression with somewhat low feeling were
291
+ more likely to be vulnerable (OR 1.26, p < 0.001) (Table 3).
292
+ Anxiety about implication of COVID-19 on life did not associate
293
+ with increased vulnerability. Interestingly, who were “somewhat
294
+ anxious” were less likely to be vulnerable (OR 0.83, p < 0.001)
295
+ (Table 3).
296
+ We enquired on five aspects of fear. Fear of getting infected
297
+ with COVID-19 and associated physical suffering was associated
298
+ with vulnerability (OR 1.29, p < 0.001). Concerns about financial
299
+ implications (OR 0.74, p < 0.001) and fear of infecting near and
300
+ dear ones (OR 0.76, p < 0.001 for somewhat; OR 0.79, p = 0.001
301
+ for very much) were not associated with vulnerability (Table 3).
302
+ About 21% of the respondents were not sure about stress and
303
+ insecurity, which did not associated with vulnerability (OR 0.84, p
304
+ < 0.001). Those who agreed that they were stressed and insecure
305
+ were less likely to be in vulnerable category (OR 0.83, p = 0.007).
306
+ Coping
307
+ Coping ability was good in 75.3% and poor in 24.7% of the
308
+ total respondents but was non-significant between vulnerable
309
+ and non-vulnerable respondents.
310
+ Those who did not spend time reading (OR 1.27, p < 0.001) or
311
+ cooking activity (OR 1.28, p < 0.001) or spend time on exercise
312
+ (OR 1.25, p < 0.001), or did not do Yogasana (OR 1.18, p < 0.001)
313
+ were more likely to be vulnerable (Table 3). The respondents who
314
+ spend less time on internet were more likely to be vulnerable (OR
315
+ 1.50, p < 0.001).
316
+ Frontiers in Public Health | www.frontiersin.org
317
+ 3
318
+ May 2022 | Volume 10 | Article 814328
319
+ Nagarathna et al.
320
+ Lifestyle During Lockdown in India
321
+ TABLE 1 | Comparison of demographic details of vulnerable with non-vulnerable groups.
322
+ Variables
323
+ Variable
324
+ Non-
325
+ vulnerable
326
+ (n = 18,901)
327
+ Vulnerable
328
+ (n = 4,416)
329
+ Total
330
+ (n = 23,317)
331
+ Odd’s
332
+ Ratio
333
+ CI: 2.5%
334
+ CI:
335
+ 97.5%
336
+ p-Value
337
+ Gender
338
+ Female
339
+ 7,727 (40.9%)
340
+ 1,883 (42.6%)
341
+ 9,610 (41.2%)
342
+ Ref
343
+ Male
344
+ 11,174
345
+ (59.1%)
346
+ 2,533 (57.4%)
347
+ 13,707
348
+ (58.8%)
349
+ 1.10
350
+ 1.00
351
+ 1.21
352
+ 0.052
353
+ States zones*
354
+ Red
355
+ 6,925 (36.7%)
356
+ 1,731 (39.2%)
357
+ 8,656 (37.2%)
358
+ Ref
359
+ Orange
360
+ 4,215 (22.3%)
361
+ 825 (18.7%)
362
+ 5,040 (21.6%)
363
+ 0.99
364
+ 0.89
365
+ 1.10
366
+ 0.839
367
+ Green
368
+ 7,737 (41.0%)
369
+ 1,857 (42.1%)
370
+ 9,594 (41.2%)
371
+ 1.02
372
+ 0.93
373
+ 1.13
374
+ 0.663
375
+ Occupation
376
+ Agriculture
377
+ 647 (3·4%)
378
+ 101 (2·3%)
379
+ 748 (3.2%)
380
+ Ref
381
+ Business
382
+ 1.070 (5.7%)
383
+ 321 (7·3%)
384
+ 1,391 (6.0%)
385
+ 1.87
386
+ 1.47
387
+ 2.41
388
+ <0.001
389
+ Employed
390
+ 6,648 (35.2%)
391
+ 1,036 (23.5%)
392
+ 7,684 (33.0%)
393
+ 1.18
394
+ 0.95
395
+ 1.48
396
+ 0.152
397
+ Homemaker
398
+ 1,916 (10.1%)
399
+ 891 (20.2%)
400
+ 2,807 (12.0%)
401
+ 2.91
402
+ 2.29
403
+ 3.73
404
+ <0.001
405
+ Student
406
+ 4,377 (23.2%)
407
+ 188 (4.3%)
408
+ 4,565 (19.6%)
409
+ 0.26
410
+ 0.20
411
+ 0.34
412
+ <0.001
413
+ Professional
414
+ 1,831 (9·7%)
415
+ 436 (9·9%)
416
+ 2,267 (9·7%)
417
+ 1.72
418
+ 1.36
419
+ 2.20
420
+ <0.001
421
+ Other
422
+ 2,142 (11.3%)
423
+ 449 (10.2%)
424
+ 2,591 (11.1%)
425
+ 1.40
426
+ 1.11
427
+ 1.79
428
+ 0.005
429
+ Education
430
+ Less than
431
+ Graduation
432
+ 5,127 (27.1%)
433
+ 1,296 (29.3%)
434
+ 6,423 (27.5%)
435
+ Ref
436
+ Graduate
437
+ 7,569 (40.0%)
438
+ 1,640 (37.1%)
439
+ 9,209 (39.5%)
440
+ 0.77
441
+ 0.70
442
+ 0.84
443
+ <0.001
444
+ Post-
445
+ graduate
446
+ 6,205 (32.8%)
447
+ 1,480 (33.5%)
448
+ 7,685 (33.0%)
449
+ 1.11
450
+ 1.01
451
+ 1.21
452
+ 0.027
453
+ During lockdown staying
454
+ with
455
+ Family
456
+ 15.781
457
+ (83.5%)
458
+ 3,942 (89.3%)
459
+ 19,723
460
+ (84.6%)
461
+ Ref
462
+ Friends
463
+ 278 (1.5%)
464
+ 32 (0.7%)
465
+ 310 (1.3%)
466
+ 0.62
467
+ 0.41
468
+ 0.90
469
+ 0.017
470
+ Colleagues
471
+ 903 (4.8%)
472
+ 79 (1.8%)
473
+ 982 (4.2%)
474
+ 0.41
475
+ 0.31
476
+ 0.52
477
+ <0.001
478
+ Alone
479
+ 1,064 (5.6%)
480
+ 254 (5.8%)
481
+ 1,318 (5.7%)
482
+ 1.01
483
+ 0.86
484
+ 1.18
485
+ 0.947
486
+ Away from
487
+ home
488
+ 875 (4.6%)
489
+ 109 (2.5%)
490
+ 984 (4.2%)
491
+ 0.41
492
+ 0.52
493
+ 0.81
494
+ <0.001
495
+ During lockdown are
496
+ you
497
+ Working
498
+ from home
499
+ 7,474 (39.5%)
500
+ 1,479 (33.5%)
501
+ 8,953 (38.4%)
502
+ Ref
503
+ Working
504
+ from office
505
+ 4,185 (22.1%)
506
+ 604 (13.7%)
507
+ 4,789 (20.5%)
508
+ 0.79
509
+ 0.70
510
+ 0.88
511
+ <0.001
512
+ Not
513
+ working
514
+ 7,242 (38.3%)
515
+ 2,333 (52.8%)
516
+ 9,575 (41.1%)
517
+ 1.22
518
+ 1.12
519
+ 1.33
520
+ <0.001
521
+ Are you experiencing
522
+ any of the following?
523
+ No
524
+ symptoms
525
+ 16,866
526
+ (89.2%)
527
+ 3,791 (85.8%)
528
+ 20,657
529
+ (88.6%)
530
+ Ref
531
+ Cough
532
+ 202 (1.1%)
533
+ 66 (1.5%)
534
+ 268 (1.1%)
535
+ 2.08
536
+ 1.52
537
+ 2.81
538
+ <0.001
539
+ Fever
540
+ 27 (0.1%)
541
+ 5 (0.1%)
542
+ 32 (0.1%)
543
+ 1.24
544
+ 0.41
545
+ 3.06
546
+ 0.674
547
+ Breathing
548
+ Difficulty
549
+ 23 (0.1%)
550
+ 24 (0.5%)
551
+ 47 (0.2%)
552
+ 7.52
553
+ 3.95
554
+ 14.37
555
+ <0.001
556
+ Other
557
+ 1.783 (9.4%)
558
+ 530 (12.0%)
559
+ 2.313 (9.9%)
560
+ 1.74
561
+ 1.55
562
+ 1.95
563
+ <0.001
564
+ Have you undertaken
565
+ International travel since
566
+ January 2020?
567
+ Yes
568
+ 372 (2·0%)
569
+ 110 (2·5%)
570
+ 482 (2·1%)
571
+ Ref
572
+ No
573
+ 18,529
574
+ (98.0%)
575
+ 4,306 (97.5%)
576
+ 22,835
577
+ (97.9%)
578
+ 1.01
579
+ 0.79
580
+ 1.30
581
+ 0.969
582
+ *States in red zone (>10,000 positive cases in the state)—Maharashtra, Tamil Nadu, Delhi, Gujarat; orange zone (5,000 to 10,000 cases)—Rajasthan, Madhya Pradesh, Uttar Pradesh;
583
+ and green zone (<5,000 cases)—All other states and Union Territories. Odds ratio was calculated using sequential contrasts for ordinal variables and odds ratio calculated with first row
584
+ and first column as reference for nominal variables. Ref indicates reference group.
585
+ DISCUSSION
586
+ This first largest pan-India online survey, during the third
587
+ phase of nation-wide Indian lockdown, looked at the life style,
588
+ physical health, mental health and the coping abilities using
589
+ logistic regression.
590
+ There is a well-established association between old age and
591
+ co-morbidities such as hypertension (30%), diabetes (19%), and
592
+ coronary heart disease (8%) with risk of COVID-19 infection
593
+ (13–15). UK risk factor estimates had shown a dose-dependent
594
+ increase in risk of COVID-19 with 4-fold higher risk in
595
+ individuals with most adverse life style (51% of severely infected
596
+ Frontiers in Public Health | www.frontiersin.org
597
+ 4
598
+ May 2022 | Volume 10 | Article 814328
599
+ Nagarathna et al.
600
+ Lifestyle During Lockdown in India
601
+ TABLE 2 | Lifestyle in vulnerable and non-vulnerable groups.
602
+ Domain
603
+ Variable
604
+ Non-
605
+ vulnerable
606
+ (n = 18,901)
607
+ Vulnerable
608
+ (n = 4,416)
609
+ Total
610
+ Odd’s
611
+ Ratio**
612
+ CI: 2.5%
613
+ CI:
614
+ 97.5%
615
+ p-value
616
+ Addictions
617
+ Tobacco
618
+ Never
619
+ 17,807
620
+ (94.2%)
621
+ 4,198 (95.1%)
622
+ 22,005
623
+ (94.4%)
624
+ Ref
625
+ Occasionally
626
+ 837 (4.4%)
627
+ 146 (3.3%)
628
+ 983 (4.2%)
629
+ 1.09
630
+ 0.89
631
+ 1.33
632
+ 0·381
633
+ Regularly
634
+ 257 (1.4%)
635
+ 72 (1.6%)
636
+ 329 (1·4%)
637
+ 1·62
638
+ 1·14
639
+ 2·28
640
+ 0·006
641
+ Alcohol
642
+ Never
643
+ 17,299
644
+ (91.5%)
645
+ 4,165 (94.3%)
646
+ 21,464
647
+ (92.1%)
648
+ Ref
649
+ Occasionally
650
+ 1,509 (8.0%)
651
+ 233 (5.3%)
652
+ 1,742 (7.5%)
653
+ 1.00
654
+ 0.84
655
+ 1.17
656
+ 0·959
657
+ Regularly
658
+ 93 (0.5%)
659
+ 18 (0.4%)
660
+ 111 (0.5%)
661
+ 0.77
662
+ 0.40
663
+ 1.43
664
+ 0·431
665
+ Substance use
666
+ Never
667
+ 18,407
668
+ (97.4%)
669
+ 4,332 (98.1%)
670
+ 22,739
671
+ (97.5%)
672
+ Ref
673
+ Occasionally
674
+ 378 (2.0%)
675
+ 55 (1.2%)
676
+ 433 (1.9%)
677
+ 0.77
678
+ 0.57
679
+ 1.02
680
+ 0·081
681
+ Regularly
682
+ 116 (0.6%)
683
+ 29 (0.7%)
684
+ 145 (0.6%)
685
+ 1.80
686
+ 1.02
687
+ 3.12
688
+ 0·039
689
+ Increased substance
690
+ abuse during lockdown
691
+ Yes
692
+ 221 (1.2%)
693
+ 34 (0.8%)
694
+ 255 (1.1%)
695
+ Ref
696
+ No
697
+ 5,273 (27.9%)
698
+ 990 (22.4%)
699
+ 6,263 (26.9%)
700
+ 1.10
701
+ 0.76
702
+ 1.65
703
+ 0·618
704
+ Not
705
+ Applicable
706
+ 13,407
707
+ (70.9%)
708
+ 3,392 (76.8%)
709
+ 16,799
710
+ (72.0%)
711
+ 1.21
712
+ 0.83
713
+ 1.80
714
+ 0·34
715
+ Diet
716
+ Eat discipline before
717
+ Yes
718
+ 15,852
719
+ (83.9%)
720
+ 3,898 (88.3%)
721
+ 19,750
722
+ (84.7%)
723
+ Ref
724
+ No
725
+ 3,049 (16.1%)
726
+ 518 (11·7%)
727
+ 3,567 (15.3%)
728
+ 0·89
729
+ 0·80
730
+ 0·99
731
+ 0·032
732
+ Strict vegetarian/vegan
733
+ Yes
734
+ 13,732
735
+ (72.7%)
736
+ 3842 (87.0%)
737
+ 17574
738
+ (75.4%)
739
+ Ref
740
+ No
741
+ 5,169 (27.3%)
742
+ 574 (13.0%)
743
+ 5,743 (24.6%)
744
+ 0.49
745
+ 0.44
746
+ 0.54
747
+ <0·001
748
+ I like eating junk food
749
+ Yes
750
+ 4,684 (24·8%)
751
+ 454 (10.3%)
752
+ 5,138 (22.0%)
753
+ Ref
754
+ No
755
+ 14,217
756
+ (75.2%)
757
+ 3,962 (89.7%)
758
+ 18,179
759
+ (78.0%)
760
+ 2.19
761
+ 1.96
762
+ 2.45
763
+ <0·001
764
+ I tend to frequently
765
+ snack
766
+ Yes
767
+ 7,273 (38.5%)
768
+ 1,279 (29.0%)
769
+ 8,552 (36.7%)
770
+ Ref
771
+ No
772
+ 11,628
773
+ (61.5%)
774
+ 3,137 (71.0%)
775
+ 14,765
776
+ (63.3%)
777
+ 1.16
778
+ 107
779
+ 1.25
780
+ <0·001
781
+ Sleep
782
+ Quality of sleep before
783
+ lockdown
784
+ Good
785
+ 15,707
786
+ (83.1%)
787
+ 3,599 (81.5%)
788
+ 19,306
789
+ (82.8%)
790
+ Ref
791
+ Ok
792
+ 2,724 (14.4%)
793
+ 731 (16.6%)
794
+ 3,455 (14.8%)
795
+ 1.31
796
+ 1.17
797
+ 1.47
798
+ <0·001
799
+ Bad
800
+ 470 (2.5%)
801
+ 86 (1.9%)
802
+ 556 (2.4%)
803
+ 0.82
804
+ 0.63
805
+ 1.07
806
+ 0·157
807
+ Quality of sleep during
808
+ lockdown
809
+ Good
810
+ 14,964
811
+ (79.2%)
812
+ 3,472 (78.6%)
813
+ 18,436
814
+ (79.1%)
815
+ Ref
816
+ Ok
817
+ 3,093 (16.4%)
818
+ 799 (18.1%)
819
+ 3892 (16.7%)
820
+ 1.22
821
+ 1.09
822
+ 1.37
823
+ <0·001
824
+ Bad
825
+ 844 (4.5%)
826
+ 145 (3.3%)
827
+ 989 (4.2%)
828
+ 0.96
829
+ 0.77
830
+ 1.18
831
+ 0·685
832
+ Activity
833
+ Physical activity before
834
+ lock-down
835
+ Did yoga
836
+ 8,493 (44.9%)
837
+ 2,377 (53.8%)
838
+ 10,870
839
+ (46.6%)
840
+ Ref
841
+ Went
842
+ fitness
843
+ 1,271 (6.7%)
844
+ 107 (2.4%)
845
+ 1,378 (5.9%)
846
+ 0.57
847
+ 0.45
848
+ 0.71
849
+ <0·001
850
+ Went
851
+ walking
852
+ 3,546 (18.8%)
853
+ 925 (20.9%)
854
+ 4,471 (19.2%)
855
+ 1.28
856
+ 1.13
857
+ 1.43
858
+ <0·001
859
+ Did
860
+ household
861
+ 2,071 (11.0%)
862
+ 417 (9.4%)
863
+ 2,488 (10.7%)
864
+ 0.88
865
+ 0.75
866
+ 1.03
867
+ 0·102
868
+ Other
869
+ 3,520 (18.6%)
870
+ 590 (13.4%)
871
+ 4,110 (17.6%)
872
+ 0.81
873
+ 0.71
874
+ 0.93
875
+ 0·004
876
+ Physical activity during
877
+ lock-down
878
+ Yoga
879
+ 9,864 (52.2%)
880
+ 2,721 (61.6%)
881
+ 12,585
882
+ (54.0%)
883
+ Ref
884
+ Fitness
885
+ 893 (4.7%)
886
+ 74 (1.7%)
887
+ 967 (4.1%)
888
+ 0.56
889
+ 0.43
890
+ 0.73
891
+ <0·001
892
+ (Continued)
893
+ Frontiers in Public Health | www.frontiersin.org
894
+ 5
895
+ May 2022 | Volume 10 | Article 814328
896
+ Nagarathna et al.
897
+ Lifestyle During Lockdown in India
898
+ TABLE 2 | Continued
899
+ Domain
900
+ Variable
901
+ Non-
902
+ vulnerable
903
+ (n = 18,901)
904
+ Vulnerable
905
+ (n = 4,416)
906
+ Total
907
+ Odd’s
908
+ Ratio**
909
+ CI: 2.5%
910
+ CI:
911
+ 97.5%
912
+ p-value
913
+ Walking
914
+ 2,377 (12.6%)
915
+ 534 (12.1%)
916
+ 2,911 (12.5%)
917
+ 0.96
918
+ 0.84
919
+ 1.10
920
+ 0·591
921
+ Household
922
+ work
923
+ 3,070 (16.2%)
924
+ 622 (14.1%)
925
+ 3,692 (15.8%)
926
+ 0.94
927
+ 0.82
928
+ 1.07
929
+ 0·36
930
+ Other
931
+ 2,697 (14.3%)
932
+ 465 (10.5%)
933
+ 3,162 (13.6%)
934
+ 0.93
935
+ 0.80
936
+ 1.08
937
+ 0·326
938
+ Duration of the Activity
939
+ During Lock-Down
940
+ Never
941
+ 1,239 (6.6%)
942
+ 256 (5.8%)
943
+ 1,495 (6.4%)
944
+ Ref
945
+ < 30 min
946
+ 4,783 (25.3%)
947
+ 890 (20.2%)
948
+ 5,673 (24.3%)
949
+ 0.79
950
+ 0.68
951
+ 0.93
952
+ 0·004
953
+ 30
954
+ min−1 h
955
+ 7,381 (39.1%)
956
+ 1,703 (38.6%)
957
+ 9,084 (39.0%)
958
+ 1.15
959
+ 1.05
960
+ 1.26
961
+ 0·004**
962
+ > 1 h
963
+ 5,498 (29.1%)
964
+ 1,567 (35.5%)
965
+ 7,065 (30.3%)
966
+ 1.12
967
+ 1.04
968
+ 1.22
969
+ 0·004**
970
+ Odds ratio was calculated using sequential contrasts for ordinal variables and odds ratio was calculated with first row and first column as reference for nominal variables. Ref indicates
971
+ reference group.
972
+ cases) compared to those with optimal lifestyle (7). Although our
973
+ survey did not target COVID-19 positive cases, we looked at the
974
+ potential associations between life style correlates of respondents,
975
+ vulnerable to COVID-19 infection, with the non-vulnerable.
976
+ We observed similar gender distribution among vulnerable
977
+ and non-vulnerable. However, it is reported that males are more
978
+ vulnerable (13). Graduates/post graduates and those who had
979
+ employment or business were more likely to be vulnerable than
980
+ unemployed persons or agriculturists, who are physically active,
981
+ similar to observations in China (16). This observation indicates
982
+ that individuals having stressful job in urban regions make
983
+ them vulnerable. It is important to state here that individuals
984
+ residing in urban regions are at risk of getting infected, where
985
+ day to day physical contact with each other is high, such as at
986
+ offices, institutes, colleges, airport, markets, due to fast-pace life
987
+ style. Good lifestyle before lockdown seems to have contributed
988
+ to adopting healthy activities (reading, writing, cooking, yoga,
989
+ exercise, and household) with good psychological coping ability
990
+ during lockdown. Higher education and good life style seen
991
+ in this cohort may not reflect the lifestyle or the behavioral
992
+ characteristics of the general Indian population. The limitation
993
+ being that response to a call on social media may reflect the
994
+ social responsibility of those with good life style by responding
995
+ voluntarily to this unstructured survey.
996
+ Eating Habits
997
+ A healthy diet, rich in fruits and vegetables and low in sugar
998
+ and calorie-dense processed foods, is essential to health, which
999
+ was observed in majority of our respondents with majority
1000
+ being strict vegetarians. Diet rich in saturated fat, refined
1001
+ carbohydrates, and sugars with low levels of fiber that promotes
1002
+ obesity and type-2 diabetes poses increased risk for severe
1003
+ COVID-19 pathology and mortality by inhibiting adaptive
1004
+ immune system (17).
1005
+ Sleep
1006
+ In a study, during the present pandemic, the prevalence of
1007
+ clinical insomnia in France was 19%, close to prevalence reported
1008
+ in China (20·1%) and Italy (19·8%) but lower than in Greece
1009
+ (37·6%) (18–21). We observed much lower prevalence with only
1010
+ 2·4% and 4·2% respondents reporting “bad” insomnia before and
1011
+ during lockdown. This appears to be because of the milder form
1012
+ of the disease in India and good family support.
1013
+ Addictions
1014
+ Studies have observed that past or current smokers (18%)
1015
+ with COVID-19 had double the risk of progression to severe
1016
+ disease compared with never-smokers (9%) (22, 23). A small
1017
+ percentage (1.1%) who agreed that they had increased the
1018
+ consumption of addictive substances during lockdown did show
1019
+ increased vulnerability.
1020
+ Physical Health
1021
+ Further, obesity is known to be an important contributor for
1022
+ many non-communicable diseases and also for respiratory and
1023
+ other infections (17). Pietrobelli et al. reported that children
1024
+ during social isolation in Italy gained weight which may have
1025
+ long term implications (8). We observed that the vulnerable
1026
+ group had higher representation of overweight individuals
1027
+ as compared to non-vulnerable group. Higher BMI denotes
1028
+ disturbed metabolism and an overall inflammatory state that
1029
+ could further increase the likelihood of COVID-19 infection in
1030
+ the vulnerable individuals (24).
1031
+ Physical activity maintaining regular exercise with good
1032
+ physical endurance counteracts the negative effects of the
1033
+ pandemic stress on immune competency (25). In the present
1034
+ study, 71.7% did physical activities and those who did not do
1035
+ exercises and reported poor physical endurance were more likely
1036
+ to be vulnerable. Yoga, practiced by 54.0% of our respondents
1037
+ during lockdown, is an unexpected observation of this study
1038
+ (Table 2). Duggal et al. observed that exercise augments
1039
+ host immune defenses by catecholamine-mediated preferential
1040
+ mobilization of lymphocytes primed to recognize and kill virus-
1041
+ infected cells (26). Exercise also enhances proliferation of virus-
1042
+ specific memory T-cells and promotes their mobilization to
1043
+ the site.
1044
+ Frontiers in Public Health | www.frontiersin.org
1045
+ 6
1046
+ May 2022 | Volume 10 | Article 814328
1047
+ Nagarathna et al.
1048
+ Lifestyle During Lockdown in India
1049
+ TABLE 3 | Comparison of health and coping between vulnerable and non-vulnerable groups.
1050
+ Domain /Variable
1051
+ Non-
1052
+ vulnerable
1053
+ (n = 18,901)
1054
+ Vulnerable
1055
+ (n = 4,416)
1056
+ Total N (%)
1057
+ OR
1058
+ CI: 2.5%
1059
+ CI:
1060
+ 97.5%
1061
+ p-value
1062
+ Physical health
1063
+ How do you rate your physical
1064
+ strength and endurance?
1065
+ Good
1066
+ 16,973
1067
+ (89.8%)
1068
+ 3,662 (82.9%)
1069
+ 20,635
1070
+ (88.5%)
1071
+ Ref
1072
+ Average
1073
+ 1,824 (9.7%)
1074
+ 693 (15.7%)
1075
+ 2,517 (10.8%)
1076
+ 1.72
1077
+ 1.55
1078
+ 1.89
1079
+ <0.001
1080
+ Bad
1081
+ 104 (0.6%)
1082
+ 61 (1.4%)
1083
+ 165 (0.7%)
1084
+ 1.55
1085
+ 1.09
1086
+ 2.18
1087
+ 0.014
1088
+ BMI
1089
+ (N) mean
1090
+ ± SD
1091
+ (17,666)
1092
+ 24.05 ± 4.31
1093
+ (4,139)
1094
+ 25.49 ± 4.34
1095
+ < 0.001
1096
+ <23
1097
+ 7,489 (42.4%)
1098
+ 1,140 (27.5%)
1099
+ 8,629 (39.6%)
1100
+ Ref
1101
+ 23–24·9
1102
+ 3,703 (21.0%)
1103
+ 903 (21.8%)
1104
+ 4,606 (21.1%)
1105
+ 1.63
1106
+ 1.48
1107
+ 1.79
1108
+ <0.001
1109
+ >25
1110
+ 6,474 (36.6%)
1111
+ 2,096 (50.6%)
1112
+ 8,570 (39.3%)
1113
+ 1.31
1114
+ 1.20
1115
+ 1.43
1116
+ <0.001
1117
+ Mental health
1118
+ Depression: Do you feel you are
1119
+ low in energy and downhearted
1120
+ during this lock-down period?
1121
+ Not at all
1122
+ 15,653
1123
+ (82.8%)
1124
+ 3,735 (84.6%)
1125
+ 19,388
1126
+ (83.1%)
1127
+ Ref
1128
+ Somewhat
1129
+ 3,000 (15.9%)
1130
+ 629 (14.2%)
1131
+ 3,629 (15.6%)
1132
+ 1.26
1133
+ 1.13
1134
+ 1.40
1135
+ <0.001
1136
+ Very much
1137
+ 248 (1.3%)
1138
+ 52 (1.2%)
1139
+ 300 (1·3%)
1140
+ 1.06
1141
+ 0.77
1142
+ 1.45
1143
+ 0.718
1144
+ Anxiety: How anxious are you
1145
+ about the implications of
1146
+ COVID-19 in your life?
1147
+ Not at all
1148
+ 10,399
1149
+ (55.0%)
1150
+ 2,856 (64.7%)
1151
+ 13,255
1152
+ (56.8%)
1153
+ ref
1154
+ Some what
1155
+ 6,495 (34.4%)
1156
+ 1,256 (28.4%)
1157
+ 7,751 (33.2%)
1158
+ 0.83
1159
+ 0.76
1160
+ 0.91
1161
+ <0.001
1162
+ Very much
1163
+ 2,007 (10.6%)
1164
+ 304 (6·9%)
1165
+ 2,311 (9.9%)
1166
+ 0.89
1167
+ 0.77
1168
+ 1.03
1169
+ 0.113
1170
+ Fear: How much do the following issues worry you during this lock-down period?
1171
+ Fear of getting infected and the
1172
+ associated physical suffering
1173
+ Not at all
1174
+ 11,726
1175
+ (62.0%)
1176
+ 2,982 (67.5%)
1177
+ 14,708
1178
+ (63.1%)
1179
+ Ref
1180
+ Somewhat
1181
+ 5,818 (30.8%)
1182
+ 1,239 (28.1%)
1183
+ 7,057 (30.3%)
1184
+ 1.29
1185
+ 1.17
1186
+ 1.42
1187
+ <0.001
1188
+ Very much
1189
+ 1,357 (7.2%)
1190
+ 195 (4.4%)
1191
+ 1,552 (6.7%)
1192
+ 0.97
1193
+ 0.80
1194
+ 1.17
1195
+ 0.741
1196
+ Fear of death
1197
+ Not at all
1198
+ 15,303
1199
+ (81.0%)
1200
+ 3,802 (86.1%)
1201
+ 19,105
1202
+ (81.9%)
1203
+ Ref
1204
+ Somewhat
1205
+ 2,825 (14.9%)
1206
+ 505 (11.4%)
1207
+ 3,330 (14.3%)
1208
+ 1.02
1209
+ 0.91
1210
+ 1.15
1211
+ 0.743
1212
+ Very much
1213
+ 773 (4.1%)
1214
+ 109 (2.5%)
1215
+ 882 (3.8%)
1216
+ 1.01
1217
+ 0.79
1218
+ 1.28
1219
+ 0.925
1220
+ Fear of a possible financial burden
1221
+ Not at all
1222
+ 10,359
1223
+ (54.8%)
1224
+ 2,939 (66.6%)
1225
+ 13,298
1226
+ (57.0%)
1227
+ Ref
1228
+ Somewhat
1229
+ 6,299 (33.3%)
1230
+ 1,130 (25.6%)
1231
+ 7,429 (31.9%)
1232
+ 0.74
1233
+ 0.67
1234
+ 0.80
1235
+ <0.001
1236
+ Very much
1237
+ 2,243 (11.9%)
1238
+ 347 (7.9%)
1239
+ 2,590 (11.1%)
1240
+ 1.01
1241
+ 0.87
1242
+ 1.16
1243
+ 0.94
1244
+ Fear of unknown related to
1245
+ COVID 19
1246
+ Not at all
1247
+ 11,566
1248
+ (61.2%)
1249
+ 3,110 (70.4%)
1250
+ 14,676
1251
+ (62.9%)
1252
+ Ref
1253
+ Somewhat
1254
+ 5,625 (29.8%)
1255
+ 1,078 (24.4%)
1256
+ 6,703 (28.7%)
1257
+ 0.96
1258
+ 0.87
1259
+ 1.06
1260
+ 0.456
1261
+ Very much
1262
+ 1,710 (9.0%)
1263
+ 228 (5.2%)
1264
+ 1,938 (8.3%)
1265
+ 0.90
1266
+ 0.75
1267
+ 1.07
1268
+ 0.231
1269
+ Fear of spreading infection to near
1270
+ and dear ones
1271
+ Not at all
1272
+ 9,564 (50.6%)
1273
+ 2744 (62.1%)
1274
+ 12,308
1275
+ (52.8%)
1276
+ Ref
1277
+ Somewhat
1278
+ 6,353 (33.6%)
1279
+ 1260 (28.5%)
1280
+ 7,613 (32.6%)
1281
+ 0.76
1282
+ 0.70
1283
+ 0.83
1284
+ <0.001
1285
+ Very much
1286
+ 2,984 (15.8%)
1287
+ 412 (9.3%)
1288
+ 3,396 (14.6%)
1289
+ 0.79
1290
+ 0.69
1291
+ 0.91
1292
+ 0.001
1293
+ Stress: Do you always feel
1294
+ insecure; stressed and have
1295
+ mood swings
1296
+ disagree
1297
+ 12,470
1298
+ (66.0%)
1299
+ 3,251 (73·6%)
1300
+ 15,721
1301
+ (67.4%)
1302
+ Ref
1303
+ Maybe
1304
+ 4,117 (21.8%)
1305
+ 790 (17.9%)
1306
+ 4,907 (21.0%)
1307
+ 0.84
1308
+ 0.77
1309
+ 0.92
1310
+ <0.001
1311
+ Agree
1312
+ 2,314 (12.2%)
1313
+ 375 (8.5%)
1314
+ 2,689 (11.5%)
1315
+ 0.83
1316
+ 0.72
1317
+ 0.95
1318
+ 0.007
1319
+ Coping ability
1320
+ Poor
1321
+ 4,727 (25.0%)
1322
+ 1,036 (23.5%)
1323
+ 5,763 (24.7%)
1324
+ Ref
1325
+ Good
1326
+ 14,174
1327
+ (75.0%)
1328
+ 3,380 (76.5%)
1329
+ 17,554
1330
+ (75.3%)
1331
+ 1.00
1332
+ 0.92
1333
+ 1.08
1334
+ 0.965
1335
+ (Continued)
1336
+ Frontiers in Public Health | www.frontiersin.org
1337
+ 7
1338
+ May 2022 | Volume 10 | Article 814328
1339
+ Nagarathna et al.
1340
+ Lifestyle During Lockdown in India
1341
+ TABLE 3 | Continued
1342
+ Domain /Variable
1343
+ Non-
1344
+ Vulnerable
1345
+ (n = 18,901)
1346
+ Vulnerable
1347
+ (n = 4,416)
1348
+ Total N (%)
1349
+ OR
1350
+ CI: 2.5%
1351
+ CI:
1352
+ 97.5%
1353
+ p-value
1354
+ How do you prefer spending time (apart from your regular, work-related engagements) during this national lock-down period?
1355
+ TV
1356
+ Yes
1357
+ 10,018
1358
+ (53.0%)
1359
+ 2,188 (49.5%)
1360
+ 12,206
1361
+ (52.3%)
1362
+ Ref
1363
+ No
1364
+ 8,883 (47.0%)
1365
+ 2,228 (50.5%)
1366
+ 11,111
1367
+ (47.7%)
1368
+ 0.92
1369
+ 0.86
1370
+ 0.99
1371
+ 0.022
1372
+ Read/Write
1373
+ Yes
1374
+ 16,199
1375
+ (85.7%)
1376
+ 3,676 (83.2%)
1377
+ 19,875
1378
+ (85.2%)
1379
+ Ref
1380
+ No
1381
+ 2,702 (14.3%)
1382
+ 740 (16.8%)
1383
+ 3,442 (14.8%)
1384
+ 1.27
1385
+ 1.15
1386
+ 1.39
1387
+ <0.001
1388
+ Cook
1389
+ Yes
1390
+ 13.658
1391
+ (72.3%)
1392
+ 2,995 (67.8%)
1393
+ 16,653
1394
+ (71.4%)
1395
+ Ref
1396
+ No
1397
+ 5,243 (27.7%)
1398
+ 1,421 (32.2%)
1399
+ 6,664 (28.6%)
1400
+ 1.28
1401
+ 1.19
1402
+ 1.38
1403
+ <0.001
1404
+ Exercise
1405
+ Yes
1406
+ 14,962
1407
+ (79.2%)
1408
+ 3,329 (75.4%)
1409
+ 18,291
1410
+ (78.4%)
1411
+ Ref
1412
+ No
1413
+ 3,939 (20.8%)
1414
+ 1,087 (24.6%)
1415
+ 5,026 (21.6%)
1416
+ 1.25
1417
+ 1.15
1418
+ 1.37
1419
+ <0.001
1420
+ Yoga-asana
1421
+ Yes
1422
+ 12,671
1423
+ (67·0%)
1424
+ 2,903 (65·7%)
1425
+ 15,574
1426
+ (66·8%)
1427
+ Ref
1428
+ No
1429
+ 6,230 (33.0%)
1430
+ 1,513 (34.3%)
1431
+ 7,743 (33.2%)
1432
+ 1.18
1433
+ 1.08
1434
+ 1.28
1435
+ <0.001
1436
+ Meditation
1437
+ Yes
1438
+ 14,481
1439
+ (76.6%)
1440
+ 3,838 (86.9%)
1441
+ 18,319
1442
+ (78.6%)
1443
+ Ref
1444
+ No
1445
+ 4,420 (23.4%)
1446
+ 578 (13.1%)
1447
+ 4,998 (21.4%)
1448
+ 0.42
1449
+ 0.38
1450
+ 0.47
1451
+ <0.001
1452
+ Faith practice
1453
+ Yes
1454
+ 14,095
1455
+ (74·6%)
1456
+ 3,374 (76·4%)
1457
+ 17,469
1458
+ (74·9%)
1459
+ Ref
1460
+ No
1461
+ 4,806 (25.4%)
1462
+ 1,042 (23.6%)
1463
+ 5,848 (25.1%)
1464
+ 0.97
1465
+ 0.90
1466
+ 1.06
1467
+ 0.497
1468
+ Internet
1469
+ Yes
1470
+ 14,353
1471
+ (75.9%)
1472
+ 2,929 (66.3%)
1473
+ 17,282
1474
+ (74.1%)
1475
+ Ref
1476
+ No
1477
+ 4,548 (24.1%)
1478
+ 1,487 (33.7%)
1479
+ 6,035 (25.9%)
1480
+ 1.50
1481
+ 1.39
1482
+ 1.62
1483
+ <0.001
1484
+ Odds ratio was calculated using sequential contrasts for ordinal variables and odds ratio was calculated with first row and first column as reference for nominal variables. Ref indicates
1485
+ reference group.
1486
+ Mental Health
1487
+ Anxiety and Depression
1488
+ A meta-analysis of 65 studies during severe infections of
1489
+ SARS had noted that apart from the immediate mental health
1490
+ effects, PTSD could emerge at a later stage (27). “Somewhat”
1491
+ depressive low feeling and anxiety was noted in 15.6% and
1492
+ 33.2%, respectively while 1.3% and 9.9% were “very much”
1493
+ depressed and anxious, respectively. Similar observations have
1494
+ been reported by studies during this pandemic using different
1495
+ psychological battery. The first mental health survey in India
1496
+ during the initial phase of pandemic showed 33.2% had
1497
+ significant (mild/moderate/severe) psychological impact (11).
1498
+ Qiu et al. reported 29% had mild to moderate and 5%
1499
+ had severe psychological distress in China (28). Wang et al.
1500
+ reported psychological impact in higher percentage (53.8%) of
1501
+ respondents with higher stress scores that remained high in the
1502
+ 4th week (5). Thus, anxiety (28.8% in Wang et al. vs. 9·9%
1503
+ in present study) and depression (16·5% in Wang et al. vs.
1504
+ 1·3% in present study) seemed to be higher in China. This
1505
+ may be attributed to the good lifestyle in our respondents with
1506
+ higher educational level. In another Indian study, Rehman et al.
1507
+ observed that people who do not have enough supplies to sustain
1508
+ the lockdown were most affected and the affluent were negatively
1509
+ correlated with psychological distress (29).
1510
+ Fear and Stress
1511
+ A smaller percentage of respondents in our study were
1512
+ stressed (11.5%) or expressed “very much” fear of death
1513
+ (3.8%) or getting infected (6.7%) or financial burden (11.1%)
1514
+ as compared to Chinese respondents with high level of
1515
+ education (75%) similar to our cohort (72.5%), who experienced
1516
+ higher levels of stress (52.1% felt horrified and apprehensive)
1517
+ (15). Milder form of the disease, stricter lockdown and
1518
+ higher family support in Indian community may explain
1519
+ this difference.
1520
+ The growing stress highlights the importance of funding
1521
+ translational and alternative medicine research (30) over
1522
+ fundamental research in vitro (31), in vivo (32–36) and
1523
+ biomarker
1524
+ studies
1525
+ (37–41),
1526
+ which
1527
+ is
1528
+ often
1529
+ restricted
1530
+ to
1531
+ publications. Translating this knowledge into practice may
1532
+ accelerate the pace of discovery and practice of integrative
1533
+ medicine. Several online surveys were conducted in India
1534
+ during this period; however, these surveys reported data
1535
+ on a small sample size (42–44), specific cohort (43, 45, 46),
1536
+ selective
1537
+ parameters
1538
+ such
1539
+ as
1540
+ psychological
1541
+ or
1542
+ life
1543
+ style
1544
+ or coping strategy (41, 44, 45, 47–49) as compared to
1545
+ our study. Another uniqueness of this study is that we
1546
+ used Delphi protocol to develop CHAS questionnaire for
1547
+ the survey.
1548
+ Frontiers in Public Health | www.frontiersin.org
1549
+ 8
1550
+ May 2022 | Volume 10 | Article 814328
1551
+ Nagarathna et al.
1552
+ Lifestyle During Lockdown in India
1553
+ Limitations
1554
+ Although, this survey was aimed at general population, the
1555
+ responses were received by only those with high level of
1556
+ education which prevents us from drawing any conclusion
1557
+ related to Indian race in general.
1558
+ CHAS was prepared to suit the research question as we did not
1559
+ find a scale that had all the components we planned to assess. As
1560
+ the scale was self-reported, social desirability factor influencing
1561
+ the answers may be a limitation.
1562
+ CONCLUSION
1563
+ This is the first nationwide large scale health survey, covering
1564
+ 34 states of India during the 3rd phase of lockdown of COVID-
1565
+ 19 pandemic that shows that those with a good lifestyle
1566
+ including good eating, sleeping, and non-addictive habits with
1567
+ good physical activities adopt good coping abilities during
1568
+ the challenging times of life, irrespective of gender. Increased
1569
+ weight, unhealthy food, addictions and history of international
1570
+ travel increase the risk of getting infected with COVID-19 in
1571
+ vulnerable individuals. This study provides evidence for the
1572
+ media, policy makers and general population to include good life
1573
+ style recommendations for prevention.
1574
+ DATA AVAILABILITY STATEMENT
1575
+ The raw data supporting the conclusions of this article will be
1576
+ made available by the authors, without undue reservation.
1577
+ ETHICS STATEMENT
1578
+ The studies involving human participants were reviewed
1579
+ and approved by Swami Vivekananda Yoga Anusandhana
1580
+ Samsthana, Bengaluru, India. Written informed consent for
1581
+ participation was not required for this study in accordance with
1582
+ the national legislation and the institutional requirements.
1583
+ AUTHOR CONTRIBUTIONS
1584
+ RN: concept, design, definition of intellectual content, literature
1585
+ search, manuscript preparation, manuscript editing, manuscript
1586
+ review, and guarantor. MS: concept, design, definition of
1587
+ intellectual content, manuscript preparation, manuscript editing,
1588
+ and manuscript review. RK: concept, design, definition of
1589
+ intellectual content, data acquisition, data analysis, statistical
1590
+ analysis, manuscript preparation, manuscript editing, and
1591
+ manuscript review. JI: concept, design, definition of intellectual
1592
+ content, data acquisition, data analysis, statistical analysis,
1593
+ manuscript editing, and manuscript review. AA: concept. VM:
1594
+ design, definition of intellectual content, literature search, data
1595
+ acquisition, manuscript editing, and manuscript review. AS:
1596
+ concept, design, definition of intellectual content, literature
1597
+ search, data acquisition, manuscript editing, and manuscript
1598
+ review. JR and MR: manuscript editing and manuscript
1599
+ review. HN: concept, design, definition of intellectual content,
1600
+ data acquisition, manuscript editing, and manuscript review.
1601
+ All authors contributed to the article and approved the
1602
+ submitted version.
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+ Publisher’s Note: All claims expressed in this article are solely those of the authors
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+ the publisher, the editors and the reviewers. Any product that may be evaluated in
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+ this article, or claim that may be made by its manufacturer, is not guaranteed or
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+ endorsed by the publisher.
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+ Copyright © 2022 Nagarathna, Sharma, Ilavarasu, Kulkarni, Anand, Majumdar,
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+ Singh, Ram, Rain and Nagendra. This is an open-access article distributed under the
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+ or reproduction in other forums is permitted, provided the original author(s) and
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+ Frontiers in Public Health | www.frontiersin.org
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+ May 2022 | Volume 10 | Article 814328
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1
+ © 2023 Journal of Mental Health and Human Behaviour | Published by Wolters Kluwer - Medknow
2
+ 65
3
+ Abstract
4
+ Original Article
5
+ Introduction
6
+ Smartphones have become indispensable in the current mode
7
+ of communication and in doing our daily life activities. Among
8
+ many technology‑related addictions, smartphone addiction
9
+ is newer and emerged as a more serious menace than other
10
+ addictions. Recent statistics show a significant rise in the
11
+ usage of smartphones every year. The estimated prevalence of
12
+ smartphone addiction is in the range of 10%–30%.[1] Studies
13
+ have reported the prevalence of problematic smartphone use
14
+ among children and adolescents is as high as 10% in the
15
+ United Kingdom,[2] 16.7% in Taiwan,[3] 16.9% in Switzerland,[4]
16
+ 30.9% in Korea,[5] and 31% in India.[6] Further, a survey among
17
+ the six Asian countries showed the highest prevalence of
18
+ internet addiction through smartphone ownership is 62%.[7]
19
+ Although addiction was previously defined as “a pathologic
20
+ condition that one cannot tolerate without continuous
21
+ administration of substances,” it is now applied to behavioral
22
+ addictions, such as gaming and internet use.[8] These symptoms
23
+ have a negative influence on the psychophysiological
24
+ problems[9] with low psychological well‑being,[10] depression,
25
+ loneliness,[11] social anxiety,[12] cognitive disorders,[13]
26
+ and distressed interpersonal relationships. A high level of
27
+ gamma‑aminobutyric acid has been found in the brains of
28
+ those who use smartphones excessively, causing impaired
29
+ attention and control, as well as being more easily distracted.[14]
30
+ Because of the ease of access to information, adolescents’
31
+ Objectives: The primary aim of the current study was to examine the unique contribution of psychological need frustration and need
32
+ satisfaction in the prediction of excessive usage of smartphones and its relation to psychological distress and mindfulness. Methods: We
33
+ conducted a correlational study using the smartphone addiction scale – shorter version, basic psychological needs satisfaction and frustration
34
+ scale, psychological distress, and mindfulness among 423 graduate and postgraduate engineering students from Bengaluru, South India.
35
+ Results: The results showed that excessive usage of smartphones is positively correlated with the time spent on the phone r = 0.19, P ≤ 0.05;
36
+ and basic psychological needs frustration r = 0.18, P ≤ 0.05; and negatively correlated with basic psychological needs satisfaction r = −0.19,
37
+ P ≤ 0.05 and mindfulness r = −0.39, P ≤ 0.001. However, among the optimal users of the smartphone group, time spent is positively correlated
38
+ with satisfaction at r = 0.13, P ≤ 0.05, and further, basic psychological needs satisfaction is negatively correlated with frustration at r = 0.30,
39
+ P ≤ 0.001 and also found a positive correlation between mindfulness and basic psychological needs satisfaction at r = 0.31, P ≤ 0.001.
40
+ Conclusion: The results suggest that excessive usage of smartphones is associated with frustration, psychological distress, and time spent on
41
+ the mobile. However, there is a positive trend in the time spent on the phone among the optimal users of smartphones suggests that smartphones
42
+ are used as a coping mechanism to gain momentary satisfaction.
43
+ Keywords: Basic psychological needs, excessive usage of smartphone, mindfulness, psychological distress, smartphone addiction, time
44
+ spent on the phone
45
+ Address for correspondence: Dr. Singh Deepeshwar,
46
+ Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana
47
+ Samsthana (S‑VYASA, Deemed to be University), Bengaluru, Karnataka,
48
+ India.
49
+ E‑mail: [email protected]
50
+ Access this article online
51
+ Quick Response Code:
52
+ Website:
53
+ https://journals.lww.com/mhhb
54
+ DOI:
55
+ 10.4103/jmhhb.jmhhb_158_22
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+ How to cite this article: Putchavayala KC, Sasidharan KR, Krishna D,
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+ Deepeshwar S. Correlation between excessive smartphone usage, basic
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+ psychological needs, and mental health of university students. J Mental
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+ Health Hum Behav 2023;28:65-71.
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+ Correlation between Excessive Smartphone usage, Basic
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+ Psychological Needs, and Mental Health of University Students
62
+ Krishna Chaitanya Putchavayala, K. Rajesh Sasidharan, Dwivedi Krishna1, Singh Deepeshwar1
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+ Division of Yoga and Physical Sciences, Swami Vivekananda Yoga Anusandhana Samsthana (S‑VYASA, Deemed to be University), 1Division of Yoga and Life
64
+ Sciences, Swami Vivekananda Yoga Anusandhana Samsthana (S‑VYASA, Deemed to be University), Bengaluru, Karnataka, India
65
+ This is an open access journal, and articles are distributed under the terms of the Creative
66
+ Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
67
+ remix, tweak, and build upon the work non‑commercially, as long as appropriate credit
68
+ is given and the new creations are licensed under the identical terms.
69
+ For reprints contact: [email protected]
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+ Submitted: 01‑Jul‑2022
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+ Accepted: 20‑Aug‑2022
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+ Revised: 10‑Aug‑2022
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+ Published: 21-Jul-2023
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+ Downloaded from http://journals.lww.com/mhhb by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AW
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+ nYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/20/2023
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+ Putchavayala, et al.: Relation between smartphone addiction and psychological health
77
+ 66
78
+ Journal of Mental Health and Human Behaviour  ¦  Volume 28  ¦  Issue 1  ¦  January-June 2023
79
+ smartphones can lead to reduced attention spans as well.[15] As
80
+ adolescents are neurologically immature, they tend to become
81
+ reliant on instant rewards provided by smartphones rather
82
+ than those derived from interactions with friends or family
83
+ members, or their hobbies.[16] Excessive smartphone use may
84
+ affect the connectivity in brain regions that control emotions,
85
+ decision‑making, inhibition, and impulsive control.[17]
86
+ Excessive usage of smartphones and distress
87
+ Research has indicated that a maladaptive use of smartphones
88
+ can lead to psychological distress. In a systematic review of
89
+ 11 studies measuring depressive symptoms in children and
90
+ adolescents, there was a small but statistically significant
91
+ association between social media use and depression.[18] A
92
+ meta‑analysis of 23 studies reported problematic use of Facebook
93
+ is associated with psychological distress in adolescents and
94
+ young adults.[19] When adolescents become overly reliant on
95
+ smartphones, especially to connect with others, they lose the
96
+ opportunity to practice nonverbal skills like understanding
97
+ facial expressions or emotional reactions. Furthermore, they
98
+ are inflexible in their communication and less sensitive to their
99
+ behaviors.[20] It has been found that checking new messages
100
+ and notifications obsessively can lead to personal stress and a
101
+ high frequency of texting is reported to be associated with a
102
+ reduced level of emotional connection with others.[21]
103
+ Compulsive smartphone users struggle to refrain from using the
104
+ devices for a short time, owing to how much of their lives revolve
105
+ around the device.[22] As a result, their performance at school or
106
+ during other activities can suffer when they do not have access
107
+ to these devices. In some adolescents, smartphones serve as a
108
+ coping mechanism to alleviate depression and boredom.[21,22] As
109
+ a result of using devices, they feel less distressed and can divert
110
+ their attention away from more important problems in their lives.
111
+ In the short term, such behavior may provide adolescents with
112
+ relief and as a means of escaping from their problems, but it is
113
+ not beneficial in the long run as the issues remain unresolved. As
114
+ a result, more people will become dependent on smartphones to
115
+ cope with psychological problems.[23] In addition, those seeking
116
+ out companionship in a safe virtual environment may develop
117
+ depression or being more depressed as they become more
118
+ socially isolated, but just focused on their phone.[24]
119
+ Basic psychological needs and frustration
120
+ Self‑determination theory (SDT) is postulated by Deci and
121
+ Ryan for human motivation developed through empirical
122
+ evidence. It is a framework of mini‑theories that taps into
123
+ multiple facets of human motivation. It has been widely used
124
+ in sports, education, health, and employment sectors.[25] Basic
125
+ psychological needs form the core of SDT. It is understood
126
+ that every human has to satisfy their set of basic psychological
127
+ needs for their growth and wellbeing. The primary focus is
128
+ on fulfilling three basic needs: autonomy, relatedness, and
129
+ competence.[26] Basic psychological needs theory (BPNT)
130
+ encompasses both the satisfaction of these thr three needs,
131
+ as well as their frustration, with frustration being a stronger
132
+ and more threatening experience than a purely lacking need.
133
+ Autonomy describes the capacity for free will and willingness
134
+ to act. Satisfaction generates a feeling of integrity that
135
+ permeates our actions, thoughts, and feelings. Feelings of
136
+ frustration can often manifest as pressure and conflict, such
137
+ as feeling pushed in an undesirable direction. Relatedness
138
+ includes the desire to feel connected, be a part of, and
139
+ feel significant to others, as well as a feeling of warmth.
140
+ Relatedness frustration is associated with feelings of social
141
+ exclusion, loneliness, and alienation. We relate competence
142
+ to mastery and effectiveness. It becomes satisfied as one
143
+ capably engages in activities and experiences opportunities
144
+ for using and extending skills and expertise. The frustrated
145
+ often feel ineffective, or outright helpless. A growing number
146
+ of researchers have drawn attention to the concept of need
147
+ frustration, where they demonstrate adverse effects when
148
+ the basic psychological needs for autonomy, competence,
149
+ and relatedness are interfered with.[27,28] Further, the need
150
+ frustration is viewed as a separate process rather than being
151
+ at the other end of a continuum of need satisfaction.[29,30] Need
152
+ frustration is more common when the social context actively
153
+ undermines the basic psychological needs.[31] Performing a
154
+ particular role when one is forced to, being told they are not
155
+ capable, or being discouraged or rejected result in a loss of
156
+ autonomy, competence, or relatedness. Consequently, need
157
+ frustration can be distinguished from lack of need satisfaction,
158
+ which is more passively inhibited psychological needs. Need
159
+ satisfaction and frustration be in an asymmetrical relationship,
160
+ in which the absence of need satisfaction does not necessarily
161
+ indicate the presence of need frustration, but the existence of
162
+ need frustration is implied the absence of need satisfaction.[32]
163
+ In addition, research has shown that need frustrations result in
164
+ adverse outcomes as a direct threat to psychological needs.[33]
165
+ Mindfulness
166
+ Mindfulness can be defined as “an openhearted,
167
+ moment‑to‑moment, nonjudgmental awareness” or
168
+ maintenance of the attention to the present moment.[34] By
169
+ practicing mindfulness, one can pay attention to one’s self
170
+ and surroundings nonjudgmentally and with purpose, leading
171
+ to happiness, self‑awareness, inner calm, and self‑respect.[35]
172
+ Many researchers have applied mindfulness as a treatment
173
+ modality for behavioral addictions, such as pathological
174
+ gambling, workaholics, and Internet addiction.[36‑38] Students
175
+ with excessive usage of smartphones have reported that
176
+ mindfulness‑based interventions resulted in a decline in phone
177
+ usage time and self‑reported scores.[39]
178
+ Van Gordon proposed that the mindfulness approach may
179
+ be suitable for behavioral addictions for several reasons: (a)
180
+ substitution of addictive behaviors with meditation can
181
+ reduce relapse and withdrawal symptoms; (b) cultivation of
182
+ compassion helps with addiction‑related negative emotions; (c)
183
+ shift of focus to the intrinsic value of life and life priorities from
184
+ the instant reward from addictive activities; (d) reduce salience;
185
+ and (e) improve on patience.[36] Mindfulness was also found
186
+ to have a positive relationship with well‑being[40] including
187
+ higher levels of positive emotions, vitality, life satisfaction,
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+ Downloaded from http://journals.lww.com/mhhb by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AW
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+ nYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/20/2023
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+ Putchavayala, et al.: Relation between smartphone addiction and psychological health
191
+ 67
192
+ Journal of Mental Health and Human Behaviour  ¦  Volume 28  ¦  Issue 1  ¦  January-June 2023
193
+ and adaptive emotion regulation and lower levels of negative
194
+ emotions and psychopathological symptoms.[41]
195
+ In the present study, we intend to investigate the relation
196
+ between basic psychological needs satisfaction and frustration,
197
+ and mindfulness with psychological distress and excessive
198
+ usage of smartphones among college students.
199
+ Methods
200
+ Participants
201
+ A total of 423 graduate and postgraduate students from
202
+ an engineering college in Bengaluru, South India were
203
+ recruited for the present study. The sample was distributed
204
+ as (76% of males; 24% of females) with a mean age = 20.29,
205
+ standard deviation (SD) =1.38 years. These participants were
206
+ screened by using the smartphone addiction scale – shorter
207
+ version (SAS‑SV) and 164 participants reported to be having
208
+ excessive usage with cutoff scores ≥31 for males and ≥33 for
209
+ females and 259 students are found to be optimal users of the
210
+ smartphone below the cutoff scores. The average time spent
211
+ on the phone by the participants is 3.26 ± 0.86 h/day. Among
212
+ them, the excessive users spend 3.91 ± 0.70 h and optimal
213
+ users of smartphones spend 2.85 ± 0.67 h/day
214
+ Procedure
215
+ We have contacted students through their college WhatsApp
216
+ groups. Students who are interested in the study took part
217
+ by filling up the forms using a pen and pencil. The data
218
+ were collected during the 2021–2022 academic year. The
219
+ Institutional Ethics Committee of S‑VYASA Yoga University
220
+ approved this study with a reference number of IEC (RES/
221
+ IEC‑SVYASA/113/2017).
222
+ Measures
223
+ The questionnaires include demographic data such as age,
224
+ gender, education qualification, time spent on the smartphone
225
+ in a day, and how long they are using the smartphones. The
226
+ following questionnaires were included: the SAS‑SV,[42] Basic
227
+ psychological needs Satisfaction and Frustration Scale,[28]
228
+ Psychological Distress Scale (K‑10),[43] and Mindful Attention
229
+ Awareness Scale (MAAS).[44]
230
+ Smartphone addiction scale shorter version
231
+ The SAS is a 10‑item questionnaire. The sores on this scale are
232
+ measured on a 6‑point Likert scale. The six factors analyzed
233
+ by this questionnaire were daily‑life disturbance, positive
234
+ anticipation, withdrawal, cyberspace‑oriented relationship,
235
+ overuse, and tolerance. The cutoff levels to be considered as
236
+ addicted were 31 for males and 33 for females. The SAS‑SV
237
+ showed good reliability and validity for the assessment of
238
+ smartphone addiction.
239
+ Basic psychological needs satisfaction and frustration
240
+ scale
241
+ Basic Psychological Need Theory, the satisfaction of the
242
+ psychological needs for Autonomy, competence, and
243
+ relatedness are said to represent essential nutrients of growth,
244
+ and their psychological well‑being and health should be
245
+ enhanced. The Basic Psychological Need Satisfaction
246
+ and Frustration Scale were developed, which includes a
247
+ balanced combination of satisfaction and frustration items.
248
+ The scale consists of 24 items, four items for each of the six
249
+ subscales (i.e. autonomy satisfaction, autonomy frustration,
250
+ relatedness satisfaction, relatedness frustration, competence
251
+ satisfaction, and competence frustration). Respondents
252
+ answered the questions concerning their feelings about their
253
+ jobs during the previous 4 weeks, on a 7‑point response scale
254
+ ranging from 1 (strongly disagree) to 7 (strongly agree).
255
+ Kessler psychological distress scale (K‑10)
256
+ The Kessler psychological distress scale (K‑10) is a widely
257
+ used, simple self‑report measure of psychological distress
258
+ which can be used to identify those in need of further
259
+ assessment for anxiety and depression. This measure was
260
+ designed for use in the general population; however, it may also
261
+ serve as a useful clinical tool. The scale comprises 10 questions
262
+ that are answered using a five‑point scale (where 5 = all of the
263
+ time, and 1 = none of the time). For all questions, the client
264
+ circles the answer truest for them in the past 4 weeks. Scores
265
+ are then summed with a maximum score of 50 indicating severe
266
+ distress, and a minimum score of 10 indicating no distress.
267
+ Mindful attention awareness scale
268
+ The MAAS was used to measure dispositional mindfulness.
269
+ This instrument consists of 15 items, all of which indicate a
270
+ lack of mindfulness. These items are rated on a 6‑point Likert
271
+ scale ranging from 1 (almost always) to 6 (almost never);
272
+ higher scores indicate more mindfulness, and the total score
273
+ can range from 15 to 90. The measures assess the quality of
274
+ attention and awareness that individuals apply to their daily
275
+ lives. The MAAS has good convergent and discriminant
276
+ validity, as well as good psychometric properties.
277
+ Data collection and statistical analysis
278
+ Data were collected by using paper and pencil for all the
279
+ questionnaires. The data were statistically analyzed using the
280
+ Statistical Package for the Social Sciences (SPSS) (version
281
+ 21, IBM Corp., Armonk, NY, USA). The mean and SD were
282
+ calculated for the participant’s age and time spent on the phone.
283
+ Data were checked for the normality using Shapiro test. Data
284
+ were not normally distributed hence Mann–Whitney U‑test
285
+ was used for between‑groups analysis. Spearman correlation
286
+ was used to predict the correlation between the variables. The
287
+ results were considered statistically significant if the P ≤ 0.05.
288
+ Results
289
+ The Mann–Whitney U‑test showed significant differences
290
+ in excessive usage of the smartphone compared to optimal
291
+ users of the smartphone. The excessive usage of smartphone
292
+ group reported significant differences in the variables
293
+ including time spent (U = 6134.5, P < 0.001, r = 0.711),
294
+ SAS (U = 5.5, P < 0.001, r = 1), frustration (U = 18824,
295
+ P  <  0.05, r  =  0.114), K‑10  (U  =  16426.5, P  <  0.001,
296
+ Downloaded from http://journals.lww.com/mhhb by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AW
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+ nYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/20/2023
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+ Putchavayala, et al.: Relation between smartphone addiction and psychological health
299
+ 68
300
+ Journal of Mental Health and Human Behaviour  ¦  Volume 28  ¦  Issue 1  ¦  January-June 2023
301
+ r = 0.227), satisfaction (U = 17767.5, P < 0.01, r = 0.163),
302
+ and MAAS (U = 18804, P < 0.05, r = 0.115). These results
303
+ are illustrated in Table 1.
304
+ Mann–Whitney U‑test  (To compare the differences of
305
+ Variables) between excessive usage and optimal usage
306
+ participants.
307
+ The results of correlation analyses were reported as: among
308
+ the excessive usage of smartphones group, excessive usage
309
+ of smartphones is positively correlated with time spent on
310
+ the mobile at r = 0.19, P ≤ 0.05; basic psychological needs
311
+ frustration at r = 0.18, P ≤ 0.05; and negatively correlated with
312
+ basic psychological needs satisfaction at r = −0.19, P ≤ 0.05;
313
+ and mindfulness at r = −0.39, P ≤ 0.001. Further, time spent
314
+ on the smartphone is positively correlated with psychological
315
+ distress at r = 0.18, P ≤ 0.05; and basic psychological needs
316
+ frustration at r = 0.19, P ≤ 0.05; and negatively correlated with
317
+ basic psychological needs satisfaction at r = 0.24, P ≤ 0.01; and
318
+ mindfulness at r = −0.20, P ≤ 0.01. Furthermore, mindfulness
319
+ is negatively correlated with frustration at r = −0.16, P ≤ 0.05.
320
+ The correlation analysis among the optimal usage group
321
+ reported as time spent is positively correlated with satisfaction
322
+ at r = 0.13, P ≤ 0.05; and mindfulness is positively correlated
323
+ with basic psychological needs satisfaction at r  =  0.31,
324
+ P ≤ 0.001 and negatively correlated with basic psychological
325
+ needs frustration at r = −0.17, P ≤ 0.05; and further, basic
326
+ psychological needs satisfaction is negatively correlated with
327
+ frustration at r = 0.30, P ≤ 0.001. The correlation analysis
328
+ results are reported in Table 2.
329
+ Discussion
330
+ Smartphone usage has been on a drastic rise among
331
+ college‑going students. The research fraternity has extensively
332
+ discussed the implications of excessive usage. However,
333
+ this study intends to understand the intricacies of excessive
334
+ usage of smartphones and its relationship with the theory of
335
+ basic psychological needs satisfaction and frustration with
336
+ psychological distress and mindfulness.
337
+ The prevalence of excessive usage of smartphones in this
338
+ study is reported at 39%. This shows an ongoing trend
339
+ of an upsurge in excessive usage of smartphones among
340
+ college students.[45] It is reported that the excessive usage of
341
+ smartphones ratio in this study is higher among males. The
342
+ results from the current study suggest that the correlations are
343
+ significant but, relatively weak. Among them, time spent on the
344
+ smartphone is positively correlated with basic psychological
345
+ needs frustration, excessive usage of smartphone scores, and
346
+ psychological distress implying low emotion regulation and
347
+ psychological well‑being. However, smartphone excessive
348
+ usage is significantly and negatively associated with
349
+ mindfulness and also, the mindfulness is negatively correlated
350
+ with basic psychological needs and frustration among the
351
+ excessive usage of smartphone group.
352
+ The results from the optimal users of smartphone group reflect
353
+ that time spent on the smartphone is also positively associated
354
+ with basic psychological need satisfaction suggesting that the
355
+ smartphone is used as a coping mechanism to negate boredom
356
+ and loneliness.[11] Furthermore, basic psychological need
357
+ satisfaction has a strong correlation with mindfulness. This
358
+ could imply that basic psychological need satisfaction has
359
+ a major role in defining the symptoms of excessive usage of
360
+ the smartphone. In the absence, it may lead to psychological
361
+ distress and frustration and low levels of mindfulness
362
+ suggesting low psychosocial well‑being.
363
+ Excessive usage of smartphones and psychological
364
+ distress
365
+ The present study found that psychological distress is
366
+ positively correlated with excessive usage of smartphone.
367
+ It is understood that psychological distress, which includes
368
+ anxiety and depression are key symptoms of excessive usage of
369
+ smartphones. We found that distress levels are more prominent
370
+ in the excessive usage of the smartphone group when compared
371
+ to the optimal users of the smartphone group. Similarly, a study
372
+ on university students found that psychological distress and
373
+ neuroticism are positively correlated with excessive usage of
374
+ smartphones[46] which were similar to our research findings.
375
+ Excessive usage of smartphones and basic psychological
376
+ needs, satisfaction, and frustration
377
+ According to Ryan, the satisfaction of the basic psychological
378
+ needs are essential for an individual’s growth, health, and
379
+ psychological well‑being. Looking at the recent studies, it
380
+ is increasingly clear that the absence of basic psychological
381
+ needs satisfaction does not by definition imply it is frustration.
382
+ Psychological needs frustration involves more than a mere
383
+ Table 1: Mean and standard deviation of excessive usage of smartphone and optimal usage participants
384
+ Variables
385
+ Excessive usage
386
+ Optimal usage
387
+ U
388
+ P
389
+ Effect size (r)
390
+ Time spent
391
+ 3.91±0.7
392
+ 2.85±0.67
393
+ 6134.5
394
+ <0.001
395
+ 0.711
396
+ SAS
397
+ 37.28±5.04
398
+ 22.83±4.33
399
+ 5.50
400
+ <0.001
401
+ 1.000
402
+ Need frustration
403
+ 27.34±7.86
404
+ 25.64±6.75
405
+ 18824
406
+ <0.05
407
+ 0.114
408
+ K‑10
409
+ 20.71±3.46
410
+ 19.27±3.79
411
+ 16426.5
412
+ <0.001
413
+ 0.227
414
+ Need satisfaction
415
+ 22.62±6.53
416
+ 24.21±6.53
417
+ 17767.5
418
+ <0.01
419
+ 0.163
420
+ MAAS
421
+ 46.52±8.03
422
+ 48.21±9.42
423
+ 18804
424
+ <0.05
425
+ 0.115
426
+ Mann–Whitney U‑test (to compare the differences of variables) between excessive usage and optimal usage participants. SAS: Smartphone addiction
427
+ scale – shorter version, K‑10: Psychological distress scale, MAAS: Mindfulness attention awareness scale, Satisfaction, and Frustration: Basic
428
+ psychological needs satisfaction and frustration scale, Time spent: Time spent on the smartphone in a day
429
+ Downloaded from http://journals.lww.com/mhhb by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AW
430
+ nYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/20/2023
431
+ Putchavayala, et al.: Relation between smartphone addiction and psychological health
432
+ 69
433
+ Journal of Mental Health and Human Behaviour  ¦  Volume 28  ¦  Issue 1  ¦  January-June 2023
434
+ deficit of one’s needs. Given this asymmetrical relation
435
+ between need satisfaction and need frustration, a moderate
436
+ negative relationship between both can be theoretically
437
+ expected. Our findings reflect the theoretical presumptions
438
+ being excessive usage of the smartphone has a significant
439
+ negative relation with satisfaction and a positive correlation
440
+ with frustration and the time spent on the mobile phone.
441
+ Between‑group analyses showed that students with excessive
442
+ usage of the smartphone have a significant negative correlation
443
+ with satisfaction and vice versa with frustration and time
444
+ spent on their mobile phones. These results were similar to
445
+ the earlier studies on need frustration with the smartphone
446
+ over‑usage.[47] However, it is also reported that there is a
447
+ positive relationship between the time spent on the mobile and
448
+ satisfaction among the optimal usage as well. We can interpret
449
+ this result by drawing a comparison with the earlier reports,
450
+ that smartphones can be used as a coping mechanism to give
451
+ temporary satisfaction and happiness to negate the proneness
452
+ to boredom and loneliness.
453
+ Time spent on the smartphones
454
+ According to a survey, the average time spent on smartphones
455
+ is 5 h a day.[48] This has become a key predictor in defining
456
+ excessive usage of the smartphone. The current study shows
457
+ an average time spent is around 3 h excluding their academic
458
+ activity on smartphones due to the COVID situation. This is
459
+ less than the predicted values. However, we found that the time
460
+ spent on the mobile has a positive relationship with excessive
461
+ usage of smartphone scores, psychological distress, and need
462
+ frustration;[49] and is negatively correlated with mindfulness.
463
+ Excessive usage of smartphones and mindfulness
464
+ Based on the empirical evidence, higher mindfulness
465
+ levels were significantly associated with lower levels of
466
+ proneness to boredom, impulsivity, and problematic usage
467
+ of smartphones.[50] Our study findings suggest that higher
468
+ mindfulness is associated with higher satisfaction levels and
469
+ negatively associated with frustration and psychological
470
+ distress scores among smartphone the optimal usage group.
471
+ As per the previous studies, lower mindfulness levels may lead
472
+ to lower attention levels and academic performance.[51] This
473
+ report suggests that the practice of mindfulness may lead to
474
+ minimizing the symptoms of excessive usage of smartphones.
475
+ Limitations and future scope
476
+ This is a basic study constrained to only engineering graduate
477
+ students and one particular geographical location. Hence,
478
+ future studies should focus on finding the results with
479
+ multi‑ethnic populations to generalize the results. The data are
480
+ a selfreported which can be further explored with objective
481
+ variables. This study tried to establish the primary relation
482
+ between the BPNT and excessive usage of smartphones.
483
+ Further, doing randomized controlled trial with mindfulness as
484
+ an adjunct modality can be studied to understand the intricacies
485
+ of the relation between the BPNT and excessive usage of
486
+ smartphone symptoms.
487
+ Conclusion
488
+ Results suggest that there is a positive association between
489
+ excessive usage of smartphones, psychological distress, time
490
+ spent on the mobile, and need frustration. These results linked
491
+ to the smartphone as a coping mechanism to gain momentary
492
+ satisfaction. However, prolonged time spent on the phone
493
+ may lead to frustration and maladaptive behavior in the
494
+ future. Moreover, the negative association between the need
495
+ satisfaction and frustration in the optimal users of smartphone
496
+ group suggests that fulfillment of need satisfaction plays a key
497
+ role in controlling the symptomatic nature of excessive usage
498
+ of the smartphone.
499
+ Acknowledgments
500
+ We acknowledge the management of Jain University,
501
+ Bengaluru for giving permission to conduct the study on
502
+ students of engineering on their campus.
503
+ Financial support and sponsorship
504
+ Nil.
505
+ Conflicts of interest
506
+ There are no conflicts of interest.
507
+ References
508
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516
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517
+ participants
518
+ Variables
519
+ Spearman’s, r
520
+ Excessive users
521
+ Optimal usage
522
+ Time spent
523
+ SA
524
+ 0.19*
525
+
526
+ K‑10
527
+ 0.18*
528
+
529
+ Need frustration
530
+ 0.19*
531
+
532
+ Need satisfaction
533
+ −0.24**
534
+ 0.13*
535
+ MAAS
536
+ −0.20**
537
+
538
+ SAS
539
+ MAAS
540
+ −0.39***
541
+
542
+ Need frustration
543
+ 0.18*
544
+
545
+ Need satisfaction
546
+ −0.19*
547
+
548
+ MAAS
549
+ Need satisfaction
550
+
551
+ 0.31***
552
+ Need frustration
553
+ −0.16*
554
+ −0.17*
555
+ Satisfaction
556
+ Need frustration
557
+
558
+ −0.30***
559
+ *P<0.05, **P<0.01, and **P<0.001. SAS: Smartphone addiction
560
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+ nYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/20/2023
566
+ Putchavayala, et al.: Relation between smartphone addiction and psychological health
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+ 70
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1
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
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+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
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+ VOLUME 3, ISSUE 8(4), AUGUST 2014
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+
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+
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+ DEVELOPMENT AND STANDARDIZATION OF JATARAGNI
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+ IMPAIRMENT CHECKLIST (JIC)
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+ PKL Nandini1, Raghavendra Rao M2, Malur R Usharani2
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+ Naik Radheshyam2, Nagarathna R1, Shubha H3
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+ Dr. Mariyamma philip4 Shekhar G Patil2, Diwakar B Ravi2
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+ H P Shashidhara2, C T Satheesh2, Basavalinga S Ajaikumar2
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+ 1. Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru
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+ 2. Health Care Global Enterprises Ltd., Bengaluru
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+ 3. Sri Kalabhireshwara Ayurvedic Medical College, Bengaluru
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+ 4. Department of Biostatistics, National Institute of Mental Health and Neurosciences,
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+ Bangalore,
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+
18
+ Introduction
19
+ Cancer treatment cause both physical & psychological distress (Haes
20
+ et al, 1990). Multiple physical distress symptoms are observed in
21
+ majority of patients during chemotherapy, either alone or cluster of
22
+ symptoms like nausea & vomiting, loss of appetite, taste alteration etc.
23
+ (Barsevick et al, 2006). Their intensity varies with type, stage and
24
+ treatment of the disease. (Rebecca Siegel, et al, 2012) It is observed
25
+ that, nausea does not occur as a single symptom, but a conglomeration
26
+ of symptoms like feeling sick, retching, loss of appetite and other
27
+ abdominal discomfort (GI disturbances) (Dodd et al, 2001, 2004).
28
+ Also, nausea has been relatively compared to vomiting as an ‘urge to
29
+ vomit’(Trikamji, 1935 Chap 20 Verse 6)Though vomiting is fairly
30
+ controlled with new antiemetic therapies, delayed nausea still remains
31
+ the most distressing concern experienced by seventy per cent of the
32
+ patients undergoing moderately emetogenic chemotherapy. As a result,
33
+ this subjective symptom is less understood and more so less treated.
34
+ Although Antiemetic’s are used to ease temporary nausea and
35
+ vomiting, some are known to cause side effects despite their clinical
36
+ benefits. (Osoba et al, 1997), (Feyer & Jordan, 2011) & (Roila et al,
37
+ 2005) But use of antiemetic is necessary in CCINV.
38
+ 1
39
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
40
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
41
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
42
+
43
+
44
+ Another significant problem is that, substantial gap remains between
45
+ antiemetic guidelines and practice (Angelis et al, 2003)with majority
46
+ of patients poorly controlled for Cancer Chemotherapy induced nausea
47
+ and vomiting –CCINV in developing countries. Conventional
48
+ antiemetic questionnaires (Functional living Index Emesis and
49
+ Morrow Assessment of Nausea and Emesis) only measure nausea and
50
+ emesis and their impact on quality of life(Martin et al, 2003), whereas
51
+ other
52
+ accompanying
53
+ symptoms
54
+ such
55
+ as
56
+ anorexia,
57
+ abdominal
58
+ discomfort etc. causing patients’ distress are not elicited. Health in
59
+ Ayurveda is defined in individuals as equilibrium of dosha (three vital
60
+ Bio energy), Agni (Bio energy),dhatu (Tissue),mala (Waste products),
61
+ kriya (Physiology) with sound soul, sense and mind (Trikamji, 1935
62
+ Chap 1 Verse 53 & 1981 Chap 15 Verse 44) •.
63
+ In order to address the problem in holistic way, we used concept of
64
+ “Agni” from Ayurveda scriptures to address this cluster of symptoms as
65
+ a manifestation of “Agni impairment” and that there are thirteen types
66
+ of Agni governing all cellular metabolic processes such as anabolism
67
+ and catabolism in all organ systems to bring about a change. (Haridasa
68
+ Samskritha Granthamala 106 Chap 11 Verse 34) & (Trikamji, 1935
69
+ Chap 15 Verse 3)Jataragni is the bio energy present in the GI tract.
70
+ Epicentred in duodenum and regulates the complete digestion and
71
+ assimilation process including gastric emptying phase of digestion and
72
+ regulates transit of food through the GI tract facilitating digestion
73
+ (Akash Kumar et al 2010) The discomforts caused due to
74
+ chemotherapy are related to formation of “ama” because of sluggish
75
+ digestion
76
+ or
77
+ impaired
78
+ jataragni
79
+ (Haridasa
80
+ Samskritha
81
+ Granthamala 106 Chap 13 Verse 25 & 27) resulting in Vata
82
+ Pittajachardilakshanas, taken in the present study as CCINV (Trikamji,
83
+ 1935 Chap 20 Verse 7 & 20)Ayurveda texts prescribe correction of
84
+ dosha imbalance and Agni ultimately through VayuNiyantrana
85
+ (directing the energy channels) (Trikamji, 1935 Chap 28 Verse 3 & 4).
86
+ 2
87
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
88
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
89
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
90
+
91
+
92
+ So, improving Agni and gastric motility play a vital role in management
93
+ of CCINV. In this study we attempted to measure the impairment of
94
+ Jataragni using a checklist that measures symptomatic manifestation
95
+ of Agni impairment. This was done by collectively using all available
96
+ information from Ayurveda texts on impairment of Jataragni.
97
+ Aim and objective
98
+ To develop a comprehensive checklist to evaluate impaired Jataragni
99
+ level among the CCINV patients, test the measurability of the items in
100
+ the checklist and examine the reliability and validity of Checklist-JIC
101
+ Methods
102
+ Checklist development procedure
103
+ Comprehensive description of methods and steps are as follows:
104
+ (Vranda-2009) & (Kiran Rao et al, 1989,)
105
+ Phase-1 Pooling of items. Item reduction, Scale construction,
106
+ consensual validation.
107
+ Pooling of items
108
+ As a first step identification of the universe of item pool for the
109
+ checklist (Nunnaly, 1978; Messick1980), the researcher contacted
110
+ thirty different Ayurveda experts, explained the rationale of the study
111
+ and documented their views on Agni with respect to its various
112
+ functionalities and manifestations. In short, experts suggested that the
113
+ checklist should be based on symptoms of jataragni impairment, as the
114
+ study covers the role of jataragni in CCINV. A total of about 30
115
+ Jataragni impaired symptoms were listed as per the experts’ suggestion
116
+ with
117
+ references
118
+ from
119
+ Charakasamhitha,
120
+ Sushrutha
121
+ samhitha
122
+ Madhavanidana, Ashtangahrudaya, Ashtangahsangraha and text book-
123
+ concept of Jataragni in Ayurveda with special reference to Jataragni
124
+ bala pariksha by Vd. Bhagwan Dash. Common Chemotherapy side
125
+ 3
126
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
127
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
128
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
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+
130
+
131
+ effects and cancer symptoms were also referred as per CTCAE criteria.
132
+ The original Sanskrit phrases, their meanings in English were compiled
133
+ as a checklist. Thus, thirty original sanskrit symptoms on jataragni
134
+ impairment formed the initial item pool of JIC.
135
+ Item reduction
136
+ Focus Group Discussion (FGD) I- In order to minimize the number of
137
+ symptoms in JIC, researcher conducted a group discussion programme-
138
+ FGD I at Bangalore where a team of 10 Ayurveda experts were present
139
+ in the focus group discussion for corrections and inclusions based on
140
+ appropriateness. The researcher posed each of the symptoms to the
141
+ group of experts. Those items which were completely agreed and voted
142
+ by five or more judges were retained in the checklist. Overlapping,
143
+ repeated, irrelevant ambiguous or vague items were eliminated. Thus a
144
+ total of nineteen symptoms formed the checklist and eleven were
145
+ eliminated.
146
+ Scale construction:
147
+ The scale was constructed keeping in mind the criteria for uniformity
148
+ in scoring using a Likert scale - none, mild, moderate and severe
149
+ (Likert-Zyzanski et al, 1974). After considering different bias of scale
150
+ construction, the experts also confirmed that the items of the checklist
151
+ were linguistically equivalent (Sanskrit terms were translated to
152
+ English).
153
+ FGD II- the researcher posed each of the 19 symptoms to the group
154
+ comprising five oncologists to conform the appropriateness of items.
155
+ Those items that received three or more votes were retained in the
156
+ checklist. They suggested that the symptom checklist be modelled on
157
+ Common Terminology Criteria for Adverse Events (CTCAE) Version
158
+ 3.0. Field testing for confirming the measurability of the checklist was
159
+ carried out among both non cancer patients taking Ayurveda treatment
160
+ 4
161
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
162
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
163
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
164
+
165
+
166
+ and those with cancer on chemotherapy. The provisional checklist was
167
+ customised and prepared accordingly. Field testing 1-was conducted at
168
+ Ayurveda collage Bangalore on ten patients. Outcome: checklist was
169
+ able to show the difference in the level of Agni impairment before and
170
+ after panchakarma treatment. Field testing 2-was conducted on cancer
171
+ patients at HCG who were undergoing first cycle of chemotherapy. It
172
+ was observed that the majority of patients had zero score for nausea
173
+ and vomiting items at baseline before chemotherapy. Verbal consent
174
+ was first obtained from all subjects prior to their study activities and
175
+ confidentiality was maintained regarding the information collected for
176
+ the research. No invasive procedures were used in the study.
177
+ Consensual and content validity
178
+ FGD III-Consensual and content validation of the JIC was done by
179
+ convening a expert group of 17 members from Ayurveda, oncology, yoga
180
+ and clinical psychology. The experts were asked to validate each of the
181
+ items for, cultural relevance, clarity and ease with comprehension,
182
+ readability and suitability for a 4-point rating format. Those items
183
+ which were completely agreed and voted by nine or more judges
184
+ confirmed validity and were retained in the checklist. The experts
185
+ accepted the items subject to following conditions:
186
+ 1. To change the rating of scale from none, mild, moderate and severe
187
+ to none, asymptomatic but present occasionally or evident on clinical
188
+ examination, symptomatic and frequent but does not interfere with
189
+ GI function, Symptomatic but interferes with GI function in lines of
190
+ CTCAE criteria version 3 for a clear definition of the grade severity
191
+ (See JIC checklist).
192
+ 2. To capture symptoms other than Nausea and Vomiting to prove
193
+ divergent validity.
194
+ 3. To retain only thirteen symptoms for the checklist (Annexsure-1)
195
+ 5
196
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
197
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
198
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
199
+
200
+
201
+ 4. The patients simultaneously were to complete Visual analogue Scale
202
+ (Objective assessment).for 2 symptoms- Time interval between each
203
+ meal and Quantity taken at each meal. The provisional checklist was
204
+ customised and prepared accordingly Final JIC comprised of 13
205
+ symptoms (Annexsure-1).
206
+ Phase-2 Pilot Study
207
+ Patients for pilot study were chosen from a randomised controlled
208
+ study conducted at Health Care Global (HCG) Bangalore i.e. from first
209
+ sixty randomized patients, 15 patients were randomly chosen
210
+ representing all the 3 groups equally- Random 5 from each group. Pilot
211
+ study was carried out with 13 items of checklist. Sampling procedure
212
+ was similar to main study. (Usharani et al, 2014)
213
+ The aim was to assess the feasibility and comprehensibility of checklist.
214
+ This
215
+ self-reported
216
+ checklist
217
+ was
218
+ found
219
+ to
220
+ be
221
+ readable
222
+ and
223
+ comprehendible. The checklist was able to capture the difference in the
224
+ jataragni impairment level before and after chemotherapy. The mean
225
+ time taken to complete the checklist was found to be 10minutes.
226
+ Phase-3
227
+ The final 13 items of JIC were tested to examine the measurability of
228
+ the checklist, to establish the norms for final interpretation of scores
229
+ and Standardization of Final 13-Items- for Validity and Reliability.
230
+ Sampling Procedure:
231
+ Study subjects: The study was carried out at Health Care Global
232
+ (HCG) Bangalore over 16 months period. (Usharani RM, et al)
233
+ Sample Size: The sample size was based on the three arm original
234
+ study to evaluate the effects of yoga intervention to manage CCINV
235
+ (Usharani et al, 2014).
236
+ 6
237
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
238
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
239
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
240
+
241
+
242
+ This study included patients with solid malignancies except those with
243
+ brain metastasises/ brain tumours and GI malignancies.
244
+ Ethical issues: The study was approved by institutional ethics
245
+ committee and written informed consent was taken from all
246
+ participants prior to their participation in the study.
247
+ JIC was administered prior to chemotherapy and post 6 days for 1st,
248
+ 2nd, 3rd cycles of chemotherapy. Here simultaneously patient
249
+ completed the Jataragni checklist on par with FLIE quality-of-life (Qol)
250
+ questionnaire.
251
+ Results
252
+ The mean age of study sample was 49.3 ± 11.3 years. Data was not
253
+ normally distributed.
254
+ Reliability and validity:
255
+ Reliability: The reliability of 13 item JIC was good with Cronbachs
256
+ alpha=0.74 and inter rater reliability between three raters varied
257
+ between 0.68 to 0.80
258
+ Validity: Good divergent validity of JIC with FLIE indicating that it
259
+ captured items that were not captured in the FLIE. The kappa values,
260
+ ranges between 0.01 to 0.09 across four cycles of chemotherapy in the
261
+ overall study sample, indicating divergent validity. Values within each
262
+ group also showed similar divergent validity compared to overall study
263
+ sample indicating that intervention did not influence validity of the
264
+ scale. This strong validity demonstrates the robustness of the scale to
265
+ capture Jataragni symptoms independent of FLIE (See table 1&2). The
266
+ evidence of content validity has already been established in the initial
267
+ phase.
268
+
269
+
270
+ 7
271
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
272
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
273
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
274
+
275
+
276
+ Table 1: Divergent validity of Jataragni checklist with FLIE
277
+ TIME
278
+ Agni &
279
+ FLIE
280
+ similar
281
+ Agni & FLIE
282
+ dissimilar
283
+
284
+ Kappa
285
+
286
+ p-value
287
+ No (%)
288
+ D0 (n=120)
289
+ 45 (37.5)
290
+ 75 (62.5)
291
+ -
292
+ -
293
+ D7 (n=112)
294
+ 57 (50.9)
295
+ 55 (49.2)
296
+ 0.064
297
+ 0.318
298
+ C2 (n=104)
299
+ 45 (43.3)
300
+ 59 (56.7)
301
+ 0.019
302
+ 0.769
303
+ C3 (n=94)
304
+ 48 (51.1)
305
+ 46 (48.9)
306
+ 0.097
307
+ 0.097
308
+ - couldn’t calculate Kappa, as FLIE @ D0 was 0 for all
309
+
310
+ Symptom severity Symptoms were graded based on their presence
311
+ (subjective/clinical) and interference with GI function. Anorexia, taste
312
+ alteration and dry mouth were some of the major symptoms that
313
+ interfered with GI function. Though most of these symptoms were
314
+ reported by patients many of them did not interfere with GI function
315
+ (See Table 2 &3).
316
+
317
+ Table 2: Severity of symptoms related to agni in Jataragni
318
+ checklist
319
+ Cycle
320
+ Mild (1)
321
+ No (%)
322
+ Moderate (2)
323
+ No (%)
324
+ Severe (3)
325
+ No (%)
326
+ D0 (n=120)
327
+ 45 (37.5)
328
+ 38 (31.7)
329
+ 37(30.7)
330
+ D7 (n=120)
331
+ 43(35.9)
332
+ 38 (31.6)
333
+ 39 (32.5)
334
+ C2 (n=109)
335
+ 41 (37.6)
336
+ 46 (42.2)
337
+ 22 (20)
338
+ C3 (n=102)
339
+ 39 (38.2)
340
+ 32 (31.3)
341
+ 31 (30.4)
342
+
343
+
344
+ 8
345
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
346
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
347
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
348
+
349
+
350
+ Table 3: Severity of individual symptoms in Jataragni checklist
351
+ Symptoms
352
+ None 0
353
+ No (%)
354
+ Mild 1
355
+ No (%)
356
+ Moderate
357
+ 2
358
+ No (%)
359
+ Severe
360
+ 3
361
+ No (%)
362
+ Anorexia D5/7
363
+ 41 (37)
364
+ 45(40)
365
+ 22(20)
366
+ 3 (3)
367
+ C2
368
+ 74 (69.2)
369
+ 21 (19.6)
370
+ 10 (9.3)
371
+ 2 (1.9)
372
+ C4
373
+ 61 (61.0)
374
+ 25 (25.0)
375
+ 11 (11.0)
376
+ 3(3.0)
377
+ ConstipationD5/7
378
+ 75 (68)
379
+ 28 (25)
380
+ 7 (6)
381
+ 1(1)
382
+ C2
383
+ 91 (85.0)
384
+ 14 (13.1)
385
+ 2 (1.9)
386
+
387
+ -
388
+ C4
389
+ 81 (81.0)
390
+ 16 (16.0)
391
+ 2 (2.0)
392
+ 1 (1.0)
393
+ Diarrhea D5/7
394
+ 87(78.4)
395
+ 19 (17.1)
396
+ 4 (3.6)
397
+ 1 (0.9)
398
+ C2
399
+ 100
400
+ (93.5)
401
+ 6 (5.6)
402
+ 1 (0.9)
403
+ -
404
+ C4
405
+ 90 (90.0)
406
+ 9 (9.0)
407
+ 1 (1.0)
408
+ -
409
+ Distention D5/7
410
+ 75 (67.6)
411
+ 29 (26.1)
412
+ 5 (4.5)
413
+ 2 (1.8)
414
+ C2
415
+ 96 (89.7)
416
+ 9 (8.4)
417
+ 2 (1.9)
418
+ -
419
+ C4
420
+ 80 (80.8)
421
+ 14 (14.1)
422
+ 4 (4.0)
423
+ 1 (1.0)
424
+ Drymouth D5/7
425
+ 48 (43.2)
426
+ 51(45.9)
427
+ 11(9.9)
428
+ 1(0.9)
429
+ C2
430
+ 63 (58.9)
431
+ 31 (29.0)
432
+ 12 (11.2)
433
+ 1 (0.9)
434
+ C4
435
+ 56 (56.0)
436
+ 38 (38.0)
437
+ 5 (5.0)
438
+ 1 (1.0)
439
+ Flatulence D5/7
440
+ 79 (71.2)
441
+ 23 (20.7)
442
+ 8 (7.2)
443
+ 1 (0.9)
444
+ C2
445
+ 89 (84.0)
446
+ 11 (10.4)
447
+ 6 (5.7)
448
+ -
449
+ C4
450
+ 72 (72.0)
451
+ 24 (24.0)
452
+ 4 (4.0)
453
+ -
454
+ Heartburn D5/7
455
+ 71 (64.0)
456
+ 31 (27.9)
457
+ 7 (6.3)
458
+ 2((1.8)
459
+ C2
460
+ 93 (86.9)
461
+ 10 (9.3)
462
+ 4 (3.7)
463
+ -
464
+ C4
465
+ 78 (78.8)
466
+ 17 (17.2)
467
+ 4 (4.0)
468
+
469
+ Taste alteration
470
+ D5/7
471
+ 40 (36.0)
472
+ 46 (41.4)
473
+ 24 (21.6)
474
+ 1 (0.9)
475
+ C2
476
+ 55 (51.4)
477
+ 39 (36.4)
478
+ 13 (12.1)
479
+ -
480
+ C4
481
+ 37 (37.0)
482
+ 37 (37.0)
483
+ 25 (25.0)
484
+ 1 (1.0)
485
+ Heaviness D5/7
486
+ 75 (67.6)
487
+ 28 (25.2)
488
+ 8 (7.2)
489
+ -
490
+ C2
491
+ 93 (86.9)
492
+ 10 (9.3)
493
+ 3 (2.8)
494
+ 1 (0.9)
495
+ C4
496
+ 80 (80.0)
497
+ 17 (17.0)
498
+ 3 (3.0)
499
+ -
500
+ Gurgling D5/7
501
+ 81 (73.0)
502
+ 28 (25.2)
503
+ 2 (1.8)
504
+ -
505
+ C2
506
+ 96 (90.6)
507
+ 9 (8.5)
508
+ 1 (0.9)
509
+ -
510
+ C4
511
+ 81 (81.0)
512
+ 17 (17.0)
513
+ 2 (2.0)
514
+ -
515
+ Eructation D5/7
516
+ 74 (66.7)
517
+ 31 (27.9)
518
+ 5 (4.5)
519
+ 1 (0.9)
520
+ 9
521
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
522
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
523
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
524
+
525
+
526
+ C2
527
+ 88 (83.0)
528
+ 17 (16.0)
529
+ 1 (0.9
530
+ -
531
+ C4
532
+ 82 (82.0)
533
+ 14 14.0)
534
+ 4 (4.0)
535
+ -
536
+ Excess salivation
537
+ D5/7
538
+ 92 (82.9)
539
+ 16 (14.4)
540
+ 2 (1.8)
541
+ 1 (0.9)
542
+ C2
543
+ 101
544
+ (94.4)
545
+ 5 (4.7)
546
+ 1 (0.9)
547
+ -
548
+ C4
549
+ 84 (84.0)
550
+ 13 (13.0)
551
+ 3 (3.0)
552
+ -
553
+ Quantity at each
554
+ meal D5/7
555
+ 35 (31.5)
556
+ 37 (33.3)
557
+ 23 (20.7)
558
+ 16 (14.4)
559
+ C2
560
+ 51 (47.7)
561
+ 36 (33.6)
562
+ 16 (15.0)
563
+ 4 (3.7)
564
+ C4
565
+ 39 (39.0)
566
+ 38 (38.0)
567
+ 15 (15.0)
568
+ 8 (8.0)
569
+
570
+ Cut off scores
571
+ The 33rd percentile cut off scores was 2 (mean across all chemo cycles)
572
+ and 66th percentile cut off was 6 (mean across all chemo cycles) in this
573
+ study for Jataragni impairment checklist.
574
+ Convergent Validity
575
+ Quantity of meal is an extrapolation of Agni quality as per ancient
576
+ texts (Trikamji, 1935 Chap 12 Verse 11). We compared the convergent
577
+ validity of all items on JIC with quantity of meal at chemotherapy
578
+ cycle. There was a strong correlation on Spearmans rank correlation
579
+ at different chemotherapy cycles of total Agni of JIC with quantity of
580
+ each meal (All p’s=0.001).
581
+
582
+
583
+
584
+
585
+
586
+
587
+ 10
588
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
589
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
590
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
591
+
592
+
593
+ 4: Spearmans rank correlation between total agni with
594
+ quantity of each meal at different chemotherapy cycles.
595
+
596
+ Quantity of each meal at
597
+ various chemotherapy
598
+ cycles
599
+
600
+ TOTALA
601
+ GNI C1
602
+ TOTALAG
603
+ NID5/7
604
+ TOTALA
605
+ GNIC2
606
+ TOTALAG
607
+ NIC4
608
+ Quantity At Each
609
+ Meal{C1}, N=116
610
+ .619**
611
+ Quantity At Each
612
+ Meal{D5/D7}, N=111
613
+ .674**
614
+ Quantity At Each
615
+ meal{C2}, N=107
616
+ .673**
617
+ Quantity At Each
618
+ Meal{C4}, N=100
619
+ .641**
620
+ **p<0.01, using Sperman’s rank correlation
621
+ Findings:
622
+ There was strong reliability for JIC to measure impairment in Agni.
623
+ There was a poor agreement between FLIE and Agni scores indicating
624
+ strong discriminant validity and suggesting that JIC measures a
625
+ construct different from that of FLIE. However this Checklist measures
626
+ only impairment of Agni and is more suited to chemotherapy setting as
627
+ it’s known to measure some acute effects. The results suggest that this
628
+ questionnaire captures subtleties of symptoms that need not
629
+ individually impair GI function but can collectively increase distress.
630
+ These symptoms so mentioned are subjective and similar to concept of
631
+ symptom clusters proposed by Dodd et al, 2001and 2004.
632
+ Secondly, this did show divergent validity with FLIE, but does not
633
+ mean that these symptoms had no impact on quality of life as FLIE
634
+ 11
635
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
636
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
637
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
638
+
639
+
640
+ measured only the impact of nausea or emesis on their respective
641
+ quality of life domains and not a collective or global quality of life.
642
+ Third, being subjective checklist the ensuing psychologic distress could
643
+ have increased the symptomatology in these patients confounding the
644
+ effects. However despite these limitations these subjective symptoms
645
+ still elucidate impairment in jataragni. Ayurvedic texts also describe
646
+ that psychological distress is known to affect Agni imbalance, therefore
647
+ the presence of these symptoms and distress give more credence to
648
+ studying agni in this current context.
649
+ As per ancient texts Jataragni is a physiological entity which converts
650
+ the substance from biological level to physiological level. It is subtle and
651
+ its presence can only be felt and observed but not seen. JIC assessment
652
+ helps in clinical evaluation of the diseased- in predicting severity of the
653
+ adverse effects, planning management (dietary and pharmacological,)
654
+ and in prognosis. But it is a self-reported measure to capture distress
655
+ and not a diagnostic tool. It measures only presence or absence of
656
+ symptoms and its severity, if present. Thus a comprehensive tool to
657
+ evaluate and asses the whole aspects of GI disturbances in its literal
658
+ sense, as Western point of view is not contributing much in
659
+ understanding the complex mechanism and subtler aspect of patient’s
660
+ problems at a time because Chemotherapy further simulates these
661
+ symptoms, leading to hypo or hyper functioning of JatarJataragni
662
+ affecting Pachaka Pitta) (Trikamji, 1935 Chap 8 Verse 20) .Vitiated
663
+ Jataragni ,situated as pachaka pitta influences and have a cascading
664
+ effect on other Jataragnis, and further aggravates pranadivayus
665
+ resulting in Nausea and Vomiting.
666
+ Suggestions:
667
+ There is a need to validate if this checklist can be used in other chronic
668
+ illnesses as well. Future studies should look at a larger population and
669
+ to develop ideal subscales using factor analysis.
670
+ 12
671
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
672
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
673
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
674
+
675
+
676
+ References:
677
+ 1. Akash Kumar Agrawal, C. R. Yadav and M. S. Meena .(2010) .
678
+ Physiological
679
+ aspectsof
680
+ Agni.Ayu.
681
+ Jul-Sep;
682
+ 31(3):395–398.doi:
683
+ 10.4103/0974-8520.77159PMCID: PMC3221079.
684
+ 2. Andrea M. Barsevick, , Kyra Whitmer,, Lillian M. Nail, Susan L. and
685
+ William N. Dudley.(2006). Symptom Cluster Research: Conceptual,
686
+ Design, Measurement, and Analysis Issues. Journal of Pain and
687
+ Symptom Management Vol.31.
688
+ 3. De Angelis V, Roila F, Sabbatini R. (Eds.). (2003) Cancer
689
+ chemotherapy-induced delayed emesis: antiemetic prescriptions in
690
+ clinical practice.
691
+ 4. Dodd M, Miaskowski C & Paul SM. (2001). Symptom clusters and
692
+ their effect on the functional status of patients with cancer. Oncol
693
+ Nurs Forum; 28:465--470.
694
+ 5. Dodd MJ, Miaskowski C & Lee KA. (2004). Occurrence of symptom
695
+ clusters. J Natl Cancer Inst Monogr 32:76--78. .
696
+ 6. Feyer P and Jordan K. (2011). Update and new trends in antiemetic
697
+ therapy: the continuing need for novel therapies. Annals of
698
+ Oncology. 22(1):30-8.
699
+ 7. Haridasa Samskritha Granthamala 106. Ashtanga Hrudaya of
700
+ Vagbhata, Sootra Sthana; Doshadivijnaneedi: Chapter 11, Verse 34
701
+ .Chowkamba Press.
702
+ 8. Haridasa Samskritha Granthamala 106. Ashtanga Hrudaya of
703
+ Vagbhata, Sootra Sthana; Doshopakramaniyam: Chapter 13, Verse
704
+ 25. Chowkamba Press.
705
+ 9. Haridasa Samskritha Granthamala 106. Ashtanga Hrudaya of
706
+ Vagbhata, Sootra Sthana; Doshopakramaniyam: Chapter 13, Verse
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+ 27 Chowkamba Press
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+ 13
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+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
710
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
711
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
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+
713
+
714
+ 10. J.C.J.M de Haes', F.C.E. van Knippenberg and J.P. Neijt3. (1990).
715
+ Measuring psychological and physical distress in cancer patients:
716
+ structure and application of the Rotterdam Symptom Checklist. Br.
717
+ J. Cancer, 62, 1034-1038.
718
+ 11. Kiran Rao,1 D.K. Subbakrishna,2 and G.G. Prabhu3. (1989)
719
+ development of a coping checklist—a preminary report, Indian J
720
+ Psychiatry Apr-Jun; 31(2): 128–133. PMCID: PMC2991673.
721
+ 12. Martin AR, Pearson JD and Cai. B. (2003). Assessing the impact of
722
+ chemotherapy-induced nausea and vomiting on patients' daily lives:
723
+ a modified version of the Functional Living Index-Emesis (FLIE)
724
+ with 5-day recall. Support Care Cancer. 11:522-7
725
+ 13. Messick, S. (1980) Test validity and the ethics of assessment.
726
+ 14. Nunnally, J.C. (1978) The psychological theory. New York:
727
+ MaGraw- Hill Company
728
+ 15. Osoba D, Zee B, Pater J, Warr D, Latreille J and Kaizer L.
729
+ (1997).Determinants of postchemotherapy nausea and vomiting in
730
+ patients with cancer. Quality of Life and Symptom. Journal of
731
+ clinical oncology. 15(1):116-23.
732
+ 16. Rebecca Siegel, Carol DeSantis, Katherine Virgo, Kevin Stein,
733
+ Angela Mariotto, Tenbroeck Smith, Dexter Cooper, Ted Gansler,
734
+ Catherine Lerro, Stacey Fedewa, Chunchieh Lin, Corinne Leach,
735
+ Rachel Spillers Cannady, Hyunsoon Cho, Steve Scoppa, Mark
736
+ Hachey, Rebecca Kirch, Ahmedin Jemal, and Elizabeth Ward.(2012)
737
+ Cancer Treatment and Survivorship Statistics
738
+ 17. Roila F, Warr D, Clark-Snow RA, Tonato M, Gralla RJ ,Einhorn LH
739
+ et al. (2005). Delayed emesis: moderately emetogenic chemotherapy.
740
+ Supportive care in cancer.;13(2):104-8.
741
+ 14
742
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
743
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
744
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
745
+
746
+
747
+ 18. Usharani RM, PKL Nandini, Raghavendra Rao M, Mahesh Kavya, S
748
+ Aishvarrya, et al. (2014) Comparison of Yoga vs. Relaxation on
749
+ Chemotherapy Induced Nausea and Vomiting Outcomes: A
750
+ Randomized
751
+ Controlled
752
+ Trial.
753
+ J
754
+ Integr
755
+ Oncol
756
+ 3:116.
757
+ doi:
758
+ 10.4172/2329-6771.1000116
759
+ 19. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
760
+ Agnivesha revised by Charaka and Dridahabala. Sootra Sthana; 1I
761
+ ed. Chapter1 Verse 53. Nirnaya Sagar Press.
762
+ 20. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
763
+ Agnivesha revised by Charaka and Dridahabala. Vimana Sthana;; 1I
764
+ ed. Chapter8 Verse 20 Nirnaya Sagar Press.
765
+ 21. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
766
+ Agnivesha revised by Charaka and Dridahabala. Sootra Sthana; 1I
767
+ ed. Chapter12 Verse 11 Nirnaya Sagar Press.
768
+ 22. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
769
+ Agnivesha revised by Charaka and Dridahabala. Sootra Sthana; 1I
770
+ ed. Chapter15 Verse 3. Nirnaya Sagar Press.
771
+ 23. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
772
+ Agnivesha revised by Charaka and Dridahabala. Chikitsa Sthana; 1I
773
+ ed. Chapter20 Verse 6 Nirnaya Sagar Press.
774
+ 24. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
775
+ Agnivesha revised by Charaka and Dridahabala. Chikitsa Sthana; 1I
776
+ ed. Chapter20 Verse 7 Nirnaya Sagar Press.
777
+ 25. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
778
+ Agnivesha revised by Charaka and Dridahabala. Chikitsa Sthana; 1I
779
+ ed. Chapter20 Verse 20 Nirnaya Sagar Press.
780
+ 15
781
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
782
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
783
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
784
+
785
+
786
+ 26. Vaidya Jadavji Trikamji Acharya. (Ed.). (1935). Charaka Samhita of
787
+ Agnivesha revised by Charaka and Dridahabala. Chikitsa Sthana; 1I
788
+ ed. Chapter28 Verse 3&4 Nirnaya Sagar Press.
789
+ 27. Vaidya Jadavji Trikamji Acharya. (Ed.). (1981). Sushrutha Samhita
790
+ of Sushrutacharya, Sootra Sthana; 1 ed, Chapter 15 Verse 44.
791
+ Nirnaya Sagar Press.
792
+ 28. M.N Vranda. (2009).Development and standardization of life skills
793
+ scale, Indian Journal of Social Psychiatry. 25(1-2), 17 - 28.
794
+ 29. Zyzanski, S.J., Hulka, B.S., Cassel. J.C. (1974) Scale for
795
+ measurement of satisfaction with medical care: Modification of
796
+ content format scoring. Medical Care, 3, 294-323. American
797
+ Psychologist, 35, 1012-1027.
798
+ 16
799
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
800
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
801
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
802
+
803
+
804
+ CHECKLIST FOR EVALUATING STATE OF AGNI WITH SPECIAL REFERENCE TO
805
+ JATARAGNI - JIC
806
+ Symptom
807
+ 0
808
+ 1
809
+ 2
810
+ 3
811
+ 1. Anorexia
812
+ none
813
+ Loss of appetite without
814
+ alteration in eating
815
+ habits
816
+ Oral intake altered
817
+ without significant
818
+ weight loss or
819
+ malnutrition, oral
820
+ nutritional
821
+ supplements
822
+ indicated
823
+ Associated with significant
824
+ weight loss or malnutrition, IV
825
+ fluids, tube feeding or TPN
826
+ indicated
827
+ 2. Constipation
828
+ none
829
+ Occasional or
830
+ intermittent symptoms,
831
+ occasional use of stool
832
+ softeners, laxatives,
833
+ dietary modification or
834
+ enema
835
+ Persistent
836
+ symptoms with
837
+ regular use of
838
+ laxatives or enema
839
+ indicated
840
+ Symptoms interfering with
841
+ ADL, obstipation with manual
842
+ evacuation indicated
843
+ 3. Diarrhea
844
+ none
845
+ Increase of <4stools
846
+ /day over baseline,
847
+ Increase of 4-6
848
+ stools/day over
849
+ baseline, IV fluids
850
+ indicated <24hrs,
851
+ Increase of _> 7 stools/day over
852
+ baseline, incontinence, IV
853
+ fluids _>24hrs hospitalization,
854
+ 4. Distension/
855
+ bloating,
856
+ none
857
+ Asymptomatic but
858
+ evident on clinical
859
+ Symptomatic but
860
+ not interfering with
861
+ Symptomatic, interfering with
862
+ GI function
863
+ 17
864
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
865
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
866
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
867
+
868
+
869
+ abdominal
870
+ examination
871
+ GI function
872
+ 5. Dry mouth
873
+ none
874
+ Symptomatic(dry or
875
+ thick saliva) without
876
+ significant dietary
877
+ alteration,
878
+ Symptomatic and
879
+ significant oral
880
+ intake alteration,
881
+ Symptoms leading to inability
882
+ to adequately aliment orally, IV
883
+ fluids, tube feedings or TPN
884
+ indicated,
885
+ 6. Flatulence
886
+ none
887
+ Asymptomatic but
888
+ evident on clinical
889
+ examination
890
+ Symptomatic but
891
+ not interfering with
892
+ GI function
893
+ Symptomatic, interfering with
894
+ GI function ----
895
+ 7. Heart
896
+ burn/Dyspepsia
897
+ none
898
+ Asymptomatic but
899
+ evident on clinical
900
+ examination
901
+ Symptomatic but
902
+ not interfering with
903
+ GI function
904
+ Symptomatic, interfering with
905
+ GI function
906
+ 8. Taste
907
+ alteration
908
+ none
909
+ Altered taste but no
910
+ change in diet
911
+ Altered taste with
912
+ change in diet,
913
+ noxious or
914
+ unpleasant taste,
915
+ loss of taste.
916
+ ----
917
+ 9. Gastro-
918
+ intestinal-others
919
+ a) Heaviness of
920
+ abdomen
921
+ none
922
+ Asymptomatic but
923
+ evident on clinical
924
+ examination
925
+ Symptomatic but
926
+ not interfering with
927
+ GI function
928
+ Symptomatic, interfering with
929
+ GI function
930
+ 18
931
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
932
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
933
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
934
+
935
+
936
+ b) Gurgling
937
+ sound in the
938
+ intestine
939
+ none
940
+ Asymptomatic but
941
+ evident on clinical
942
+ examination
943
+ Symptomatic but
944
+ not interfering with
945
+ GI function
946
+ Symptomatic, interfering with
947
+ GI function
948
+ c) Eructations
949
+ none
950
+ Asymptomatic or very
951
+ occasional
952
+ Symptomatic and
953
+ frequent but not
954
+ interfering with GI
955
+ function
956
+ Symptomatic, interfering with
957
+ GI function
958
+ d) Excessive
959
+ salivation
960
+ none
961
+ Asymptomatic or very
962
+ occasional
963
+ Symptomatic and
964
+ frequent but not
965
+ interfering with GI
966
+ function
967
+ Symptomatic, interfering with
968
+ GI function
969
+
970
+ Note: The symptoms mentioned as 9a, b, c, d categorized under gastrointestinal-others is graded
971
+ depending on the patient’s response (Subjective response)
972
+ 19
973
+ INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY EDUCATIONAL RESEARCH
974
+ ISSN : 2277-7881; IMPACT FACTOR - 2.735; IC VALUE:5.16
975
+ VOLUME 3, ISSUE 8(4), AUGUST 2014
976
+
977
+
978
+ Reference: The grading of symptoms mentioned in the above checklist
979
+ is customized for this study based on Common Terminology Criteria for
980
+ Adverse Events (CTCAE) Version 3.0 published by U.S. Department of
981
+ health and human services, National Institutes of Health and National
982
+ Cancer Institute
983
+ 20
subfolder_0/Design and validation of integrated yoga therapy module for antarctic expeditioners.txt ADDED
@@ -0,0 +1,406 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Original Research Article
2
+ Design and validation of Integrated Yoga Therapy module for Antarctic
3
+ expeditioners
4
+ Ragavendrasamy Balakrishnan a, Ramesh Mavathur Nanjundaiah a, *, Mohit Nirwan b,
5
+ Manjunath Krishnamurthy Sharma c, Lilly Ganju b, Mantu Saha b, Shashi Bala Singh d,
6
+ Nagendra Hongasandra Ramarao e
7
+ a Molecular Biosciences Laboratory, Anvesana Research Laboratories, S-VYASA University, Bangalore, India
8
+ b Defence Institute of Physiology and Allied Sciences, New Delhi, India
9
+ c Anvesana Research Laboratories, S-VYASA University, Bangalore, India
10
+ d Life Sciences Research Board, Defence Research and Development Organisation, New Delhi, India
11
+ e S-VYASA University, Bangalore, India
12
+ a r t i c l e i n f o
13
+ Article history:
14
+ Received 20 July 2017
15
+ Received in revised form
16
+ 27 October 2017
17
+ Accepted 18 November 2017
18
+ Available online xxx
19
+ Keywords:
20
+ Yoga module
21
+ Antarctica
22
+ Stress
23
+ IAYT
24
+ a b s t r a c t
25
+ Background: Extreme environments are inherently stressful and are characterized by a variety of physical
26
+ and psychosocial stressors, including, but not limited to, isolation, confinement, social tensions, minimal
27
+ possibility of medical evacuation, boredom, monotony, and danger. Previous research studies recom-
28
+ mend adaptation to the environment to maintain optimal function and remain healthy. Different in-
29
+ terventions have been tried in the past for effective management of stress. Yoga practices have been
30
+ shown to be beneficial for coping with stress and enhance quality of life, sleep and immune status.
31
+ Objective: The current article describes preparation of a Yoga module for better management of stressors
32
+ in extreme environmental condition of Antarctica.
33
+ Materials and methods: A Yoga module was designed based on the traditional and contemporary yoga
34
+ literature as well as published studies. The Yoga module was sent for validation to forty experts of which
35
+ thirty responded.
36
+ Results: Experts (n ¼ 30) gave their opinion on the usefulness of the yoga module. In total 29 out of 30
37
+ practices were retained. The average content validity ratio and intra class correlation of the entire
38
+ module was 0.89 & 0.78 respectively.
39
+ Conclusion: A specific yoga module for coping and facilitating adaptation in Antarctica was designed and
40
+ validated. This module was used in the 35th Indian Scientific expedition to Antarctica, and experiments
41
+ are underway to understand the efficacy and utility of Yoga on psychological stress, sleep, serum bio-
42
+ markers and gene expression. Further outcomes shall provide the efficacy and utility of this module in
43
+ Antarctic environments.
44
+ © 2018 The Authors. Published by Elsevier B.V. on behalf of Institute of Transdisciplinary Health Sciences
45
+ and Technology and World Ayurveda Foundation. This is an open access article under the CC BY-NC-ND
46
+ license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
47
+ 1. Introduction
48
+ Characteristics
49
+ and
50
+ determinants
51
+ of
52
+ human
53
+ response
54
+ to
55
+ extreme environmental conditions prevailing in the Antarctic
56
+ continent has interested psychologists and physiologists. Extreme
57
+ environments are inherently stressful and are characterised by a
58
+ variety of physical and psychosocial stressors including but not
59
+ limiting
60
+ to
61
+ capsule
62
+ environment,
63
+ isolation,
64
+ social
65
+ tensions,
66
+ boredom, monotony and danger [1]. The international commit-
67
+ tees, COMNAP (The Council of Managers for National Antarctic
68
+ Program) and SCAR (Scientific Committee of Antarctic Research),
69
+ in addition to the organisers of the expedition from individual
70
+ countries, are primarily concerned to enhance the overall well-
71
+ ness of the members sent to the Antarctic stations. Even though
72
+ scientific research is the primary goal of Antarctic expedition,
73
+ equal importance is given to take care of the physical and psy-
74
+ chological health of the expeditioners starting from selection of
75
+ expeditioners to emergency evacuation to involving behavioural
76
+ * Corresponding author.
77
+ E-mail: [email protected] (R.M. Nanjundaiah).
78
+ Peer review under responsibility of Transdisciplinary University, Bangalore.
79
+ Contents lists available at ScienceDirect
80
+ Journal of Ayurveda and Integrative Medicine
81
+ journal homepage: http://elsevier.com/locate/jaim
82
+ https://doi.org/10.1016/j.jaim.2017.11.005
83
+ 0975-9476/© 2018 The Authors. Published by Elsevier B.V. on behalf of Institute of Transdisciplinary Health Sciences and Technology and World Ayurveda Foundation. This is
84
+ an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
85
+ Journal of Ayurveda and Integrative Medicine xxx (2018) 1e4
86
+ Please cite this article in press as: Balakrishnan R, et al., Design and validation of Integrated Yoga Therapy module for Antarctic expeditioners,
87
+ J Ayurveda Integr Med (2018), https://doi.org/10.1016/j.jaim.2017.11.005
88
+ scientist and psychologists to offering periodic support through
89
+ online group or individual psychological counselling sessions for
90
+ helping expeditioners deal with the stress [2].
91
+ Several psychological and physiological changes are observed in
92
+ Antarctic expeditioners. Psychological changes range from behav-
93
+ ioural changes like aggression, mood swings to psychiatric prob-
94
+ lems like depression [3]. Isolation seems to have a considerable
95
+ effect. Isolation and inherent danger associated in Antarctic envi-
96
+ ronment might enhance the extent of repetitive negative thinking
97
+ based on the personality of the individual. Reports suggest an in-
98
+ crease in smoking, loneliness, homesickness and a reduction in
99
+ rapport during the isolated dark winter months [4]. Physiologically,
100
+ decreased immune responsiveness accompanied with variations in
101
+ circulating insulin, thyroid stimulating hormones, testosterone,
102
+ cortisol, melatonin, pro-inflammatory Cytokines, 25-OH-vitamin D
103
+ and a significant increase in total cholesterol have been recorded
104
+ [5e8]. Some studies also suggest that such challenging environ-
105
+ ments also turn to be salutogenic in certain individuals. With
106
+ limited access to health care in the Antarctic environment, strate-
107
+ gies are required to be adopted to promote overall psycho-physical
108
+ wellness of an individual and also the group. Interestingly, Yoga
109
+ practices have been known to be beneficial and promote psycho-
110
+ physiological wellbeing across human cultures.
111
+ Physical postures (asana), voluntarily regulated breathing (pra-
112
+ nayama), and meditation (dhyana) are the three main components
113
+ of Yoga practiced in India over thousands of years. In the past
114
+ decade, Yoga has gained popularity as a fitness strategy and as well
115
+ as an adjunct therapeutic tool in the management of obesity [9],
116
+ diabetes [10], hypertension [11] and even auto-immune disorders
117
+ [12]. Yoga practices have been shown to alleviate anxiety, fear
118
+ [13,14], negative thinking [15], and enhance cardio-pulmonary
119
+ fitness [16], immune status [17,18], and also telomere length [19]
120
+ in regular practitioners. Yoga practices improve the overall sleep
121
+ efficiency and total sleep time [20]. Yoga practice in high altitudes
122
+ showed a lower reduction in oral temperature and lower increase
123
+ in Oxygen consumption and energy expenditure compared to
124
+ physical therapy [21]. Meta-analysis of data on Yoga recommend
125
+ Yoga to be considered as an ancillary treatment option in the
126
+ management of depressive disorders [22].
127
+ A study was conducted on the summer and wintering over
128
+ members of the 35th Indian Scientific Expedition Members to
129
+ Antarctica to understand the role of Yoga practices on facilitating
130
+ human adaptation to extreme climatic conditions. Even though
131
+ Yoga practices are known to be beneficial for individuals irre-
132
+ spective of their health and disease states, it is essential to structure
133
+ specific Yoga practices that are intended to provide most benefits.
134
+ Yoga practices for Antarctica were designed with the following
135
+ objectives:
136
+ i. To regulate mood and alleviate psychological stress caused
137
+ due to isolation
138
+ ii. To enhance physical wellness, overcome fatigue and regulate
139
+ metabolism
140
+ iii. To enable better thermoregulation
141
+ iv. To
142
+ enhance
143
+ better
144
+ sleep
145
+ and
146
+ promote
147
+ interpersonal
148
+ relationship
149
+ The objectives were listed based on the earlier reports on the
150
+ psychological and physiological changes in Antarctic expeditioners.
151
+ Practices identified were compiled together to promote calmness of
152
+ mind and sleep, overcome stress and fatigue, promote overall
153
+ endurance of the body, regulate digestion, metabolism and enable
154
+ better pulmonary functions (supplementary material 1). The cur-
155
+ rent study present the data on the designing and validation of the
156
+ Yoga module that was implemented in the expedition members.
157
+ 2. Materials and methods
158
+ The classical and contemporary yoga texts were reviewed to
159
+ develop the content of the Yoga module. Texts on Yoga Sutras of
160
+ Patanjali, Hatha Yoga Pradipika, Shiva Samhitha, Gheranda Samhita,
161
+ Hatharathnavali, Bhagavad Gita, Upanishads, Yoga Vashishta and
162
+ Yogic Sukshma Vyayama were reviewed [23e31]. Practices that
163
+ might be difficult for the expeditioners to practice and those that
164
+ are contra-indicated in common disorders such as hypertension
165
+ and cardiovascular disorders were not included. Similarly, those
166
+ practices that were difficult to objectively verify and certain
167
+ Sükshma vy€
168
+ ay€
169
+ ama (loosening exercise) practices that might not be
170
+ feasible to practice in group inside the Antarctic stations like
171
+ Jangha Shakti vikasaka [31] were not included. The Yoga module
172
+ that was designed consisted of postures with slow movements
173
+ and breath
174
+ awareness, loosening exercises, suryanamaskara,
175
+ asana, pra€
176
+ eayama, relaxation and nadanusandhana. The duration
177
+ of the entire practice is 1 h.
178
+ The Yoga module was sent along with the objectives to forty
179
+ yoga experts out of whom thirty responded with their scores and
180
+ comments. Members with allopathic & AYUSH streams of med-
181
+ icine with post graduate medical degree in Yoga therapy, re-
182
+ searchers with doctoral degree in yoga, and yoga & naturopathic
183
+ physicians with over 7 years of clinical experience were consid-
184
+ ered to be included in the expert panel for validating the Yoga
185
+ module. The experts rated the usefulness of the module on a
186
+ scale of 1e5 (1 not at all useful, 2 a little useful, 3 moderately
187
+ useful, 4 very useful, 5 extremely useful). Content Validity Ratio
188
+ (CVR) for suitability of items was calculated following Lawshe's
189
+ method [32]. Dichotomous (yes/no) responses were obtained to
190
+ determine the duration of the individual practice and the entire
191
+ yoga session.
192
+ 2.1. Statistical analysis
193
+ Lawshe's CVR ratio was calculated [32] for each item in the
194
+ module. Items with a CVR of 0.6 and above were considered beyond
195
+ change agreement (p < 0.05, one tailed) for 30 experts. Intra class
196
+ correlation was calculated for inter-rater reliability [33].
197
+ 3. Results
198
+ Thirty experts in Yoga therapy and research consented to
199
+ contribute to the content validation of the Yoga module for
200
+ extreme Antarctic environmental conditions. These Yoga experts
201
+ had experience in various traditions of Yoga. The experts age
202
+ ranged from 32 to 50 years (mean 36.3 ± 4.17 years). The average
203
+ experience following formal yoga training was 12.3 years
204
+ ranging between 8 and 26 years. The scores obtained for the
205
+ individual practices and the calculated CVR are shown in the
206
+ supplementary material 2. One practice viparitakarani with CVR
207
+ <0.6 was excluded. The average CVR for the entire Yoga module
208
+ was 0.89. Good agreement is noted for most practices listed in
209
+ the yoga module. Intra Class Correlation [33] for the entire
210
+ module was 0.78.
211
+ All
212
+ the experts opined on the need
213
+ for practicing
214
+ Sur-
215
+ yanamaskara (sun salutation), relaxation and breath awareness
216
+ based practices and pranayama. Most experts agreed on the dura-
217
+ tion of 1 h for the Yoga practices (Table 1). In addition to the
218
+ practices that were asked to be scored by experts, seven experts
219
+ recommended to include vaman dhauti kriya (voluntarily induced
220
+ vomiting after drinking saline water in empty stomach). But, was
221
+ not considered in module due to challenges in water treatment and
222
+ discharge at Antarctica.
223
+ R. Balakrishnan et al. / Journal of Ayurveda and Integrative Medicine xxx (2018) 1e4
224
+ 2
225
+ Please cite this article in press as: Balakrishnan R, et al., Design and validation of Integrated Yoga Therapy module for Antarctic expeditioners,
226
+ J Ayurveda Integr Med (2018), https://doi.org/10.1016/j.jaim.2017.11.005
227
+ 4. Discussion
228
+ The Yoga module for application in the extreme Antarctic con-
229
+ ditions appears to be acceptable for most of the experts. Similar
230
+ strategy was used in earlier studies for validating yoga modules for
231
+ various pathological conditions [34,35].
232
+ The experts from different schools of yoga were in agreement
233
+ with the contents of the module. Only viparitakarani was not fav-
234
+ oured to be included in the final module as indicated by the CVR
235
+ score (<0.6). Seven experts suggested including vaman dhauti kriya.
236
+ However, with concerns over processing the waste water and
237
+ maintenance in the Antarctic stations and the decision of experts
238
+ not being unanimous, the recommendation was not taken further
239
+ into validation.
240
+ Several interventions like psychiatric counselling, group ther-
241
+ apy, medications and diet are tried on the expeditioners to reduce
242
+ their psycho-physiological stress. Yoga, a widely accepted reliever
243
+ of stress [36], has never been tried in Antarctica until now. Also, the
244
+ strengths of this module is that it consists of simple postures that
245
+ are easy to follow and as the practices are derived from traditional
246
+ yoga texts, yoga instructor following any school of Yoga should be
247
+ able to teach the module. The classical Yoga texts does not describe
248
+ specific symptom based guidelines for their practice e as the pri-
249
+ mary objective of Yoga practices is to gain mastery over mind [26]
250
+ and the observed physical and mental benefits might be actual by-
251
+ product of yoga practice. Therefore, the practices have been
252
+ selected from the texts based on the approximating descriptions of
253
+ mental and physical health benefits of specific Yoga practices and
254
+ that are feasible to be practiced at the Indian Antarctic station. This
255
+ is the first attempt made to administer structured Yoga practices
256
+ with an objective to understand its mechanisms of action in iso-
257
+ lated, stressful and extreme Antarctic conditions. The effect of the
258
+ Yoga intervention will be known when the study on the summer
259
+ [Voyage team] and wintering over [Bharati, Larsemann hills,
260
+ (692402800S 761101400E)] members of the 35th Indian Scientific
261
+ Expedition to Antarctica will be analysed for changes in their psy-
262
+ chological stress, sleep, serum biomarkers, and gene expression
263
+ regulations.
264
+ 5. Conclusion
265
+ A comprehensive and traditional text based Yoga module was
266
+ developed as an intervention to facilitate coping up with the psy-
267
+ chological and physiological stressors in the Antarctica. The Yoga
268
+ module was validated by 30 experts who agreed to most of the
269
+ practices. The final module was used as an intervention in the 35th
270
+ Indian Scientific Expedition to Antarctica. Testing of efficacy of the
271
+ intervention on alleviating psycho-physiological stress at genetic
272
+ and molecular level is underway and might prove to be an efficient
273
+ way to deal the stressors associated with the extreme Antarctic
274
+ environments.
275
+ Funding
276
+ This project was funded by Defence Institute of Physiology and
277
+ Allied Sciences, New Delhi (TC/DIP-265/CARS-05/DIPAS/2-15).
278
+ Acknowledgements
279
+ The authors acknowledge all the experts for offering their
280
+ comments and inputs to develop this module.
281
+ Appendix A. Supplementary data
282
+ Supplementary data to this article can be found online at
283
+ https://doi.org/10.1016/j.jaim.2017.11.005.
284
+ References
285
+ [1] Suedfeld P. Applying positive psychology in the study of extreme environ-
286
+ ments. Hum Perform Extreme Environ 2001;6. p 21e5.
287
+ [2] Suedfeld P, Steel GD. The environmental psychology of capsule habitats. Annu
288
+ Rev Psychol 2000;51. p 227e53.
289
+ [3] Gunderson EKE. Emotional symptoms in extremely isolated groups. Arch Gen
290
+ Psychiatr 1963;9. p 362.
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+ [4] Bhargava R, Mukerji S, Sachdeva U. Psychological impact of the Antarctic
292
+ winter on Indian expeditioners. Environ Behav 2000;32. p 111e27.
293
+ [5] Muller HK, Lugg DJ, Ursin H, Quinn D, Donovan K. Immune responses during
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+ an Antarctic summer. Pathology 1995;27. p 186e90.
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+ [6] Sawhney RC, Malhotra AS, Prasad R, Pal K, Kumar R, Bajaj AC. Pituitary-
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+ gonadal hormones during prolonged residency in Antarctica. Int J Biometeorol
297
+ 1998;42. p 51e4.
298
+ Table 1
299
+ List of Practices.
300
+ R. Balakrishnan et al. / Journal of Ayurveda and Integrative Medicine xxx (2018) 1e4
301
+ 3
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+ Please cite this article in press as: Balakrishnan R, et al., Design and validation of Integrated Yoga Therapy module for Antarctic expeditioners,
303
+ J Ayurveda Integr Med (2018), https://doi.org/10.1016/j.jaim.2017.11.005
304
+ [7] Farrace S, Cenni P, Tuozzi G, Casagrande M, Barbarito B, Peri A. Endocrine and
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+ psychophysiological aspects of human adaptation to the extreme. Physiol
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+ Behav 1999;66. p 613e20.
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+ [8] Steinach M, Kohlberg E, Maggioni MA, Mendt S, Opatz O, Stahn A, et al. Sleep
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+ quality changes during overwintering at the German antarctic stations neu-
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+ mayer II and III: the gender factor. PLoS One 2016;11, e0144130.
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+ [9] Bernstein AM, Bar J, Ehrman JP, Golubic M, Roizen MF. Yoga in the manage-
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+ ment of overweight and obesity. Am J Lifestyle Med 2014;8. p 33e41.
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+ [10] Nagarathna R, Usharani MR, Rao AR, Chaku R, Kulkarni R, Nagendra HR. Ef-
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+ ficacy of yoga based life style modification program on medication score and
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+ lipid profile in type 2 diabetesda randomized control study. Int J Diabetes
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+ Dev Ctries 2012;32. p 122e30.
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+ [11] Hagins M, States R, Selfe T, Innes K. Effectiveness of yoga for hypertension:
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+ systematic review and meta-analysis. Evid base Compl Alternative Med
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+ 2013;2013. p 649836.
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+ [12] Dash M, Telles S. Improvement in hand grip strength in normal volunteers
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+ Pharmacol 2001;45. p 355e60.
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+ [13] Smith C, Hancock H, Blake-Mortimer J, Eckert K. A randomised comparative
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+ trial of yoga and relaxation to reduce stress and anxiety. Compl Ther Med
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+ 2007;15. p 77e83.
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+ [14] Telles S, Naveen KV, Dash M. Yoga reduces symptoms of distress in tsunami
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+ survivors in the Andaman Islands. Evid base Compl Alternative Med 2007;4.
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+ p 503e9.
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+ [15] Frewen PA, Evans EM, Maraj N, Dozois DJA, Partridge K. Letting go: mind-
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+ fulness and negative automatic thinking. Cognit Ther Res 2008;32. p 758e74.
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+ [16] Raub JA. Psychophysiologic effects of Hatha yoga on musculoskeletal and
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+ cardiopulmonary function: a literature review. J Alternative Compl Med
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+ 2002;8. p 797e812.
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+ [17] Jiang Q, Li A, Zhang X. Research on the effect of yoga on the lgG level of college
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+ students. J Mianynag Norm Univ 2009;5.
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+ [18] Rao RM, Nagendra HR, Raghuram N, Vinay C, Chandrashekara S, Gopinath KS,
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+ et al. Influence of yoga on mood states, distress, quality of life and immune
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+ outcomes in early stage breast cancer patients undergoing surgery. Int J Yoga
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+ 2008;1. p 11e20.
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+ [19] Epel E, Daubenmier J, Moskowitz JT, Folkman S, Blackburn E. Can meditation
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+ slow rate of cellular aging? Cognitive stress, mindfulness, and telomeres. Ann
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+ N Y Acad Sci 2009;1172. p 34e53.
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+ [20] Khalsa SBS. Treatment of chronic insomnia with yoga: a preliminary study
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+ with
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+ sleep-wake
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+ diaries.
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+ Appl
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+ Psychophysiol
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+ Biofeedback
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+ 2004;29.
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+ p 269e78.
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+ [21] Selvamurthy W, Ray US, Hegde KS, Sharma RP. Physiological responses to cold
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+ (10C) in men after six months' practice of yoga exercises. Int J Biometeorol
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+ 1988;32. p 188e93.
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+ [22] Cramer H, Lauche R, Langhorst J, Dobos G. Yoga for depression: a systematic
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+ review and meta-analysis. Depress Anxiety 2013;30. p 1068e83.
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+ [23] Müller FM, Friedrich M. Upanishads : the holy spirit of Vedas : earliest phil-
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+ osophical compositions also known as Vedanta. Vijay Goel; 2007.
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+ [24] Swami SP. The Bhagavad Gita, vol. 19. Books Abroad; 1945. p. 150.
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+ [25] Iyengar BKS. Light on the Yoga Su
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+ ̄
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+ tras of Patan
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+ e
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+ jali. Harper Collins; 1996.
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+ [26] Taimni IK, Iqbal K, Patan
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+ jali. The science of yoga : the yoga sutras of Patanjali.
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+ Theosophical Publishing House; 1999.
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+ [27] Satyananda Saraswati S. Four chapters on freedom : commentary on Yoga
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+ sutras of Patanjali. Yoga Publications Trust; 2002.
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+ [28] Gharote ML, Devnath P, Jha VK. S
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+ active 17th century. India):
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+ Hatharatna
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+ . Lonavala Yoga Institute; 2002.
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+ [29] Muktibodhananda SS, Satyananda SS. Hatha yoga Pradipika. Bihar, Yoga
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+ Publications Trust; 1998.
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+ [30] Niranjanananda Saraswati S. Gheranda Samhita. Bihar, Yoga Publications
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+ Trust; 2012.
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+ [31] Brahmachari Dhirendra. Yogic suksma vyayasama. Illustrated. Indian Book
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+ Company; 1975.
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+ [32] Lawshe CH. A Quantitative approach to content validity. Person Psychol
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+ 1975;28. p 563e75.
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+ [33] Harris JA. On the calculation of intra-class and inter-class coefficients of cor-
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+ relation from class moments when the number of possible combinations is
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+ large. Biometrika 1913;9. p 446e72.
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+ [34] Kakde N, Metri KG, Varambally S, Nagaratna R, Nagendra HR. Development
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+ and validation of a yoga module for Parkinson disease. J Compl Integr Med
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+ 2017;14.
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+ [35] Varambally S, Varambally P, Thirthalli J, Basavaraddi I, Gangadhar B,
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+ Hariprasad V. Designing, validation and feasibility of a yoga-based interven-
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+ tion for elderly. Indian J Psychiatr 2013;55. p 3442.
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+ [36] Li AW, Goldsmith CAW. The effects of yoga on anxiety and stress. Altern Med
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+ Rev 2012;17. p 21e35.
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+ R. Balakrishnan et al. / Journal of Ayurveda and Integrative Medicine xxx (2018) 1e4
404
+ 4
405
+ Please cite this article in press as: Balakrishnan R, et al., Design and validation of Integrated Yoga Therapy module for Antarctic expeditioners,
406
+ J Ayurveda Integr Med (2018), https://doi.org/10.1016/j.jaim.2017.11.005
subfolder_0/Development of a Trans-disciplinary Intervention Module for Adolescent Girls on Self-awareness.txt ADDED
@@ -0,0 +1,643 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Journal of Clinical and Diagnostic Research. 2017 Aug, Vol-11(8): VC07-VC10
2
+ 7
3
+ DOI: 10.7860/JCDR/2017/25765.10462
4
+ Original Article
5
+ Psychiatry/Mental
6
+ Health Section
7
+ Development of a Trans-disciplinary
8
+ Intervention Module for Adolescent
9
+ Girls on Self-awareness
10
+ Jasmine Mary John1, Janardhan Navneetham2, H R Nagendra3
11
+ Keywords: Adolescence, Females, Mental health promotion
12
+ ABSTRACT
13
+ Introduction: Mental health promotion among adolescents
14
+ has been a key area of intervention for professionals working
15
+ with children and adolescents. The opinions of experts in the
16
+ field of mental health have taken to frame a trans-disciplinary
17
+ intervention for adolescent girls on self awareness.
18
+ Aim: To discuss the development and validation of a structured
19
+ intervention by combining the knowledge from different
20
+ disciplines in helping adolescents enhancing self awareness.
21
+ Materials and Methods: Both qualitative and quantitative
22
+ methodologies were followed for the development and validation
23
+ of the module. First phase of the development of intervention
24
+ module was the framing of intervention module after conducting
25
+ in-depth interviews with experts in both mental health and yoga
26
+ fields. Six experts each from mental health and yoga field were
27
+ chosen for interview through convenient sampling. Validated
28
+ interview guides were used for the process. The framed
29
+ intervention module was given to six mental health experts
30
+ and six yoga experts for content validation. The experts rated
31
+ the usefulness of the intervention on a scale 0-4 (4=extremely
32
+ helpful).
33
+ Results: The themes derived in the interviews were importance
34
+ of self awareness, autonomy of self, physical level of self
35
+ understanding, self regulation of emotions and self monitoring.
36
+ The interviews were consolidated to frame the intervention
37
+ module consisting of eight sessions having two parts in each
38
+ session. Part one of each session is activities and interactions
39
+ on mental health and part two is guided instructions for body
40
+ focused meditation. Sessions were finalized with rating and
41
+ suggestions from the experts. The final version of the module
42
+ was pilot tested and had found to have enhanced self awareness
43
+ among adolescent girls.
44
+ Conclusion: Integration of multiple disciplines brought in novel
45
+ perspectives in intervention.
46
+ INTRODUCTION
47
+ Adolescence is a developmental period with many major internal and
48
+ external changes. Developmental challenges during adolescence
49
+ includes increased need for independence, evolving sexuality,
50
+ consolidating advanced cognitive abilities, negotiating changing
51
+ relationships in family, peers and broader social connections [1].
52
+ This paper discusses the development of a structured intervention
53
+ in combining the knowledge from different disciplines in helping
54
+ adolescents enhancing self awareness. The opinions of experts in
55
+ the field of mental health and yoga were sought to frame a trans-
56
+ disciplinary intervention for adolescent girls on self awareness.
57
+ Interventions aimed at adolescent population in Indian context
58
+ majorly include adolescent health education, sexual and
59
+ reproductive health, sexuality and sexual abstinence etc., [2]. Life
60
+ skills education programmes and resilient training have brought in
61
+ significant changes in the self-esteem, motivation and self-efficacy
62
+ of adolescents [3].
63
+ The concept of self awareness has higher meanings in transcendental
64
+ terms but for an adolescent who is going through the developmental
65
+ stage; it is about knowing about the physical changes in oneself
66
+ and understanding where their thoughts and emotions take them.
67
+ Studies on awareness in adolescents had majorly looked into their
68
+ knowledge about the physical changes [4,5]. Self as a construct
69
+ in an individual is developed in relation with their interaction with
70
+ others in the society. Recent understanding of self could be seen
71
+ as the accumulation of experiences one gains by the continuous
72
+ interaction with the environment [6].
73
+ Children could safely practice meditation and simple breathing
74
+ exercises as long as the breath is never held. Children trained in
75
+ these techniques are better able to manage emotional upsets and
76
+ cope with stressful events [7]. A study recommended carefully
77
+ constructed research to enhance understanding of sitting meditation
78
+ and its future use as an effective treatment modality among younger
79
+ population [8]. Body focused techniques help in understanding the
80
+ subtle changes of physical body frame [9] and subjective features of
81
+ internal body responses [10]. Although self awareness and physical
82
+ changes of adolescence has been addressed in many of these
83
+ studies, we couldn’t find any intervention modules with combined
84
+ modalities like knowledge, awareness relaxation, breathing exercises
85
+ or meditation.
86
+ The current research was carried out between the months of
87
+ February, 2015 to October, 2015 in Bengaluru, Karnataka, India,
88
+ with the aim of developing a trans-disciplinary intervention module
89
+ for adolescent girls on self awareness.
90
+ MATERIALS AND METHODS
91
+ The development of the module was carried out in two phases.
92
+ The Phase 1 was the consolidation of ideas and techniques into
93
+ framing the intervention module through literature reviews and in-
94
+ depth interviews with experts in the field. Interview guides were
95
+ prepared through literature review [10-12]. Separate probes were
96
+ framed for mental health experts and yoga professionals and
97
+ validated. In-depth interviews were conducted among six mental
98
+ health experts and six yoga practitioners to know the preferences
99
+ of the professionals in aspects of designing the intervention like the
100
+ structure and content of intervention module. Mental health experts
101
+ included psychiatric social workers, clinical psychologists and
102
+ psychiatrists who had knowledge and experience in child mental
103
+ health. All of the experts were professors in the respective fields. Six
104
+ mental health experts from three different institutions were chosen
105
+ for the in-depth interview. Yoga professionals were those experts in
106
+ Jasmine Mary John et al., Development of a Trans-Disciplinary Intervention Module for Adolescent Girls on Self-Awareness
107
+ www.jcdr.net
108
+ Journal of Clinical and Diagnostic Research. 2017 Aug, Vol-11(8): VC07-VC10
109
+ 8
110
+ yoga and meditation who were professors and practitioners in yoga
111
+ education. Experts for the interview were selected by convenient
112
+ sampling method. Researcher personally contacted the experts
113
+ and interviews were conducted at their offices. The interviews were
114
+ later transcribed and themes were identified. Thematic analysis
115
+ was carried out to categorize the commonly accepted themes from
116
+ the interview. Intervention module was prepared from the topics
117
+ discussed and themes derived.
118
+ Phase 2 was a quantitative phase wherein the validation of the
119
+ framed module was done quantitatively. Six experts from each field
120
+ who were not part of the interview were contacted personally by
121
+ researcher for validation. Out of the six experts in mental health field,
122
+ two were psychiatric social workers, two were clinical psychologists
123
+ and two were psychiatrists; all working as professors and assistant
124
+ professors. All the six experts in yoga were having Doctoral degree
125
+ in yoga.
126
+ Ethical consideration: Prior permission was taken from each of the
127
+ experts for in-depth interviews and validation. Interviews were done
128
+ by researcher by visiting their offices with prior appointment. The
129
+ objectives of the interview were explained and informed consent
130
+ was taken from each of them. Consent for audio recording was
131
+ sought for and done for all who agreed for. Confidentiality maintained
132
+ while transcribing the interviews. The research had received ethical
133
+ clearance from Institute Ethical Committee, National Institute of
134
+ Mental Health and Neuro Sciences, Bengaluru, Karnataka, India.
135
+ RESULTS
136
+ Phase 1
137
+ In-depth Interview
138
+ The main theme derived was the importance of self awareness.
139
+ There were four sub themes emerged from the interview. Some
140
+ of the voices corresponding to the theme and sub themes are
141
+ discussed below.
142
+ Main theme: Importance of self-awareness
143
+ Most of the experts had given their opinion on the importance of
144
+ self awareness.
145
+ “Awareness of what they are good at; what they are not good at;
146
+ what their strengths are; weaknesses are; those things.”(MH 4)
147
+ “A holistic approach is needed to enhance awareness in the girl.
148
+ (MH 5)
149
+ With better awareness of oneself, they would gain confidence to
150
+ face and deal with day to day issues in a better way. The yoga
151
+ practitioners opined the need of clearly demarcating the self
152
+ awareness in adolescent period from that of older people.
153
+ Sub themes
154
+ 1. Autonomy of self: Experts viewed that seeking autonomy is a
155
+ prime factor during adolescence, and intervention on self awareness
156
+ helps in the achievement of autonomy.
157
+ “..so as part of the development itself during that phase, their style
158
+ of functioning was of seeking freedom and also they do not want to
159
+ get dependant on the parents.” (MH 1)
160
+ Experts shared that though dependence on peers is seen in
161
+ adolescents, they want to experience their freedom and hence the
162
+ responsibility of understanding about self can be given to a growing
163
+ individual.
164
+ 2. Physical level of self understanding: The need for physical
165
+ level of understanding for adolescent was enquired into.
166
+ Mental Health
167
+ intervention
168
+ sessions
169
+ Scoring (0-4) (Number of
170
+ experts)
171
+ n (%) of
172
+ experts rat­
173
+ ing ≥2
174
+ Content
175
+ Validity
176
+ Ratio
177
+ MH session 1
178
+ 0 (0)
179
+ 1 (1)
180
+ 2 (1)
181
+ 3 (4)
182
+ 4 (0)
183
+ 5 (83.33)
184
+ 0.6
185
+ MH session 2
186
+ 0 (0)
187
+ 1 (0)
188
+ 2 (1)
189
+ 3 (3)
190
+ 4 (2)
191
+ 6 (100)
192
+ 1.0
193
+ MH session 3
194
+ 0 (0)
195
+ 1 (0)
196
+ 2 (0)
197
+ 3 (4)
198
+ 4 (2)
199
+ 6 (100)
200
+ 1.0
201
+ MH session 4
202
+ 0 (0)
203
+ 1 (0)
204
+ 2 (0)
205
+ 3 (3)
206
+ 4 (3)
207
+ 6 (100)
208
+ 1.0
209
+ MH session 5
210
+ 0 (0)
211
+ 1 (0)
212
+ 2 (1)
213
+ 3 (3)
214
+ 4 (2)
215
+ 6 (100)
216
+ 1.0
217
+ MH session 6
218
+ 0 (0)
219
+ 1 (0)
220
+ 2 (0)
221
+ 3 (2)
222
+ 4 (4)
223
+ 6 (100)
224
+ 1.0
225
+ MH session 7
226
+ 0 (0)
227
+ 1 (0)
228
+ 2 (0)
229
+ 3 (3)
230
+ 4 (3)
231
+ 6 (100)
232
+ 1.0
233
+ MH session 8
234
+ 0 (0)
235
+ 1 (0)
236
+ 2 (0)
237
+ 3 (4)
238
+ 4 (2)
239
+ 6 (100)
240
+ 1.0
241
+ [Table/Fig-2]: Content validity ratio of mental health intervention sessions.
242
+ [Table/Fig-1]: Session wise details of the module: Each session has introduction
243
+ and conclusion activities ranging from 10 to 15 minutes.
244
+ Part 1:
245
+ Part 2:
246
+ Session 1
247
+ Mental Health Intervention
248
+ Introductory session:
249
+ Ice breaking and knowing
250
+ oneself.
251
+ Duration: 25 minutes
252
+ Body Focused Meditation
253
+ Sitting
254
+ posture
255
+ was
256
+ described;
257
+ Breathing awareness and conclusion
258
+ with wareness of outer space
259
+ Duration of part 2: 5 minutes
260
+ Session 2
261
+ Self; “I, me and myself”.
262
+ Session on knowing about
263
+ oneself.
264
+ Duration: 30 minutes
265
+ Berating awareness and concluding
266
+ with awareness of outer space
267
+ Duration was 5 minutes
268
+ Session 3
269
+ Multiple selves, one’s
270
+ functioning in different
271
+ social roles.
272
+ Duration: 28 minutes
273
+ Detailing of breathing-inhaling and
274
+ exhaling with awareness of physical
275
+ body part, subtle movement of body
276
+ while breathing etc. Closure with
277
+ awareness of outer space
278
+ Duration was 7 minutes
279
+ Session 4
280
+ Session on physical
281
+ body awareness. Body
282
+ mapping.
283
+ Duration: 25 minutes
284
+ Sitting descriptions and brief outer
285
+ awareness, detailing of breath with
286
+ physical awareness, awareness of
287
+ body part on a bottom to top manner
288
+ and closure with awareness of outer
289
+ space.
290
+ From this session onwards, duration
291
+ of instructions was 10 minutes
292
+ Session 5
293
+ Emotions- identification
294
+ and regulation.
295
+ Duration: 25 minutes
296
+ Brief sitting description with more
297
+ autonomy for them to get settle.
298
+ Awareness on body parts; to do on
299
+ their own with freedom given to choose
300
+ between top to bottom or bottom
301
+ to top approach, reminding of any
302
+ incident where emotions experienced
303
+ with increased awareness about body
304
+ parts feelings in its memory.
305
+ Long and slow breathing instructions.
306
+ (to help them come out of the changes
307
+ in body created by memory); Brief
308
+ positive suggestions and closure with
309
+ outer awareness.
310
+ Duration was 10 minutes
311
+ Session 6
312
+ Identifying emotional
313
+ responses during
314
+ interpersonal situations
315
+ and an activity to letting
316
+ of oneself (guided
317
+ instructions)
318
+ Duration: 25 minutes
319
+ Awareness on body parts; to do
320
+ on their own with freedom given to
321
+ choose between top to bottom or
322
+ bottom to top approach with focus on
323
+ specific sensations which they would
324
+ be aware of and positive suggestions
325
+ on
326
+ confidence
327
+ and
328
+ experiencing
329
+ relaxation.
330
+ Duration was 10 minutes
331
+ Session 7
332
+ 3 R’s: Reacting,
333
+ responding and
334
+ Responsible.
335
+ Duration: 25 minutes
336
+ Awareness on body parts; to do
337
+ on their own with freedom given to
338
+ choose between top to bottom or
339
+ bottom to top approach with focus on
340
+ specific sensations which they would
341
+ be aware of, positive suggestions
342
+ and confidence and future life and
343
+ experiencing relaxation.
344
+ Duration was 10 minutes
345
+ Session 8
346
+ Introducing the concept
347
+ of monitoring device and
348
+ conclusion.
349
+ Duration: 25 minutes
350
+ Sitting descriptions and brief outer
351
+ awareness Awareness on body parts;
352
+ to do on their own with freedom given
353
+ to choose between top to bottom or
354
+ bottom to top approach with focus on
355
+ specific sensations which they would
356
+ be aware of and positive suggestions
357
+ on
358
+ confidence
359
+ and
360
+ experiencing
361
+ relaxation.
362
+ Duration was 10 minutes
363
+ www.jcdr.net
364
+ Jasmine Mary John et al., Development of a Trans-Disciplinary Intervention Module for Adolescent Girls on Self-Awareness
365
+ Journal of Clinical and Diagnostic Research. 2017 Aug, Vol-11(8): VC07-VC10
366
+ 9
367
+ “they can be given guided instruction to focus on big to smaller
368
+ things..by starting with awareness of external reality, like listening to
369
+ the sounds..breath and then each part of the body..”(YP 4)
370
+ The use of physical body as a frame for focusing also was opined
371
+ by experts. The process helps one in reconstruction of one’s idea
372
+ about one’s physique.
373
+ 3. Self regulation of emotions: Majority of experts stated that the
374
+ emotional regulation can be a significant part in self awareness.
375
+ “ immediate emotional reactivity is something that they need to
376
+ examine in and learn to tone it down and delay it..” (MH 6)
377
+ They can cognitively understand the world, but the understanding
378
+ their own emotions and those with whom they interact with,
379
+ becomes difficult due to their age.
380
+ 4. Self-monitoring: Experts suggested encouraging self monitoring
381
+ of adolescent even after the intervention.
382
+ “..They can write it and discuss with someone if required. Recording
383
+ it and even discussing with peers under supervision helps them to
384
+ understand them better.” (YP 3)
385
+ Both mental health experts and yoga practitioners shared the view
386
+ of having self monitoring frameworks for continued understanding
387
+ of oneself.
388
+ The Module: After analysing the interviews and conducting further
389
+ discussions among the authors, the intervention module was framed
390
+ focusing on three aspects:
391
+ 1.
392
+ Knowledge of physical changes during adolescent period;
393
+ 2.
394
+ Knowledge about emotional fluctuations during adolescence;
395
+ 3.
396
+ A technique to enable them to understand and accepts these
397
+ changes.
398
+ The part I of the intervention addressed the first two aspects and
399
+ part II of the intervention addresses the third aspect. Thus the
400
+ intervention module had eight sessions with two parts in each
401
+ session. The methodology used in Part I was interaction, activity
402
+ and group based activities. Part II was activity based on body
403
+ focused meditation, in which, guided instructions were given to the
404
+ participants of the intervention.
405
+ [Table/Fig-1] detailed the intervention module which was
406
+ consolidated from the responses discussed and topics derived. The
407
+ intervention module has got eight sessions with two parts in each
408
+ session. Each session had an introductory discussion, followed
409
+ by the main section of intervention (which had two parts-Mental
410
+ Health Intervention and Body Focused Meditation) and a conclusion
411
+ discussion. Each session of the intervention module was timed for
412
+ 45-50 minutes. The introductory discussion was for less than ten
413
+ minutes of duration. The methodology used in Part I of the main
414
+ section was that of interaction, individual activity and group based
415
+ activities. Part II had activity based on body focused meditation, in
416
+ which, guided instructions are given and it has to be followed by the
417
+ students. It is prepared in such a way that the beginning sessions,
418
+ is of shorter duration, and the time increases for the later sessions.
419
+ The concluding interaction stretches up to ten minutes wherein
420
+ participants share about their experiences while in the session.
421
+ Phase 2
422
+ Validation of the intervention module: Part 1 of each session
423
+ which had mental health interventions were validated by the
424
+ mental health experts and Part 2 which has guided instructions
425
+ for body focused meditation were validated by the yoga experts.
426
+ Experts were requested to rate the usefulness of the activities in
427
+ each session in a five point scale ranging from 0 to 4 wherein, ‘0’
428
+ signifies the activities in that session ‘not helpful’ and ‘4’ signifies
429
+ extremely helpful. Activities that were rated with a score (based on
430
+ their knowledge and experience in the field) of two and above by
431
+ majority of experts were retained for final module.
432
+ [Table/Fig-2] gives the validation score for Part 1 of the intervention
433
+ module, that is, the Mental Health Intervention Session. Practices
434
+ that received a score of 2 or more from 80% of the experts were
435
+ retained in the final module. Content validity ratio for majority of the
436
+ sessions was 1.0 which indicated high validity and hence used for
437
+ the main intervention. [Table/Fig-3] showed the validation score
438
+ for Part 2 of the intervention module, that is, the Body Focused
439
+ Meditation part. Practices that received a score of 2 or more from
440
+ 80% of the experts were retained in the final module. All sessions
441
+ had a content validity ratio of 1.0 which indicated high validity of the
442
+ intervention as rated by the experts.
443
+ Pilot study was done among 18 adolescent girls by providing the
444
+ intervention and assessing their self awareness before and after the
445
+ intervention. The intervention was provided by the researcher for
446
+ eight days (weekly two sessions) for a period of four weeks during
447
+ September 2016. The scale used was the Life Skills Assessment
448
+ Scale (Vranda, 2007), the subsection of self awareness. The data
449
+ was normally distributed and ANOVA was conducted to find out the
450
+ changes. The score at baseline was 31.39 (SD=4.975) and at the
451
+ post intervention was 39.85 (SD=4.590) which indicated significant
452
+ change at 0.05 level in the perception of self awareness among
453
+ adolescent girls.
454
+ DISCUSSION
455
+ In this study, we attempted to develop an intervention module for
456
+ adolescent girls with trans-disciplinary approach by combining
457
+ mental health intervention for adolescents with body focused
458
+ meditation techniques. The module was developed after in-depth
459
+ interviews with experts from both the fields and further validated
460
+ by another set of experts in both fields. The topics derived out of
461
+ interviews were importance of self awareness, autonomy of self,
462
+ physical level of understanding, self regulation of emotions and self-
463
+ monitoring. Experts viewed the need for understanding of physical
464
+ level is crucial for healthy development and that can happen in the
465
+ beginning of puberty itself. Mental health experts suggested the
466
+ inclusion of the concept of brain changes and the related changes
467
+ in behaviour and emotional aspects in adolescent girls for the
468
+ intervention. Knowing about self in different situations also was
469
+ stressed on. Aspects of autonomy were given importance by all in
470
+ the mental health field.
471
+ The CVR scores show that majority of the experts rated each
472
+ session as extremely helpful and hence suggested to retain sessions
473
+ with minor changes. Earlier studies have used similar methodology
474
+ in validating yoga interventions for persons with different mental
475
+ illnesses and the content validity scores correspond to the current
476
+ study [11,12]. Future directions include the testing of the module
477
+ among adolescent population and assessing the efficacy of this
478
+ module in enhancing self awareness. The module could be used in
479
+ the community for promotional mental health interventions among
480
+ adolescent girls.
481
+ The pilot study conducted was able to demonstrate change in the
482
+ variable of self awareness due to the intervention. This marked
483
+ the need of optimizing the intervention and providing it for a larger
484
+ population.
485
+ [Table/Fig-3]: Content validity ratio of body focused meditation sessions.
486
+ Body Focused
487
+ Meditation ses­
488
+ sions
489
+ Scoring (0-4) (Number of
490
+ experts)
491
+ n (%) of
492
+ experts
493
+ rating ≥2
494
+ Content
495
+ Validity
496
+ Ratio
497
+ BFM session 1
498
+ 0 (0)
499
+ 1 (0)
500
+ 2 (0)
501
+ 3 (2)
502
+ 4 (4)
503
+ 6 (100)
504
+ 1.0
505
+ BFM session 2
506
+ 0 (0)
507
+ 1 (0)
508
+ 2 (0)
509
+ 3 (2)
510
+ 4 (4)
511
+ 6 (100)
512
+ 1.0
513
+ BFM session 3
514
+ 0 (0)
515
+ 1 (0)
516
+ 2 (0)
517
+ 3 (2)
518
+ 4 (4)
519
+ 6 (100)
520
+ 1.0
521
+ BFM session 4
522
+ 0 (0)
523
+ 1 (0)
524
+ 2 (0)
525
+ 3 (1)
526
+ 4 (5)
527
+ 6 (100)
528
+ 1.0
529
+ BFM session 5
530
+ 0 (0)
531
+ 1 (0)
532
+ 2 (0)
533
+ 3 (2)
534
+ 4 (4)
535
+ 6 (100)
536
+ 1.0
537
+ BFM session 6
538
+ 0 (0)
539
+ 1 (0)
540
+ 2 (0)
541
+ 3 (3)
542
+ 4 (3)
543
+ 6 (100)
544
+ 1.0
545
+ BFM session 7
546
+ 0 (0)
547
+ 1 (0)
548
+ 2 (0)
549
+ 3 (2)
550
+ 4 (4)
551
+ 6 (100)
552
+ 1.0
553
+ BFM session 8
554
+ 0 (0)
555
+ 1 (0)
556
+ 2 (0)
557
+ 3 (2)
558
+ 4 (4)
559
+ 6 (100)
560
+ 1.0
561
+ Jasmine Mary John et al., Development of a Trans-Disciplinary Intervention Module for Adolescent Girls on Self-Awareness
562
+ www.jcdr.net
563
+ Journal of Clinical and Diagnostic Research. 2017 Aug, Vol-11(8): VC07-VC10
564
+ 10
565
+ 10
566
+ LIMITATION
567
+ Experts were contacted only once for the validation of the
568
+ intervention module. They were not revisited for further opinion after
569
+ incorporating the suggestions given. Pilot testing was done with
570
+ single variable; other related variables were to be studied for further
571
+ evidence.
572
+ CONCLUSION
573
+ The intervention module provided evidence multiple disciplinary
574
+ approaches for the promotion of mental health among adolescent
575
+ girls. Mental health professionals working with children could be
576
+ trained for implementing this intervention among adolescent girls.
577
+ Acknowledgements
578
+ The research was carried out by the funding from Indian Council
579
+ of Medical Research (ICMR) as Junior Research Fellowship (JRF)
580
+ 2011 batch.
581
+ REFERENCES
582
+ Cameron G, Karabanow J. The nature and effectiveness of program models for
583
+ [1]
584
+ adolescents at risk of entering the formal child protection system. 2003. pp. 443-74.
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+ Jejeebhoy SJ. Adolescent sexual and reproductive behaviour: a review of the
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+ [2]
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+ evidence from India. Social Science and Medicine (1982). 1998;46(10):1275-
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+ 90.
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+ Barry MM, Clarke AM, Jenkins R, Patel V. A systematic review of the effectiveness
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+ [3]
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+ of mental health promotion interventions for young people in low and middle
592
+ income countries. BMC Public Health. 2013;13(1):835.
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+ Jain RB, Kumar A, Khanna P
594
+ . Assessment of self-awareness among
595
+ [4]
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+ rural adolescents: A cross-sectional study. Indian J Endocrinol Metab.
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+ 2013;17(Suppl1):S367–S372.
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+ Kumar D, Goel NK, Puri S, Pathak R, Singh Sarpal S, Gupta S, et al. Menstrual
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+ pattern among unmarried women from Northern India. J Clin Diagn Res.
601
+ 2013;7(9):1926-29.
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+ Gjersoe NL, Hood B. Changing children's understanding of the brain: A
603
+ [6]
604
+ longitudinal study of the royal institution christmas lectures as a measure of
605
+ public engagement. PLoS ONE. 2013;8(11):e80928.
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+ Kaley-Isley LC, Peterson J, Fischer C, Peterson E. Yoga as a complementary
607
+ [7]
608
+ therapy for children and adolescents: a guide for clinicians. Psychiatry (Edgmont
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+ (Pa: Township). 2010;7(8):20-32.
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+
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+ [8]
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+ Black DS, Milam J, Sussman S. Sitting-meditation interventions among youth: a
613
+ review of treatment efficacy. Pediatrics. 2009;124(3):e532-41.
614
+ Sperduti M, Martinelli P
615
+ , Piolino P
616
+ . A neurocognitive model of meditation based
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+ [9]
618
+ on activation likelihood estimation (ALE) meta-analysis. Consciousness and
619
+ Cognition. 2012;21(1):269-76.
620
+ Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring
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+ [10]
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+ in meditation. Trends Cogn Sci. 2008;12(4):163-69.
623
+ Bhat S, Varambally S, Karmani S, Gangadhar BN. International Review of
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+ [11]
625
+ Psychiatry Designing and validation of a yoga-based intervention for obsessive
626
+ compulsive disorder. Int Rev Psychiatry. 2016;28(3):327-33.
627
+ Govindaraj R, Varambally S, Sharma M. International Review of Psychiatry
628
+ [12]
629
+ Designing and validation of a yoga-based intervention for schizophrenia.
630
+ 2016;0261(October):2-6.
631
+ PARTICULARS OF CONTRIBUTORS:
632
+ 1. PhD Scholar, Department of Psychiatric Social Work, NIMHANS, Bengaluru, Karnataka, India.
633
+ 2. Associate Professor, Department of Psychiatric Social Work, NIMHANS, Bengaluru, Karnataka, India.
634
+ 3. Chancellor, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.
635
+ NAME, ADDRESS, E-MAIL ID OF THE CORRESPONDING AUTHOR:
636
+ Dr. Jasmine Mary John,
637
+ PhD Scholar, Department of Psychiatric Social Work, NIMHANS, Bengaluru-560029, Karnataka, India.
638
+ E-mail: [email protected]
639
+ Financial OR OTHER COMPETING INTERESTS: None.
640
+ Date of Submission: Dec 01, 2016
641
+ Date of Peer Review: Mar 16, 2017
642
+ Date of Acceptance: Jul 13, 2017
643
+ Date of Publishing: Aug 01, 2017
subfolder_0/Diabetic yoga protocol improves glycemic, anthropometric and lipid levels in high risk individuals for diabetes a randomized controlled trial from Northern India..txt ADDED
@@ -0,0 +1,1072 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
2
+ https://doi.org/10.1186/s13098-021-00761-1
3
+ SHORT REPORT
4
+ Diabetic yoga protocol improves glycemic,
5
+ anthropometric and lipid levels in high
6
+ risk individuals for diabetes: a randomized
7
+ controlled trial from Northern India
8
+ Navneet Kaur1,4, Vijaya Majumdar2, Raghuram Nagarathna2*, Neeru Malik3, Akshay Anand4* and
9
+ Hongasandra Ramarao Nagendra2 
10
+ Abstract 
11
+ Purpose:  To study the effectiveness of diabetic yoga protocol (DYP) against management of cardiovascular risk pro-
12
+ file in a high-risk community for diabetes, from Chandigarh, India.
13
+ Methods:  The study was a randomized controlled trial, conducted as a sub study of the Pan India trial Niyantrita
14
+ Madhumeha Bharath (NMB). The cohort was identified through the Indian Diabetes Risk Scoring (IDRS) (≥ 60) and a
15
+ total of 184 individuals were randomized into intervention (n = 91) and control groups (n = 93). The DYP group under-
16
+ went the specific DYP training whereas the control group followed their daily regimen. The study outcomes included
17
+ changes in glycemic and lipid profile. Analysis was done under intent-to-treat principle.
18
+ Results:  The 3 months DYP practice showed diverse results showing glycemic and lipid profile of the high risk indi-
19
+ viduals. Three months of DYP intervention was found to significantly reduce the levels of post-prandial glucose levels
20
+ (p = 0.035) and LDL-c levels (p = 0.014) and waist circumference (P = 0.001).
21
+ Conclusion:  The findings indicate that the DYP intervention could improve the metabolic status of the high-dia-
22
+ betes-risk individuals with respect to their glucose tolerance and lipid levels, partially explained by the reduction in
23
+ abdominal obesity. The study highlights the potential role of yoga intervention in real time improvement of cardio-
24
+ vascular profile in a high diabetes risk cohort.
25
+ Trial registration: CTRI, CTRI/2018/03/012804. Registered 01 March 2018—Retrospectively registered, http://​
26
+ www.​
27
+ ctri.​
28
+ nic.​
29
+ in/CTRI/2018/03/012804.
30
+ Keywords:  Diabetic yoga protocol, Indian diabetes risk score, Glycated hemoglobin, Diabetes, Prediabetes
31
+ © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
32
+ permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
33
+ original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
34
+ other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line
35
+ to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
36
+ regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
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+ licence, visit http://​
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+ ses/​
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+ by/4.​
45
+ 0/. The Creative Commons Public Domain Dedication waiver (http://​
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+ 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
55
+ Introduction
56
+ The rise of diabetes in the developing world poses a
57
+ threat to meager health budgets. Owing to the strong
58
+ association between various morbidity and mortality
59
+ outcomes as complications of this dreaded disease, early
60
+ detection of diabetes risk through non-invasive param-
61
+ eters is a primary requisite. Observational studies show
62
+ that the risk reduction for diabetes can be decreased by
63
+ 58% or 63–65% if risk factors could be controlled [1, 2].
64
+ Open Access
65
+ Diabetology &
66
+ Metabolic Syndrome
67
68
+ 2 Division of Life Sciences, Swami Vivekananda Yoga Anusandhana
69
+ Samsathana, Bengaluru, Karnataka 560106, India
70
+ 4 Department of Neurology, Neuroscience Research Lab, Postgraduate
71
+ Institute of Medical Education and Research, Chandigarh 160012, India
72
+ Full list of author information is available at the end of the article
73
+ Page 2 of 10
74
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
75
+ Many argue that such experimental strategies for the
76
+ possible halting of conversion of prediabetes into diabe-
77
+ tes must continue to include pharmacological interven-
78
+ tions even though the rates have not been compared
79
+ [3]. Identification of individuals at increased risk for the
80
+ disease with invasive measurements of fasting and post
81
+ challenge (postprandial) blood glucose are costly and
82
+ time consuming. Hence, it has been advocated that the
83
+ realistic prevention of diabetes should identify high-risk
84
+ subjects with the use of the non-invasive risk scores [4].
85
+ Such studies should also target subjects with normogly-
86
+ cemia and prevent their progression to poor glycemic
87
+ status [4].
88
+ Yoga plays a promising role in minimizing the risk of
89
+ Diabetes for high-risk individuals with prediabetes [5, 6].
90
+ It reduces body weight, glucose, and lipid levels, though,
91
+ most of these studies comply with the guidelines of ran-
92
+ domized controlled trials adhered to the CONSORT
93
+ statements [7–11] whereas majority of studies have not
94
+ reported as per CONSORT statements [12–15]. Several
95
+ review of published studies, in people with diabetes and
96
+ prediabetes, have concluded that the practice of yoga
97
+ may reduce insulin resistance and related cardiovascular
98
+ disease (CVD) risk factors and improve clinical outcomes
99
+ [16]. Specifically, reports suggest that a yoga-based life-
100
+ style intervention reduces body weight, glucose and lipid
101
+ levels that should reduce diabetes risk. Keeping in view
102
+ the high transition rates of diabetes in India, we selected
103
+ a high-risk cohort from Chandigarh, one of the most
104
+ affluent Union Territories of India with highest reported
105
+ prevalence of diabetes in order to establish the efficacy of
106
+ yoga to alleviate the cardiovascular disease. Indian Dia-
107
+ betes Risk Score (IDRS), specific for Indian ethnicity a
108
+ validated tool was used for identification of the high-risk
109
+ population [17]. We developed a national consensus ‘Dia-
110
+ betes Yoga protocol’ based on published reports and clas-
111
+ sical literature with an aim to stimulate weight reduction
112
+ by combination of postures and meditation techniques
113
+ [18, 19]. Additionally, cardiometabolic risk reduction has
114
+ also been recognized as one of the potential outcomes
115
+ of yoga-based interventions [20]. Yoga has been shown
116
+ to be regulating the risk parameters of diabetes, waist
117
+ circumference (WC), body mass index (BMI), oxida-
118
+ tive stress, fasting blood sugar (FBS) and systolic blood
119
+ pressure (SBP) respectively [21]. Hence, in this study we
120
+ tested the efficacy of diabetic yoga protocol (DYP) on
121
+ alleviation of glycemic and lipid imbalances in individu-
122
+ als at high risk of diabetes.
123
+ Materials and methods
124
+ Study population
125
+ Under the multi-region survey of Niyantarita Maduh-
126
+ meha Bharat (NMB-2017) a door-to-door screening
127
+ was carried out for the identification of high risk indi-
128
+ viduals among the population of Chandigarh (U.T) and
129
+ Panchkula (District in Haryana state) on the basis of
130
+ Indian Diabetes Risk Score (IDRS). The data collection
131
+ was carried out by well trained yoga volunteers for dia-
132
+ betes management (YVDMs). Written informed con-
133
+ sents were taken from every subject during door to door
134
+ screening as well as at the time of registration. All the
135
+ experimental protocol, methods and procedures were
136
+ approved by Ethics committee of Indian Yoga Asso-
137
+ ciation (IYA) (ID: RES/IEC-IYA/001). All experiments
138
+ methods and procedures were carried out in accordance
139
+ with relevant guidelines and regulations of ethics com-
140
+ mittee. The study was registered at clinical trial registry
141
+ of India, CTRI/2018/03/012804 (dated: 01/03/2018).
142
+ Study design
143
+ The present study is the two-armed randomized con-
144
+ trolled trial conducted in the population of Chandigarh
145
+ and Panchkula regions of northern India. Indian Dia-
146
+ betes Risk Score (IDRS) was used for detection of high
147
+ risk (≥ 60 score) individuals from the study. Self-declared
148
+ diabetics and low (< 30  score) and moderate [between
149
+ 30–50 score] risk individuals were excluded from the
150
+ study. As evident from the flow of patients presented in
151
+ the flowchart, out of 1214 eligible subjects, there was
152
+ approximately 50% loss of sample data due to error in the
153
+ sampling. Further out of 564, we had to exclude as they
154
+ were self-declared patients with diabetes and did not fur-
155
+ ther participate in the study. However, this led to final
156
+ participation of only 184 subjects in the study and alloca-
157
+ tion of these subjects diminishing the random selection
158
+ of the study cohort. A cohort of high diabetes-risk cohort
159
+ consisting of n = 184 participants was randomized into
160
+ the interventional and control groups (n = 91:93). After
161
+ excluding the dropouts from the study, based on CON-
162
+ SORT guidelines, the remaining subjects in the DYP and
163
+ control group were further assessed for selected anthro-
164
+ pometric, glycemic and lipid parameters. The interven-
165
+ tion group was given the Diabetic Yoga Protocol for three
166
+ months and control group continued with their daily rou-
167
+ tine activities. The detailed categorization of the samples
168
+ is shown in Fig. 1. The control group was waitlisted for
169
+ yoga.
170
+ Randomization
171
+ Simple randomization technique was used to allocate
172
+ participants into the intervention and the control groups.
173
+ An independent statistician generated a computer-gen-
174
+ erated random number sequence and the sequence was
175
+ given to an external staff who had no involvement in the
176
+ study procedures. The participants were allocated their
177
+ consecutive numbers, after baseline measurements.
178
+ Page 3 of 10
179
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
180
+
181
+ Fig. 1  Flowchart of study design. PCA ��principal component analysis, MIPCA multiple imputations with PCA
182
+ Page 4 of 10
183
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
184
+ Blinding of the participants was not possible due to the
185
+ nature of the intervention. However, the outcome asses-
186
+ sors were blinded.
187
+ Risk assessment
188
+ To identify the individuals at high-risk of diabetes, Indian
189
+ Diabetes Risk Score (IDRS) was administered as pro-
190
+ posed by Mohan et al. [22]. It consisted of two unmodi-
191
+ fiable (i.e. age, and family history) and two modifiable
192
+ (physical activity and waist circumference) risk factors
193
+ for diabetes, which can predict the level of risk for the
194
+ development of diabetes in the community. The IDRS
195
+ is one of the easily accessible and budget friendly ques-
196
+ tionnaire to be administered. The aggregate score of the
197
+ unmodifiable and modifiable risk used to probe the level
198
+ of risk among the population (i.e. High risk > 60, Moder-
199
+ ate risk-30–50, Low risk < 30).
200
+ Sample size
201
+ Sample size estimation for the main Pan India study
202
+ was focused for prediabetes subjects [23]. However, for
203
+ the present pilot scale study we calculated sample size
204
+ assuming a small effect size 0.3 [5] of DYP vs waitlist con-
205
+ trol 0.25, α = 0.80 as 180 (n = 90:90). Further, assuming
206
+ an attrition rate of 20%, the final sample size was n = 220.
207
+ Study outcomes
208
+ Changes in the glycemic and other metabolic variables
209
+ (anthropometric and lipid) over 3  months were docu-
210
+ mented. The fasting blood sample was withdrawn. For
211
+ glucose analysis, fasting samples for 10–12 h were taken
212
+ early in the morning for the estimation of FBS and after-
213
+ wards 75  g glucose was given to the participants. The
214
+ blood sampling was repeated after 2 h. for estimation of
215
+ OGTT.
216
+ Biochemical analysis
217
+ For the estimation of biochemical parameters viz. FBS
218
+ (Fasting Blood Sugar, Rxl-Max 500), OGTT (Oral Glu-
219
+ cose Tolerance Test), HbA1c (Bio-Rad D-10), Triglycer-
220
+ ides, Cholesterol, HDL, LDL, Chol/HDL ratio, HDL/LDL
221
+ ratio (Rxl-Max 500) and VLDL about 9 ml of blood was
222
+ drawn and analyzed by phlebotomist of Sisco Research
223
+ Laboratories (SRL) of Chandigarh. Anthropometric
224
+ measurements were also obtained (i.e. height, weight,
225
+ waist circumference) by trained researcher. The waist cir-
226
+ cumference (WC) was reported in centimeters. The BMI
227
+ was obtained by using the formula (weight in kg/height
228
+ (meter)2).
229
+ Interventions
230
+ The study protocol consisted of Diabetic Yoga Protocol
231
+ (DYP) approved by the Ministry of AYUSH and Quality
232
+ Council of India as shown in Table 1. This is the first pro-
233
+ tocol to be made specifically for the prediabetics and dia-
234
+ betics. The complete sequence of prayer, yogic postures,
235
+ breathing and meditative techniques, along with speci-
236
+ fied time, was shown in previously published paper [24].
237
+ The Yogic practices were performed for 3  months for
238
+ 60 min. Certified yoga instructors took the yoga classes
239
+ and they recorded regular attendance. Randomization
240
+ was done through a computer-generated list of random
241
+ numbers and allocation was concealed to the participants
242
+ until the completion of the baseline assessment.
243
+ Statistical analysis
244
+ For the analysis of data SPSS for Windows (version 22;
245
+ IBM  SPSS  Inc., Chicago IL) 0 and R statistical pack-
246
+ age were used. The normality of data was analyzed
247
+ using Kolmogorov–Smirnov test. The paired t-test was
248
+ used to estimate the Baseline and posttest differences
249
+ of DYP, and control group and the significant level was
250
+ set at ≤ 0.05. The trial outcomes were analyzed accord-
251
+ ing to the intention-to-treat principle; hence multiple
252
+ imputation was carried for the missing variables account-
253
+ ing for the loss to follow up. We used absolute change
254
+ (time and treatment interaction), to estimate interven-
255
+ tion effects refers to the difference in the outcome of
256
+ the intervention and control over different time-points
257
+ of assessment. Absolute change was determined as fol-
258
+ lows: absolute change = [(intervention group follow-
259
+ up) – (intervention group baseline)] – [(control group
260
+ follow-up) – (control group baseline)]. The percentage
261
+ change, also called the relative change was determined as
262
+ relative change = (absolute change / intervention group
263
+ baseline) × 100%. To evaluate the influence of miss-
264
+ ing data, we applied multiple imputations to the data
265
+ using missMDA R package (v1.13) based on the princi-
266
+ pal component analysis method [25] from the package,
267
+ using 5 components to reconstruct the data and over
268
+ 1000 imputed datasets. One-way multivariate analysis of
269
+ covariance (MANCOVA) was conducted to compare the
270
+ effects of the DYP with control group glycemic and meta-
271
+ bolic measures, while controlling for the age, gender and
272
+ baseline values of the covariates.
273
+ Results
274
+ Baseline characteristics
275
+ The data used in this study was collected in (NMB-
276
+ 2017) the northern region of India i.e. Chandigarh and
277
+ Panchkula. The age range of participants was 3–70
278
+ years; [mean age 48.51 (SD 10.08) years]with base-
279
+ line characteristics of the yoga and control groups as
280
+ shown in Table 2. Mean HbA1c of the high-risk cohort
281
+ was 5.64% (0.38), mean FBS was 97.13 mg/dl (SD
282
+ 11.10), and mean PPBS were 108.40 mg/dl (SD 28.79).
283
+ Page 5 of 10
284
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
285
+
286
+ Distributions of age and gender was similar between
287
+ the intervention and the control groups. The IDRS and
288
+ anthropometric values were also similarly distributed
289
+ between the groups. Overall, there was no significant
290
+ difference in the distribution of demographic, anthro-
291
+ pometric, or biochemical parameters between the DYP
292
+ and the control groups at the baseline.
293
+ When analyzed by multivariate analysis of covari-
294
+ ance (MANCOVA), adjusting for age, gender and status
295
+ of diabetes/prediabetes/normoglycemia, and baseline
296
+ values of the covariates, yoga intervention was found
297
+ to have significant influence on few cardinal param-
298
+ eters related to glycemic control (PPBS), and lipid con-
299
+ trol (LDL-C) as shown in Table 3. We also observed a
300
+ significant influence of DPP on waist circumference
301
+ reduction [relative changes, − 1.94%. Compared to the
302
+ control, DYP also resulted in significant reductions in
303
+ LDL-C and, − 0.16% and − 2.81%, for LDL-Cholesterol
304
+ and post-prandial blood glucose levels from baseline
305
+ to 3  months [absolute changes, − 0.18% and −  3.08%,
306
+ respectively and relative changes, − 0.16% and − 2.81%,
307
+ respectively].
308
+ Discussion
309
+ We examined the effect of Diabetic Yoga Protocol on
310
+ baseline and post (3 months) levels of HbA1c and other
311
+ glycemic (OGTT and FBS), Lipid (Total cholesterol, tri-
312
+ glycerides, HDL-c, LDL-c, and VLDL-c, CDL/HDL,
313
+ LDL/HDL) and anthropometric parameters (BMI). In the
314
+ present study, we show the efficacy of DYP in substantial
315
+ improvement in the waist circumference in a high-risk
316
+ diabetes population from Chandigarh (relative change of
317
+ 1.94 cm). We could also demonstrate a significant decline
318
+ in the worsening of post prandial glucose levels with yoga
319
+ intervention as compared to the wait-list control group
320
+ (relative change of 2.82  mg/ml). However, for LDL-c
321
+ levels, there were clinically significant improvements by
322
+ 0.16 units. Notably, over 3 months study duration there
323
+ was an overall increase in the levels of total cholesterol,
324
+ triglyceride and VLDL means in the study cohort, while
325
+ Table 1  Diabetic yoga protocol (DYP)
326
+ S. No.
327
+ Name of practice
328
+ Duration
329
+ (min)
330
+ 1
331
+ Starting prayer: Asatoma Sat Gamaya
332
+ 2
333
+ 2
334
+ Preparatory Sukshma Vyayamas and Shithililarna Practices
335
+ 1. Urdhavahastashvasan(Hand stretching breathing 3 rounds at 90°, 135° and 180o each)
336
+ 2. Kati-Shakti Vikasaka (3 rounds)
337
+ a) Forward and Backward Bending b) Twisting
338
+ 3. Sarvangapushti (3 rounds clockwise, 3 rounds anticlockwise)
339
+ 6
340
+ 3
341
+ Surya Namaskara (SN)
342
+ 10 step fast Surya Namaskara 6 rounds
343
+ 12 step slow Surya Namaskara 1 round
344
+ Modified version Chair SN 7 rounds
345
+ 9
346
+ 4
347
+ Asanas (1 min per Asana)
348
+ 1 Standing Position (1 min per Asana)
349
+ Trikonasana, Parvritta Trikonasana, Prasarita Padhastasana
350
+ 2 Supine Position
351
+ Jatara Parivartanasana, Pawanmuktasana, Viparitakarani
352
+ 3 Prone Position
353
+ Bhujangasana, Dharuasana followed by Pawanmuktasana
354
+ 4 Sitting Position
355
+ Mandukasana, Vakrasana/ Ardhamatsayendrasana, Paschimatanasana, Ardha Ushtrasana
356
+ At the end, relaxation with abdominal breathing in supine position (vishranti), 10–15 rounds (2 min)
357
+ 15
358
+ 5
359
+ Kriya
360
+ a. Agnisara:1 min b. Kapalabhati(@60 breaths per minute for 1 min followed by rest for 1 min)
361
+ 3
362
+ 6
363
+ Pranayama
364
+ Nadishuddhi (for 6 min, with antarkumbhak and jalandhar bandh for 2 s)
365
+ Bhamari 3 min
366
+ 9
367
+ 7
368
+ Meditation (for Stress, for deep relaxation and silencing of mind)
369
+ Cyclic Meditation
370
+ 15
371
+ 8
372
+ Resolve (I am Completely Healthy)
373
+ 1
374
+ 9
375
+ Closing Prayer: Sarvebhavantu Sukhina…………
376
+ 1
377
+ Total duration
378
+ 60
379
+ Page 6 of 10
380
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
381
+ HDL levels had decreased. In particular TG levels have
382
+ gone from normal range to mildly high (> 150 mg/dl) [26]
383
+ which draws our attention towards accelerated pace of
384
+ metabolic dysfunction in the high risk population. These
385
+ findings comply with Chandigarh being an affluent union
386
+ territory of India with high per-capita GDP and has
387
+ been documented to have highest prevalence of diabe-
388
+ tes 13.6%, 12.8–15·2 as compared to other Indian states
389
+ [27]. As mentioned above, there was a significant influ-
390
+ ence of DYP on the waist circumference, one of the two
391
+ important modifiable parameters of Indian Diabetes Risk
392
+ Score [17]. The relevance of WC reduction in context of
393
+ reduced risk of CVD is well established; a 1 cm increase
394
+ in WC has been associated with a 2% increase in the rela-
395
+ tive risk of future CVD [28]. The visceral adipose tissue
396
+ is a primary source of cytokine production and insu-
397
+ lin resistance (IR) [29]. Given the higher susceptibility
398
+ towards visceral fat accumulation and insulin resistance
399
+ in Asian populations as compared to their Caucasian
400
+ counterparts, the observed influence of DYP on WC is
401
+ of particular relevance to the metabolically obese pheno-
402
+ type of Asian Indians [30].
403
+ In relation to the glucose metabolism, we could also
404
+ demonstrate a significant decline in the worsening of
405
+ post prandial glucose levels with DYP as compared to
406
+ the wait-list control group (relative change = −  2.81%,
407
+ P < 0.05); however, no significant influence could be
408
+ established for fasting blood glucose concentration. These
409
+ findings could be justified by the phenotypic differences
410
+ underlying fasting and post-challenge hyperglycemia
411
+ that represent distinct natural histories in the evolution
412
+ of type 2 diabetes [31]. Postprandial glucose disposal is
413
+ the primary pathogenic manifestation in impaired glu-
414
+ cose tolerance (IGT), and impaired fasting glucose (IFG)
415
+ merely signifies an abnormal glucose set point [31, 32].
416
+ Our relevance of the study findings is further underlined
417
+ by the previous results wherein PPG has been reported
418
+ to contribute more than FBS to overall hyperglycemia
419
+ and its control was found essential either to decrease or
420
+ to obtain HbA1c goals of < 7 [33]. Several epidemiological
421
+ studies have suggested that increased glycemic exposure,
422
+ especially post challenge or postprandial hyperglycemia,
423
+ is an independent risk factor for macrovascular disease
424
+ with no apparent upper or lower threshold. Our results
425
+ indicate a significant influence of yoga on glycemic con-
426
+ trol integrating postprandial glycemic alterations in the
427
+ high diabetes risk group. Since in the present study the
428
+ high-risk cohort was selected through A1c based diag-
429
+ nosis, and IGT was not a primary manifestation in the
430
+ cohort, hence, the overall improvement in postprandial
431
+ glucose should be specifically tested in an IGT cohort.
432
+ The findings of the current study with a 3-month inter-
433
+ vention of yoga on postprandial measures of glucose at-
434
+ risk population deserves clinical attention. Increase in
435
+ the glucose concentration even in the prediabetes stage,
436
+ manifests as a chronic inflammatory condition and pre-
437
+ disposes an individual to the risk of pathogenic infections
438
+ [32, 34, 35].
439
+ The simultaneous reduction in waist circumference
440
+ observed in the cohort, is also consistent with the obser-
441
+ vation of an association between abdominal obesity
442
+ and the risk of IGT. Based on a significant association
443
+ between IGT and CVD risk [32, 33, 36], we note a signifi-
444
+ cant improvement in lipid concentrations [LDL-c] by the
445
+ DYP protocol as compared to the control group. These
446
+ results are consistent with the previously reported overall
447
+ beneficial effect of yoga in the management of hyperlipi-
448
+ demia [36]. These results need validation at larger scale
449
+ and to ascertain the mechanistic insights into the action
450
+ of yoga, the indices of monocyte chemotaxis, endothe-
451
+ lial inflammation, oxidation, nitric oxide production,
452
+ and thrombosis should also be explored [37], including
453
+ animal models, invitro systems and other approaches
454
+ [38–44].
455
+ The findings of the present study indicate that identifi-
456
+ cation of high-risk group through IDRS and consequent
457
+ intervention of Yoga based lifestyle protocol could be an
458
+ effective strategy to combat the metabolic perturbations
459
+ Table 2  Baseline characteristics of the participants in the
460
+ intervention and control group
461
+ Continuous variables are represented as mean (SD) and compared using
462
+ independent t-test. Categorical variables are represented as number
463
+ (percentages) and compared using chi-square test. P value < 0.05 were
464
+ considered significant. FBS fasting blood sugar, PPBG postprandial blood
465
+ glucose, HbA1c glycated hemoglobin, HDL-c high density lipid-cholesterol, LDL-c
466
+ low density lipid-cholesterol, VLDL very low density lipid-cholesterol, IDRS Indian
467
+ diabetes risk score
468
+ Characteristics
469
+ DYP Group
470
+ N = 91
471
+ Control group
472
+ N = 93
473
+ P value
474
+ Gender
475
+ Male, n (%)
476
+ 19 (20.88)
477
+ 30 (32.26)
478
+ 0.096
479
+ Age (years)
480
+ 47.77 (9.59)
481
+ 49.24 (10.53)
482
+ 0.323
483
+ Weight, Kg
484
+ 70.93 (10.90)
485
+ 70.80 (12.44)
486
+ 0.936
487
+ Waist circumference, cm
488
+ 99.34 (9.05)
489
+ 99.72 (9.05)
490
+ 0.794
491
+ BMI, Kg/m2
492
+ 28.59 (5.75)
493
+ 28.53 (5.01)
494
+ 0.949
495
+ IDRS
496
+ 74.07 (10.43)
497
+ 75.27 (9.95)
498
+ 0.425
499
+ Biochemical variables
500
+ FBG, mg/dl
501
+ 96.89 (9.95)
502
+ 97.36 (12.20)
503
+ 0.776
504
+ PPBG, mg/dl
505
+ 102.88 (21.91)
506
+ 113.78 (33.47)
507
+ 0.012*
508
+ HbA1c (%)
509
+ 5.61 (0.38)
510
+ 5.66 (0.38)
511
+ 0.400
512
+ Total cholesterol mg/dl
513
+ 186.88 (37.64)
514
+ 179.98 (34.98)
515
+ 0.199
516
+ Triglycerides, mg/dl
517
+ 131.93 (68.59)
518
+ 138.44 (68.89)
519
+ 0.522
520
+ HDL-c, mg/dl
521
+ 47.76 (9.16)
522
+ 48.33 (17.43)
523
+ 0.780
524
+ LDL-c, mg/dl
525
+ 112.75 (31.02)
526
+ 104.38 (31.70)
527
+ 0.072
528
+ VLDL, mg/dl
529
+ 26.39 (13.72)
530
+ 28.00 (13.50)
531
+ 0.423
532
+ Page 7 of 10
533
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
534
+
535
+ associated with diabetes, whose co-morbidity is also
536
+ being reported to be associated with increasing vulner-
537
+ ability to the emerging viral pandemic of COVID-19.
538
+ Lifestyle interventions are reported to reduce the risk of
539
+ Type 2 diabetes in high-risk individuals after mid and
540
+ long-term follow-up. Information on determinants of
541
+ intervention outcome, adherence and the mechanisms
542
+ underlying diabetes progression are valuable for a more
543
+ targeted implementation. Weight loss is a major con-
544
+ tributor in the prevention and management of type 2 dia-
545
+ betes. In many of the earlier lifestyle intervention group
546
+ of the DPP, weight loss was the dominant predictor of
547
+ reduced diabetes risk, with a 16% reduction observed for
548
+ every kilogram of weight loss during the 3.2-year follow-
549
+ up [45]. Though we failed to observe a significant weight
550
+ loss over 3 months of DYP intervention, the significant
551
+ reductions in WC indicate the plausibility of significant
552
+ weight loss on longer interventions and follow ups.
553
+ Whether Yoga alters the conversion of prediabetics
554
+ into healthy status and if it helps in maintenance of glyce-
555
+ mic index can be assessed by longitudinal studies. There
556
+ was a significant improvement in the glycemic status of
557
+ Table 3  Comparative assessment of influence of DYP on biochemical and weight related variables with the control group
558
+ Absolute change = [(intervention group follow-up) – (intervention group baseline)] – [(control group follow-up) – (control group baseline)]. Relative
559
+ change = (absolute change / intervention group baseline) × 100%; p value for difference between the intervention and the control groups by MANCOVA adjusting for
560
+ age, gender, status of diabetes/prediabetes/normoglycemia baseline values of glycemic and lipid variables, length of time having had prior exposure of yoga
561
+ Variables
562
+ Baseline
563
+ mean (SD)
564
+ After 3 months
565
+ mean (SD)
566
+ Absolute
567
+ change
568
+ Relative change
569
+ P value
570
+ Partial η2
571
+ Waist circumference (cm)
572
+ DYP
573
+ 99.34 (9.05)
574
+ 98.14 (6.88)
575
+ − 1.93
576
+ − 1.94
577
+ 0.032
578
+ 0.029
579
+ Control
580
+ 99.72 (9.05)
581
+ 100.25 (7.72)
582
+ BMI, kg/m2
583
+ DYP
584
+ 28.59 (5.75)
585
+ 28.00 (6.84)
586
+ − 0.4
587
+ − 1.40
588
+ 0.622
589
+ 0.002
590
+ Control
591
+ 28.53 (5.01)
592
+ 28.34 (4.98)
593
+ Weight, Kg
594
+ DYP
595
+ 70.93 (10.90)
596
+ 69.04 (9.13)
597
+ − 1.04
598
+ − 1.47
599
+ 0.397
600
+ 0.005
601
+ Control
602
+ 70.80 (12.44)
603
+ 69.95 (10.44)
604
+ Postprandial blood glucose, mg/dl
605
+ DYP
606
+ 102.88 (21.91)
607
+ 118.32 (29.89)
608
+ − 1.51
609
+ − 1.47
610
+ 0.006
611
+ 0.046
612
+ Control
613
+ 113.78 (33.47)
614
+ 130.73 (36.98)
615
+ Fasting blood glucose, mg/dl
616
+ DYP
617
+ 96.89 (9.95)
618
+ 99.82 (9.49)
619
+ 1.44
620
+ 1.49
621
+ 0.287
622
+ 0.007
623
+ Control
624
+ 97.36 (12.20)
625
+ 98.85 (9.26)
626
+ HBA1c (%)
627
+ DYP
628
+ 5.61 (0.38)
629
+ 5.61 (0.39)
630
+ − 0.02
631
+ − 0.36
632
+ 0.077
633
+ 0.020
634
+ Control
635
+ 5.66 (0.38)
636
+ 5.68 (0.38)
637
+ Total Cholesterol, mg/dl
638
+ DYP
639
+ 186.88(37.64)
640
+ 189.01 (25.64)
641
+ − 0.4
642
+ − 0.21
643
+ 0.130
644
+ 0.014
645
+ Control
646
+ 179.98 (34.98)
647
+ 182.51(20.82)
648
+ Triglycerides, TG, mg/dl
649
+ DYP
650
+ 131.93 (68.59)
651
+ 148.14 (54.92)
652
+ − 13.98
653
+ − 10.60
654
+ 0.138
655
+ 0.014
656
+ Control
657
+ 138.44 (68.89)
658
+ 168.63 (75.06)
659
+ HDL-C, mg/dl
660
+ DYP
661
+ 47.76 (9.16)
662
+ 47.01 (9.16)
663
+ 2.2
664
+ 4.61
665
+ 0.097
666
+ 0.017
667
+ Control
668
+ 48.33 (17.43)
669
+ 45.38 (12.57)
670
+ LDL-C, mg/dl
671
+ DYP
672
+ 112.75 (31.02)
673
+ 103.39 (21.44)
674
+ − 17.56
675
+ − 15.57
676
+ 0.044*
677
+ 0.025
678
+ Control
679
+ 104.38 (31.70)
680
+ 112.58 (21.99)
681
+ VLDL, mg/dl
682
+ DYP
683
+ 26.39 (13.72)
684
+ 28.85 (10.47)
685
+ − 1.23
686
+ − 4.66
687
+ 0.229
688
+ 0.009
689
+ Control
690
+ 28.00 (13.50)
691
+ 31.69 (10.57)
692
+ Page 8 of 10
693
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
694
+ the high risk population at administration of DYP. The
695
+ analysis shows the aptness of Diabetic protocol which is
696
+ apparently superior to previous studies where no stand-
697
+ ardized protocols were used for intervention [46, 47]. The
698
+ findings suggest that there is potential of DYP to manage
699
+ glucose levels in diabetes patients if public intervention is
700
+ planned through forthcoming wellness centers in India.
701
+ There are additional studies showing beneficial effects of
702
+ Yoga on FBS [48], PPBS [49–51], HbA1c [50, 51], total
703
+ cholesterol, LDL [50, 51]. The analysis of the yoga proto-
704
+ cols used in above said studies reveal the incorporation
705
+ of some common and important postures in DYP, which
706
+ seem to be important in managing the disease. It is also
707
+ the possible that the beneficial effects of mind body tech-
708
+ niques are sensitive to mental disposition of subjects and
709
+ has been characterized by various measures like psycho-
710
+ metric analysis [52, 53], namely, Tridosha and Triguna
711
+ scoring [54, 55]. These were not analyzed in this study.
712
+ Briefly, DYP’s promising efficacy on glycemic and met-
713
+ abolic parameters requires mechanistic insights. This can
714
+ be examined by further studies, and long term follow up
715
+ which was not possible in this study. As DYP is a non-
716
+ pharmacological, cost-effective method to halt the con-
717
+ version of early diabetes into prediabetes and/or healthy
718
+ individuals, the success of its integration into public
719
+ health policy will depend on its wider acceptability and
720
+ perception of benefits by both public as well as health-
721
+ care workers [56–59]. Yoga’s benefits in maintaining and
722
+ regulation of the glycemic status are supported by sev-
723
+ eral other studies [49, 50], which might enable its inclu-
724
+ sion in the National Ayushman Bharat scheme or as part
725
+ COVID pandemic management protocol in which a large
726
+ number of individuals with diabetes and heart disease are
727
+ falling prey [60, 61]. This will further encourage molecu-
728
+ lar and Ayurgenomic studies which presumably underlie
729
+ the stated clinical outcome.
730
+ Limitations
731
+ Moreover, there are some limitations of our study that we
732
+ only studied in two regions of North India and thus the
733
+ result of this study cannot be generalized on the remain-
734
+ ing population. Further, in this study, the socio economic
735
+ status and psychological assessments were not carried
736
+ out. We were not able to control for the dietary habits
737
+ and psychological status of the study participants. How-
738
+ ever, the small sample size and absence of long term eval-
739
+ uations limit the strength of the study.
740
+ Conclusion
741
+ The findings indicate that the DYP intervention could
742
+ improve the metabolic status of the high-diabetes-
743
+ risk individuals with respect to their glucose tolerance
744
+ and lipid levels, partially explained by the reduction in
745
+ abdominal obesity. The study highlights the potential role
746
+ of yoga intervention in real time improvement of cardio-
747
+ vascular profile in a high diabetes risk cohort.
748
+ Abbreviations
749
+ ADA: American Diabetes Association; BMI: Body mass Index; CVD: Cardiovas-
750
+ cular disease; DYP: Diabetic yoga protocol; FBS: Fasting blood sugar; HbA1c:
751
+ Glycated hemoglobin; HDL-c: High density lipid-cholesterol; IDRS: Indian
752
+ Diabetes Risk Score; IFG: Impaired fasting glucose; IGT: Impaired glucose
753
+ tolerance; IYA: Indian Yoga Association; LDL-c: Low density lipid-cholesterol;
754
+ NMB: Niyantarita Maduhmeha Bharat; OGTT​
755
+ : Oral glucose tolerance test; PPBG:
756
+ Postprandial blood glucose; SBP: Systolic blood pressure; VLDL: Very low
757
+ density lipid-cholesterol; WC: Waist circumference; YVDM: Yoga volunteers for
758
+ diabetes management.
759
+ Acknowledgements
760
+ The authors would like to thank Central Council for Research in Yoga &
761
+ Naturopathy (CCRYN) for their support for man power, Ministry of Health and
762
+ Family Welfare (MOHFW) for support the cost of investigations and Indian
763
+ Yoga Association (IYA) for the overall project implementation. The authors also
764
+ like to thank to thank Yoga Volunteer for Diabetes Management (YVDMs) for
765
+ helping in collection of data and also for training participants for yoga.
766
+ Authors’ contributions
767
+ NK: writing of manuscript, collection of data. VM: writing of manuscript,
768
+ analysis. RN: conceptualization of manuscript, supervision and study design.
769
+ NM: co-conceptualization of manuscript. AA: conceptualization of manuscript.
770
+ HRN: supervision. All authors read and approved the final manuscript.
771
+ Funding
772
+ The Project was funded by Ministry of AYUSH, Government of India (grant
773
+ number 16-63/2016-17/CCRYN/RES/Y&D/ MCT/).
774
+ Availability of data and materials
775
+ The datasets used during the present study are available from the correspond-
776
+ ing author on reasonable request.
777
+ Declarations
778
+ Ethics approval and consent to participate
779
+ Written informed consents were taken from every subject during door to door
780
+ screening as well as at the time of registration. All the experimental protocol,
781
+ methods and procedures were approved by Ethics committee of Indian Yoga
782
+ Association (IYA) (ID: RES/IEC-IYA/001). All experiments methods and proce-
783
+ dures were carried out in accordance with relevant guidelines and regulations
784
+ of ethics committee.
785
+ Consent for publication
786
+ Not applicable.
787
+ Competing interests
788
+ The authors declare that they have no competing interests.
789
+ Author details
790
+ 1 
791
+ Department of Physical Education, Panjab University, Chandigarh 160014,
792
+ India. 2 
793
+ Division of Life Sciences, Swami Vivekananda Yoga Anusandhana Sam-
794
+ sathana, Bengaluru, Karnataka 560106, India. 3 
795
+ Dev Samaj College of Education,
796
+ Sector 36B, Chandigarh 160036, India. 4 
797
+ Department of Neurology, Neurosci-
798
+ ence Research Lab, Postgraduate Institute of Medical Education and Research,
799
+ Chandigarh 160012, India.
800
+ Received: 26 August 2021 Accepted: 17 November 2021
801
+ Page 9 of 10
802
+ Kaur et al. Diabetology & Metabolic Syndrome (2021) 13:149
803
+
804
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+ Publisher’s Note
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+ Springer Nature remains neutral with regard to jurisdictional claims in pub-
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+ lished maps and institutional affiliations.
subfolder_0/Differences in Quality of Life Between American and Chinese breast cancer survivors.txt ADDED
@@ -0,0 +1,855 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ORIGINAL ARTICLE
2
+ Differences in quality of life between American and Chinese
3
+ breast cancer survivors
4
+ Qian Lu1 & Jin You2 & April Kavanagh3 & Krystal Warmoth1 & Zhiqiang Meng4 &
5
+ Zhen Chen4 & Kavita D. Chandwani5 & George H. Perkins6 & Jennifer Leigh McQuade6 &
6
+ Nelamangala V. Raghuram7 & Raghuram Nagarathna7 & Zhongxing Liao6 &
7
+ Hongasandra Ramarao Nagendra7 & Jiayi Chen4 & Xiaoma Guo4 & Luming Liu4 &
8
+ Banu Arun6 & Lorenzo Cohen6,8
9
+ Received: 17 July 2015 /Accepted: 28 March 2016
10
+ # Springer-Verlag Berlin Heidelberg 2016
11
+ Abstract
12
+ Objective It has been speculated that cancer survivors in Asia
13
+ may have lower quality of life (QOL) compared with their
14
+ Western counterparts. However, no studies have made interna-
15
+ tional comparisons in QOL using a comprehensive measure.
16
+ This study aimed to compare Chinese breast cancer survivors’
17
+ QOL with US counterparts and examine if demographic and
18
+ medical factors were associated with QOL across groups.
19
+ Method The sample consisted of 159 breast cancer patients
20
+ (97 Chinese and 62 American) who completed the Functional
21
+ Assessment for Cancer Therapy Breast Cancer (FACT-B)
22
+ scale before the start of radiotherapy in Shanghai, China and
23
+ Houston, USA.
24
+ Results Higher income was associated with higher QOL total
25
+ scores in both Chinese and American cancer patients, but
26
+ QOL was not significantly associated with other factors in-
27
+ cluding age, education, disease stage, mastectomy, and
28
+ chemotherapy. Consistent with hypotheses, compared to their
29
+ US counterparts, Chinese breast cancer survivors reported
30
+ lower QOL and all four subdimensions including functional
31
+ well-being (FWB), physical well-being (PWB), emotional
32
+ well-being (EWB), and social well-being (SWB); they also
33
+ reported more breast cancer-specific concerns (BCS).
34
+ Differences were also clinically significant for Functional
35
+ Assessment for Cancer Therapy General (FACT-G) scale total
36
+ scores and the FWB subscale. After controlling for demo-
37
+ graphic and medical covariates, these differences remained
38
+ except for the SWB and BCS. Furthermore, Chinese breast
39
+ cancer survivors receiving chemotherapy reported significant-
40
+ ly lower FACT-G scores than those who did not, but this
41
+ difference did not emerge among US breast cancer survivors.
42
+ Discussion Chinese breast cancer survivors reported
43
+ poorer
44
+ QOL on multiple domains compared to US women. Findings
45
+ indicate that better strategies are needed to help improve the
46
+ The University of Texas School of Public Health, Houston, USA.
47
+ Location when analyses were conducted
48
+ The University of Texas MD Anderson Cancer Center, Houston, USA.
49
+ Location when data was collected
50
+ * Qian Lu
51
52
+ * Lorenzo Cohen
53
54
+ 1
55
+ Department of Psychology, University of Houston, 126 Heyne
56
+ Building, Houston 77204, TX, USA
57
+ 2
58
+ WuHan University, Wuhan, China
59
+ 3
60
+ The University of Texas School of Public Health, Houston, USA
61
+ 4
62
+ Fudan University Shanghai Cancer Center, Shanghai, China
63
+ 5
64
+ University of Texas Health Science Center, Houston, USA
65
+ 6
66
+ The University of Texas MD Anderson Cancer Center,
67
+ Houston, USA
68
+ 7
69
+ Swami Vivekananda Yoga Anusandhana Samsthana,
70
+ Bengaluru, India
71
+ 8
72
+ Department of Palliative, Rehabilitation, and Integrative Medicine,
73
+ Section of Integrative Medicine, The University of Texas MD
74
+ Anderson Cancer Center, Houston, TX 77030, USA
75
+ Support Care Cancer
76
+ DOI 10.1007/s00520-016-3195-1
77
+ QOL of Chinese breast cancer survivors, especially those who
78
+ underwent chemotherapy.
79
+ Keywords Quality of life . Breast cancer . Culture . Country
80
+ Introduction
81
+ Cancer is one of the leading causes of mortality worldwide
82
+ [1]. Asia represents 60 % of the world’s population [2]. It is
83
+ estimated to experience 45 % of all new cancer cases in the
84
+ world and 50 % of all cancer deaths in 2008 [3]. China is
85
+ seeing a change in cancer rates [4] and currently observing a
86
+ country-wide increase [5]. Breast cancer is among the most
87
+ frequent types of cancer and alone accounted for 1,383,000
88
+ new cancer cases and 519,000 cancer-related deaths in 2008
89
+ worldwide [1]. Since 1990, rates of breast cancer in China
90
+ have increased 3 to 4 % annually, compared to a global annual
91
+ increase of 0.5 % [6]. As the effectiveness of cancer treatments
92
+ continues to develop in China, the number of breast cancer
93
+ patients and survivors will continue to rise. As patients live
94
+ longer, concern for psychological factors and quality of life
95
+ (QOL) among this population has grown [7]. Although a
96
+ growing number of studies have reported QOL in Asian pop-
97
+ ulations, they focus on the validation of measurement and one
98
+ population. Cross-country comparison of QOL can help to
99
+ understand possible areas of intervention and how to design
100
+ culturally sensitive interventions. However, no publications
101
+ have compared the QOL between Asian and Western breast
102
+ cancer patients. This paper aims to compare differences in
103
+ QOL between Chinese and US breast cancer patients.
104
+ In 1993, the World Health Organization (WHO) defined
105
+ QOL as Bindividuals’ perceptions of their position in life in
106
+ the context of the culture and value systems in which they live
107
+ and in relation to their goals, expectations, standards and
108
+ concerns^ [7]. This broad ranging concept is affected, in a
109
+ complex way, by a person’s physical health, psychological
110
+ state, level of independence, social relationships, and relation-
111
+ ship to their environment [7]. Many methods have been doc-
112
+ umented in the literature for the purpose of evaluating the
113
+ QOL in cancer patients. Of the 12 existing measures, the
114
+ two most commonly used were the European Organization
115
+ for Research and Treatment of Cancer’s quality of life ques-
116
+ tionnaire (EORTC QLQ-C30) and the Functional Assessment
117
+ for Cancer Therapy (FACT) scale [8]. The Functional
118
+ Assessment for Cancer Therapy Breast Cancer (FACT-B)
119
+ scale was developed as a means to evaluate a spectrum of
120
+ QOL components in breast cancer patients specifically. The
121
+ FACT-B is validated for Chinese; however, no studies have
122
+ directly compared responses on the FACT-B in Chinese pop-
123
+ ulations to responses from US populations.
124
+ Despite the lack of studies comparing Chinese to US pop-
125
+ ulations, there is reason to expect that Chinese cancer
126
+ survivors may have lower QOL than Americans. For example,
127
+ Asian American breast cancer survivors have reported lower
128
+ QOL than their European counterparts [9, 10]; Chinese
129
+ American survivors are more likely to experience poorer so-
130
+ cioeconomic well-being than non-Hispanic White survivors
131
+ [11]. Qualitative evidence has also shown that Chinese survi-
132
+ vors describe more distress than Americans [12]. Based on
133
+ these findings, we hypothesized that Chinese survivors may
134
+ have lower QOL compared with the US population.
135
+ QOL has become a consistent index of adjustment and an
136
+ end point in clinical trials in the West [8], but little research has
137
+ characterized QOL issues in Chinese breast cancer patients.
138
+ One study with newly diagnosed Chinese breast cancer pa-
139
+ tients found that income, time since diagnosis, marital status,
140
+ and education were all independently associated with overall
141
+ QOL [13]. Other studies with Chinese and US women have
142
+ observed that younger age was associated with worse QOL in
143
+ breast cancer patients [14–19]. Chinese breast cancer survi-
144
+ vors reported that women who underwent breast conservation
145
+ therapy had better body image compared to women who had
146
+ mastectomy alone [20], consistent with results from studies
147
+ with US women [21]. Patients who undergo chemotherapy
148
+ have been found to report lower quality of life [22], and this
149
+ may be especially true for Chinese cancer patients. Other fac-
150
+ tors, e.g., stage of the disease, were also found to be associated
151
+ with Chinese cancer survivors’ QOL [23–25]. The present
152
+ study therefore investigated how demographic and disease-
153
+ related factors were associated with QOL in both countries.
154
+ This study was a secondary analysis of existing data from
155
+ two intervention studies [26, 27]. The primary goal of this study
156
+ was to compare Chinese breast cancer survivors’ QOL with US
157
+ counterparts. The second goal was to examine how demograph-
158
+ ic and medical factors were associated with QOL across groups.
159
+ We hypothesized that Chinese women would have lower QOL
160
+ compared with the US women (i.e., hypothesis 1). Based on the
161
+ literature reviewed above, we also hypothesized that lower in-
162
+ come and education, younger age, later stage of diagnosis, and
163
+ more aggressive treatment would be associated with worse QOL
164
+ (i.e., hypothesis 2), independent of ethnicity. We finally explored
165
+ whether medical factors differentially influenced QOL depend-
166
+ ing on ethnicity (Chinese vs. US). We hypothesized that having
167
+ undergone chemotherapy prior to the start of radiotherapy (as-
168
+ sessment point) and later stage of diagnosis would have a greater
169
+ influence on QOL among Chinese than among US breast cancer
170
+ survivors (i.e., hypothesis 3).
171
+ Methods
172
+ Participants
173
+ A total of 159 patients (97 Chinese and 62 American) partic-
174
+ ipated in the study. Participants were recruited from two
175
+ Support Care Cancer
176
+ comparable intervention studies conducted in Shanghai,
177
+ China and Houston, USA. All the participants who enrolled
178
+ in these studies were included in this study and met all inclu-
179
+ sion and exclusion criteria of parent studies, which were the
180
+ same criteria for this study. Detailed information on the study
181
+ methods has been published previously [26, 27]. Eligible
182
+ Chinese patients were identified by physicians and research
183
+ nurses at the breast cancer clinic. These patients were sched-
184
+ uled for radiotherapy at Fudan University Shanghai Cancer
185
+ Center (FUSCC) in Shanghai, China. Eligible US patients
186
+ were identified through the Cardiac Arrest Registry to
187
+ Enhance Survival (CARES) database, which is an institutional
188
+ database that keeps track of patient schedules at MD
189
+ Anderson Cancer Center. These patients were undergoing ra-
190
+ diotherapy in the Department of Radiology Oncology, at MD
191
+ Anderson Cancer Center. Inclusion criteria were (1) women
192
+ 18 years or older, (2) with stage 0–III breast cancer, and (3)
193
+ completed surgery and/or chemotherapy and had not started
194
+ radiotherapy. Additional inclusion criteria were reading, writ-
195
+ ing, and speaking fluency in Chinese for Chinese women or
196
+ English for US women. The study excluded patients with any
197
+ major psychiatric diagnoses or metastatic disease.
198
+ Procedures
199
+ Patients were recruited and provided written informed consent
200
+ prior to the start of radiotherapy. All patients had completed
201
+ surgery and/or chemotherapy prior to consent. In the Qigong
202
+ intervention study, 123 Chinese patients were approached,
203
+ 100 patients consented and were randomized, and 96 complet-
204
+ ed the survey, yielding a response rate of 96 %. In the Yoga
205
+ intervention study, 137 of the US patients were approached,
206
+ 81 consented, 71 were randomized, and 61 completed the
207
+ survey, resulting in a response rate of 75.3 %. After patients
208
+ consented to the study and before they were randomized to the
209
+ experimental or control groups, a 45-min battery of question-
210
+ naires was given at baseline to measure QOL and demograph-
211
+ ic information, and medical data was extracted from patient
212
+ charts and electronic medical record. The MD Anderson
213
+ Institutional Review Board approved both studies, and the
214
+ Fudan University IRB approved the Chinese study.
215
+ Measures
216
+ QOL was measured by FACT-B version 4. This measure is
217
+ validated for both Chinese and US breast cancer patients [28,
218
+ 29]. Participants respond on a Likert scale ranging from 0 (not
219
+ at all) to 4 (very much). The instrument has a total of 36
220
+ statements asking respondents to rate how true each statement
221
+ is for the last 7 days. One of the items in the social well-being
222
+ subdimension asked about sexual satisfaction and was largely
223
+ skipped by Chinese participants; therefore, this item was ex-
224
+ cluded from the analysis in this paper. The FACT-B consists of
225
+ the Functional Assessment for Cancer Therapy General
226
+ (FACT-G) scale [28], with the addition of breast cancer-
227
+ specific questions. The FACT-G has four subscale scores:
228
+ physical well-being (e.g., BI have nausea.^), functional well-
229
+ being (e.g., BI am able to work, including work at home.^),
230
+ emotional well-being (e.g., BI feel nervous.^), and social/
231
+ family well-being (e.g., BI am satisfied with family communi-
232
+ cation about my illness.^). Responses are summed for a total
233
+ score, with greater scores indicating higher QOL. The BCS
234
+ subscale addresses breast cancer-specific concerns (e.g., BOne
235
+ or both of my arms are swollen or tender.^), with higher scores
236
+ on this dimension indicating fewer concerns and better QOL.
237
+ In this current study, for group comparison, we reported the
238
+ FACT-G subscale and total scores and BCS subscale separate-
239
+ ly so that future studies with non-breast and breast cancer
240
+ survivors can compare the FACT-G score with our report.
241
+ Prior literature demonstrates that the alpha coefficients of the
242
+ whole scale are 0.92 and 0.90 and for each subscale ranges
243
+ from 0.82 to 0.88 and from 0.82 to 0.85 in US and Chinese
244
+ samples, respectively.
245
+ Data analyses
246
+ In the preliminary analyses, descriptive statistics were com-
247
+ puted within each of the cultural samples and cultural group.
248
+ Comparisons of all the variables were conducted with
249
+ ANOVAs or chi-squared tests. Correlation coefficients of all
250
+ variables were computed with Pearson correlations, Spearman
251
+ correlations, or cross-tabulations. For all the analyses below,
252
+ we first used the FACT-G total score and the BCS score as the
253
+ dependent variable. When group differences emerged in the
254
+ FACT-G total score, each subscale of FACT-G was used as a
255
+ dependent variable to further illustrate cultural differences in a
256
+ particular domain of QOL.
257
+ To test hypothesis 1, ANOVAs were performed with cul-
258
+ tural groups as an independent variable. To rule out the pos-
259
+ sibility that the findings were confounded with demographic
260
+ and cancer-related characteristics, ANCOVAs were conducted
261
+ controlling for all the demographic and medical variables in-
262
+ cluding age, disease stage, surgery type (mastectomy vs. con-
263
+ servation breast surgery), chemotherapy (yes vs. no), income,
264
+ and education. When statistically controlling for income, we
265
+ used the relative income compared with the mean within the
266
+ group, rather than the absolute value to adjust for country-
267
+ related differences in income. To test hypothesis 2, regression
268
+ analyses were used with QOL and subscales as dependent
269
+ variables and with all demographic and medical variables
270
+ (age, disease stage, surgery type, chemotherapy, income, and
271
+ education) entered as independent variables. To test hypothe-
272
+ sis 3, ANCOVAs were conducted to examine how disease
273
+ stage and chemotherapy would separately interact with cultur-
274
+ al groups in predicting QOL when controlling for all demo-
275
+ graphic and medical variables. For significant interaction
276
+ Support Care Cancer
277
+ effects, we conducted simple effect analyses to illustrate how
278
+ these variables would be differently associated with QOL
279
+ within each of the two cultural samples [30].
280
+ Results
281
+ Sample characteristics and country comparisons are shown in
282
+ Table 1. Compared with the US sample, the Chinese sample
283
+ was younger, poorer, less educated, and had a higher percent-
284
+ age of women that had undergone chemotherapy, even though
285
+ there were no disease stage differences. ANOVAs for hypoth-
286
+ esis 1 showed that Chinese breast cancer survivors reported
287
+ lower scores for FACT-G total, all FACT-G subscales, and
288
+ BCS than their US counterparts (Table 2). ANCOVA analyses
289
+ revealed that after controlling for covariates including age,
290
+ disease stage, mastectomy, chemotherapy, income, and
291
+ education, the above cultural differences remained significant
292
+ except for BCS and the social well-being (SWB) subscale.
293
+ Regression analyses for hypothesis 2 for the combined
294
+ populations revealed that after controlling for other demo-
295
+ graphic and medical variables, income was positively associ-
296
+ ated with FACT-G total scores (β = 0.31, p = 0.001) and three
297
+ subscales of FACT-G, including physical well-being (PWB;
298
+ β = 0.21, p = 0.03), SWB (β = 0.38, p < 0.001), and functional
299
+ well-being (FWB; β = 0.29, p = 0.002). FACT-G was not
300
+ significantly associated with other factors including age, edu-
301
+ cation, disease stage, mastectomy, and chemotherapy.
302
+ However, age was positively associated with BCS (β = 0.18,
303
+ p = 0.04), and having chemotherapy was negatively associat-
304
+ ed with PWB (β = −0.21, p = 0.04), after controlling for the
305
+ other demographic and medical variables.
306
+ Analyses for hypothesis 3 found significant interactions
307
+ between cultural group and chemotherapy predicting FACT-
308
+ G total scores, F(1, 138) = 6.63, p = 0.01, ηp
309
+ 2 = 0.046, even
310
+ Table 1 Demographic and
311
+ cancer-related characteristics of
312
+ the samples
313
+ Total N = 159,
314
+ n (%)
315
+ Chinese
316
+ N = 97, n (%)
317
+ American
318
+ N = 62, n (%)
319
+ F/χ2
320
+ df
321
+ p
322
+ Age
323
+ 15.53
324
+ 2
325
+ <0.001
326
+ 25–45 years
327
+ 54 (34.0)
328
+ 38 (39.2)
329
+ 16 (25.8)
330
+ 46–55 years
331
+ 61 (38.4)
332
+ 43 (44.3)
333
+ 18 (29.0)
334
+ 56–68 years
335
+ 44 (27.7)
336
+ 16 (16.5)
337
+ 28 (45.2)
338
+ Annual personal income
339
+ 15.66
340
+ 2
341
+ <0.001
342
+ Below average
343
+ 9 (5.7)
344
+ 6 (6.2)
345
+ 3 (4.8)
346
+ Average
347
+ 50 (31.4)
348
+ 43 (44.3)
349
+ 7 (11.3)
350
+ Above average
351
+ 65 (40.9)
352
+ 33 (34.0)
353
+ 32 (51.7)
354
+ Missing
355
+ 35 (22.0)
356
+ 15 (15.5)
357
+ 20 (32.3)
358
+ Educational attainment
359
+ 35.11
360
+ 2
361
+ <0.001
362
+ High school or lower
363
+ 51 (32.1)
364
+ 44 (45.4)
365
+ 7 (11.3)
366
+ College
367
+ 80 (50.3)
368
+ 47 (48.4)
369
+ 33 (51.3)
370
+ Graduate degree
371
+ 25 (15.7)
372
+ 4 (4.1)
373
+ 21 (33.9)
374
+ Missing
375
+ 3 (1.9)
376
+ 2 (2.1)
377
+ 1 (1.6)
378
+ Disease stage
379
+ 1.11
380
+ 3
381
+ 0.78
382
+ 0–I
383
+ 47 (29.5)
384
+ 28 (28.9)
385
+ 19 (30.7)
386
+ II
387
+ 62 (39.0)
388
+ 35 (36.1)
389
+ 27 (43.5)
390
+ III
391
+ 40 (25.2)
392
+ 24 (24.7)
393
+ 16 (25.8)
394
+ Missing
395
+ 10 (6.3)
396
+ 10 (10.3)
397
+ 0 (0)
398
+ Mastectomy
399
+ 2.16
400
+ 1
401
+ 0.14
402
+ Yes
403
+ 79 (49.7)
404
+ 53 (54.6)
405
+ 26 (41.9)
406
+ No
407
+ 79 (49.7)
408
+ 44 (45.4)
409
+ 35 (56.5)
410
+ Missing
411
+ 1 (.6)
412
+ 0 (0)
413
+ 1 (1.6)
414
+ Chemotherapy
415
+ 15.73
416
+ 1
417
+ <0.001
418
+ Yes
419
+ 22 (13.8)
420
+ 92 (94.8)
421
+ 45 (72.6)
422
+ No
423
+ 137 (86.2)
424
+ 5 (5.2)
425
+ 17 (27.4)
426
+ The cutoff points of average and below average income are retrieved from government reports for each cultural
427
+ sample, which are $8000 and $1500 (currency rate, 6.34 Yuan = US$1) in the Chinese sample and are $50,000
428
+ and $20,000 in the US sample
429
+ Support Care Cancer
430
+ after controlling for demographic and other medical covariate
431
+ variables. Simple effect analysis demonstrated that Chinese
432
+ breast cancer survivors receiving chemotherapy (M = 71.55,
433
+ SD = 14.52) reported significantly lower FACT-G than those
434
+ who did not (M = 86.20, SD = 12.44), F(1, 138) = 7.73,
435
+ p = 0.006, but such difference did not emerge among
436
+ American breast cancer survivors, F(1, 138) = 1.94, ns (see
437
+ Fig. 1). Subscale analyses revealed that cultural group × che-
438
+ motherapy interaction effect were significant on PWB, F(1,
439
+ 138) = 4.00, p = 0.047, ηp
440
+ 2 = 0.028, and EWB, F(1,
441
+ 138) = 5.95, p = 0.016, ηp
442
+ 2 = 0.041. Chinese breast cancer
443
+ survivors who had chemotherapy (MPWB = 19.44, SD = 5.21)
444
+ reported significantly lower PWB than those who did not
445
+ (MPWB = 25.00, SD = 3.32), F(1, 138) = 11.63, p = 0.001.
446
+ However, US breast cancer survivors who had chemotherapy
447
+ (M = 20.50, SD = 2.71) reported better EWB than those who
448
+ did not (M = 18.50, SD = 3.87), F(1, 138) = 4.87, p = 0.03.
449
+ Because the Chinese sample had a significantly higher per-
450
+ centage (94.8 %) undergoing chemotherapy compared with
451
+ the US sample (72.6 %) and only five Chinese women did
452
+ not receive chemotherapy, we also compared QOL among
453
+ those with chemotherapy controlling for other covariates.
454
+ Chinese breast cancer survivors receiving chemotherapy had
455
+ significantly lower FACT-G, F(1, 119) = 11.97, p = 0.001,
456
+ ηp
457
+ 2 = 0.091, PWB, F(1, 119) = 5.81, p = 0.018, ηp
458
+ 2 = 0.047,
459
+ EWB, F(1, 119) = 9.17, p = 0.003, ηp
460
+ 2 = 0.072, and FWB,
461
+ F(1, 119) = 9.53, p = 0.003, ηp
462
+ 2 = 0.074, than did their US
463
+ counterparts, and no group differences emerged for SWB,
464
+ F(1, 119) = 3.05, ns, or BCS, F(1, 119) = 1.38, ns.
465
+ The cultural group × disease stage interaction was signifi-
466
+ cant for FACT-G even after controlling for demographic and
467
+ other medical variables, F(2, 136) = 4.32, p = 0.05, ηp
468
+ 2 = 0.06;
469
+ see Fig. 2. Simple effect analysis revealed that Chinese breast
470
+ cancer survivors with stage II (M = 66.58, SD = 2.40) had
471
+ significantly lower FACT-G than those with stages 0–I
472
+ (M = 78.86, SD = 12.30), F(2, 136) = 7.50, p = 0.001, but
473
+ such difference did not exist in the US sample, F(2,
474
+ 136) = 1.73, ns. The Chinese breast cancer survivors scored
475
+ lower on FACT-G compared to the US women if they were at
476
+ stage II, F(1, 136) = 12.86, p < 0.001, and stage III, F(1,
477
+ 136) = 5.05, p = 0.03, but not at stages 0–I, F(1,
478
+ 136) = 0.52, ns. Subscale analyses showed that cultural group
479
+ interacted with disease stage on EWB, F(2, 136) = 3.78,
480
+ p = 0.03, ηp
481
+ 2 = 0.05, only. Simple effect analyses demonstrat-
482
+ ed that Chinese survivors at stage II (M = 15.97, SD = 4.49)
483
+ displayed significantly lower EWB than those at stages 0–I
484
+ (M = 19.54, SD = 3.04), F(2, 136) = 7.59, p = 0.001, but such
485
+ difference did not exist in the US sample. No significant group
486
+ and disease stage interaction merged for BCS.
487
+ Table 2 Mean, standard
488
+ deviation, and comparison of
489
+ quality of life between Chinese
490
+ and US breast cancer patients
491
+ Chinese (N = 97)
492
+ American (N = 62)
493
+ F
494
+ df
495
+ p
496
+ ηp
497
+ 2
498
+ FACT-G (26 items)
499
+ 72.45 (15.31)
500
+ 83.30 (12.25)
501
+ 22.10
502
+ 1
503
+ <0.001
504
+ 0.123
505
+ PWB (7 items)
506
+ 19.73 (5.27)
507
+ 22.52 (4.13)
508
+ 12.46
509
+ 1
510
+ 0.001
511
+ 0.073
512
+ SWB (6 items)
513
+ 19.29 (4.07)
514
+ 21.34 (3.58)
515
+ 10.54
516
+ 1
517
+ 0.001
518
+ 0.063
519
+ EWB (6 items)
520
+ 17.68 (4.46)
521
+ 19.92 (3.27)
522
+ 11.58
523
+ 1
524
+ 0.001
525
+ 0.069
526
+ FWB (7 items)
527
+ 15.75 (5.19)
528
+ 19.53 (5.27)
529
+ 19.84
530
+ 1
531
+ <0.001
532
+ 0.112
533
+ BCS (9 items)
534
+ 22.30 (4.88)
535
+ 24.13 (4.67)
536
+ 5.51
537
+ 1
538
+ 0.020
539
+ 0.034
540
+ FWB functional well-being, PWB physical well-being, EWB emotional well-being, SWB social well-being, BCS
541
+ breast cancer-specific concerns
542
+ **
543
+ *
544
+ Fig. 1 Interaction effects between chemotherapy and cultural group on
545
+ FACT-G. *p < 0.05, **p < 0.01
546
+ **
547
+ *
548
+ *
549
+ *
550
+ Fig. 2 Interaction effects between cancer stage and cultural group on
551
+ FACT-G. *p < 0.05, **p < 0.01
552
+ Support Care Cancer
553
+ Discussion
554
+ Although the rates of breast cancer have been rising in Asian
555
+ populations [5], there has been a lack of understanding of the
556
+ QOL among Asian cancer survivors. Furthermore, previous
557
+ studies have not compared Asian breast cancer survivors’
558
+ QOL with Westerners. Studies that have been conducted sep-
559
+ arately, either in the USA or China, are difficult to compare as
560
+ a result of inconsistencies in the time points assessed, tools
561
+ used for assessment, and the population of breast cancer pa-
562
+ tients examined. This is the first study that has compared re-
563
+ sponses on the FACT-B in Chinese and US women with breast
564
+ cancer. Both populations were obtained from a similar group
565
+ of patients and examined at the same time point (before the
566
+ start of radiotherapy).
567
+ This study revealed that Chinese breast cancer survivors
568
+ had lower overall FACT-G total scores compared to US wom-
569
+ en. Furthermore, Chinese women reported lower levels of
570
+ functional, physical, social, and emotional well-being and
571
+ more breast cancer concerns than US women. A difference
572
+ in FACT-G total scores of 5–7 points is indicative of clinically
573
+ significant QOL changes/differences [31]. On average,
574
+ Chinese women were 11 points lower on the FACT-G total
575
+ score compared to the American, which is considered a clin-
576
+ ically significant difference. Moreover, the differences
577
+ remained pronounced in multiple domains of QOL including
578
+ functional, physical, and emotional well-being even after con-
579
+ trolling for age, disease stage, mastectomy, chemotherapy, in-
580
+ come, and education. The more salient differences emerged
581
+ for the functional well-being subscale (ηp
582
+ 2 = 0.112), where
583
+ differences were also clinically significant (>3).
584
+ The Chinese sample was poorer, younger, less educated,
585
+ and more likely to have undergone chemotherapy compared
586
+ with the US sample. The finding that Chinese women were
587
+ younger on average than US women is consistent with prior
588
+ research showing that Chinese women are being diagnosed
589
+ with breast cancer at a younger age than US women [32].
590
+ Even after statistically controlling for these variables, the
591
+ Chinese women still had worse quality of life. This suggests
592
+ that perhaps symptom control strategies were not as aggres-
593
+ sive for the Chinese as the US women. Nevertheless, it is still
594
+ possible that income and greater use of chemotherapy could
595
+ be reasons for country differences in QOL. Those who have
596
+ undergone chemotherapy have been found to report lower
597
+ quality of life [22]. It could be possible that Chinese patients
598
+ undergo more aggressive treatment or take drugs that have
599
+ more adverse side effects. Yet, symptom control strategies
600
+ may also be different, and these data were not collected.
601
+ Further investigation is needed.
602
+ The interaction effect also provided some possible expla-
603
+ nations. Chinese patients who underwent chemotherapy were
604
+ at later cancer stages and had a much worse quality of life
605
+ compared to their US peers, whereas Chinese patients who
606
+ did not receive chemotherapy and were at an early cancer
607
+ stage were similar to their US peers. These findings suggest
608
+ that more attention needs to be paid to improve QOL among
609
+ those with chemotherapy and those at more advanced cancer
610
+ stages. We did not find surgery type to be differentially linked
611
+ to QOL. Future studies need to investigate symptom control
612
+ strategies that may have contributed to the country differences
613
+ in QOL.
614
+ Higher income was associated with higher QOL total score
615
+ in both Chinese and US samples, a finding consistent with
616
+ previous studies in Caucasian populations [10, 15, 33]. Past
617
+ research also suggests that younger age and less education are
618
+ associated with poor QOL [22, 34, 35]. We only found an
619
+ association between younger age and worse QOL in the US
620
+ breast cancer survivors. This may be a result of the small
621
+ sample size, relative homogeneity of the samples, the fact that
622
+ the Chinese women were significantly younger and less edu-
623
+ cated than the US women, and confounded by other medical
624
+ and demographic facts known to be associated with QOL.
625
+ Studies in Chinese populations have inconsistently found as-
626
+ sociations with stage of disease and some subscales of the
627
+ FACT-G [13, 36]. In some studies, FACT total score included
628
+ the breast cancer concern subdimension, and others did not
629
+ include this subdimension. In order to easily make the com-
630
+ parisons between this study and other studies reported FACT
631
+ scores, we calculated the FACT-G total separately from the
632
+ BCS scale and reported the four subdimensions and breast
633
+ cancer concerns separately so that future studies can make
634
+ comparisons with our findings.
635
+ Comparison of responses on the FACT-B in Asian and US
636
+ breast cancer patients has not been previously conducted. The
637
+ FACT-B has been used in many studies in US breast cancer
638
+ patients, and even with the differences in the time QOL was
639
+ assessed across studies [15, 19, 37], scores on the FACT-B
640
+ subscale scores were similar to our US sample. A previous
641
+ study validated the FACT-B in Chinese breast cancer inpa-
642
+ tients at an Oncological Hospital in Yunnan providence [29].
643
+ The women in that study scored lower in all FACT-B scales
644
+ compared to Chinese women in our study. The women in our
645
+ study were treated in Shanghai at one of the best hospitals in
646
+ China. If the women in our study have better QOL than
647
+ Chinese women treated in other regions, the differences be-
648
+ tween Chinese women from regional hospitals and US women
649
+ may even be larger.
650
+ Several caveats of the current study are worth mentioning.
651
+ The study examined the country difference in QOL with two
652
+ convenience samples, which limits the generalizability.
653
+ However, the Chinese women in our study reported higher
654
+ QOL than Chinese women in two other studies, suggesting
655
+ that the major conclusion of the study that Chinese women
656
+ had worse QOL could be generalized to Chinese women from
657
+ other regions within China. Second, the small sample size
658
+ limited our analyses of interactions between covariates and
659
+ Support Care Cancer
660
+ cultural groups. There were a smaller number of breast cancer
661
+ survivors without chemotherapy in the analysis for cultural
662
+ group by chemotherapy interaction. In addition, a limited
663
+ number of covariates were examined. Other covariates that
664
+ have been shown to be associated with QOL in both
665
+ Chinese and US populations need to be included as well; these
666
+ factors include marital status, time since diagnosis, co-
667
+ morbidity factors, and social support [23–25, 36]. Other fac-
668
+ tors have also been shown to influence QOL, such as pain,
669
+ fatigue, and anxiety [18]. Future studies should examine the
670
+ relationship between these factors and QOL in both groups.
671
+ We were also not able to extract medical data related to symp-
672
+ tom control strategies used for the women, such as medica-
673
+ tions for nausea and vomiting, fatigue, and sleep disturbances.
674
+ Differences in symptom control strategies may explain some
675
+ of the QOL differences. Finally, although the FACT-B is val-
676
+ idated in Chinese, it may not be completely comparable across
677
+ populations and contain questions that introduce bias into
678
+ study results. Future studies using a mixed paradigm with both
679
+ qualitative and quantitative data may shed light into the cul-
680
+ tural equivalence of the questions.
681
+ In sum, this study demonstrated that Chinese breast cancer
682
+ survivors had worse QOL compared with US counterparts,
683
+ and these differences were clinically significant. Treatment
684
+ and cancer stage may have contributed to group differences.
685
+ However, extra efforts are needed to help improve QOL of
686
+ Chinese breast cancer patients. Future studies are warranted to
687
+ further understand what contributed to country differences in
688
+ QOL and how to design better behavioral and medical inter-
689
+ ventions to improve women’s lives in countries where QOL
690
+ needs to be improved.
691
+ Acknowledgments
692
+ Support was provided in part by the US National
693
+ Cancer Institute (NCI) grants CA108084 and CA121503 (principal in-
694
+ vestigator, Lorenzo Cohen) and the American Cancer Society MRSGT-
695
+ 10-011-01-CPPB (principal investigator, Qian Lu). Partial support for
696
+ Lorenzo Cohen was provided by the Richard E. Haynes Distinguished
697
+ Professorship in Clinical Cancer Prevention. Jennifer McQuade is sup-
698
+ ported by an institutional T32 training grant and an ASCO Young
699
+ Investigator Award.
700
+ Compliance with ethical standards
701
+ Financial disclosures
702
+ There are no financial disclosures from any
703
+ authors.
704
+ Conflict of interest
705
+ The authors declare that they have no conflict of
706
+ interest.
707
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+ breast cancer surgery: rehabilitation needs and patterns of recovery.
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+ Breast Cancer Res Treat 56:45–57
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+ Ganz PA, Lee JJ, Siau J (1991) Quality of life assessment. An
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+ independent prognostic variable for survival in lung cancer.
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+ Cancer 67:3131–3135
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+ 12:183–193
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+ ger women with breast cancer. J Clin Oncol 23:3322–3330
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+ Support Care Cancer
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1
+ Volume 7 | Issue 2 | July-December | 2014
2
+ Official
3
+ Publication
4
+ of
5
+ Swami
6
+ Vivekananda
7
+ Yoga
8
+ Anusandhana
9
+ Samsthana
10
+ University
11
+ Online full text at
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+ http://www.ijoy.org.in
13
+ IJ Y
14
+ O
15
+ International Journal of Yoga
16
+ Guest Editorial
17
+ Original Articles
18
+ Comparative immediate effect of different yoga asanas on heart rate and blood pressure in healthy young volunteers
19
+ Effect of trataka on cognitive functions in the elderly
20
+ Effect of Bhramari pranayama and OM chanting on pulmonary function inhealthy individuals: A prospective randomized control trial
21
+ Effect of yogic colon cleansing (Laghu Sankhaprakshalana Kriya) on pain, spinal flexibility, disability and state anxiety in chronic low back pain
22
+ Toward building evidence for yoga
23
+ Contents
24
+ ISSN
25
+ 0973-6131
26
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
27
+ 138
28
+ Effect of Bhramari Pranayama on response inhibition:
29
+ Evidence from the stop signal task
30
+ Sasidharan K Rajesh, Judu V Ilavarasu, Thaiyar M Srinivasan1
31
+ Department of Psychology, 1Division of Yoga and Physical Sciences, Swami Vivekananda Yoga Anusandhana Samsthana,
32
+ Kempegowda Nagar, Bengaluru, Karnataka, India
33
+ Address for correspondence: Mr. Sasidharan K Rajesh,
34
+ #19 Eknath Bhavan, No. 19, Gavipuram Circle, Kempgowda Nagar, Bengaluru ‑ 560 019, Karnataka, India.
35
+ E‑mail: [email protected]
36
+ to be a useful tool for the study of response inhibition
37
+ in cognitive psychology, cognitive neuroscience, and
38
+ psychopathology.[1] In SST, subjects act upon a go reaction
39
+ time  (RT) task. On a random selection of the trials
40
+ (stop signal trials), a stop signal is presented, instructing
41
+ them to withhold their go responses.[4] The ability to
42
+ stop ongoing motor responses in a split second is a vital
43
+ element of response control and flexibility that relies on
44
+ frontal‑subcortical network.[5] The stop paradigm is based
45
+ on the race model where response execution races with
46
+ the inhibitory process to determine whether a response is
47
+ inhibited.[6] Further stop signal paradigm allows a sensitive
48
+ estimate of inhibitory control known as the stop signal
49
+ RT (SSRT), which reflects the time taken to internally
50
+ suppress a response.[7] Furthermore, previous studies have
51
+ shown medication for the treatment of attention deficit
52
+ hyperactivity disorder (ADHD) enhanced SSRT in healthy
53
+ volunteers.[8,9] To our knowledge, there is no study to date
54
+ using this paradigm in yoga based research.
55
+ INTRODUCTION
56
+ Adaptive functioning of behavior on the basis of feedback
57
+ from the environmental requirements is an important
58
+ characteristic of executive control. Response inhibition is
59
+ the hallmark of executive function. It refers to the ability
60
+ to inhibit inappropriate or irrelevant responses according
61
+ to dynamic change in environment.[1] Response inhibition
62
+ deficits have been linked to several psychopathological
63
+ disorders.[2,3] The Stop Signal Task  (SST) has proved
64
+ Context: Response inhibition is a key executive control processes. An inability to inhibit inappropriate actions has been linked
65
+ to a large range of neurologic and neuropsychiatric disorders.
66
+ Aims: Examine the effect of Bhramari Pranayama (Bhpr) on response inhibition in healthy individuals.
67
+ Settings and Design: Thirty‑one male students age ranged from 19-31 years from a residential Yoga University, Bengaluru, India
68
+ were recruited for this study. We used a randomized self as control within‑subjects design. Participants were counterbalanced
69
+ randomly into two different experimental conditions (Bhpr and deep breathing (DB)).
70
+ Materials and Methods: Response inhibition has been measured using a standard tool Stop Signal Task (SST). Each session
71
+ lasted for 50 min with 10 min for the experimental conditions, preceded and followed by 20 min of assessment. The primary
72
+ outcome measure was stop signal reaction time (SSRT), an estimate of the subject’s capacity for inhibiting prepotent motor
73
+ responses. Additional measures of interest were the probability of responding on stop signal trials, P (r | s) and mean RT to
74
+ go stimuli.
75
+ Results: The mean probability of responding on stop signal trials (p (r | s)) during Bhpr and DB are close to 50%, indicating
76
+ reliable SSRT. Paired sample t‑tests showed a significant decrease (P = 0.024) in SSRT after Bhpr session, while the  DB
77
+ group did not show any significant change. Further, t‑tests show that the go RT increased significantly after Bhpr (P = 0.007)
78
+ and no other changes/differences were observed.
79
+ Conclusions: Bhpr enhanced response inhibition and cognitive control in nonclinical participants.
80
+ Key words: Bhramari; response inhibition; stop signal; yoga
81
+ ABSTRACT
82
+ Access this article online
83
+ Website:
84
+ www.ijoy.org.in
85
+ Quick Response Code
86
+ DOI:
87
+ 10.4103/0973-6131.133896
88
+ Short Communication
89
+ Rajesh, et al.: Bhramari pranayama on response inhibition
90
+ 139
91
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
92
+ Yoga in its original form consisted of a system of
93
+ ethical, psychological, and physical practices;
94
+ although of ancient origin, it transcends cultures and
95
+ languages.[10] Yoga lays emphasis on manipulation of breath
96
+ movement (Pranayama), which contributes to a positive
97
+ neurophysiologic response.[11] Yogic breathing technique
98
+ called Bhramari Pranayama (Bhpr), involves producing
99
+ a vibrating constant pitch sound emulating the buzzing
100
+ of female bumble bee. The term Bhramari is a Sanskrit
101
+ word meaning a female bee. In the Bhramari breathing
102
+ technique, a humming sound resembling that of a female
103
+ bee is produced. In this Pranayama, one produces a low
104
+ pitched humming audible sound resembling the sound
105
+ of a female bee as long as possible, during exhalation.
106
+ EEG paroxysmal gamma waves were measured during
107
+ approximately 20 breathing episode of Bhpr in eight
108
+ subjects. The result shows an increased theta range
109
+ activity, which is similar to results obtained with other
110
+ meditation techniques.[12] Further, Bhpr as a therapy shows
111
+ significantly reduced irritability, depression, and anxiety
112
+ associated with tinnitus.[13] However, the effect of Bhpr on
113
+ cognitive function has not been reported. In this study,
114
+ we examine the effect of yogic breathing Bhpr on SST in
115
+ healthy individuals.
116
+ MATERIALS AND METHODS
117
+ Subjects
118
+ Thirty‑four undergraduate and graduate male students
119
+ from a residential Yoga University, Bengaluru, India were
120
+ recruited for this study. The final sample comprised
121
+ 31 volunteers, because the data for three subjects were
122
+ excluded due to failure of software. Participants’ age
123
+ ranged from 19 to 31 years with a mean age of 23.90 years
124
+ (standard deviation (SD) =3.48). All reported having a
125
+ normal or corrected vision and normal hearing. Females
126
+ were excluded because of reported varying SST during
127
+ phases of the menstrual cycle.[14] Participants were free
128
+ from medication, smoking, alcohol consumption, and
129
+ cardiorespiratory ailments by self‑report. Since the
130
+ handedness effects are not known, all subjects selected were
131
+ right handed only. The experience of subjects practicing
132
+ breathing techniques ranges from 6  months–5  years.
133
+ The approval of the Institutional Ethics Committee was
134
+ obtained and informed consent was collected. Participants
135
+ received no monetary compensation for their participation.
136
+ Design and procedure
137
+ This was a randomized self as control within‑subjects
138
+ design. Participants were counterbalanced randomly into
139
+ two different experimental conditions (Bhpr and deep
140
+ breathing (DB)). Each session was on a different day. Half of
141
+ the subject’s undergone Bhpr session the first day and DB
142
+ on the next day. For remaining half the order of the sessions
143
+ reversed. Subjects were counterbalanced to either one of
144
+ the conditions, to wash out any possible learning effect.
145
+ The time of day was kept constant for both sessions for
146
+ an individual (6 am-8 am). Each session lasted for 50 min.
147
+ The SST was recorded before and after the trial conditions.
148
+ All subjects had undergone orientation in the experimental
149
+ conditions (Bhpr and DB) for 15 days before the actual
150
+ assessment. All subjects received a practice session 1 day
151
+ prior to the experimental sessions in order to familiarize
152
+ them with the SST and procedures. During the practice
153
+ trails, experimenter shows the task on a laptop screen.
154
+ Volunteers then undertook brief practice, until it was
155
+ evident to the experimenter that the volunteer was
156
+ responding appropriately. The experiment was conducted
157
+ individually in a room under normal fluorescent lighting
158
+ with a laptop in the research lab. Care was taken that
159
+ during the experiment no external distractions or noises
160
+ were present.
161
+ SST
162
+ The stimuli were presented on a laptop using STOP‑IT,
163
+ which is a free‑to‑use SST program.[7] Participants were
164
+ seated approximately at 50  cm from the screen. The
165
+ primary task is to perform a two‑choice RT task in which
166
+ subjects had to react as quickly and accurately as possible
167
+ to discriminate between a square and a circle stimulus.
168
+ The primary task stimulus followed by fixation sign (+)
169
+ is presented in the center of the computer screen, in
170
+ white, on a black background. The subject responds
171
+ with ‘Z’ (for square) and ‘/’  (for circle) on a keyboard
172
+ with the left and right index finger, respectively. On
173
+ no‑signal trials (go task), only the primary task stimulus
174
+ is presented. On stop‑signal trials (Stop Task), an auditory
175
+ ‘stop signal’ beep is presented at a variable delay (stop
176
+ signal delay, SSD) following the go stimulus. Subjects
177
+ are instructed to inhibit their responses on the trials with
178
+ a stop signal beep. Tasks were presented randomly: Go
179
+ task (75%) and stop task (25%). SSD is initially set at
180
+ 250 ms and is adjusted continuously with dynamically
181
+ tracking procedure, dependent upon the performance
182
+ of the participant. Successful inhibitions resulted in an
183
+ increase of the SSD by 50 ms, whereas failed inhibitions
184
+ resulted in a reduction of the SSD by 50 ms. This procedure
185
+ ensured that on average each participant in each session
186
+ had a probability of successful inhibition approaching
187
+ 50%.[7] A total of 392 trials were presented, divided over
188
+ six blocks of 64 trials, lasting 3 min each. Subjects had
189
+ waited for 10 s between blocks before they start the next
190
+ block. The primary outcome measure is SSRT, an estimate
191
+ of the subject’s capacity for inhibiting prepotent motor
192
+ responses. SSRT was calculated by subtracting mean stop
193
+ signal delay from mean RT to go stimuli (go RT). Additional
194
+ measures of interest are the probability of responding on
195
+ stop signal trials, p (r | s) and Go RT.
196
+ Rajesh, et al.: Bhramari pranayama on response inhibition
197
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
198
+ 140
199
+ Experimental conditions
200
+ Subjects sat on a comfortable cushion on the floor of the
201
+ experimental room, in a crossed leg posture keeping the
202
+ spine erect, with eyes closed condition. On experimental
203
+ session  (Bhpr), after a deep inhalation, participant
204
+ exhale strictly through the nasal airways, emulating the
205
+ buzzing of bumblebees with a constant pitch. On control
206
+ session (DB), the subjects assumed the Bhpr position,
207
+ but did not produce the humming sound. Instead, they
208
+ attempted to manipulate the respiratory rhythm by deep
209
+ inhalation and exhalation.[12] Both the sessions were of
210
+ 10 min in duration. Each subject performed approximately
211
+ an average of 20 inhalations and exhalations per session.
212
+ RESULTS
213
+ Statistical analysis was carried out using Statistical
214
+ Package for Social Sciences (SPSS) version 10.0. Table 1
215
+ shows the means of the SSRT and go RT and also the
216
+ p (r | s). The mean probability of responding on stop‑signal
217
+ trials (p (r | s)) during Bhpr and DB are close to 50%,
218
+ indicating that the dynamic tracking algorithm worked
219
+ well in both sessions and produced a reliable SSRT.
220
+ The data for SSRT and go RT were found to be normally
221
+ distributed and difference between the means of the two
222
+ PRE sessions was not significant. Paired sample t‑tests
223
+ showed a significant decrease (P = 0.024) in SSRT after
224
+ Bhpr session, while the DP group did not show any
225
+ significant change [Table 1]. The means in the post session
226
+ were not significantly different, but the Bhpr group showed
227
+ a notable lower value. Further, t‑tests show that the Go RT
228
+ increased significantly after Bhpr (P = 0.007) and no other
229
+ changes/differences were observed.
230
+ DISCUSSION
231
+ In the present study, we have evaluated the immediate
232
+ effect of Bhpr on SST. There was a significant reduction
233
+ in SSRT, suggesting that the practice results in enhanced
234
+ response inhibition.[1] Further, subject slow down the go
235
+ responses, indicating subject made a proactive response
236
+ strategy to achieve a balance between competing goals,
237
+ suggesting a flexible cognitive control.[15]
238
+ As per our knowledge, there is no previous report
239
+ specific to BhPr on cognitive function for comparison.
240
+ We found that, enhancement of inhibitory control is
241
+ consistent with previous behavioral studies on single dose
242
+ administration of atomoxetine[8] and methylphenidate[9]
243
+ in healthy volunteers. Atomoxetine and methylphenidate
244
+ are widely used stimulant medication for the treatment
245
+ of ADHD. The mechanism underlying the enhancement
246
+ is not known. Dynamics of electroencephalogram (EEG)
247
+ theta activity correspond to executive control demands
248
+ across different sources of cognitive interference.[16] Theta
249
+ power enhancement relates to the recruitment of cognitive
250
+ control. Earlier study has shown resonating and repetitive
251
+ effects of humming bee sound in the Bhpr breathing
252
+ technique, increased theta activity.[12] We hypothesize
253
+ that improvement in response inhibition may be due to
254
+ enhanced theta activity. Further, it is possible to use this
255
+ breathing technique as an adjunct for the management
256
+ of ADHD. More studies are required for the use of this
257
+ technique in clinical cases.
258
+ The study is limited by the small sample size, and the
259
+ lasting effect of intervention was not assessed. Future
260
+ studies should incorporate various assessment methods
261
+ to capture changes while performing the task and
262
+ intervention to understand underlying mechanism.
263
+ ACKNOWLEDGEMENT
264
+ We are especially grateful to S‑VYASA Yoga University, Bengaluru
265
+ for financial support and Prof. Gordon D. Logan for insightful
266
+ suggestions on design and assessment.
267
+ REFERENCES
268
+ 1.
269
+ Verbruggen F, Logan GD. Response inhibition in the stop‑signal paradigm.
270
+ Trends Cogn Sci 2008;12:418‑24.
271
+ 2.
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+ Enticott PG, Ogloff JR, Bradshaw JL. Response inhibition and impulsivity
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+ in schizophrenia. Psychiatry Res 2008;157:251‑4.
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+ 3.
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+ Aron AR, Poldrack RA. The cognitive neuroscience of response inhibition:
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+ Relevance for genetic research in attention‑deficit/hyperactivity disorder.
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+ Biol Psychiatry 2005;57:1285‑92.
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+ 4.
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+ Logan GD, Cowan WB, Davis KA. On the ability to inhibit simple and choice
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+ reaction time responses: A model and a method. J Exp Psychol Hum Percept
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+ Perform 1984;10:276‑91.
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+ Aron AR, Behrens TE, Smith S, Frank MJ, Poldrack RA. Triangulating a
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+ cognitive control network using diffusion‑weighted magnetic resonance
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+ imaging (MRI) and functional MRI. J Neurosci 2007;27:3743‑52.
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+ 6.
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+ Band GP, van der Molen MW, Logan GD. Horse‑race model simulations of
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+ the stop‑signal procedure. Acta Psychol (Amst) 2003;112:105‑42.
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+ 7.
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+ Verbruggen F, Logan GD, Stevens MA. STOP‑IT: Windows executable
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+ software for the stop‑signal paradigm. Behav Res Methods 2008;40:479‑83.
292
+ 8.
293
+ Chamberlain SR, Hampshire A, Muller U, Rubia K, Del Campo N, Craig K,
294
+ Table  1: Bhramari and deep breathing: Mean and standard deviations
295
+ Deep breathing
296
+ Bhramari pranayama
297
+ Pre
298
+ Post
299
+ Pre
300
+ Post
301
+ p (r|s)(%)
302
+ 48.58±1.93
303
+ 49.68±1.78
304
+ 48.96±1.77
305
+ 49.47±3.38
306
+ SSRT (ms)
307
+ 239.44±30.59
308
+ 237.35±38.40
309
+ 243.75±40.16
310
+ 232.67±43.81*
311
+ Go RT (ms)
312
+ 733.88±170.89
313
+ 751.81±182.16
314
+ 701.67±184.10
315
+ 732.24±193.40**
316
+ p (r|s) = Mean probability of responding on stop‑signal trials, SSRT = Mean stop‑signal reaction time, Go RT = Mean reaction time on no‑signal trials. *P<0.05,
317
+ **P<0.01, t test for paired data comparing “pre” with respective “post” values
318
+ Rajesh, et al.: Bhramari pranayama on response inhibition
319
+ 141
320
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
321
+ et al. Atomoxetine modulates right inferior frontal activation during inhibitory
322
+ control: A pharmacological functional magnetic resonance imaging study.
323
+ Biol Psychiatry 2009;65:550‑5.
324
+ 9.
325
+ Nandam LS, Hester R, Wagner J, Cummins TD, Garner K, Dean AJ,
326
+ et  al. Methylphenidate but not atomoxetine or citalopram modulates
327
+ inhibitory control and response time variability. Biol Psychiatry 2011;69:
328
+ 902‑4.
329
+ 10. Nagendra HR. Defining yoga. Int J Yoga 2008;1:43‑4.
330
+ 11.
331
+ Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic
332
+ breathing: Neural respiratory elements may provide a mechanism that
333
+ explains how slow deep breathing shifts the autonomic nervous system. Med
334
+ Hypotheses 2006;67:566‑71.
335
+ 12. Vialatte FB, Bakardjian H, Prasad R, Cichocki A. EEG paroxysmal gamma
336
+ waves during Bhramari Pranayama: A yoga breathing technique. Conscious
337
+ Cogn 2009;18:977‑88.
338
+ 13. Sidheshwar  P, Niladri  KM, Ravishankar  N. Role of self‑induced
339
+ sound therapy: Bhramari Pranayama in Tinnitus. Audiol Med 2010;8:
340
+ 137‑41.
341
+ 14. Colzato LS, Hertsig G, van den Wildenberg WP, Hommel B. Estrogen
342
+ modulates inhibitory control in healthy human females: Evidence from the
343
+ stop‑signal paradigm. Neuroscience 2010;167:709‑15.
344
+ 15. Verbruggen F, Logan GD. Proactive adjustments of response strategies in the
345
+ stop‑signal paradigm. J Exp Psychol Hum Percept Perform 2009;35:835‑54.
346
+ 16. Nigbur R, Ivanova G, Sturmer B, Theta power as a marker for cognitive
347
+ interference. Clin Neurophysiol 2011;122:2185‑94.
348
+ How to cite this article: Rajesh SK, Ilavarasu JV, Srinivasan TM. Effect
349
+ of Bhramari Pranayama on response inhibition: Evidence from the stop
350
+ signal task. Int J Yoga 2014;7:138-41.
351
+ Source of Support: S-VYASA University, Conflict of Interest:
352
+ None declared
353
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+ possible articles in PubMed will be given.
subfolder_0/Effect of Holistic Module of Yoga and Ayurvedic.txt ADDED
@@ -0,0 +1,1081 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Open Journal of Endocrine and Metabolic Diseases, 2013, 3, 90-98
2
+ http://dx.doi.org/10.4236/ojemd.2013.31014 Published Online February 2013 (http://www.scirp.org/journal/ojemd)
3
+ Effect of Holistic Module of Yoga and Ayurvedic
4
+ Panchakarma in Type 2 Diabetes Mellitus—A Pilot Study
5
+ Barve Vaibhavi, Tripathi Satyam, Patra Sanjibkumar, Nagarathna Raghuram, Nagendra H. Ramarao
6
+ Division of Life Sciences, SVYASA, Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore, India
7
8
+
9
+ Received November 24, 2012; revised December 26, 2012; accepted January 28, 2013
10
+ ABSTRACT
11
+ Objective: Ayurveda and Yoga have emerged as beneficial adjuvant in management of diabetes. This pilot study was
12
+ planned to understand the concepts and assess the effect of a combination of Ayurvedic panchakarma and Yoga. Design:
13
+ Experimental pilot study with pre post design. Subjects: Twelve patients with type 2 diabetes in age between 40 - 70
14
+ years (mean 56 ± 9.08) with no cardiac, renal or retinal complications. Settings: Residential Holistic Health Centre of
15
+ S-VYASA. Intervention: A validated Ayurveda protocol comprising of panchakarma followed by maintenance the-
16
+ rapy with a specific module of Integrated Approach of Yoga Therapy for Diabetes that included selected physical pos-
17
+ tures (asanas), pranayama, meditation, lifestyle change and yogic counseling for stress management. All subjects un-
18
+ derwent a residential program for six weeks followed by therapy at home for 12 weeks. Results were analyzed using
19
+ paired “t” test. Results: After 6 weeks, Fasting Blood Glucose reduced (p < 0.05) from 129.31 ± 58.11 to 103.54 ±
20
+ 40.74 (19.93%), Post Prandial Blood Glucose from 191.69 ± 76.77 to 152.92 ± 62.06 (20.23%, p < 0.05), Total choles-
21
+ terol from 209 ± 33.7 to 186.92 ± 23.36 (10.56%, p < 0.05), Triglycerides from 198.25 ± 94.78 to 151.25 ± 43.65
22
+ (23.71%, p < 0.05), HbA1c reduced (p = 0.014) from 8.79 ± 2.12 to 8.07 ± 1.77 (8.19%) in 6th week and further to 7.63
23
+ ± 2.12 (13.19%, p = 0.001) after 12th week. Oral Hypoglycemic Agent (OHA) drug score reduced from 2.83 ± 0.93 to 1
24
+ ± 1.27 (64.66%, p < 0.001). Symptom score reduced from 2.83 ± 1.02 to 1.66 ± 0.65 (p < 0.001). At baseline guna
25
+ questionnaire showed six subjects each with rajas and tamas dominance. On post assessments, two subjects shifted from
26
+ tamas to rajas dominance. Conclusion: This first pilot study has indication of a potentially beneficial effect of combin-
27
+ ing traditionally recommended Ayurveda panchakarma with maintenance herbs and Yoga, in reducing blood glucose
28
+ and lipids. Long term RCT is recommended.
29
+
30
+ Keywords: Ayurveda; Yoga; Diabetes
31
+ 1. Introduction
32
+ Diabetes mellitus imposes a sizeable burden globally in
33
+ terms of early mortality, morbidity, and health care costs.
34
+ The incidence of diabetes worldwide was likely to be
35
+ 2.8% in 2000 and expected to rise to 4.4% by 2030, and
36
+ above three-quarters of people with diabetes would be
37
+ living in developing countries [1]. Diabetes mellitus
38
+ (madhumeha) was known to ancient Indian physicians
39
+ with detailed description of its clinical features and
40
+ management protocols [2]. Ayurveda is a comprehensive
41
+ system of traditional health care, which originated in
42
+ India approximately three thousand years ago. Its unique
43
+ holistic approach appears to have become relevant today
44
+ due to the increasing prevalence of non communicable
45
+ diseases. This science of life deals with body, mind, and
46
+ spirit as a single entity with clear understanding of the
47
+ techniques of managing them. Ancient Ayurveda classics
48
+ by Charaka, Sushruta, and Vagbhata contain ample
49
+ literature about Prameha and its treatment. Prameha is a
50
+ metabolic disorder and is diagnosed mainly with the help
51
+ of signs and symptoms related to “Mutra” (Urine).
52
+ Genetic predisposition with sedentary life style, inju-
53
+ dicious intake of food, and stress are recognized as some
54
+ of the important etiological factors of Prameha, [3]. The
55
+ diagnosis and management of diabetes (madhumeha) is
56
+ based on tridosa (bodily humor) theory which says that
57
+ kapha (phlegm), pitta (bile) and vata (wind) are the basic
58
+ pillars of life [4]; balanced functioning of these tridosas
59
+ is health and imbalance is disease [5]. A disturbance in
60
+ the doshas precedes the genesis of various pathological
61
+ states which results to 20 types of Prameha where finally
62
+ diabetes (madhumeha) is one of the chronic type of
63
+ Prameha. Thus, the primary aim in prevention, diagnosis
64
+ and treatment of a disease is to detect the degree of
65
+ vitiation in these doshas.
66
+ Several studies have shown the beneficial effects of
67
+ Ayurveda in T2DM with significant reduction in Glyco-
68
+ sylated Haemoglobin (HbA1c), Fasting and Post Prandial
69
+ Copyright © 2013 SciRes. OJEMD
70
+ B. VAIBHAVI ET AL.
71
+ 91
72
+ Blood Glucose (FBG, PPBG) levels and lipids [6-8]. A
73
+ study by Ahmed et al. that treated diabetic rats with the
74
+ fruit juice of Momordia charantia has reported rege-
75
+ neration or increase in the number of beta cells [9],
76
+ which appears to offer some evidence to the additional
77
+ benefits of Ayurveda because none of the conventional
78
+ Oral Hypoglycemic Agents (OHA) exhibit this property.
79
+ Momordia charantia also has exhibited extra-pancreatic
80
+ effects with improved peripheral glucose utilization [10].
81
+ Recent studies [11,12] have described the role of a few
82
+ herbs like Trigonella foenum graecum and Tinospora
83
+ cordifolia on activities of enzymes involved in carbo-
84
+ hydrate and lipid metabolism. In animal based studies,
85
+ herbs like Curcuma longa have shown reduction in
86
+ dyslipidemia in diabetics [13] through its effect on lipid
87
+ peroxidation [14].
88
+ Ayurveda being a holistic science, it has to be pra-
89
+ cticed as a whole science including several steps of
90
+ management and cannot be given only as one capsule of
91
+ a proven herbal preparation. Hence it was necessary to
92
+ review the classical texts and compile them to present a
93
+ holistic management protocol in the form of flow chart
94
+ with different steps, which was finally done and sent for
95
+ validation from various Ayurveda experts [15].
96
+ Yoga is also one of the modalities in Complimentary
97
+ and Alternative Medicine (CAM) which is an integral
98
+ part of Ayurveda (mentioned in classical texts) [16].
99
+ Yoga is found to be very effective as a complimentary
100
+ treatment for type 2 diabetes in several studies [17-19].
101
+ Studies have demonstrated significant reduction in FBG,
102
+ PPBG [20-22] Glycosylated Haemoglobin (HbA1c) [22],
103
+ improvement in nerve functions [22], reduction in oral
104
+ glycemic agents [23] and Body Mass Index (BMI) [24]
105
+ after the practice of Yoga.
106
+ Multiple factors involved in the pathogenesis of
107
+ diabetes demands a multi-modal remedial approach [25].
108
+ Although there are many studies that reveal the efficacy
109
+ of CAM modalities, there are very few studies which
110
+ report the efficacy of these modalities when used
111
+ together. Since there are ample evidences that Ayurveda
112
+ can be a potential complimentary therapy for diabetes
113
+ [6-8], it would be worthwhile to test its efficacy when
114
+ combined with Yoga, which is also one of the CAM
115
+ modalities having large number evidence based studies
116
+ supporting its effect in type 2 diabetes.
117
+ Hence this pilot study was planned with an intention of
118
+ assessing the feasibility and safety of this residential
119
+ Ayurveda and Yoga therapy before launching a con-
120
+ trolled study on a larger population.
121
+ 2. Materials and Methods
122
+ 2.1. Subjects
123
+ Twelve (n = 12) subjects (7 female, 5 male) in age range
124
+ of 40 - 70 years (mean 56 ± 9.08) with Type 2 Diabetes
125
+ Mellitus (T2DM) were recruited for the study. The
126
+ sample size was calculated based on an effect size
127
+ (Cohen’s effect size, ε = 2.45) obtained from a previous
128
+ study of changes following the practices of Yoga in DM
129
+ patients [16]. It was calculated using G*Power software,
130
+ Version 3.0.10, where the level was 0.05 and power =
131
+ 0.95 and the recommended sample size was twelve. Thus,
132
+ a sample size of twelve was recruited for the present study.
133
+ Subjects who satisfied the American Diabetes Association
134
+ (ADA) criteria for T2DM [26], not practicing Yoga for at
135
+ least previous three months and willing to participate in
136
+ the trial were included. Those with cardiac complications
137
+ and nephropathy were excluded after checking ECG,
138
+ FBG, blood urea, and creatinin. Those with proliferative
139
+ retinopathy (screened by an ophthalmologist) and had
140
+ practiced Yoga in the recent past (three months) were
141
+ also excluded. Ethical clearance was obtained from
142
+ institutional ethical committee. Signed informed consent
143
+ was obtained from all subjects.
144
+ 2.2. Design
145
+ This was an experimental pilot study with a pre post
146
+ design in a single group.
147
+ 2.3. Methods
148
+ All subjects went through a daily routine (Table 1) that
149
+ included Integrated Approach of Yoga Therapy for Diabetes
150
+ (IAYTD) along with a progressive plan of panchakarma
151
+ (purificatory therapy) and maintenance herbs.
152
+ The protocol had the flexibility for changes in medica-
153
+ tion or Yoga practices based on their daily response as-
154
+ sessments. After admission, first week was planned for
155
+ stabilization of the baseline parameters without any in-
156
+ tervention. The fasting (12-hr) blood sample was ob-
157
+ tained via a veni-puncture in the arm with the individual
158
+ in an upright position and after at least 5 min in a resting
159
+ state. Supervised intervention with strict adherence to the
160
+ schedule was followed from the beginning of second to
161
+ end of fifth week. The clinical progress was monitored
162
+ daily by one Ayurveda and one allopathic physician;
163
+ therapies were carried out by certified therapists and
164
+ documentation was done by the research team. The sub-
165
+ jects were monitored daily for symptoms scores, medica-
166
+ tion scores (number of OHA tablets per day), pulse rate,
167
+ blood pressure, respiratory rate and blood glucose (glu-
168
+ cometer). Diet was planned based on nutritional and
169
+ dosha assessments. Post assessments were done in sixth
170
+ week when the patients continued to remain in the cam-
171
+ pus attending the same daily routine on their own without
172
+ instructions by the therapists. After discharge they were
173
+ given the diet chart, personalized Yoga chart with in-
174
+ struction DVD, and maintenance medication. Home
175
+ Copyright © 2013 SciRes. OJEMD
176
+ B. VAIBHAVI ET AL.
177
+ 92
178
+ Table 1. Ayurveda protocol.
179
+ Ayurveda protocol
180
+ Treatment plan
181
+ Drugs used in treatment plan
182
+ with their dosage and time
183
+ Appetizer, digestive drugs
184
+ (Deepana/Paachan) for 3 - 7
185
+ days
186
+ Trikatu churna [27] 2 gms twice
187
+ daily before food
188
+ Internal oleation for 3 - 7
189
+ days (Snehapaan)
190
+ Sarshapa tail [28]
191
+ 30ml/60ml/90ml in increasing
192
+ dose
193
+ External oleation with
194
+ sudation (Abhyanga/Swedan)
195
+ for 3 days
196
+ Brihat saindhavadi Taila [29]
197
+ (external application)
198
+ Purgation (Virechan) 1 day
199
+ Trivrit lehyam [30] 30 - 60 gms
200
+ Post purgation diet
201
+ restrictions
202
+ (Samsarjana/Krama ) for 3 -
203
+ 5 days
204
+ -
205
+ Palliative therapy (Shamana)
206
+ to be continued
207
+ Kathakhadiradi kashaya [31] 15
208
+ ml twice daily. Amritmehari
209
+ churna [32] 2 gms twice daily.
210
+ Shilajatwadi vati [33] 2 tabs
211
+ thrice daily
212
+
213
+ practice was monitored up to 12 weeks by regular moti-
214
+ vating phone calls. HbA1c was assessed at the end of
215
+ twelfth week.
216
+ 2.4. Intervention
217
+ A validated Ayurveda protocol developed on the basis of
218
+ classical scriptural references was used which included
219
+ panchakarma followed by maintenance medication (Ta-
220
+ ble 2). Along with Ayurveda protocol, the module of
221
+ Integrated Approach of Yoga Therapy (IAYTD) for dia-
222
+ betes comprised of Yogasanas, Pranayama, meditation
223
+ and lectures as used in our two earlier studies in India
224
+ [23,34] and UK [17] (Table 3).
225
+ 2.5. Outcome Measures
226
+ Ama, agni and kostha were assessed at baseline using a
227
+ check list prepared for the purpose of this study based on
228
+ guidelines in classical texts. Agni was scored on a three
229
+ point scale 1 = mandagni (less digestive capacity), 2 = mad-
230
+ hyagni (medium digestive capacity) and 3 = pravaragni
231
+ (more digestive capacity). The end point of the cleansing
232
+ procedure was considered to be when ama score reached
233
+ a balanced score of 1. Koshta (colonic sensitivity) was
234
+ assessed based on seven questions with three response
235
+ choices. A total score of 1 to 7 indicates mrudu koshta
236
+ (more colonic sensitivity), 8 to 18 madhyam koshta (me-
237
+ dium colonic sensitivity) and 19 to 21 krura koshta (less co-
238
+ lonic sensitivity). These assessments were done at baseline
239
+ and daily for assessing the effect of panchakarma procedure.
240
+ Table 2. Daily schedule of subjects.
241
+ Daily schedule of subjects
242
+ Time (hours)
243
+ Duration
244
+ (minutes)
245
+ Yoga practice
246
+ 5.00 - 5.30
247
+ 30
248
+ Om meditation
249
+ 5.30 - 6.30
250
+ 60
251
+ Yoga based special technique 1
252
+ (physical practices)/kriyas
253
+ 6.30 - 7.30
254
+ 60
255
+ Bath and wash
256
+ 7.30 - 8.15
257
+ 45
258
+ Lecture on bhagvadgita/chanting
259
+ 8.15 - 8.45
260
+ 30
261
+ Breakfast
262
+ 8.45 - 10.00
263
+ 75
264
+ Rest
265
+ 10.00 - 11.00
266
+ 60
267
+ Lecture (on ayurvedic and yogic
268
+ lifestyle)
269
+ 11.00 - 12.00
270
+ 60
271
+ Pranayama (breathing practices)
272
+ 12.00 - 13.00
273
+ 60
274
+ Yoga based special technique 2
275
+ (physical practices)
276
+ 13.00 - 14.00
277
+ 60
278
+ Lunch (vegetarian diabetic diet)
279
+ 14.00 - 14.30
280
+ 30
281
+ Deep Relaxation Technique (DRT)
282
+ 14.30 - 16.00
283
+ 90
284
+ Assessments, psychological and
285
+ yogic counseling
286
+ 16.00 - 17.00
287
+ 60
288
+ Cyclic Meditation (CM)
289
+ 17.00 - 18.00
290
+ 60
291
+ Tuning to nature
292
+ 18.00 - 19.00
293
+ 60
294
+ Divine hymns session (Bhajan)
295
+ 19.00 - 19.45
296
+ 45
297
+ Mind sound resonance technique
298
+ 19.45 - 20.30
299
+ 45
300
+ Dinner ( vegetarian diabetic diet)
301
+ 20.30 - 21.30
302
+ 60
303
+ Cleansing technique for eye
304
+ (Trataka)
305
+ 21.30 - 22.00
306
+ 30
307
+ Self study
308
+ 22.00
309
+ -
310
+ Lights off
311
+ 2.5.1. Symptom Score
312
+ The average severity of all symptoms documented before
313
+ and after the 6 weeks was recorded. Severity was scored
314
+ on a 4-point scale of 0 - 3 (0 = nil, 1-mild not disturbing
315
+ the daily routine, 2 = moderate-disturbs routine requires
316
+ symptomatic medication, 3 = severe-require hospital-
317
+ ization or parenteral medication).
318
+ 2.5.2. Medication Score
319
+ Number of tables of Oral Hypoglycemic Agent (OHA)/day;
320
+ 1 tablet = the standard strength each for adults quoted in
321
+ pharmacopeia index e.g. one tablet of Metformin = 500 mg.
322
+ 2.5.3. Guna Assessment
323
+ The G-Inventory [35] (GI) assessed the shift of guna
324
+ dominance after the intervention. GI is a measure of the
325
+ Copyright © 2013 SciRes. OJEMD
326
+ B. VAIBHAVI ET AL.
327
+ Copyright © 2013 SciRes. OJEMD
328
+ 93
329
+
330
+ Table 3 Demographic details of the subject
331
+ Sub no.
332
+ Name
333
+ Age
334
+ (years)
335
+ Sex
336
+ (M/F)
337
+ Duration of
338
+ DM in years
339
+ **Family H/O
340
+ DM
341
+ Creatinine
342
+ (mg/dl)
343
+ Urea
344
+ (mg/dl)
345
+ Agni
346
+ Ama
347
+ Kostha
348
+ 1
349
+ SS
350
+ 69
351
+ M
352
+ 03
353
+ N
354
+ 1.3
355
+ 30.8
356
+ 1
357
+ 3
358
+ 19
359
+ 2
360
+ AS
361
+ 48
362
+ F
363
+ 5.5
364
+ N
365
+ 0.78
366
+ 29.4
367
+ 3
368
+ 3
369
+ 9
370
+ 3
371
+ MG
372
+ 55
373
+ M
374
+ 12
375
+ N
376
+ 0.90
377
+ 30.3
378
+ 1
379
+ 3
380
+ 9
381
+ 4
382
+ R
383
+ 68
384
+ F
385
+ 08
386
+ N
387
+ 0.7
388
+ 28
389
+ 1
390
+ 3
391
+ 12
392
+ 5
393
+ H
394
+ 56
395
+ F
396
+ 15
397
+ F
398
+ 0.86
399
+ 34.2
400
+ 1
401
+ 3
402
+ 8
403
+ 6
404
+ TC
405
+ 49
406
+ F
407
+ 14
408
+ M/B
409
+ 0.85
410
+ 18.6
411
+ 3
412
+ 2
413
+ 9
414
+ 7
415
+ BS
416
+ 50
417
+ F
418
+ 16
419
+ B/S
420
+ 0.86
421
+ 21.7
422
+ 1
423
+ 3
424
+ 7
425
+ 8
426
+ AS
427
+ 40
428
+ M
429
+ 04
430
+ B
431
+ 0.72
432
+ 22.8
433
+ 1
434
+ 3
435
+ 18
436
+ 9
437
+ Hu
438
+ 52
439
+ M
440
+ 07
441
+ N
442
+ 0.8
443
+ 39.5
444
+ 2
445
+ 3
446
+ 19
447
+ 10
448
+ A
449
+ 61
450
+ F
451
+ 11
452
+ S
453
+ 1.0
454
+ 20.0
455
+ 1
456
+ 3
457
+ 11
458
+ 11
459
+ S
460
+ 63
461
+ F
462
+ 25
463
+ GF
464
+ 1.0
465
+ 23.0
466
+ 2
467
+ 2
468
+ 13
469
+ 12
470
+ D
471
+ 66
472
+ M
473
+ 9
474
+ B
475
+ 1.2
476
+ 19.0
477
+ 1
478
+ 3
479
+ 7
480
+ **F—Father, M—Mother, B—Brother, S—Sister, GF—Grandfather, GM—Grandmother, N—Nil history.
481
+
482
+ three gunas (sattva, rajas and tamas) and contains ten
483
+ questions with three response choices. A total score of
484
+ above 28 indicates sattva, 24 to 28 rajas and <24 tamas.
485
+ This test has a test retest reliability of 0.60 with a confi-
486
+ dence level of 99% and has been validated. Biochemical
487
+ parameters: these included Fasting (FBG) and Post Pran-
488
+ dial Blood Glucose (PPBG), HbA1c and lipid profile
489
+ determined at baseline and at the end of 6th week. HbA1c
490
+ was repeated at end of 12th week. A semi-auto analyzer
491
+ was used for the biochemical measurements. Blood Glu-
492
+ cose was determined by enzymatic oxidation method
493
+ using glucose peroxidase [36]. HbA1c was estimated by
494
+ glucose oxidase method and cation-exchange resin me-
495
+ thod [37]. Cholesterol was determined after enzymatic
496
+ hydrolysis and oxidation [38]. Triglycerides were deter-
497
+ mined after enzymatic splitting with lipoprotein lipase.
498
+ Indicator for the same was generated from 4-aminoanti-
499
+ pyrine and 4-chlorophenol by hydrogen peroxide under
500
+ the catalytic action of peroxidase. LDL-VLDL Choles-
501
+ terol was determined by using Friedewald’s equation
502
+ [39].
503
+ 3. Statistical Analysis
504
+ Data were analyzed using SPSS version 16.0; checked
505
+ for normal distribution by Shapiro Wilk’s test. As the
506
+ data were normally distributed for all variables student’s
507
+ paired samples “t” test was used with a significance
508
+ value set at 0.05 for two-sided hypothesis testing.
509
+ 4. Results
510
+ Table 3 gives the demographic characteristics of subjects.
511
+ The mean age was 56 ± 9.08 years. None had cardiac,
512
+ renal or retinal complications. There were no drop outs in
513
+ this study. At baseline, 2 subjects had madhyam ama and
514
+ 10 had pravara ama, while 10 subjects had manda agni
515
+ and 2 had madhyam agni and 3 subjects had mrudu
516
+ kostha, 7 had madhyam kostha and 2 had krura kostha.
517
+ Table 4 shows the results after the intervention.
518
+ After 6 weeks of intervention, the symptom score re-
519
+ duced from 2.83 ± 1.02 to 1.66 ± 0.65 (p < 0.001). OHA
520
+ score reduced (p < 0.001) from 2.83 ± 0.93 to 1 ± 1.27
521
+ (64.66%). FBG reduced (p < 0.05) from 129.31 ± 58.11
522
+ to 103.54 ± 40.74 (19.93%). PPBG decreased from
523
+ 191.69 ± 76.77 to 152.92 ± 62.06 (20.23%, p < 0.05).
524
+ HbA1c reduced (p = 0.014) from 8.79 ± 2.12 to 8.07±
525
+ 1.77 (8.19%) in 6th week. It reduced further to 7.63 ±
526
+ 2.12 (13.19%, p = 0.001) after 12th week. At baseline
527
+ guna questionnaire showed 6 subjects each with rajas and
528
+ tamas dominance. On post assessments, two subjects
529
+ shifted from tamas to rajas dominance. All of them had
530
+ balanced functioning of agni, ama and kostha at the end
531
+ of 6 weeks.
532
+ Lipid profile: Total Cholesterol decreased significantly
533
+ (p < 0.05) from 209 ± 33.7 to 186.92 ± 23.36 (10.56%).
534
+ Triglycerides reduced (p < 0.05) from 198.25 ± 94.78 to
535
+ 151.25 ± 43.65 (23.71%). There was non-significant
536
+ reduction in the levels of LDL, VLDL and HDL.
537
+ 5. Discussion
538
+ This pilot study on twelve subjects with T2DM has
539
+ shown significant reduction in FBG, PPBG, HbA1c, TC
540
+ nd TG along with reduction in oral hypoglycemic
541
+ a
542
+
543
+ B. VAIBHAVI ET AL.
544
+ 94
545
+
546
+ Table 4. Results after the intervention.
547
+ Post intervention changes#
548
+ Variables
549
+ Pre (1st week)
550
+ Mean ± SD
551
+ Post (6th week)
552
+ Mean ± SD
553
+ Post2 (12th week)
554
+ Mean ± SD
555
+ p-value
556
+ Medication scores
557
+ 2.83 ± 0.93
558
+ 1 ±1.27***
559
+ -
560
+ 0.001
561
+ Symptom score
562
+ 2.83 ± 1.02
563
+ 1.66 ± 0.65***
564
+ -
565
+ 0.001
566
+ FBG
567
+ 129.31 ± 58.11
568
+ 103.54 ± 40.74*
569
+ -
570
+ 0.017
571
+ PPBG
572
+ 191.69 ± 76.77
573
+ 152.92 ± 62.06*
574
+ -
575
+ 0.013
576
+ HbA1c
577
+ 8.79 ± 2.12
578
+ -
579
+ 7.63 ± 2.12***
580
+ 0.001
581
+ Total Cholesterol
582
+ 209 ± 33.7
583
+ 186.92 ± 23.36*
584
+ -
585
+ 0.024
586
+ Total Triglycerides
587
+ 198.25 ± 94.78
588
+ 151.25 ± 43.65*
589
+ -
590
+ 0.020
591
+ LDL
592
+ 129.42 ± 29.63
593
+ 115.25 ± 15.63
594
+ -
595
+ 0.121
596
+ VLDL
597
+ 39.65 ± 18.96
598
+ 38.5 ± 33.5
599
+ -
600
+ 0.907
601
+ *p < 0.05, **p < 0.01, ***p < 0.001, baseline data compared with the post data using a paired “t” test. Fasting Blood Glucose (FBG), Post Prandial Blood Glu-
602
+ cose (PPBG), Glycosylated Hemoglobin (HbA1c), Total Cholesterol (TC), Total Triglycerides (TG), Low Density Lipoprotein (LDL), Very Low Density
603
+ Lipoprotein (VLDL). #Note: These significant values stated are based on single group pre comparison to post. There is no control group which is an imita-
604
+ tion of this study and that can also effect p-values when compared with control groups in main efficacy study.
605
+
606
+ medication and balanced functioning of agni, ama and
607
+ kostha after six weeks of residential intervention using
608
+ Yoga and Ayurveda.
609
+ 5.1. Comparisons
610
+ To the best of our knowledge, there are no studies which
611
+ report the effect of a combination of Yoga and Ayurveda
612
+ (panchakarma and maintenance therapy) although there
613
+ are studies on these two therapeutic modalities used
614
+ independently in comparison to conventional medicine.
615
+ Kumari et al. [8]. Assessed the effect of panchakarma
616
+ followed by maintenance ayurvedic herbal therapy in
617
+ forty two subjects with T2DM, which showed significant
618
+ reduction in FBG and PPBG by 10.2% and 6.4%
619
+ respectively after one month of intervention. In one of
620
+ our earlier Yoga studies we had observed a decrease in
621
+ FBG and HbA1c by 6.9% and 15.5% after an integrated
622
+ Yoga protocol in a control study on diabetics in London
623
+ [17]. Sahay et al. showed that Yoga was effective in
624
+ reducing TC (by 0.47%) and TG (by 18.03%) [25]. In
625
+ comparison, the present study has shown reduction in
626
+ mean values of FBG (19.9%), PPBG (20.2%), HbA1c
627
+ (13.2%), TC (10.6%), and TG (23.7%). These values
628
+ (except HbA1c) showed higher magnitude of change
629
+ than the independent Yoga or Ayurveda studies. There
630
+ are other studies on Ayurveda in T2DM that have shown
631
+ encouraging results. Elder et al. randomized 60 adults
632
+ with newly diagnosed T2DM (baseline HbA1c of 6.0 to
633
+ 8.0) into experimental and control groups. The Ayurveda
634
+ protocol included Ayurvedic diet, meditation and
635
+ Ayurvedic herbal supplement (MA 471). The results
636
+ showed significant difference between groups (ANCOVA)
637
+ in HbA1c, FBG, TC, LDL and body weight in those who
638
+ had higher baseline HbA1c [6]. Saxena and Vikram
639
+ reviewed the accumulated literature on ten herbs with
640
+ antidiabetic activity and reported that momordica
641
+ charantia, pterocarpus marsupium and trigonella foenum
642
+ greacum have beneficial effects in treating T2DM [40].
643
+ The results of many other studies on Yoga are also
644
+ consistent with the outcomes of present study [17]. Yoga
645
+ nidra (a form of guided relaxation) resulted in decreased
646
+ FBG, PPBG, in patients with T2DM [41]. Looking at
647
+ cardiac functions Singh et al. showed that training in
648
+ Yoga asanas for forty days in 24 T2DM decreased their
649
+ pulse rate, blood pressure, and Corrected QT interval in
650
+ addition to decrease in FBG (25.5%), PPBG (27.03%)
651
+ and HbA1c (13.3%) [42]. A randomized control study
652
+ that used Nadishodhana Pranayama and Sun Salutation
653
+ for 5 weeks in twenty T2DM has shown significant
654
+ decrease in plasma glucose, serum cortisol and serum
655
+ Malone-Di-Aldehyde (MDA) levels and a significant
656
+ increase in serum Super Oxide Dismutase (SOD) activity,
657
+ more prominently in those who has poor glycemic
658
+ control [43].
659
+ 5.2. Mechanism
660
+ According to the present day molecular biological under-
661
+ standing of T2DM, the etiology is traceable to erratic life
662
+ style that promotes expression of the diabetes related
663
+ genes [44]; this results in a series of imbalances [calorie
664
+ intake-out put = obesity, adipoleptin-nectin = IR; [45]
665
+ proinflammatory—anti-inflammatory cytokines = tissue
666
+ Copyright © 2013 SciRes. OJEMD
667
+ B. VAIBHAVI ET AL.
668
+ 95
669
+ inflammation [46] resulting in insulin resistance which in
670
+ turn is responsible for the biochemical changes and the
671
+ clinical manifestations. Thus, the benefits may be traced
672
+ to reduction in oxidative stress mediators, modified HPA
673
+ axis [47], reduction in adipoleptin [48], and pro-inflam-
674
+ matory cytokines [49] that are known to induce IR. The
675
+ mechanism described by Yoga and Ayurveda offers a
676
+ different model of understanding T2DM. Accordingly,
677
+ diabetes is the effect of erratic life style that has resulted
678
+ from lack of mastery over the mind and wrong notion
679
+ about the meaning and purpose of life (prajnaparadha).
680
+ The flow chart in Table 5 shows the pathogenesis of
681
+ T2DM. Yoga masters proposed that the human system is
682
+ made of five levels of subtle bodies [annamaya (physi-
683
+ cal), pranamaya (vital energy), manomaya (mental), vij-
684
+ nanamaya (intellectual) and anandamaya (bliss) kosas]
685
+ [50]. Three gunas (satva, rajas and tamas) that grossify
686
+ into three doshas (vata, pitta and kapha) constitute the
687
+ physical body (annamaya kosha). Man is in best of health
688
+ when there is a balanced functioning of the tridosas
689
+ which is possible when the mind is in a state of satva
690
+ (freedom from stress) and established in anandamaya
691
+ kosha. T2DM, madhumeha [8] is a tridoshaja vyadhi, i.e.
692
+ there is vitiation of all three dosas which is preceded by
693
+ imbalance of the three gunas [dominance of tamas and/or
694
+ rajas]. T2DM, a life style disease (samanya adhija vya-
695
+ dhi), begins in manomaya kosha. This is due to lack of
696
+ right knowledge (a function of vijnanamaya kosha) that
697
+ “I am made of happiness and freedom from all thoughts”.
698
+ This leads to craving for happiness from outside objects
699
+ (wealth and fame). Long standing stresses (due to unsat-
700
+ isfied desires) leads to sleeplessness, irritability, indeci-
701
+ siveness, depression, and/or frustration (violent negative
702
+ emotions). The long standing suppressed emotions are
703
+ characterized by uncontrolled rewinding of thoughts in
704
+ the mind (yogic definition of stress).This habituated un-
705
+ controlled speed percolates in to the pranamaya kosha
706
+ and drains large quantities of prana leading to early aging
707
+ (DM is an aging disease). This uncontrolled habituated
708
+ speed results in an imbalance that further settles down in
709
+ the physical body as structural damage (inflammation =
710
+ speed at annamaya kosha). This descent (prasava) from a
711
+ balanced state of functioning of the mind-body complex
712
+ results in an imbalance of the three doshas. Caraka, the
713
+ father of Ayurveda, describes T2DM as a disease char-
714
+ acterized by covering (avarana) of excess kapha over
715
+ vata that leads to obstruction in the harmonious move-
716
+ ment of vata, and this obstructed/restricted movement in
717
+ turn leads to stagnation and unavailability of pitta that is
718
+ responsible for healthy metabolic processes in tissues. In
719
+ addition, the obstructed vata gets aggravated and gets
720
+ vitiated further [51]. Thus, T2DM begins with wrong life
721
+ style due to adnyana (pragnaparadha) that leads to kapha
722
+ dosha or tamo guna pradhanaka vihara and ahara (seden-
723
+ tary life- style, day time sleeping, excessive intake of
724
+ fermented foods, oily foods, excess sweets and meat).
725
+ This domi- nance of kapha results in agnimandya (im-
726
+ proper func- tioning of digestive fire). This goes on to
727
+ produce excess ama (endotoxins) which blocks the
728
+ channels (srotas) thus preventing the balanced flow of
729
+ vata. The vitiated kapha circulates throughout the body
730
+ resulting in dhatwagni mandya (poor functioning of di-
731
+ gestive fire at tissue level). It affects the dushya struc-
732
+ tures, the dhatus (tissues). Adipose tissue (medas) is the
733
+ first dushya to be affected. Then it goes on to affect all
734
+ other structures of the body including muscular tissue
735
+ (mansa), intracellular and extra cellular fluids (kleda),
736
+ vasa (muscle fat), shukra (semen), rakta (blood), majja
737
+ (marrow tissue), rasa (blood plasma), lasika (fluids &
738
+ plasma) and ojas (vital substance that maintains immu-
739
+ nity). Mutravaha srotas is the main channel to be affected
740
+ that leads to madhumeha [52].
741
+ The holistic module of management of T2DM is based
742
+ on measurement of the status of guna, the genetic per-
743
+ sonality type (prakrti), the present state of imbalance of
744
+ the doshas (vikrti), the status of dushya, srotas, agni and
745
+ ama at all stages of therapy.
746
+ It includes manifold techniques that possess the ability
747
+ to reinstate homeostasis (pratiprasava) through increas-
748
+ ing the satva guna and balancing the vitiated doshas. The
749
+ integrated approach to yoga therapy (IAYT) prescribes
750
+ practices at all the five koshas to arrive at complete mas-
751
+ tery over the modifications of mind and remain in a state
752
+ of inner contentment and joyful existence under all cir-
753
+ cumstances of life. The physical practices begin with
754
+ cleansing the system of all endotoxins. This is achieved
755
+ through satkriyas (Yoga) or panchakarma (Ayurveda).
756
+ The stepwise progression of panchakarma starts with
757
+ stimulating the excretion of the endotoxins (ama) through
758
+ Snehana-Abhyangam (external and internal oleation
759
+ through medicated massage) and swedana (induced
760
+ sweating) followed by Virechana that helps in dislodging
761
+ the vitiated doshas (excess kapha and pitta) [8] through
762
+ purgation. This is followed by sanshamana (soothing
763
+ relaxation) through herbal therapies for maintenance of
764
+ balance. Thus, panchakarma removes ama, reduces
765
+ kapha, clears the avarana (covering), cleanses the srotas,
766
+ improves agni, promotes normal flow of vata, normalizes
767
+ pitta and restores dhatwagni that promotes normal func-
768
+ tioning of dhatus. IAYT, a mind body intervention adds
769
+ on the component of self corrective processes to restore
770
+ balance at all levels through deep rest. In summary,
771
+ avoiding the etiological factors (nidan parivarjana)
772
+ through lifestyle change [by mind mastery through jnana
773
+ Yoga (right knowledge), raja Yoga, karma Yoga and
774
+ bhakti Yoga] [55], detoxification through panchakarma,
775
+ Copyright © 2013 SciRes. OJEMD
776
+ B. VAIBHAVI ET AL.
777
+ Copyright © 2013 SciRes. OJEMD
778
+ 96
779
+
780
+
781
+
782
+
783
+ Table 5. Pathophysiology and management of Type 2 Diabetes Mellitus according to Ayurveda, Yoga and biomedicine.
784
+ Pathophysiology according to
785
+ Ayurveda and Yoga [53]
786
+ Reversing Pathophysiology Ayurveda
787
+ and Yoga [54]
788
+ Pathophysiology according to
789
+ modern [46]
790
+ Reversing the
791
+ Pathophysiology
792
+ modern [46]
793
+
794
+
795
+
796
+ correct the dosha imbalance and clear the subtle channels
797
+ through medication, asanas and pranayama forms the
798
+ basis of this integrated Yoga and Ayurveda model used
799
+ in this program. Long term regular monitoring is neces-
800
+ sary to prevent return of the imbalance that is genetically
801
+ determined in T2DM. This is ensured by lifelong regular
802
+ IAYT and medication.
803
+ 6. Strength of the Study
804
+ This is the first attempt to test the efficacy of multi mo-
805
+ dalities of CAM in a residential setting using standard
806
+ tools of assessment. The development of an integrated
807
+ module by an exhaustive search of all available texts of
808
+ Ayurveda and Yoga (16 texts) with a sound conceptual
809
+ basis for the holistic approach is the major contribution
810
+ of this study. Rendering the traditional knowledge in an
811
+ acceptable capsule for the present day elite community of
812
+ diabetics has been achieved by this pilot study.
813
+ 7. Limitations of the Study
814
+ Sample size was small and no control group was planned.
815
+ There is lack of a control group using either of Yoga and
816
+ Ayurveda, the comparison with other single method
817
+ study is not very valid. As this was a pilot study and not
818
+ an efficacy trial the conclusions from the study are only
819
+ pointers to a larger study and not a proof of concept.
820
+ 8. Implications and Suggestions for Future
821
+ Work
822
+ The Yoga and Ayurveda model of etio-pathogenesis of
823
+ T2DM based on the concepts of imbalance of gunas and
824
+ doshas offers an opening to subtler dimensions Holistic
825
+ way of understanding of this disease and may bring about
826
+ a paradigm shift in diabetes research. This pilot study has
827
+ prepared the ground for a four armed control study that
828
+ has been funded by dept. of AYUSH, ministry of health
829
+ and family welfare, Govt. of Karnataka, India. Statisti-
830
+ cally acceptable sample sizes, with a battery of assess-
831
+ ment of the cognitive functions (subjective and objective),
832
+ autonomic functions along with biochemical, molecular,
833
+ genetic, immunological variables has been included in
834
+ the proposed project.
835
+ 9. Conclusion
836
+ This pilot study has shown the safety, feasibility and in-
837
+ dication of a potentially beneficial effect of an integrated
838
+ Yoga and Ayurveda module in achieving good glycemic
839
+ control and lipid profile with reduced requirement of
840
+ B. VAIBHAVI ET AL.
841
+ 97
842
+ Oral Hypoglycemic Agents in patients with T2DM. This
843
+ has prepared the ground for an efficacy trial.
844
+ 10. Acknowledgements
845
+ We thank the faculty of Susruta Ayurveda College, Ban-
846
+ galore for their help in preparing the module of Ayurveda
847
+ protocol. We thank the therapists of S-VYASA for their
848
+ support in carrying out the study. We thank Dr. Pradhan
849
+ B. for his support with statistics and Dr. Haldavnekar R.
850
+ for her continuous support during the study.
851
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852
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853
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+ [10] I. Ahmed, E. Adeghate, A. K. Sharma, D. J. Pallot and J.
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+ the Association of Physicians of India, Vol. 52, 2004, pp.
950
+ 203-206.
951
+ [22] V. Malhotra, S. Singh, O. P. Tandon, S. V. Madhu, A.
952
+ Prasad and S. B. Sharma, “Effect of Yogasanas on Nerve
953
+ Conduction in Type 2 Diabetes,” Indian Journal of
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+ Physiology and Pharmacology, Vol. 46, No. 3, 2002, pp.
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+ 298-306.
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+ [23] S. C. Jain, A. Uppal, S. O. Bhatnagar and B. Talukdar, “A
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+ Study of Response Pattern of Noninsulin Dependent
958
+ Diabetics to Yoga Therapy,” Diabetes Research and
959
+ Clinical Practice, Vol. 19, No. 1, 1993, pp. 69-74.
960
+ doi:10.1016/0168-8227(93)90146-V
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+ [24] M. Kosuri and G. Sridhar, “Yoga Practice in Diabetes
962
+ Improves Physical and Psychological Outcomes,” Meta-
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+ Copyright © 2013 SciRes. OJEMD
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+ B. VAIBHAVI ET AL.
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+ Copyright © 2013 SciRes. OJEMD
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+ bolic Syndrome and Related Disorders, Vol. 7, No. 6,
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+ 2009, pp. 515-517. doi:10.1089/met.2009.0011
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+ tiple Therapeutic Approaches of Phytochemicals: Present
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+ Status and Future Prospects,” Current Science, Vol. 83,
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+ Care in Diabetes—2011”, American Diabetes Association
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+ Diabetes Care, Vol. 34, No. 1, 2011, pp. S11-S61.
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+ [27] G. K. Garde, “Sartha Vaghbhata,” In: Sutrasthana, Rag-
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+ huvamshi Publishers, Pune, 1996, p. 35.
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+ [28] K. N. Shastri and G. N. Chaturvedi, “Agnivesha’s Cha-
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+ raka Samhita, Vidyotini Commentary,” In: Chikitsast-
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+ hana, Chaukhamba Bharati Academy, Varanasi, 2004, p.
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+ 235.
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+ [29] G. M. Shastri, “Bhavprakash,” In: Chikitsa Prakarana
983
+ Verse 117-118, Sastu Sahitya Vardhaka Karyalaya, Ah-
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+ medabad, 1966, p. 1117.
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+ huvamshi Publishers, Pune, 1996, p. 338.
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+ [31] D. K. Nishteswar and R. Vidyanath, “Sahasrayogam,” In:
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+ Prameha Prakarana, Chawkhamba Samkrit Series Office,
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+ Varanasi, 2006, p. 30.
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+ [32] D. K. Nishteswar and R. Vidyanath, “Sahasrayogam,” In:
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+ Prameha Prakarana, Chawkhamba Samkrit Series Office,
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+ Varanasi, 2006.
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+ [33] S. Ambikadutta, “Bhaishajyaratnavali,” In: Pradararoga
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+ Chikitsa, Chowkhamba Samskrit Academy, Varanasi,
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+ 2008, p. 1035.
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+ [34] B. K. Sahay, “Role of Yoga in Diabetes,” Journal of the
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+ Association of Physicians of India, Vol. 55, 2007, pp. 121-
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+ 126.
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+ [35] S. Despande, H. R. Nagendra and R. Nagarathna, “A
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+ Randomized Control Trial of the Effect of Yoga on
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+ Gunas (Personality) and Health in Healthy Volunteers,”
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+ International Journal of Yoga, Vol. 1, No. 1, 2008, pp. 2-
1003
+ 10. doi:10.4103/0973-6131.36785
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+ [36] P. Trinder, “Analysis of Glucose,” Ann Clin Biochem,
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+ Vol. 6, 1969, p. 24.
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+ [37] D. M. Nathan, D. E. Singer, K. Hurxthal and J. D.
1007
+ Goodson, “The Clinical Information Value of the Glyco-
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+ sylated Hemoglobin Assay,” The New England Journal of
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+ Medicine, Vol. 310, No. 6, 1984, pp. 341-346.
1010
+ doi:10.1056/NEJM198402093100602
1011
+ [38] J. D. Artiss and B. Zak, “Measurement of Cholesterol
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+ Concentration,” In: N. Rifai, G. R. Warnick and M. H.
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+ Dominiczak, Eds., Handbook of Lipoprotein Testing,
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+ AACC Press, Washington, 1997, pp. 99-114.
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+ [39] W. T. Friedewald, R. I. Levy and D. S. Fredrickson, “Es-
1016
+ timation of the Concentration of Low Density Lipoprotein
1017
+ Cholesterol in Plasma without the Use of Preparatory
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+ [40] A. Saxena and N. K. Vikram, “Role of Selected Indian
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+ Plants in Management of Type 2 Diabetes: A Review,”
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+ Journal of Alternative and Complementary Medicine, Vol.
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+ 10, No. 2, 2004, pp. 369-378.
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+ doi:10.1089/107555304323062365
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+ [41] S. Amita, S. Prabhakar, I. Manoj, S. Harminder and T.
1026
+ Pavan, “Effect of Yoga-Nidra on Blood Glucose Level in
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+ Diabetic Patients,” Indian Journal of Physiology and
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+ Pharmacology, Vol. 53, No. 1, 2009, pp. 97-101.
1029
+ [42] S. Singh, V. Malhotra, K. P. Singh, S. V. Madhu and O. P.
1030
+ Tandon, “Role of Yoga in Modifying Certain Cardiovas-
1031
+ cular Functions in Type 2 Diabetic Patients,” Journal of
1032
+ the Association of Physicians of India, Vol. 52, 2004, pp.
1033
+ 203-206.
1034
+ [43] H. H. Mahapure, S. U. Shete and T. K. Bera, “Effect of
1035
+ Yogic Exercise on Super Oxide Dismutase Levels in
1036
+ Diabetics,” International Journal of Yoga, Vol. 1, No. 1,
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+ 2008, pp. 21-26. doi:10.4103/0973-6131.36792
1038
+ [44] W. F. Paul, M. Jose-Luis, H. H. Anne and J. W. Nicholas,
1039
+ “Gene-Lifestyle Interaction on Risk of Type 2 Diabetes,”
1040
+ Nutrition, Metabolism and Cardiovascular Diseases, Vol.
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+ 17, No. 2, 2007, pp. 104-124.
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+ doi:10.1016/j.numecd.2006.04.001
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+ [45] E. Y. Jung, S. K. Young, R. C. Mi and R. Choue, “Ratio
1044
+ of Fat to Energy Intake Independently Associated with
1045
+ the Duration of Diabetes and Total Cholesterol Levels in
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+ Type 2 Diabetes,” Nutrition Research and Practice, Vol.
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+ 5, No. 2, 2011, pp. 157-162.
1048
+ doi:10.4162/nrp.2011.5.2.157
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+ [46] A. Fauci, E. Braunwald, D. Kasper, S. Hauser, D. Longo,
1050
+ J. Jameson and J. Loscalzo, “Diabetes Mellitus. Harri-
1051
+ sons’ Principles of Internal Medicine,” McGraw-Hill,
1052
+ Boston, 2008.
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+ [47] H. L. Fehm, W. Kern and A. Peters, “The Selfish Brain:
1054
+ Competition for Energy Resources,” Progress in Brain
1055
+ Research, Vol. 153, 2006, pp. 129-140.
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+ doi:10.1016/S0079-6123(06)53007-9
1057
+ [48] S. C. Woods, S. C. Benoit and D. J. Clegg, “The Brain-
1058
+ Gut-Islet Connection,” Diabetes, Vol. 55, Suppl. 2, 2006,
1059
+ pp. S114-S121. doi:10.2337/db06-S015
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+ [49] J. S. Yudkin, “Adipose Tissue, Insulin Action and Vascu-
1061
+ lar Disease: Inflammatory Signals,” International Journal
1062
+ of Obesity, Vol. 27, Suppl. 3, 2003, pp. S25-S28.
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1065
+ rishna Mission Institute of Culture, Kolkatta, 1996.
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1067
+ khamba Bharati Academy, Varanasi, 2007, pp. 251-252.
1068
+ [52] K. N. Shastri and G. N. Chaturvedi, “Agnivesha’s Cha-
1069
+ raka Samhita,” In: Chikitsasthana, Chaukhamba Bharati
1070
+ Academy, Varanasi, 2004, pp. 228-229.
1071
+ [53] K. N. Shastri and G. N. Chaturvedi, “Agnivesha’s
1072
+ Charaka Samhita Vidyotini Commentary,” In: Chikitsas-
1073
+ thana, Chaukhamba Bharati Academy, Varanasi, 2004, p.
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+ [54] K. N. Shastri and G. N. Chaturvedi, “Agnivesha’s Cha-
1076
+ raka Samhita,” In: Chikitsasthana, Chaukhamba Bharati
1077
+ Academy, Varanasi, 2004, pp. 234-235
1078
+ [55] R. Nagarathna and H. R. Nagendra, “Integrated Approach
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+ anda Yoga Prakashana, Bangalore, 2008.
1081
+
subfolder_0/Effect of Mind Sound Resonance Technique.txt ADDED
@@ -0,0 +1,602 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Complementary Therapies in Medicine 56 (2021) 102606
2
+ Available online 13 November 2020
3
+ 0965-2299/©
4
+ 2020
5
+ The
6
+ Author(s).
7
+ Published
8
+ by
9
+ Elsevier
10
+ Ltd.
11
+ This
12
+ is
13
+ an
14
+ open
15
+ access
16
+ article
17
+ under
18
+ the
19
+ CC
20
+ BY-NC-ND
21
+ license
22
+ (http://creativecommons.org/licenses/by-nc-nd/4.0/).
23
+ Effect of Mind Sound Resonance Technique (MSRT – A yoga-based
24
+ relaxation technique) on psychological variables and cognition in school
25
+ children: A randomized controlled trial
26
+ U.S. Anusuya a, Sriloy Mohanty b, Apar Avinash Saoji c,*
27
+ a Annai College of Naturopathy and Yoga Sciences, Anaikudi Road, Kovilachery, Kumbakonam, Tamil Nadu, India
28
+ b Center for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, India
29
+ c Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
30
+ A R T I C L E I N F O
31
+ Keywords:
32
+ MSRT
33
+ Yoga-based relaxation
34
+ Children
35
+ Cognition
36
+ Mind wandering
37
+ Mindfulness
38
+ A B S T R A C T
39
+ Objective: School children undergo stress, which could impact their psychological functions and cognitive abil­
40
+ ities. Yoga practices have been found useful in enhancing psychological functions and performance. The current
41
+ study was planned to evaluate a yoga-based relaxation technique’s efficacy as an extracurricular activity on
42
+ psychological state and cognitive function.
43
+ Design and setting: This study was a parallel-group randomized controlled trial conducted at a government school
44
+ in south India.
45
+ Participants: Sixty students with age ranging between 14–16 years (mean age ± SD; 15.3 ± 0.71 years) satisfying
46
+ the inclusion and exclusion criteria were randomized to experimental and control groups with an allocation ratio
47
+ of 1:1.
48
+ Intervention: Experimental group received Mind Sound Resonance Technique (MSRT), whereas the control group
49
+ performed supine rest (SR) for two-weeks.
50
+ Outcome measures: Participants were assessed with State trait anxiety inventory - short form, Mind Wandering
51
+ Questionnaire, State Mindfulness Attention Awareness Scale, and Trail making task at baseline and post-
52
+ intervention.
53
+ Results: Experimental group showed a reduction in state anxiety and mind wandering with improvement in state
54
+ mindfulness and performance in the Trail-making task compared to the control group.
55
+ Conclusion: Results of the current trial indicate the beneficial role of MSRT in enhancing psychological and
56
+ cognitive functions in children. Further, large-scale trials are warranted to ascertain the usefulness of the
57
+ technique.
58
+ 1. Introduction
59
+ School children face stress, both physical as well as psycho-social.
60
+ They are subjected to high levels of stress, anxiety and depression
61
+ arising from peer pressure.1 Studies demonstrate a high level of aca­
62
+ demic stress in high-school students with depressive symptoms.2 Such
63
+ stress could lead to declined cognitive abilities, impaired verbal pro­
64
+ cessing, and complex problem-solving abilities and could also lead to
65
+ physical health issues, resulting in decreased academic performance.
66
+ Studies demonstrate declined cognition and academic performance
67
+ associated with anxiety in school children.3,4 Also, physical conditions
68
+ such as tension-type headaches5 and chronic fatigue syndrome 6 were
69
+ prevalent among students. If not addressed in time, the stress and anx­
70
+ iety among children could lead to a cascade of physical and
71
+ psycho-social issues, which may impact cognition among children.
72
+ In science, cognition is referred to all sets of mental abilities and
73
+ processes related to acquizition and utilization of knowledge. It includes
74
+ the processes such as attention, memory and working memory, judg­
75
+ ment and evaluation, reasoning and computation, problem-solving and
76
+ decision making, comprehension and production of language, etc.7
77
+ Human cognition is conscious and unconscious, concrete, or abstract, as
78
+ well as intuitive. Cognition helps to generate new knowledge through a
79
+ * Corresponding author at: Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, 19, Eknath Bhvan, Gavipuram Circle, KG Nagar,
80
+ Bengaluru, 560019, India.
81
+ E-mail address: [email protected] (A.A. Saoji).
82
+ Contents lists available at ScienceDirect
83
+ Complementary Therapies in Medicine
84
+ journal homepage: www.elsevier.com/locate/ctim
85
+ https://doi.org/10.1016/j.ctim.2020.102606
86
+ Received 14 January 2020; Received in revised form 24 October 2020; Accepted 26 October 2020
87
+ Complementary Therapies in Medicine 56 (2021) 102606
88
+ 2
89
+ mental process and helps to use the knowledge people have in daily life.
90
+ Several Mind-Body techniques have been used to combat stress and
91
+ enhance cognitive abilities. Relaxation techniques have a significant
92
+ impact on human physiology and psychology.8 Yoga has emerged as a
93
+ popular Mind-body therapy for managing stress and anxiety in the
94
+ recent past. A study performed in school children demonstrated a pos­
95
+ itive impact of Yoga for anxiety.9 Several studies show the beneficial
96
+ effects of Yoga to reduce stress and enhance well-being among stu­
97
+ dents.10 There is also a positive impact of specific yoga practices such as
98
+ yoga breathing on psychological functions in adults.11,31 Yogic practices
99
+ are also known to restore autonomic balance12 and help reduce the risk
100
+ of complications of long-standing stress. The practice of Yoga is also
101
+ found to enhance cognitive abilities in students.13
102
+ Mind Sound Resonance Technique (MSRT) is one of the yoga-based
103
+ relaxation techniques that uses mantra to generate resonance, which is
104
+ used to induce deep relaxation for mind and body. MSRT can be prac­
105
+ ticed for improving well-being, concentration, willpower, and relaxa­
106
+ tion.14 The practice of MSRT has demonstrated to improve stress,
107
+ anxiety, depression, self-esteem, blood pressure, and heart rate in clin­
108
+ ical and non-clinical populations.15,16 It is also found to decrease state
109
+ anxiety and improve psychomotor performance.17 A single-session of
110
+ MSRT positively impacted cognitive performance in University medical
111
+ students.18 Another study demonstrated that a month-long intervention
112
+ of MSRT facilitates a reduction in stress, anxiety, fatigue, and psycho­
113
+ logical distress. The relaxation technique also enhanced self-esteem and
114
+ quality of sleep among female teachers working in primary schools.16
115
+ Though these studies indicate a positive impact of MSRT, there are no
116
+ studies to understand the effect of MSRT on psychological functions and
117
+ cognitive abilities in school children. Hence, the present study was
118
+ planned to evaluate the impact of a two-week practice of MSRT on
119
+ psychological factors and cognition of school students.
120
+ 2. Materials and methods
121
+ 2.1. Design and setting
122
+ The current trial was a single-center randomized controlled trial with
123
+ two assessment points, i.e., baseline and two-weeks. The study consisted
124
+ of two groups, i.e., experimental and control, in which the allocation of
125
+ subjects was done with a 1:1 ratio. Experimental group received guided
126
+ relaxation sessions of MSRT for 30 min/day, six days/week for two
127
+ weeks. Beyond the guided sessions at school, subjects were asked not to
128
+ perform the practice at home to maintain practice uniformity. The
129
+ Control group continued their routine activities, along with supine rest
130
+ (SR), for a similar duration of MSRT. The study was executed at a gov­
131
+ ernment school in Tamilnadu, India. The trial was not registered in the
132
+ clinical trial registry.
133
+ 2.2. Participants
134
+ The subjects were recruited from a pool of eighth and ninth-grade
135
+ students of a government school in Tamilnadu, India, based on the in­
136
+ clusion and exclusion criteria. Sixty healthy school going children with
137
+ equal gender distribution were allocated to either of the groups with an
138
+ allocation ratio of 1:1. The inclusion criteria were; healthy children
139
+ regardless of their gender, aged between 14–16 years with no history of
140
+ any illness for at least six months before the study. Unwilling subjects
141
+ and the ones could not comprehend and follow the instructions given by
142
+ the instructor were excluded. Written informed consent was obtained
143
+ from the participant and their guardians after explaining the steps of the
144
+ study. They also underwent systemic health checkup by a trained
145
+ physician, who otherwise had no role in the study. The sample size was
146
+ not calculated a priori. All eligible 60 students satisfying inclusion and
147
+ exclusion criteria from grade eighth and ninth were recruited for the
148
+ study.
149
+ 2.3. Randomization
150
+ Eligible subjects were identified and were stratified based on their
151
+ gender. Then subjects from each stratum were randomly divided into
152
+ two groups, i.e., experimental and control groups. A computer-based
153
+ program generated the random numbers with an allocation ratio of
154
+ 1:1 by a statistician who had no role in the study. Further, to maintain
155
+ concealment, serial number specific opaque sealed envelopes were made
156
+ by the same statistician. Authors enrolled the patients and allotted in
157
+ groups to them. The current study was a non-blinded trial. However, the
158
+ outcome assessors were blinded to group allocation.
159
+ 2.4. Ethical considerations
160
+ The study’s protocol was reviewed and approved by the Institutional
161
+ Ethics Committee of the Swami Vivekananda Yoga Anusandhana
162
+ Samsthana, Bengaluru. Written Informed consent was obtained from the
163
+ participants and their legal guardians after a briefing about the protocol.
164
+ It was ensured that the participants and the guardians understood the
165
+ implications of signing the consent form; all the details were explained
166
+ to them in their vernacular language. A participant information sheet
167
+ (PIS) in the colloquial language was also provided to all the eligible
168
+ participants before randomization. PIS document provides detail on the
169
+ purpose of this study, assessments and procedures involved, risks, and
170
+ benefits of participation in the trial.
171
+ 2.5. Intervention
172
+ 2.5.1. Experimental group
173
+ The study group received the advanced yogic technique called MSRT
174
+ done in a supine position, with closed eyes. MSRT involves experiencing
175
+ with closed eyes the internal vibrations and resonance developed while
176
+ chanting the syllables A, U, M, Om, and Maha-Mrityunjaya Mantra.14,17
177
+ The intervention was given by an institutionally trained yoga therapist
178
+ for 30 min every day for two weeks at school. The participants were
179
+ asked to appreciate the resonance all over the body during loud (Ahata:
180
+ heard) and mental chanting (Anahata: unheard). This is done alter­
181
+ nately, starting from Ahata (loud) ’A’ followed by Anahata(mental) ’A’
182
+ repeated three times. Similar repetitions of all other chants follow this.
183
+ 2.5.2. Control group
184
+ Participants in the control group practiced SR for the same duration,
185
+ i.e., 30 min in Shavasana, as described in the Hatha Yoga Pradipika with
186
+ closed eyes and palms facing roof.19 A teacher supervised the sessions.
187
+ All subjects, irrespective of their group allocation, were advised to
188
+ follow their routine day to day schedule and not practice at home to
189
+ maintain homogeneity of intervention.
190
+ 2.5.3. Environment of the therapy room
191
+ A suitable environment for the practice of MSRT was created to avoid
192
+ disturbance due to external sound or light. The MSRT sessions were
193
+ conducted in a dimly lit yoga hall, which had sufficient space to
194
+ accommodate all the participants, and it was made sure that the in­
195
+ structor’s voice was audible to everyone.
196
+ 2.5.4. Outcome measures
197
+ The outcome measures were planned to assess the psychological
198
+ function and cognition in children. Since the study was an exploratory
199
+ one, no primary endpoint was decided. The four instruments used were
200
+ State anxiety inventory-short form (STAI-SF), State mindfulness atten­
201
+ tion awareness scale (SMAAS), Mind wandering questionnaire (MWQ),
202
+ and Trail making test (TMT). Data were obtained at baseline and at the
203
+ end of two-weeks. The instruments were administered in their original
204
+ English versions since all the study participants were comfortable with
205
+ English.
206
+ STAI-SF is a six-item short version for assessing state anxiety from the
207
+ U.S. Anusuya et al.
208
+ Complementary Therapies in Medicine 56 (2021) 102606
209
+ 3
210
+ original Spielberg’s State-Trait Anxiety inventory. The participants were
211
+ asked to respond to each question on a Likert scale ranging from 1 to 4.20
212
+ SMAAS is a reliable and valid tool to assess state mindfulness. The
213
+ questionnaire contains five questions to be answered on a scale of 1 (not
214
+ at all) to 6 (very much). MWQ is a reliable and validated five-item
215
+ self-rated questionnaire, in which subjects filled responses on a scale
216
+ of 1 (almost never) to 6 (almost always).21 TMT was used to evaluate
217
+ changes in attention and working memory.22 The tool consists of two
218
+ parts: TMT "A" involved subjects drawing lines connecting 25 consecu­
219
+ tive circled numbers in a numerical sequence (i.e., 1–2–3, etc.) as rapidly
220
+ as possible. In TMT "B," the subjects were directed to draw lines to
221
+ connect 12 consecutive circled numbers and 12 following letters in an
222
+ alternate numeric and alphabetic sequence (i.e., 1-A-2-B, etc.) as rapidly
223
+ as possible. Time (in seconds) taken for completing the tasks was noted
224
+ using a stopwatch. The score on each part represents the amount of time
225
+ required to complete the task.23 The errors committed during task
226
+ completion were scored accurately.
227
+ Cronbach’s alphas for the scales were as follows: STAI-SF = 0.82;
228
+ SMAAS = 0.92; MWQ = 0.85; and TMT = 0.89.
229
+ 2.5.5. Data analysis
230
+ The data were extracted using the questionnaires/tools’ manuals and
231
+ arranged in JASP statistical package version 0.11.1 (JASP Team, 2019).
232
+ We performed an analysis of covariance (ANCOVA) using the baseline
233
+ values as covariates.
234
+ 3. Results
235
+ A schematic representation of the trial profile is depicted in Fig. 1.
236
+ Sixty participants from grades 8 and 9 with a mean age (±SD) of 15.03 ±
237
+ 0.71 years completed the study with an allocation ratio of 1:1. There
238
+ were no dropouts in the current trial. The participants’ socioeconomic
239
+ status was assessed using the Kuppuswamy and Udai Pareekh’s scale
240
+ adapted by the Govt. of India.24 The demographic data from the whole
241
+ study population are presented in Table 1.
242
+ A one-way analysis of covariates (ANCOVA) was performed to
243
+ determine the significant differences between groups in the post values,
244
+ controlling for the baseline values, age, and gender as covariates. Sta­
245
+ tistically significant changes were observed in STAI-SF scores (p =
246
+ 0.0308) SMAAS scores (p = 0.0017); MWQ scores (p < 0.001) and each
247
+ component of TMT scores (p < 0.001). The details of the same are
248
+ depicted in Table 2.
249
+ We performed within-group analyses using paired samples t-test.
250
+ Significant reductions were observed in the STAI-SF and MWQ scores,
251
+ with improvements in SMAAS scores and performance in the TMT in the
252
+ experimental group. In the control group, however, only two variables
253
+ changed significantly. MWQ scores increased significantly (p = 0.049),
254
+ indicating increased mind wandering, which increased the time taken in
255
+ TMT task B significantly (p = 0.01). Thus, there was deterioration in
256
+ performance in the control group. The within-group changes in experi­
257
+ mental and control groups are indicated in Table 3, respectively.
258
+ 4. Discussion
259
+ This study was conducted to assess the effect of a two-week session of
260
+ Fig. 1. Trial profile.
261
+ Table 1
262
+ Demographic Characteristics of the participants at baseline.
263
+ Experimental
264
+ Group
265
+ Control
266
+ Group
267
+ Total
268
+ Age (years)
269
+ 15.13 ± 0.63
270
+ 14.93 ± 0.78
271
+ 15.03 ± 0.71
272
+ Gender
273
+ Male: 15
274
+ Male: 15
275
+ Male: 30
276
+ Female: 15
277
+ Female: 15
278
+ Female: 30
279
+ Socioeconomic status
280
+ High: 01
281
+ High: 03
282
+ High: 04
283
+ Middle: 19
284
+ Middle: 17
285
+ Middle: 36
286
+ Lower: 09
287
+ Lower: 11
288
+ Lower: 20
289
+ Educational Status
290
+ Grade 8th :15
291
+ Grade 8th : 15
292
+ Grade 8th: 30
293
+ Grade 9th:15
294
+ Grade 9th : 15
295
+ Grade 9th: 30
296
+ State of anxiety at
297
+ baseline
298
+ Normal: 15
299
+ Normal: 12
300
+ Normal: 27
301
+ Anxious: 15
302
+ Anxious: 18
303
+ Anxious: 33
304
+ U.S. Anusuya et al.
305
+ Complementary Therapies in Medicine 56 (2021) 102606
306
+ 4
307
+ MSRT on psychological functions and cognition in school children. The
308
+ study results revealed a reduction in anxiety and mind wandering with
309
+ increased state mindfulness, awareness, attention, and working memory
310
+ in school children. This is the first study assessing the effect of MSRT in
311
+ school children to the best of our knowledge. Our findings indicate
312
+ enhanced psychological functions and cognition among children
313
+ following a two-week intervention period compared to the control
314
+ group, which continued to perform their routine activities and SR for 30
315
+ min.
316
+ Our findings concur with previous studies conducted with the MSRT
317
+ and other yogic relaxation/meditation techniques. In an earlier study
318
+ conducted on effects of MSRT, a single session of MSRT was found to be
319
+ beneficial in enhancing the performance in cognitive tasks that demand
320
+ sustained attention, concentration, visual scanning, and activation and
321
+ inhibition of rapid responses, psychomotor speed, mental flexibility, and
322
+ speed of information processing, when compared to SR for the same
323
+ duration .18 Ten days of MSRT was applied to patients with generalized
324
+ anxiety, in which Bhargav et al. could demonstrate reduced anxiety and
325
+ enhanced cognitive abilities.17 An earlier randomized controlled trial
326
+ showed a reduction in anxiety in patients with chronic neck pain by the
327
+ practice of MSRT for ten days compared to SR.25 The possible mecha­
328
+ nism involved in reducing stress, anxiety and the improvement in the
329
+ psychological variables assessed could be attributed to parasympathetic
330
+ dominance resulting from om chanting and mantra chanting. An fMRI
331
+ study performed on chanting of OM was found to have a similar effect to
332
+ that of vagal stimulation,26 which could have led to a state of para­
333
+ sympathetic dominance. Reduction of anxiety through the practice of
334
+ MSRT, as seen in an earlier study,17 could also be attributed to enhanced
335
+ performance in the TMT, as anxiety can impact cognition negatively.3,4
336
+ A systematic review mentioned that yoga and meditation interven­
337
+ tion nurture mindfulness and may be a feasible and effective building
338
+ resilience method in childhood and adolescence.27
339
+ Enhanced
340
+ mindfulness was associated with reduced anxiety and mind-wandering
341
+ in an earlier study with Yoga breathing.11 Mind-wandering is related
342
+ to low mood and depression,28 a reduction of the same may have
343
+ contributed to enhanced cognitive abilities. Earlier studies on medita­
344
+ tion practices are shown to have increased mindfulness and reduced
345
+ mind-wandering.29,30 In all the trials mentioned above, the common
346
+ limitation was the short duration of the intervention (ranging from a
347
+ single session to a maximum of one week). In the current experiment,
348
+ the length of the intervention was comparatively extended than the
349
+ other trials (for two-weeks).
350
+ Clinically, the data we gathered in the current study indicate a trend
351
+ towards reduced anxiety and mind-wandering and improved mindful­
352
+ ness and performance in the cognitive tasks. Both the trends are sig­
353
+ nificant in the learning abilities, especially in school-children. The
354
+ results warrant further inquiry into the impact of MSRT in school-
355
+ children.
356
+ Since the study was conducted at the school, there were no dropouts
357
+ throughout the study. Though we used the robust design of RCT, a
358
+ relatively small sample size and lack of objective measures to determine
359
+ the possible mechanism of action of MSRT are amongst the limitation of
360
+ the study. There was also no follow-up, and so, it is not known whether
361
+ improvements in task performance and self-efficacy sustained. Studies
362
+ with an extended follow-up period and robust objective assessment tools
363
+ to assess the effects of MSRT may be planned to ascertain the impact and
364
+ the underlying mechanisms of action.
365
+ 5. Conclusion
366
+ The current study suggests that training in MSRT may enhance
367
+ psychological functions and cognitive abilities in school children.
368
+ Incorporating MSRT as a regular practice in schools may help enhance
369
+ the psychological well-being and cognitive functions of school children.
370
+ Research involving human participants
371
+ The study was approved by the institutional ethics committee and
372
+ have therefore been performed in accordance with the ethical standards
373
+ laid down in the 1964 Declaration of Helsinki and its later amendments.
374
+ Informed consent
375
+ All the participants who participated and their legal guardians pro­
376
+ vided a written informed consent.
377
+ CRediT authorship contribution statement
378
+ U.S. Anusuya: Data curation, Investigation, Project administration,
379
+ Writing - original draft, Writing - review & editing. Sriloy Mohanty:
380
+ Conceptualization, Data curation, Formal analysis, Methodology, Vali­
381
+ dation, Writing - original draft, Writing - review & editing. Apar
382
+ Table 2
383
+ Changes between the experimental and control groups following two-week
384
+ assessment duration.
385
+ Outcome
386
+ Adj. R2
387
+ F
388
+ p
389
+ Cohen’s d
390
+ MWQ
391
+ 0.50
392
+ 15.93
393
+ < 0.0001
394
+ −1.936
395
+ SMAAS
396
+ 0.21
397
+ 4.99
398
+ 0.0017
399
+ 0.998
400
+ STAI
401
+ 0.11
402
+ 2.88
403
+ 0.0308
404
+ −0.573
405
+ TMT- A
406
+ 0.80
407
+ 61.86
408
+ < 0.0001
409
+ −0.702
410
+ TMT-B
411
+ 0.87
412
+ 105.75
413
+ <0.0001
414
+ −0.801
415
+ TMT- Total Time
416
+ 0.69
417
+ 34.94
418
+ <0.0001
419
+ −1.302
420
+ TMT Executive function
421
+ 0.72
422
+ 38.92
423
+ <0.0001
424
+ −0.571
425
+ MWQ: Mind Wandering Questionnaire, SMAAS: State Mindfulness Attention
426
+ Awareness Scale, STAI-SF: State trait anxiety inventory - short form; TMT: Trail
427
+ making task.
428
+ The results are obtained from fitting ANCOVA model in which post test result
429
+ taken as dependent variable & pre-test result, group(experimental and control),
430
+ age and gender(male and female) taken as independent variables.
431
+ Table 3
432
+ Changes within the experimental and control groups before and following the two-week assessment duration.
433
+ Variable
434
+ Experimental Group
435
+ (n = 30; df = 29)
436
+ Control Group
437
+ (n = 30; df = 29)
438
+ Pre
439
+ Post
440
+ t
441
+ Pre
442
+ Post
443
+ T
444
+ MWQ Score
445
+ 3.65 ± 9.86
446
+ 2.51 ± 0.96***
447
+ 5.500
448
+ 3.76 ± 0.66
449
+ 4.10 ± 0.58*
450
+ −2.053
451
+ SMAAS Scores
452
+ 4.04 ± 1.45
453
+ 5.00 ± 0.92**
454
+ −2.995
455
+ 4.11 ± 0.90
456
+ 3.87 ± 1.27
457
+ 0.954
458
+ STAI- SF Scores
459
+ 39.56 ± 9.74
460
+ 33.22 ± 7.14***
461
+ 3.658
462
+ 42.55 ± 10.46
463
+ 38.89 ± 10.52
464
+ 1.427
465
+ TMT A (Sec)
466
+ 30.40 ± 4.03
467
+ 28.20 ± 3.85***
468
+ 4.826
469
+ 34.07 ± 5.84
470
+ 34.70 ± 5.79
471
+ −1.208
472
+ TMT B (Sec)
473
+ 65.50 ± 9.77
474
+ 61.30 ± 9.11***
475
+ 7.290
476
+ 73.73 ± 9.70
477
+ 76.57 ± 10.50**
478
+ −2.746
479
+ TMT Total time
480
+ 95.90 ± 12.21
481
+ 89.50 ± 11.91***
482
+ 8.222
483
+ 105.43 ± 19.42
484
+ 111.27 ± 13.50
485
+ −1.970
486
+ TMT Executive Function
487
+ 35.10 ± 8.63
488
+ 33.10 ± 7.35**
489
+ 2.906
490
+ 39.67 ± 9.24
491
+ 41.87 ± 10.27
492
+ −1.677
493
+ Paired samples t-test. * = p < 0.05, **= p < 0.01, *** = p < 0.001.
494
+ MWQ: Mind Wandering Questionnaire, SMAAS: State Mindfulness Attention Awareness Scale, STAI-SF: State trait anxiety inventory - short form; TMT: Trail making
495
+ task.
496
+ U.S. Anusuya et al.
497
+ Complementary Therapies in Medicine 56 (2021) 102606
498
+ 5
499
+ Avinash Saoji: Conceptualization, Data curation, Formal analysis,
500
+ Investigation, Methodology, Project administration, Supervision, Vali­
501
+ dation, Visualization, Writing - original draft, Writing - review &
502
+ editing.
503
+ Declaration of Competing Interest
504
+ The authors report no declarations of interest.
505
+ References
506
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+ cognitive vulnerability and risk for depression among youth. J Abnorm Child Psychol.
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subfolder_0/Effect of Needling at CV-12 (Zhongwan) on Blood Glucose Levels in Healthy Volunteers_.txt ADDED
@@ -0,0 +1,353 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ RESEARCH ARTICLE
2
+ Effect of Needling at CV-12 (Zhongwan) on
3
+ Blood Glucose Levels in Healthy Volunteers:
4
+ A Pilot Randomized Placebo Controlled Trial
5
+ Sriloy Mohanty 1, A. Mooventhan 2,*, Nandi Krishnamurthy Manjunath 2
6
+ 1 Department of Naturopathy, S-VYASA University, Bangalore, Karnataka, India
7
+ 2 Department of Research and Development, S-VYASA University, Bangalore,
8
+ Karnataka, India
9
+ Available online 20 September 2016
10
+ Received: May 30, 2016
11
+ Revised: Aug 20, 2016
12
+ Accepted: Aug 24, 2016
13
+ KEYWORDS
14
+ acupuncture;
15
+ blood glucose;
16
+ Zhongwan
17
+ Abstract
18
+ Introduction: Acupuncture, a key part of traditional Chinese medicine, is used to relieve symp-
19
+ toms of diabetes mellitus. The aim of this study was to evaluate the effect of needling CV-12
20
+ (Zhongwan) on blood glucose levels in healthy volunteers.
21
+ Materials and methods: Thirty-six individuals were recruited and randomized into either the
22
+ acupuncture group or the placebo control group. The participants in the acupuncture
23
+ group were needled at CV-12 (4 cun above the center of the umbilicus), and those in the pla-
24
+ cebo control group were needled at a nonexisting “sham” point on the right side of the
25
+ abdomen (1 cun beside the CV-12)da nonacupuncture point. For both groups, the needle
26
+ was retained for 20 minutes without stimulation. Assessments were performed prior to and af-
27
+ ter the intervention. Statistical analysis was performed using the Statistical Package for the
28
+ Social Sciences, version 16.
29
+ Results: The result of this study showed a mild reduction in random blood glucose (RBG) levels
30
+ in the acupuncture group and a mild increase in RBG levels in the placebo control group.
31
+ However, these changes were not statistically significant both within and between groups.
32
+ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://
33
+ creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any me-
34
+ dium, provided the original work is properly cited.
35
+ * Corresponding author. Department of Research and Development, S-VYASA University, #19, Eknath Bhavan, Kavipuram Circle,
36
+ Kempegowda Nagar, Bengaluru 560019, Karnataka, India.
37
+ E-mail: [email protected] (A. Mooventhan).
38
+ pISSN 2005-2901
39
+ eISSN 2093-8152
40
+ http://dx.doi.org/10.1016/j.jams.2016.08.002
41
+ Copyright ª 2016, Medical Association of Pharmacopuncture Institute.
42
+ Available online at www.sciencedirect.com
43
+ Journal of Acupuncture and Meridian Studies
44
+ journal homepage: www.jams-kpi.com
45
+ J Acupunct Meridian Stud 2016;9(6):307e310
46
+ Conclusion: The result of this study suggests that although 20 minutes of needling at CV-12
47
+ without stimulation produced a mild reduction in RBG levels in healthy volunteers, it did
48
+ not produce a statistically significant result.
49
+ 1. Introduction
50
+ Diabetes
51
+ is
52
+ a
53
+ major
54
+ public
55
+ health
56
+ problem
57
+ that
58
+ is
59
+ approaching epidemic proportions globally. The number of
60
+ people with diabetes is likely to increase up to 380 million
61
+ by 2025. Almost 80% of total adults with diabetes are from
62
+ developing countries. India leads the global top 10 coun-
63
+ tries in terms of the highest number of people with dia-
64
+ betes, and there is a growing incidence of diabetes at a
65
+ younger age [1].
66
+ Acupuncture at CV-12 (Zhongwan) has been widely used
67
+ in traditional Chinese medicine to relieve symptoms of
68
+ diabetes. Previous studies using electroacupuncture on only
69
+ CV-12 [2] and combining this with CV-4 (Guanyuan) [3,4],
70
+ SP-6 (Sanyinjiao), and ST-36 (Housanli) have produced a
71
+ hypoglycemic effect [2e4] with normalized insulin sensi-
72
+ tivity, ameliorating both insulin resistance and hyper-
73
+ insulinemia [3] in diabetic rats.
74
+ In
75
+ a
76
+ human
77
+ study,
78
+ CV-12din
79
+ combination
80
+ with
81
+ acupuncture points such as CV-4, CV-6 (Qihai), CV-10 (Xia-
82
+ wan), ST-24 (Huaroumen), ST-25 (Tianshu), TE-5 (Wailing),
83
+ SP-15 (Daheng), and KI-13 (Qixue)dwas shown to decrease
84
+ blood glucose levels and improve insulin resistance with no
85
+ adverse effects in obese Type 2 diabetic volunteers [5].
86
+ Other studies have focused on single needling at CV-12
87
+ [2], ST-36 [6], BL20 (Pishu) [7], and GB 26 (Daimai) [8] in a
88
+ rat model; however, there is lack of studies on human
89
+ volunteers. Hence, the aim of this study aims was to eval-
90
+ uate the effect of single point acupuncture at CV-12 on
91
+ blood glucose levels in healthy human volunteers.
92
+ 2. Materials and methods
93
+ 2.1. Participants
94
+ A total of 36 healthy volunteers whose ages ranged from 18
95
+ years to 24 years were recruited from a residential college
96
+ based on the following inclusion and exclusion criteria. The
97
+ inclusion criteria called for male and female volunteers
98
+ who were 18 years and above, and were willing to partici-
99
+ pate in the study. The exclusion criteria were as follows:
100
+ individuals with a history of any systemic and mental
101
+ illness, regular use of medication for any diseases, needle
102
+ phobia, chronic smoking, and alcoholism. The study pro-
103
+ tocol was approved by the institutional ethics committee,
104
+ and a written informed consent was obtained from each
105
+ participant.
106
+ 2.2. Study design
107
+ This is a pilot randomized placebo-controlled trial, in which
108
+ all participants were randomly assigned into either the
109
+ acupuncture group or the placebo control group. The
110
+ acupuncture group received needling at CV-12 and the
111
+ placebo
112
+ control
113
+ group
114
+ received
115
+ needling
116
+ at
117
+ a
118
+ non-
119
+ acupuncture point for 20 minutes. Data assessment was
120
+ performed prior to and after the intervention.
121
+ 2.3. Randomization
122
+ All participants were allotted with random numbers. The
123
+ first volunteer was allocated to a group on the basis of a flip
124
+ of a coin, then the next volunteer was assigned to the
125
+ opposite group, in a randomization ratio of 1:1. Thus, all
126
+ members of the group had an equal chance to be in either
127
+ group. This randomization was performed by one of the
128
+ authors, who was involved in intervention but was not
129
+ involved in any part of the investigation.
130
+ 2.4. Blinding/masking
131
+ All participants were blind to the acupuncture (CV-12) and
132
+ the placebo control points. The investigator who assessed
133
+ the blood glucose was blind to the acupuncture and placebo
134
+ control groups.
135
+ 2.5. Assessments
136
+ 2.5.1. Random blood glucose
137
+ The random blood glucose (RBG) level was assessed be-
138
+ tween 10:30 and 11:30 A.M. using a portable ACCU-CHEK,
139
+ Performa Nano machine (Roche Diagnostics India Pvt. Ltd,
140
+ Mumbai, India). Assessments were performed prior to and
141
+ after the intervention for both groups.
142
+ 2.6. Intervention
143
+ 2.6.1. Acupuncture group
144
+ The participants received traditional Chinese medicine-
145
+ style of acupuncture. Needling was performed at CV-12 (4
146
+ cun above the center of the umbilicus) [9] at a depth of 0.5
147
+ cun. The participants were informed about the procedure,
148
+ sensations of needle insertion, and response sought. The
149
+ needle was left out without any stimulation. We used 0.5-
150
+ cun filiform locally manufactured cupper needle with
151
+ 0.38 mm diameter and 13 mm length. The participants
152
+ received only one session of acupuncture for a duration of
153
+ 20 minutes. The participants did not receive any treat-
154
+ ments other than acupuncture. Needling was administered
155
+ by one of the authors who is institutionally qualified with 2
156
+ years’ experience in clinical acupuncture.
157
+ 2.6.2. Placebo control group
158
+ The participants in this group received needling in the right
159
+ side of the abdomen 1 cun lateral to CV-12 where there is
160
+ no known acupuncture point.
161
+ 308
162
+ S. Mohanty et al.
163
+ 2.7. Data analysis
164
+ All data were checked for normality using Kolmogor-
165
+ oveSmirnov and ShapiroeWilk tests. Statistical analysis was
166
+ performed using Student paired t test (within groups) and
167
+ analysis of variance (between groups) was carried out using
168
+ Statistical Package for the Social Sciences (SPSS) for Win-
169
+ dows, Version 16.0, Chicago, SPSS Inc.
170
+ 3. Results
171
+ Of 41 volunteers, five did not meet the inclusion criteria
172
+ and were subsequently excluded from the study. All
173
+ recruited participants (n Z 36) were randomly divided into
174
+ either the acupuncture (n Z 18) or the placebo control
175
+ group (n Z 18). Needling was performed at CV-12 and at
176
+ the right side of the abdomen 1 cun lateral to CV-12 in the
177
+ acupuncture and placebo control groups, respectively.
178
+ Baseline and posttest assessments were done prior to and
179
+ after the intervention. Demographic (Table 1) and the
180
+ baseline blood glucose levels (Fig. 1) were comparable, and
181
+ there were no significant changes between the groups.
182
+ Even though the result of this present study showed mild
183
+ reduction in RBG levels in the acupuncture group and mild
184
+ increase in the placebo control group, these changes were
185
+ not statistically significant both within and between groups
186
+ (Fig. 1).
187
+ 4. Discussion
188
+ CV-12 is known as the stomach control point in Korean
189
+ medicine and is located on the abdominal wall associated
190
+ with the pancreas. Although it is located on the Conception
191
+ Vessel Meridian, it is considered a therapeutic point for
192
+ diseases of the digestive organs such as the stomach,
193
+ pancreas, and spleen [10]. For example, electric stimula-
194
+ tion at the CV-12 was used for treatment of diabetic rats
195
+ [2,10].
196
+ The results of this present study showed that a 20-
197
+ minute single session needling at CV-12 acupuncture point
198
+ without any stimulation (manual or electrical) produced a
199
+ mild reduction in RBG levels in healthy volunteers. At the
200
+ same time a 20-minutes single session of needling at the
201
+ placebo control point produced a mild increase in RBG
202
+ levels in healthy individuals. However, these changes were
203
+ not statistically significant.
204
+ Only one session was administered on CV-12 to check for
205
+ the immediate effect on RBG. This may not be sufficient to
206
+ produce
207
+ significant
208
+ changes.
209
+ Needling
210
+ was
211
+ performed
212
+ without stimulation, however, including either manual,
213
+ electrical, laser, or catgut embedding stimulation, which
214
+ might have produced a more significant effect in reducing
215
+ RBG. It should be noted that in previous studies on elec-
216
+ troacupuncture at CV-12 alone in diabetic rats [2] and in
217
+ combination with other acupuncture points in diabetic rats
218
+ [3,4] and human studies [5], laser irradiation on CV-12 along
219
+ with other points in metabolic syndrome [9], and catgut
220
+ embedding in CV-12 along with other acupuncture points in
221
+ diabetic rats [11] have been shown to reduce blood glucose
222
+ [2e5,11] and fasting insulin [9,11].
223
+ 001As healthy individuals have normal physiological
224
+ functions and do not have abnormally elevated blood
225
+ glucose/reduced insulin levels, CV-12 might have not
226
+ influenced the blood glucose levels. In previous studies, the
227
+ hypoglycemic effect of CV-12 alone [2] and in combination
228
+ with other acupuncture points were reported mainly in
229
+ diabetic rats [3,4,11], and in diabetic patients but not in
230
+ healthy individuals [5]. Hence, we expect needling at CV-12
231
+ to be effective in participants with high blood glucose
232
+ levels; however, this needs to be confirmed in further
233
+ studies.
234
+ 4.1. Strength of the study
235
+ This is the first randomized placebo controlled study to
236
+ evaluate the effect of CV-12 on RBG levels in healthy vol-
237
+ unteers. Both the participants and the investigator were
238
+ blind to the acupuncture and placebo control groups.
239
+ 4.2. Limitations of this study
240
+ Sample size was not calculated based on the previous study.
241
+ The present study evaluated only the immediate effect
242
+ without stimulation and did not evaluate its short-term or
243
+ long-term effect with or without stimulation. Assessment of
244
+ variables such as fasting blood glucose, postprandial blood
245
+ Table 1
246
+ Demographic variables of acupuncture (n Z 18)
247
+ and placebo control groups (n Z 18).
248
+ Variables
249
+ Acupuncture
250
+ group
251
+ Placebo control
252
+ group
253
+ Age (y)
254
+ 19.61  1.975
255
+ 19.22  1.517
256
+ Sex
257
+ 9 males/9 females 9 males/9 females
258
+ Height (cm)
259
+ 161.78  11.855
260
+ 164.00  9.628
261
+ Weight (kg)
262
+ 54.94  8.003
263
+ 56.28  8.372
264
+ Body mass index
265
+ (kg/m2)
266
+ 21.40  3.520
267
+ 20.90  2.288
268
+ All values are expressed as mean  standard deviation, except
269
+ for values of sex.
270
+ Figure 1
271
+ Baseline and post-test random blood glucose levels
272
+ of acupuncture (n Z 18) and placebo groups (nZ18).
273
+ Effect of Needling at CV-12 in RBG Levels
274
+ 309
275
+ glucose, glycosylated hemoglobin, and insulin levels was
276
+ not performed. Hence, long-term studies with either
277
+ manual or electric stimulation are required in a larger
278
+ sample size, and more variables such as fasting blood
279
+ glucose, postprandial blood glucose, HbA1C, and insulin
280
+ levels should be measured in order to better understand
281
+ the effect of CV-12 on blood glucose levels.
282
+ 5. Conclusion
283
+ The result of this present study suggests that 20 minutes of
284
+ needling at CV-12 without stimulation produces a mild
285
+ reduction in RBG levels in healthy volunteers; however, it
286
+ did not produce a statistically significant result.
287
+ Disclosure statement
288
+ The authors declare that they have no conflicts of interest
289
+ and no financial interests related to the material of this
290
+ manuscript.
291
+ Acknowledgments
292
+ The authors thank Robert Mazure, Integrated Holistic Ther-
293
+ apies, London, UK, for his help in editing the manuscript.
294
+ References
295
+ [1] Tabish SA. Is diabetes becoming the biggest epidemic of the
296
+ twenty-first century? Int J Health Sci (Qassim). 2007;1:5e8.
297
+ [2] Chang SL, Lin JG, Chi TC, Liu IM, Cheng JT. An insulin-
298
+ dependent hypoglycaemia induced by electroacupuncture at
299
+ the Zhongwan (CV12) acupoint in diabetic rats. Diabetologia.
300
+ 1999;42:250e255.
301
+ [3] Zheng YH, Ding T, Ye DF, Liu H, Lai MH, Ma HX. Effect of low-
302
+ frequency
303
+ electroacupuncture
304
+ intervention
305
+ on
306
+ oxidative
307
+ stress and glucose metabolism in rats with polycystic ovary
308
+ syndrome. Zhen Ci Yan Jiu. 2015;40:125e130.
309
+ [4] Peplow PV, McLean GT. Repeated electroacupuncture: an
310
+ effective treatment for hyperglycemia in a rat model. J Acu-
311
+ punct Meridian Stud. 2015;8:71e76.
312
+ [5] Yang Y, Liu Y. BO’s abdominal acupuncture for obese type-2
313
+ diabetes mellitus. Zhongguo Zhen Jiu. 2015;35:330e334.
314
+ [6] Lee YC, Li TM, Tzeng CY, Chen YI, Ho WJ, Lin JG, et al.
315
+ Electroacupuncture at the zusanli (ST-36) acupoint induces a
316
+ hypoglycemic effect by stimulating the cholinergic nerve in a
317
+ rat model of streptozotocine-induced insulin-dependent dia-
318
+ betes mellitus. Evid Based Complement Alternat Med. 2011.
319
+ http://dx.doi.org/10.1093/ecam/neq068.
320
+ [7] Cornejo-Garrido J, Becerril-Cha
321
+ ´vez F, Carlı
322
+ ´n-Vargas G, Ordo-
323
+ n
324
+ ˜ez-Rodrı
325
+ ´guez JM, Abrajan-Gonza
326
+ ´lez Mdel C, de la Cruz-
327
+ Ramı
328
+ ´rez
329
+ R,
330
+ et
331
+ al.
332
+ Antihyperglycaemic
333
+ effect
334
+ of
335
+ laser
336
+ acupuncture treatment at BL20 in diabetic rats. Acupunct
337
+ Med. 2014;32:486e494.
338
+ [8] Li YY, Hu H, Liang CM, Wang H. Effects of electroacupuncture
339
+ stimulation of “Daimai” (GB 26) on body weight, blood glucose
340
+ and blood lipid levels in rats with metabolism syndrome. Zhen
341
+ Ci Yan Jiu. 2014;39:202e206.
342
+ [9] El-Mekawy HS, ElDeeb AM, Ghareib HO. Effect of laser
343
+ acupuncture combined with a dieteexercise intervention on
344
+ metabolic syndrome in post-menopausal women. J Adv Res.
345
+ 2015;6:757e763.
346
+ [10] Kim MS, Sung B, Ogay V, Choi CJ, Kim MS, Kang DI, et al. Novel
347
+ circulatory connection from the acupoint Zhong Wan (CV12) to
348
+ pancreas. J Korean Pharmacopunct Inst. 2008;11:13e19.
349
+ [11] Zhang H, Guo H, Zhang YC, Liu M, Ai K, Su YM, et al. Effect of
350
+ acupointecatgut-embedding intervention on type II diabetic
351
+ rats. Zhen Ci Yan Jiu. 2014;39:358e361, 381.
352
+ 310
353
+ S. Mohanty et al.
subfolder_0/Effect of Trataka on cognitive functions in the elderly.txt ADDED
@@ -0,0 +1,779 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Volume 7 | Issue 2 | July-December | 2014
2
+ Official
3
+ Publication
4
+ of
5
+ Swami
6
+ Vivekananda
7
+ Yoga
8
+ Anusandhana
9
+ Samsthana
10
+ University
11
+ Online full text at
12
+ http://www.ijoy.org.in
13
+ IJ Y
14
+ O
15
+ International Journal of Yoga
16
+ Guest Editorial
17
+ Original Articles
18
+ Comparative immediate effect of different yoga asanas on heart rate and blood pressure in healthy young volunteers
19
+ Effect of trataka on cognitive functions in the elderly
20
+ Effect of Bhramari pranayama and OM chanting on pulmonary function inhealthy individuals: A prospective randomized control trial
21
+ Effect of yogic colon cleansing (Laghu Sankhaprakshalana Kriya) on pain, spinal flexibility, disability and state anxiety in chronic low back pain
22
+ Toward building evidence for yoga
23
+ Contents
24
+ ISSN
25
+ 0973-6131
26
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
27
+ 96
28
+ Effect of trataka on cognitive functions in the elderly
29
+ Shubhada Talwadkar, Aarti Jagannathan, Nagarathna Raghuram
30
+ Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samasthana, Bengaluru, Karnataka, India
31
+ Address for correspondence: Dr. Aarti Jagannathan,
32
+ Swami Vivekananda Yoga Anusandhana Samasthana 19, Gavipuuram,
33
+
34
+ Kempegowda Nagar ‑ 560 019, Bengaluru, Karnataka, India.
35
+
36
+ E‑mail: [email protected]
37
+ Original Article
38
+ functions, as well as various other complex cognitive
39
+ functions.[5‑7] Varied treatment options have been
40
+ propagated for cognitive impairment in the elderly
41
+ such as oral medications,[8] cognitive interventions,[9]
42
+ diet,[10] etc., Many experts have suggested that mentally
43
+ challenging activities (e.g. crossword puzzles and brain
44
+ teasers) may be helpful for patients with mild cognitive
45
+ impairment.[11] Physical activity (PA), aimed at improving
46
+ cardiorespiratory health, has been proposed to be a
47
+ good, practical, and powerful candidate to overcome
48
+ cerebral and behavioral declines.[12] Yoga practices also
49
+ have shown various health benefits including the ability
50
+ to improve cognition and thereby preventing cognitive
51
+ impairments and dementia.[13]
52
+ Many scientific studies have proven that yoga is effective
53
+ to improve various cognitive functions such as remote
54
+ memory, mental balance, attention and concentration,
55
+ attention span, processing speed, attention alternation
56
+ ability, delayed and immediate recall, executive functions,
57
+ verbal retention, and recognition tests in the healthy young
58
+ subjects.[14,15] Very few studies have looked at the effect of
59
+ yoga in the elderly population. For example, relaxation
60
+ INTRODUCTION
61
+ In normal aging, decreased ability to retrieve information
62
+ can cause memory lapses that sometimes impair the ability
63
+ to perform activities of daily living.[1] These changes are
64
+ largely the result of decline in frontal lobe function,
65
+ which is measured as executive functions (the ability
66
+ to organize, plan, and focus on a topic).[2] Age‑related
67
+ decline in cognitive abilities varies considerably
68
+ across individuals and across cognitive domains.
69
+ Various cognitive domains show different degrees of
70
+ susceptibilities to aging.[3] Changes in the brain due to
71
+ aging occur earliest in the prefrontal cortex (PFC).[4] The
72
+ PFC is associated with memory, attention, executive
73
+ Background: Trataka, a type of yoga practice is considered to improve cognitive functions. The aim of this study was to test
74
+ the effect of trataka on cognitive functions of the elderly.
75
+ Materials and Methods: Elderly subjects were recruited based on inclusion and exclusion criteria (n = 60) and randomly divided
76
+ using randomized block design into two groups: Trataka and wait list control group. Trataka (a visual cleansing technique)
77
+ was given for a period of 1 month (26 days). The subjects in both groups were assessed on day 1 (pre‑ and postintervention
78
+ in trataka group and after quiet sitting in control group) and on day 30 on Digit Span Test, Six Letter Cancellation Test (SLCT),
79
+ and Trail Making Test‑B (TMT‑B).
80
+ Results: Friedman’s test and Wilcoxon signed‑rank test showed that at the 2nd follow‑up there was significant improvement
81
+ in digit span scores (z = −3.35, P < 0.01) in the trataka group. SLCT scores (t = 5.08, P < 0.01) and TMT‑B scores (t = −4.26,
82
+ P < 0.01) improved immediately after the practice of trataka (when baseline compared to first follow‑up). At 1 month follow‑up,
83
+ trataka group showed significantly better performance in the SLCT test compared to baseline (t = −3.93, P < 0.01) and TMT‑B
84
+ scores (t = 7.09, P < 0.01). Repeated measure analysis of variance (RM ANOVA) results also reiterated that there was significant
85
+ interaction effect at the end of 1 month of trataka intervention as compared to control group on TMT‑B and SLCT scores.
86
+ Conclusions: The results of this study establish that Trataka can be used as a technique to enhance cognition in the elderly.
87
+ Key words: Cognitive functions; elderly; trataka.
88
+ ABSTRACT
89
+ Access this article online
90
+ Website:
91
+ www.ijoy.org.in
92
+ Quick Response Code
93
+ DOI:
94
+ 10.4103/0973-6131.133872
95
+ Talwadkar, et al.: Trataka for cognitive functions
96
+ 97
97
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
98
+ response training is seen to improve reaction time on
99
+ simple attention/psychomotor tasks in older adults.[16]
100
+ Another cross‑sectional study comparing the cognitive
101
+ performance of 20 meditators (long‑term practitioners of
102
+ Vihangam yoga meditation) and 20 non‑meditators in the
103
+ geriatric age group showed that Vihangam yogis performed
104
+ better on all the tests of attention except for the digit
105
+ backward test.[17]
106
+ The above review depicts that the number of published
107
+ literature in the last decade on effectiveness of yoga on
108
+ cognitive functions of the elderly is limited. Although
109
+ there are no published scientific studies, authentic
110
+ traditional texts of yoga describe the benefits of trataka
111
+ on a whole range of physiological and cognitive
112
+ functions.[18,19] It is observed to be most effective on the
113
+ ajna chakra[20] (the vortice of vital energy in the forehead)
114
+ and the brain.[21] Ajna chakra is described as the “eye
115
+ of knowledge”, and it is said that with the activation of
116
+ this chakra, the intelligence, concentration, and memory
117
+ improve and the mind becomes strong and steady.[22] It
118
+ is proposed that the practice of Trataka may activate
119
+ this chakra,[23] and thus may improve attention, memory,
120
+ and concentration.[24,25] In the above context, the aim of
121
+ this study was to test the effect of trataka on cognitive
122
+ functions of the elderly. Effect of trataka was studied
123
+ as against wait list control group; in improving short
124
+ term memory, attention, concentration, and executive
125
+ functions.
126
+ MATERIALS AND METHODS
127
+ Participants were recruited from old age homes in Goa and
128
+ from individuals staying in and around Ponda and Margao
129
+ areas in Goa. The approval from Institutional Ethics
130
+ Committee of Swami Vivekananda Yoga Anusandhana
131
+ Samasthana (SVYASA) was obtained.
132
+ A total of 136 subjects were screened usinginclusion and
133
+ exclusion criteria. Those who were 60-80 years of age
134
+ and had minimum of fifth grade education were included
135
+ in the study. Further those subjects who had  (a) Any
136
+ neurological disorder,  (b) any psychiatric disorder,
137
+ and (c) had received yoga training in last 3 months were
138
+ excluded from the study. The above exclusion criteria
139
+ and abnormality in hearing and vision were examined
140
+ by a trained and qualified clinician. Based on this
141
+ screening procedure, 75 subjects were found suitable
142
+ for the study. As 15 of them declined to give consent to
143
+ participate, the remaining 60 subjects were considered
144
+ for the study and written informed consent was taken
145
+ from them.
146
+ The sample size calculation estimated that 27 participants
147
+ in each group was required to detect a clinically significant
148
+ difference equivalent to an effect size of 0.75 (Cohen’s d)
149
+ in total memory score between the groups. A sample of
150
+ 27 had 80% power to detect this difference with an alpha
151
+ of 0.05 for a between‑groups analysis. To account for a
152
+ dropout of about 10%, a sample of 30 patients in each
153
+ group was decided. Hence, it was decided to recruit a
154
+ total of 60 healthy elderly sample for the study using
155
+ purposive sampling. The CONSORT diagram of the flow
156
+ of participants and the sociodemographic data of the
157
+ participants has been provided in Figure 1 and Table 1,
158
+ respectively.
159
+ A randomized block design was used in the study where
160
+ subjects were divided into four blocks  (two old ages
161
+ homes comprising of one block each and two blocks of
162
+ individual elderly participants from Ponda area of Goa),
163
+ a sample of approximately 15 subjects comprised of one
164
+ block. The lottery method of manual randomization was
165
+ conducted due to the small number of blocks (n = 4). Two
166
+ blocks were randomized into trataka group (intervention
167
+ group) and two blocks were randomized into wait list
168
+ control group.
169
+ For the intervention group, assessments were conducted
170
+ on day 1 before intervention, immediately after trataka
171
+ intervention on day 1, and after 1  month of trataka
172
+ intervention. In the wait list control group, data was
173
+ taken on day 1 before the quite sitting and after 30 min
174
+ of quite sitting and at the end of 1 month. The variables
175
+ used in this study were:  (a) Working memory  (Digit
176
+ Span Forward and Backward Test[26]), (b) attention and
177
+ concentration  (Six Letter Cancellation Test, SLCT[27]),
178
+ and  (c) executive functions  (Trail Making Test B,
179
+ TMT‑B[28]). For SLCT and TMT‑B, the standard procedure
180
+ for translation was used; translated and back translated
181
+ from Roman to Devnagiri to Roman. The tests were
182
+ translated into Devnagiri for the ease of application of the
183
+ tests to the local population in Goa. The Digit Span (DS)
184
+ is a subtest in Wechsler Adult Intelligence Scale‑third
185
+ edition (WAIS‑III)[29] and has been standardized for use
186
+ in an Indian population. The SLCT which measures
187
+ cognitive functions such as selective and focused
188
+ attention, concentration, visual scanning as well as
189
+ activation and inhibition of rapid responses has been
190
+ employed to assess cognitive impairments in alcoholic
191
+ Table  1: Socio‑demographic details of the subjects
192
+ (n=55)
193
+ Variable
194
+ Mean  (SD)/n  (%)
195
+ t value/
196
+ chi‑square
197
+ P value
198
+ Trataka
199
+ (n=31)
200
+ Control
201
+ (n=24)
202
+ Age (years)
203
+ 67.7 (7.4) 71.2 (6.6)
204
+ −1.83
205
+ 0.07
206
+ Educational status (years) 11.8 (3.6) 11.6 (3.8)
207
+ 0.15
208
+ 0.88
209
+ Gender
210
+ Male
211
+ 8 (25.8)
212
+ 9 (37.5)
213
+ 0.87
214
+ 0.35
215
+ Female
216
+ 23 (74.2)
217
+ 15 (62.5)
218
+ SD = Standard deviation
219
+ Talwadkar, et al.: Trataka for cognitive functions
220
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
221
+ 98
222
+ cirrhotic patients,[30] and to evaluate target detection
223
+ deficits in patients who have undergone frontal
224
+ lobectomy surgery.[31] This test has also been evaluated
225
+ for its reliability and validity based on standard criteria
226
+ and has standard norms for the Indian population. TMT‑B
227
+ is one of the most popular neuropsychological tests and
228
+ is included in most test batteries, is a measure of visual
229
+ scanning, complex attention, psychomotor speed mental
230
+ flexibility, and executive functions. The TMT is sensitive
231
+ to a variety of neurological impairments.[32,33] Adequate
232
+ test‑retest reliability has been found for both Part A and
233
+ Part B of the TMT in the healthy control group (r = 0.46
234
+ and 0.44, respectively), as calculated using Pearson’s
235
+ correlation coefficients.[34]
236
+ The intervention of trataka included set of procedures
237
+ including eye exercises and gazing at the candle
238
+ flame with focused attention followed by defocussing.
239
+ Breathing and chanting were also included in the practice
240
+ that promotes internal awareness and focusing on the
241
+ Figure 1: The CONSORT (consolidated standards of reporting trials, Altman et al., 2001) diagram of flow of participants through each stage of the randomized trial
242
+ activity followed by defocusing. Each session was of
243
+ 30 min duration [Table 2]. Classes were conducted on
244
+ everyday basis, except for Sundays and attendance was
245
+ also recorded. Data of only those participants who had
246
+ completed a minimum of 75% and above class attendance
247
+ was analyzed.
248
+ The data at baseline was assessed for normality using
249
+ Shapiro‑Wilk test. As the data was found to be normal
250
+ for TMT‑B (trataka, statistics = 0.931, P = 0.05; control,
251
+ statistics = 0.929, P = 0.09) and SLCT (trataka = 0.957,
252
+ P = 0.24; control statistics = 0.946, P = 0.22) parametric
253
+ tests such as paired sample t‑tests, independent sample
254
+ t‑test, and Repeated measure analysis of variance (RM
255
+ ANOVA) were used to analyze the data. In case of the
256
+ Digit Span Test, the data was not found to be normally
257
+ distributed (trataka statistics = 0.845, P = 0.00; control
258
+ statistics = 0.931, P = 0.72). There were no outliers in
259
+ the data; however the data had distinct two peaks at the
260
+ higher and lower range of scores. If we had divided the
261
+ Talwadkar, et al.: Trataka for cognitive functions
262
+ 99
263
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
264
+ digit span scores using the median values into two groups,
265
+ we could have possibly got two independent normal
266
+ distributions. However, as we did not have any rationale
267
+ for dividing the group based on the median values,
268
+ nonparametric tests such as Mann‑Whitney, Wilcoxon
269
+ signed rank test, and Friedman’s test were used to analyze
270
+ the Digit Span Test scores. Bonferroni adjustment was
271
+ conducted as there were multiple comparisons to analyze
272
+ the time effect.
273
+ RESULTS
274
+ Out of the 60 subjects, 55 subjects completed the first
275
+ follow‑up on day 1  (postintervention). However, only
276
+ 48 subjects completed the second follow‑up, which was
277
+ conducted at the end of 1 month (trataka group n = 26,
278
+ wait list control n = 22).
279
+ There were no group differences at baseline in all three
280
+ outcome variables. Both the groups were comparable at
281
+ baseline, on all outcome variables. On Mann‑Whitney
282
+ tests, there was no significant difference between trataka
283
+ and wait list control group in Digit Span Test scores at
284
+ the first follow‑up. When compared to wait list control
285
+ group at the second follow‑up a possible trend towards
286
+ significance could be observed in the trataka group. When
287
+ compared within group (Friedman’s test and Wilcoxon
288
+ signed rank test), digit span scores improved at the first
289
+ follow‑up in trataka group, but the difference was not
290
+ significant. At the second follow‑up, there was significant
291
+ improvement in digit span scores (z = −3.35, P < 0.01).
292
+ While in control group, scores decreased at the first and
293
+ the second follow‑up, but there were no any significant
294
+ changes [Figure 2].
295
+ When compared between groups (independent sample
296
+ t‑test), there was no significant difference between the
297
+ trataka and wait list control group at first and second
298
+ follow‑up in SLCT scores. However, with respect to
299
+ time effect  (paired sample t‑test), selective as well as
300
+ sustained attention and concentration (measured using
301
+ SLCT scores) was seen to improve immediately after
302
+ the practice of trataka (when baseline compared to first
303
+ follow‑up) (t = 5.08, P < 0.01). Wait list control group
304
+ also performed better (may be because of retest effect),
305
+ but the improvement was not significant. At 1 month
306
+ follow‑up, trataka group showed significantly better
307
+ performance in the SLCT test compared to baseline
308
+ (t = −3.93, P < 0.01). Whereas, scores of wait list control
309
+ group came back to the baseline scores at the second
310
+ follow‑up.
311
+ On the independent sample t‑test, at the first follow‑up,
312
+ there was no significant difference in TMT‑B scores
313
+ between trataka and wait list control group. However at the
314
+ second follow‑up, there was a trend towards significance.
315
+ Trataka group performed significantly better at the first
316
+ follow‑up (paired sample t‑test) (t = −4.26, P < 0.01)
317
+ in TMT B test  (indicative of executive functions). In
318
+ contrast, in the wait list control group there was increase
319
+ in time taken to complete the task (suggestive of poor
320
+ performance) and the change was not significant. At the
321
+ second follow‑up, only trataka group showed significantly
322
+ improved (statistics = 7.09, P = 0.00) performance when
323
+ compared to the baseline scores.
324
+ The traditional analysis that is used to detect treatment
325
+ outcomes in randomized longitudinal clinical trials was
326
+ used; RM ANOVA. RM ANOVA results showed that
327
+ the executive functions in both the groups improved
328
+ over time  (occasion effect). Though there was no
329
+ significant group effect, trataka group showed significant
330
+ improvement in TMT‑B scores over a month period
331
+ of the study as compared to the wait list control
332
+ group (f = 6.67, P < 0.01; interaction effect) [Table 3].
333
+ Table  2: Details of trataka practice
334
+ Name of the practice
335
+ Duration
336
+ Starting prayer
337
+ 1 min
338
+ Preparatory eye exercises
339
+ 9 mins
340
+ Up and down or vertical movements‑10 rounds
341
+ 30 secs
342
+ Simple palming
343
+ 1 min
344
+ Right and left or horizontal movements‑10 rounds
345
+ 30 secs
346
+ Simple palming
347
+ 1 min
348
+ Diagonal movements‑right up‑left down‑10 rounds
349
+ 30 secs
350
+ Press and release palming
351
+ 1 min
352
+ Diagonal movements‑left up‑right down‑10 rounds
353
+ 30 secs
354
+ Press and release palming
355
+ 1 min
356
+ Rotational movements‑clockwise‑10 rounds
357
+ 30 secs
358
+ Constant pressure palming
359
+ 1 min
360
+ Rotational movements‑anticlockwise‑10 rounds
361
+ 30 secs
362
+ Constant pressure palming
363
+ 1 min
364
+ Jyoti trataka
365
+ Effortless gazing or focusing
366
+ 4 mins
367
+ ‘A’kara chanting
368
+ 1 min
369
+ Intensive focusing
370
+ 4 mins
371
+ ‘U’kara chanting
372
+ 1 min
373
+ Break
374
+ 1 min
375
+ De‑focussing
376
+ 4 mins
377
+ Bhramari
378
+ 1 min
379
+ Silence
380
+ 4 mins
381
+ Closing prayer
382
+ 1 min
383
+ Figure 2: Changes in median digit span scores across timeline in trataka and
384
+ wait list control group (Friedman’s test)
385
+ 
386
+ 
387
+ 
388
+ 
389
+ 
390
+ %DVHOLQH
391
+ VWIROORZXS
392
+ QGIROORZXS
393
+ 'LJLWVSDQWHVW
394
+ 7UDWDND*URXS
395
+ &RQWURO*URXS
396
+ Talwadkar, et al.: Trataka for cognitive functions
397
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
398
+ 100
399
+ With respect to SLCT scores, there was a trend towards
400
+ better improvement (f = 3.11, P = 0.05) in trataka group as
401
+ compared to the wait list control group over the 1 month
402
+ period of the study (interaction effect) [Table 3].
403
+ For the convenience of conducting intervention, half
404
+ of the subjects in the trataka group were provided the
405
+ intervention in the morning and the remaining half
406
+ were provided the intervention in the evening. Baseline
407
+ analysis showed that there were significant differences
408
+ in TMT‑B and SLCT scores between the morning group
409
+ and the evening group, with scores higher in the evening
410
+ group than morning group. Hence, post hoc test was
411
+ conducted to check if there was any significant interaction
412
+ effect (group X time) after controlling for baseline scores
413
+ using analysis of covariance (ANCOVA). Results show that
414
+ there was no significant difference between groups (people
415
+ who practiced in the morning as compared to people
416
+ who practiced in the evening) over the study period after
417
+ controlling for baseline differences.
418
+ DISCUSSION
419
+ In this study on elderly subjects, trataka intervention
420
+ improved cognitive functions  (short‑term memory
421
+ and working memory, selective and focused attention,
422
+ concentration, visual scanning as well as activation and
423
+ inhibition of rapid responses and executive functions)
424
+ when compared to wait list control group at the end of
425
+ 1 month. Trataka practice involves various steps like
426
+ preparatory eye exercises, focusing, defocusing, chanting,
427
+ and silence during relaxation. Each component or all
428
+ of them together could have been responsible for the
429
+ improvement in the cognitive functions. Preparatory
430
+ eye exercises improve the stamina of the eye muscles
431
+ and avoid eye strain. The degree of optical illusion is
432
+ observed to reduce post a set of yoga practices that includes
433
+ trataka (involving both focusing and defocusing of the
434
+ gaze and attention).[35] Dharana or focusing improves
435
+ concentrative attention  (“desha‑bandhashchittasya
436
+ dharanam”; Patanjali’s Yoga Sutras, Chapter III, Verse 1).[36]
437
+ Focused attention (FA) is the attention which is restricted
438
+ to a specific focus[37] such as the breath or the candle
439
+ flame (trataka). Receptive attention is a kind of attention
440
+ which is “objectless” and the goal is simply to keep attention
441
+ fully “readied” in the present moment of experience
442
+ without orienting, directing, or limiting it in any way.
443
+ Research studies have shown that intense FA meditation
444
+ effects cortical engagement, as reflected by a concomitant
445
+ reduction in event related desynchronization  (ERD)
446
+ to target tones in the beta (13-30 Hz) frequency band.
447
+ Reductions in beta ERD after practice of external tasks is
448
+ due to the decreased cognitive efforts.[38] There is enhanced
449
+ processing of task‑related auditory inputs during FA
450
+ meditation. FA meditation training is thought to improve
451
+ one’s ability to remain vigilant and monitor distractors
452
+ without losing focus. It is proposed that these mental
453
+ training‑related effects might be produced by a reduction
454
+ in cortical noise and/or by an enhancement of the rhythmic
455
+ mode of attention.
456
+ The second stage of trataka, the phase of defocussing is
457
+ akin to the stage of dhyana effortless attention (“tatra
458
+ pratyayaikatanata dhyanam”; Patanjali’s Yoga Sutras,
459
+ Chapter III, Verse 2).[39] When dharana becomes effortless,
460
+ it takes the form of dhyana, which is defined as the
461
+ uninterrupted spontaneous flow of the mind toward the
462
+ chosen object. Vigilance and attention are not required
463
+ during dhyana, which is the actual phase of meditation.[40]
464
+ Though there are different forms of meditation all of them
465
+ lead to calm yet alert mind.[41] At a more advanced level
466
+ of training in FA meditation which could be considered
467
+ a state of dhyana, the regulative attention skills are
468
+ invoked less frequently, and the ability to sustain focus
469
+ thus becomes progressively “effortless”.[38] Dhyana
470
+ is associated with reduced sympathetic activity and
471
+ increased vagal tone.[42] The defocussed phase of trataka
472
+ could be similar to the benefits of dhyana phase of
473
+ meditation. Multiple studies show that meditation may
474
+ affect multiple pathways that could play a role in brain
475
+ aging and mental fitness.[13] For example, meditation may
476
+ reduce stress‑induced cortisol secretion and this could
477
+ have neuroprotective effects potentially via elevating
478
+ levels of brain derived neurotrophic factor  (BDNF).
479
+ Meditation processes are linked to gamma‑aminobutyric
480
+ acid  (GABA) ergic cortical inhibition, a mechanism
481
+ implicated in improved cognitive performance and
482
+ enhanced emotional regulation.[43] Further, meditation
483
+ may potentially strengthen neuronal circuits and enhance
484
+ cognitive reserve capacity. Brain regions associated with
485
+ attention, interception, and sensory processing are thicker
486
+ in meditation practitioners including the PFC and right
487
+ anterior insula.[44] Advanced meditators have higher
488
+ melatonin levels (that blocks the build‑up of beta‑amyloid
489
+ plaque, a hallmark feature of Alzheimer’s disease)[45] than
490
+ nonmeditators.[46]
491
+ The results suggest that long‑term practice of trataka and
492
+ not just 1 day practice is required to improve short‑term
493
+ Table  3: RMANOVA for TMT‑B and SLCT scores
494
+ Variable
495
+ Mean (SD)
496
+ F
497
+ P value
498
+ Baseline
499
+ 1st follow up
500
+ 2nd follow up
501
+ TMT B
502
+ Trataka 170.58 (92.43) 151.45 (88.0) 111.27 (71.63) 6.67
503
+ 0.003
504
+ Control 187.96 (79.77) 191.70 (91.98) 151.76 (80.67)
505
+ SLCT
506
+ Trataka 23.88 (10.07)
507
+ 31.48 (14.68)
508
+ 31.04 (13.31) 3.11
509
+ 0.05
510
+ Control 24.96 (12.71)
511
+ 29.33 (14.61)
512
+ 26.23 (13.53)
513
+ TMT-B = Trail making test‑B; SLCT = Six letter cancellation test; SD = Standard
514
+ deviation
515
+ Talwadkar, et al.: Trataka for cognitive functions
516
+ 101
517
+ International Journal of Yoga • Vol. 7 • Jul-Dec-2014
518
+ memory. Similar study done on elderly subjects showed
519
+ that, at the 3  month follow‑up, yoga group improved
520
+ in semantic memory, short‑term primary memory, and
521
+ short‑term working memory.[47] So, the result of our study
522
+ is consistent with the results of earlier study. The only
523
+ difference is that our study period was only of 1 month;
524
+ still we could show significant improvement in the trataka
525
+ group. Thus, we can make a statement from our results
526
+ that first time yoga participants, if provided with 1 month
527
+ trataka intervention, can improve their executive, memory,
528
+ and cognitive functioning. This claim however needs to
529
+ be tested in larger samples.
530
+ In a study done on the healthy aging adults, it was seen
531
+ that performance on a simple attention task improved after
532
+ 5‑week relaxation response training program; whereas, no
533
+ improvement was seen in complex tasks of attention.[16]
534
+ In another study, net scores on the six‑letter cancellation
535
+ task were significantly higher after a session of Dharana.[48]
536
+ These results are in consistence with our results, as we
537
+ also observed increased SLCT scores immediately after
538
+ Trataka practice. Since Trataka is a type of dharana practice
539
+ that involves focused attention on a specified object, this
540
+ further strengthens that the results are valid and obtained
541
+ correctly.
542
+ There could be various other possible reasons for finding
543
+ differences over the 1 month period. The group was at a
544
+ stage when cognitive decline was a reality. All the aging
545
+ individuals  (after the age of 60  years) develop some
546
+ degree of decline in cognitive capacity as time progresses.
547
+ Studies show that 16.8% of aged people have some form
548
+ of cognitive decline without the symptoms of dementia.[49]
549
+ If the study was done on healthy young subjects, then we
550
+ might not have got the significant difference, because of
551
+ ‘ceiling effect’.
552
+ Another reason for the significant result could be that
553
+ majority of the participants of the study had never been
554
+ exposed to trataka or any yoga intervention earlier. A few
555
+ of the participants, who had earlier learnt yoga, had either
556
+ discontinued or had not practiced it for the past 3 months.
557
+ In such a case, we believe that the effect of trataka was
558
+ pronounced as there was no previous or past effect of any
559
+ similar intervention.
560
+ The fact that we got significant results to show that trataka
561
+ practice for 1 month is effective in improving cognitive
562
+ functions shows that the scales used in this study were
563
+ sensitive enough to tap the cognitive improvement in the
564
+ elderly after the trataka intervention. Three tests used in
565
+ this study were Digit Span Test, TMT‑B, and SLCT. Though
566
+ not developed specifically to test the effect of trataka, these
567
+ widely used tests have shown that they can tap significant
568
+ changes post yoga intervention.
569
+ Studies have time and again discussed the importance
570
+ of the prolonged practice of yoga.[50‑52] We assessed the
571
+ cognitive functions immediately after one session of
572
+ trataka and after 1 month of continuous daily practice. The
573
+ results pronounced that there was no significant difference
574
+ between groups at the end of one session (first follow‑up);
575
+ however, significant group and time differences including
576
+ interaction effects were observed at the end of 1 month
577
+ of intervention. Hence, we believe that our study results
578
+ validate earlier quoted studies which advocate prolonged
579
+ duration (number of days) of practice of yoga/trataka for
580
+ desirable effects.
581
+ The design of the study, that is, randomized block
582
+ design (RBD) was the main strength of the study. RBD
583
+ eliminates any bias in treatment assignment, specifically
584
+ selection bias and confounding. It maximizes statistical
585
+ power, especially in subgroup analyses. Another strength
586
+ of the study was that the intervention was provided
587
+ to the sample that needed the intervention, aging
588
+ individuals (after the age of 60), as they often develop
589
+ some degree of decline in cognitive capacity.
590
+ In spite of its strong methodology, the results of the
591
+ study need to be understood in the context that the
592
+ sampling was done only in two old age homes in Goa.
593
+ Further the sample size was small. The total sample size
594
+ was 60 based on earlier sample size calculations and
595
+ post attrition, the sample size for analysis was reduced
596
+ to 48. The results of the current study showed that
597
+ there was a trend towards significance in the trataka
598
+ group in the between group analysis  (group effect)
599
+ for some outcome variables. In this context, a larger
600
+ sample size could have depicted significant differences
601
+ between groups. Also, only three outcome variables
602
+ were used in the study. Age‑related cognitive decline
603
+ can be seen in different cognitive domains (e.g. speed
604
+ of processing, spatial ability, reasoning, etc.) and
605
+ varies individually. Further studies can be conducted
606
+ to test the effect of trataka on different neurological test
607
+ batteries.
608
+ CONCLUSION
609
+ The results of this study establish that trataka can be
610
+ used as a technique to enhance cognition in the elderly.
611
+ The trataka intervention is easy to learn, implement, and
612
+ adhere. Further trataka, after the initial few sessions, can
613
+ be practiced independently by the participant to achieve
614
+ desired results. For researchers, this study could provide
615
+ a substantial base for conducting future trials to test the
616
+ efficacy of trataka in controlled experiments.
617
+ REFERENCES
618
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619
+ Squire LR. Memory and Brain. New York: Oxford Univ Pr; AQ7 1987.
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749
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753
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760
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762
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763
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764
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765
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766
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767
+ Interest: None declared
768
+ without dementia in an elderly population. Lancet 1997;349:1793‑6.
769
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+ as an add‑on treatment in the management of patients with schizophrenia:A
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+ Varambally S, et al. Efficacy of Yoga as an Add‑on Treatment in Schizophrenia.
777
+ Project report submitted under Scheme for Extra Mural Research (EMR) to
778
+ Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH),
779
+ New Delhi; 2010.
subfolder_0/Effect of Yoga Based Lifestyle Intervention on Patients with Knee Osteoarthritis A Randomized Controlled Trial.txt ADDED
@@ -0,0 +1,1082 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ORIGINAL RESEARCH
2
+ published: 08 May 2018
3
+ doi: 10.3389/fpsyt.2018.00180
4
+ Frontiers in Psychiatry | www.frontiersin.org
5
+ 1
6
+ May 2018 | Volume 9 | Article 180
7
+ Edited by:
8
+ Mardi A. Crane-Godreau,
9
+ Department of Microbiology &
10
+ Immunology, Geisel School of
11
+ Medicine at Dartmouth, United States
12
+ Reviewed by:
13
+ Alejandro Magallares,
14
+ Universidad Nacional de Educación a
15
+ Distancia (UNED), Spain
16
+ Karin Meissner,
17
+ Ludwig-Maximilians-Universität
18
+ München, Germany
19
+ *Correspondence:
20
+ Singh Deepeshwar
21
22
+ Specialty section:
23
+ This article was submitted to
24
+ Psychosomatic Medicine,
25
+ a section of the journal
26
+ Frontiers in Psychiatry
27
+ Received: 21 February 2018
28
+ Accepted: 18 April 2018
29
+ Published: 08 May 2018
30
+ Citation:
31
+ Deepeshwar S, Tanwar M, Kavuri V
32
+ and Budhi RB (2018) Effect of Yoga
33
+ Based Lifestyle Intervention on
34
+ Patients With Knee Osteoarthritis: A
35
+ Randomized Controlled Trial.
36
+ Front. Psychiatry 9:180.
37
+ doi: 10.3389/fpsyt.2018.00180
38
+ Effect of Yoga Based Lifestyle
39
+ Intervention on Patients With Knee
40
+ Osteoarthritis: A Randomized
41
+ Controlled Trial
42
+ Singh Deepeshwar*, Monika Tanwar, Vijaya Kavuri and Rana B. Budhi
43
+ Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
44
+ Objective:
45
+ To investigate the effect of integrated approach of yoga therapy (IAYT)
46
+ intervention in individual with knee Osteoarthritis.
47
+ Design: Randomized controlled clincial trail.
48
+ Participants: Sixty-six individual prediagnosed with knee osteoarthritis aged between
49
+ 30 and 75 years were randomized into two groups, i.e., Yoga (n = 31) and Control (n
50
+ = 35). Yoga group received IAYT intervention for 1 week at yoga center of S-VYASA
51
+ whereas Control group maintained their normal lifestyle.
52
+ Outcome measures: The Falls Efficacy Scale (FES), Handgrip Strength test (left hand
53
+ LHGS and right hand RHGS), Timed Up and Go Test (TUG), Sit-to-Stand (STS), and right
54
+ & left extension and flexion were measured on day 1 and day 7.
55
+ Results: There were a significant reduction in TUG (p < 0.001), Right (p < 0.001), and
56
+ Left Flexion (p < 0.001) whereas significant improvements in LHGS (p < 0.01), and right
57
+ extension (p < 0.05) & left extension (p < 0.001) from baseline in Yoga group.
58
+ Conclusion:
59
+ IAYT practice showed an improvement in TUG, STS, HGS, and
60
+ Goniometer test, which suggest improved muscular strength, flexibility, and functional
61
+ mobility.
62
+ CTRI
63
+ Registration
64
+ Number:
65
+ http://ctri.nic.in/Clinicaltrials,
66
+ identifier
67
+ CTRI/2017/10/
68
+ 010141.
69
+ Keywords: knee osteoarthritis, integrative approach of yoga therapy (IAYT), handgrip strength (HGS), goniometer,
70
+ falls efficacy scale (FES)
71
+ INTRODUCTION
72
+ Osteoarthritis (OA) is the most common form of arthritis and leading cause of disability and loss of
73
+ functions in the elderly population. It can affect any joints, but the knee is one of the most affected
74
+ parts of the body in humans. There are several risk factors for OA such as obesity, smoking, intra-
75
+ articular fractures, chondrocalcinosis, crystals in joint fluid/cartilage, female gender, prolonged
76
+ immobilization, joint hypermobility, instability, peripheral neuropathy, prolonged occupational,
77
+ or sports stress (1). The prevalence of knee osteoarthritis increases with age (2). Approximately
78
+ 41.1% of males and 56.5% of females suffer from OA (3). Over 40% of adults between 50 and 75
79
+ years are affected with knee OA worldwide (4). The prevalence of knee OA in India is estimated to
80
+ be 28.7% (5). A total of 11 COPCORD (Community Oriented Program for Control of Rheumatic
81
+ Disorders) reports of knee OA data showed differences between rural (3.3%) and urban (5.5%)
82
+ population of India (6, 7).
83
+ Deepeshwar et al.
84
+ Yoga Based Lifestyle Intervention for Osteoarthritis
85
+ Symptoms of OA present as pain in and around the joints,
86
+ morning stiffness, restricted joint movements associated with
87
+ muscle weakness. Knee OA is associated with disrupted sleep,
88
+ depression, increased sedentary behavior, less physical activity,
89
+ obesity and decreased the quality of life (8). Bilateral knee
90
+ osteoarthritis impaired the balance and increased the risk of fall,
91
+ particularly in people with moderate knee osteoarthritis (9).
92
+ Non-pharmacological
93
+ interventions
94
+ such
95
+ as
96
+ exercise,
97
+ Yoga, integrated approach of yoga therapy (IAYT), Tai-Chi,
98
+ physiotherapy, acupressure, naturopathy, and massage therapy
99
+ showed improvements in quality of life along with a reduction
100
+ in pain, improved physical functions, psychological balance in
101
+ patients with knee OA (10–14). These non-pharmacological
102
+ rehabilitation interventions have focused mainly on practices
103
+ for Knee OA that produces only small to moderate benefits
104
+ with the limited durability of effects on the symptoms of knee
105
+ OA (15). These interventions provided substantial benefits, but
106
+ are underutilized, and the efficacy and safety remain poorly
107
+ defined. In few earlier studies, yoga showed promising changes
108
+ in reducing pain, morning stiffness, and increased flexibility,
109
+ muscular strength and overall quality of life in knee OA patients
110
+ (16–19).
111
+ Yoga, a mind-body intervention, originated in India. Different
112
+ schools of yoga (such as Iyengar yoga, IAYT, hatha yoga, etc.)
113
+ developed a therapeutical intervention for knee OA. A pilot study
114
+ was conducted on nine participants, using modified Iyengar
115
+ yoga postures (90-min classes once in a week for 8 weeks) as a
116
+ treatment modality and showed potential reductions in pain and
117
+ disability caused by knee OA (20). Few other studies compared
118
+ yoga therapy with different interventions such as traditional
119
+ stretching and strengthening exercises or no structured group
120
+ exercise for 6 weeks and showed functional changes and
121
+ improvement in the quality of life in traditional practice
122
+ and yoga-based approach (21). Ebnezar et al. investigated
123
+ transcutaneous electrical stimulation and ultrasound treatment
124
+ followed by IAYT intervention (40 min) and reported that IAYT
125
+ is better than physiotherapy exercises for reducing pain, morning
126
+ stiffness, state and trait anxiety, blood pressure and pulse rate in
127
+ OA patients (18). This study was limited to numerical pain scale
128
+ and state and trait anxiety (STAI 1&2). Meta-analyses of yoga for
129
+ musculoskeletal problems suggest that yoga is helpful for chronic
130
+ pain and low back problems in older women population (16).
131
+ Studies on aerobic exercises including physical activities, yoga,
132
+ and Tai Chi, have long been a rehabilitation intervention for
133
+ treating patients with OA in decreasing pain, joint tenderness and
134
+ improving functional status (22). Most of these studies indicate
135
+ the long-term effect of yoga on symptoms of OA. There are
136
+ very few studies reporting the immediate impact of yoga on
137
+ patients with knee OA and self-efficacy. Also, limited data are
138
+ available to support the efficacy of IAYT intervention for OA
139
+ management. Few studies have methodological issues related to
140
+ their design such as small sample size, wide-ranging age group
141
+ due to unavailability of similar age group participants, whereas
142
+ other studies have a long-term intervention, high attrition rate,
143
+ etc.
144
+ Hence, the present study intended to investigate the
145
+ immediate effect of 1-week integrated approach of yoga therapy
146
+ (IAYT) intervention in older adults with knee OA. We
147
+ hypothesized that a brief intervention of yoga practice may have
148
+ a positive effect on, (i) Falls Efficacy Scale (FES), (ii) handgrip
149
+ strength (HGS), (iii) Timed up and Test (TUG), (iv) Sit to Stand
150
+ (STS), and (v) knee extension and flexion.
151
+ MATERIALS AND METHODS
152
+ Participants
153
+ A total of 66 participants (50 female and 16 male) aged 30–
154
+ 75 years (60.2 ± 8.2 years), were recruited from Arogyadhama,
155
+ a home-based health center, S-VYASA, Bangalore and the
156
+ nearby area between April 2015–July 2015. The sample size was
157
+ calculated with G-Power software by fixing the alpha at 0.05
158
+ powered at 0.8 and an effect size of 0.71 based on the mean and
159
+ SD of an earlier study (18). The inclusion criteria were, patients
160
+ suffering from knee OA for more than 3 months (diagnosed by
161
+ a physician), fully ambulant, literate, and willing to participate
162
+ in the study. Patients with rheumatoid arthritis, autoimmune
163
+ diseases, malignancies, knee surgery or knee-arthroscopy, and
164
+ knee pain caused by congenital dysplasia were excluded. The
165
+ flow chart of study participants from enrollment to completion
166
+ is given in Figure 1.
167
+ Prospective participants were informed about the trial
168
+ through media reports and advertisements in local newspapers
169
+ and University magazine. The CONSORT Flow diagram of the
170
+ trial is given in Figure 1 and the demographic details collected
171
+ for all participants (age, gender, duration of OA complaints, BMI,
172
+ education, and Occupation) are given in Table 1.
173
+ Ethical Consideration
174
+ The
175
+ research
176
+ study
177
+ was
178
+ approved
179
+ by
180
+ the
181
+ Institutional
182
+ Review
183
+ Board
184
+ (IRB)
185
+ of
186
+ the
187
+ S-VYASA
188
+ University
189
+ (No.
190
+ SVYASA/MSc/IRB/10/21) and conducted under the guidance
191
+ of senior doctors and therapists of the University. All subjects
192
+ were informed about the trial, and written informed consent was
193
+ obtained from the participants of this study.
194
+ Design
195
+ Recruited participants were randomly divided into two groups,
196
+ i.e., Yoga group with the intervention of integrative approach
197
+ for yoga therapy (IAYT) and Control group without any form
198
+ of yoga intervention. The study set-up was completely a yoga-
199
+ based lifestyle where all participants in yoga group followed
200
+ intervention of IAYT treatment for 6 days. All assessments
201
+ and treatment plans for participants were discussed with senior
202
+ doctor and therapist. All participants in both groups continued
203
+ their medication as per the requirements. It was not possible
204
+ to mask the yoga intervention from the subjects. However, the
205
+ investigators who collected primary and secondary outcomes
206
+ were blind to the intervention (23).
207
+ Intervention
208
+ Integrated Approach of Yoga Therapy (IAYT)
209
+ IAYT module for arthritis was developed using a holistic
210
+ approach to health management at physical, mental, emotional,
211
+ and intellectual levels (24). The practices were yoga postures
212
+ Frontiers in Psychiatry | www.frontiersin.org
213
+ 2
214
+ May 2018 | Volume 9 | Article 180
215
+ Deepeshwar et al.
216
+ Yoga Based Lifestyle Intervention for Osteoarthritis
217
+ FIGURE 1 | CONSORT Flow diagram of study participants.
218
+ (asana), yoga breathing (pranayama), relaxation techniques,
219
+ meditation and lectures on yogic lifestyle, devotional sessions,
220
+ and stress management through yogic counseling. The yogic
221
+ practices for knee OA included simple yogic movements and
222
+ postures that provided stretching, flexibility, strengthening weak
223
+ muscles and relaxation of body and mind (24). Yogic breathing
224
+ helps participants to achieve a slow rhythmic pattern of breathing
225
+ with slowing down the breathing pattern, deep inhalation, and
226
+ longer exhalation as the foundation (25). Cyclic meditation,
227
+ Om meditation and devotional sessions (prayers) are part of
228
+ meditation to control the surge of negative emotions. Lectures
229
+ and individual yogic counseling for stress management were
230
+ effectively focused on knee pain (26).
231
+ Cleansing techniques (Kriyäs) were used to help clean and
232
+ refresh the optical path, respiratory tract, and gastrointestinal
233
+ tract. All participants practiced intense candlelight gazing
234
+ Frontiers in Psychiatry | www.frontiersin.org
235
+ 3
236
+ May 2018 | Volume 9 | Article 180
237
+ Deepeshwar et al.
238
+ Yoga Based Lifestyle Intervention for Osteoarthritis
239
+ TABLE 1 | Characteristics of the study participants (n = 66).
240
+ Participants
241
+ Yoga (n = 31)
242
+ Control (n = 35)
243
+ Gender—50 Females (75%)
244
+ Males
245
+ 6 (61.83 ± 9.1 years)
246
+ 10 (60.13 ± 8.6 years)
247
+ Females
248
+ 25 (59.8 ± 8.2 years)
249
+ 25 (59.4 ± 9.4 years)
250
+ Duration of pain, in years;
251
+ mean (SD)
252
+ 2–16 years; 11.52
253
+ (4.01)
254
+ 2–14 years; 12.31
255
+ (5.36)
256
+ BMI (mean; SD)
257
+ 28.15 (5.80)
258
+ 30.02 (4.15)
259
+ Education: n (%)
260
+ (<6 years)
261
+ 22 (71%)
262
+ 19 (54%)
263
+ (>6 and 12 years)
264
+ 7 (22%)
265
+ 12 (34%)
266
+ (>12 years)
267
+ 2 (7%)
268
+ 4 (11%)
269
+ Occupation: n (%)
270
+ Housewife
271
+ 18 (58%)
272
+ 24 (69%)
273
+ Govt. Employee
274
+ 2 (5%)
275
+ 1 (3%)
276
+ Private Employee
277
+ 7 (20%)
278
+ 8 (23%)
279
+ Retired
280
+ 5 (17)
281
+ 2 (5%)
282
+ (Tr¯
283
+ at
284
+ .aka), nasal cleansing with water and catheter (Jala and sutra
285
+ neti), frontal brain cleansing breath (Kap¯
286
+ alabh¯
287
+ ati), vomiting with
288
+ lukewarm saline water (Vamana dhauti), partial colon cleansing
289
+ (Laghu´
290
+ sankha Praksh¯
291
+ alana) (27). These techniques were done
292
+ everyday twice (morning and evening) during the intervention
293
+ period of 7 days. The summarized yoga practices for knee OA are
294
+ given in Table 2.
295
+ Outcome Measures
296
+ All participants were assessed for primary and secondary
297
+ outcomes twice, at baseline (day 1) and end of study period, day 7.
298
+ Primary Outcomes
299
+ (i) Timed up and go Test (TUG)—TUG is an easy and low-cost
300
+ test developed to assess the functional mobility of patients during
301
+ everyday activities. The test comprises the following sequence of
302
+ movements: to stand up from a standard chair, walk 3 m, turn,
303
+ walk back to the chair and sit down again. The time taken by
304
+ patients to complete the sequence of this movement is recorded
305
+ and compared before and after treatment (28). The internal
306
+ consistency (Cronbach’s alpha) was 0.74.
307
+ (ii) Sit-to-Stand (STS)—Participants were instructed to stand
308
+ up five times from a chair without using the support of their
309
+ arms, as fast as possible. The test was repeated twice as this
310
+ improved the reliability of the test, and the average time will be
311
+ calculated in seconds (29). The correlation coefficients of intra-
312
+ session reliability and test-retest reliability were 0.95 and 0.99,
313
+ respectively. The convergent validity of the five-repetition sit-to-
314
+ stand test was supported by significant correlation with a one-
315
+ repetition maximum of the loaded sit-to-stand test, isometric
316
+ muscle strength, scores of Gross Motor Function Measure, and
317
+ gait function (r or rho = 0.40–0.78) (30).
318
+ (iii) Goniometer test for flexibility and range of motion—
319
+ Participants were seated on a chair with legs stretched in front
320
+ called Right and Left Extension. The goniometer was placed on
321
+ the knee and was asked to bend the leg at the knee as far as
322
+ they could, Right and Left Flexion, and the degree of the bend
323
+ was measured with the goniometer. The average range of motion
324
+ (ROM) of the knee is 120–150◦(31). The data analysis revealed
325
+ that the inter-tester reliability (r = 0.98; ICC = 0.99) and validity
326
+ (r = 0.97–0.98; ICC = 0.98–0.99) were high (32). An overall
327
+ mean score was calculated for each participant.
328
+ Secondary Outcomes
329
+ (i) Handgrip Strength Test (HGS)—Handgrip strength of both
330
+ hands right handgrip strength (RHGS) and left handgrip strength
331
+ (LHGS) were assessed using a handgrip dynamometer. Subjects
332
+ were tested in 6 trials, 3 for each hand alternately, with a gap of
333
+ 10 s between trials (33).
334
+ (ii) Falls Efficacy Scale (FES)—FES is an instrument to
335
+ measure fear of falling, based on the operational definition of
336
+ this fear as “low perceived self-efficacy at avoiding falls during
337
+ essential, non-hazardous activities of daily living.” FES is a 10-
338
+ item rating scale with test–retest reliability (r = 0.71), used to
339
+ assess confidence in performing daily activities without falling
340
+ (34). Each item is rated from 1 = extreme confidence, to 10 =
341
+ no confidence at all. Participants who reported avoiding activities
342
+ because of fear of falling had higher FES scores, representing
343
+ lower self-efficacy or confidence than those not reporting fear of
344
+ falling.
345
+ Procedure
346
+ All recruited participants were randomized in two groups,
347
+ i.e., Yoga group (n = 31; 59.8 ± 10.21 years) and Control
348
+ group (n = 35; 61.07 ± 9.17 years), using systematic
349
+ sampling method. The data collected of 66 participants on
350
+ Day 1 and Day 7 were extracted with the help of the
351
+ therapist from rheumatology department. There were no
352
+ dropouts in this study, and all collected data were observed
353
+ carefully. The data were tabulated and no missing values were
354
+ found.
355
+ Data were obtained from participants as per the stipulated
356
+ instructions in the manuals of questionnaires and tests.
357
+ DATA ANALYSIS
358
+ Statistical
359
+ analysis
360
+ was
361
+ carried
362
+ out
363
+ using
364
+ the
365
+ Statistical
366
+ Package for the Social Science (SPSS version 20.00, IBM
367
+ Corp.,
368
+ USA).
369
+ The
370
+ scores
371
+ were
372
+ assessed
373
+ for
374
+ between-
375
+ group
376
+ differences
377
+ in
378
+ the
379
+ change
380
+ of
381
+ outcome
382
+ measures,
383
+ i.e., Timed up and test (TUG), Sit to stand test (STS),
384
+ Handgrip strength test (HGS), Extension and Flexion, and
385
+ Falls Efficacy Scale (FES) after the 1-week intervention of
386
+ IAYT.
387
+ Within
388
+ Group
389
+ and
390
+ Between-Group
391
+ comparisons
392
+ were
393
+ performed for exploratory reasons and are given in Table 3.
394
+ Test of normality showed no significant difference in age,
395
+ duration of osteoarthritis and socio-economic status between
396
+ the
397
+ groups.
398
+ Repeated
399
+ measures
400
+ of
401
+ Analysis
402
+ of
403
+ Variance
404
+ (ANOVA) were performed for each outcome measures with
405
+ two factors: (1) Groups: Yoga and Control; and (2) number
406
+ of assessments: Pre and Post. Repeated measures of ANOVA
407
+ were carried out separately followed by post-hoc analysis
408
+ Frontiers in Psychiatry | www.frontiersin.org
409
+ 4
410
+ May 2018 | Volume 9 | Article 180
411
+ Deepeshwar et al.
412
+ Yoga Based Lifestyle Intervention for Osteoarthritis
413
+ TABLE 2 | Yoga practices module for knee OA.
414
+ S. No.
415
+ Practices
416
+ Practice name (Sanskrit and English)
417
+ Duration of practice
418
+ 1.
419
+ Breathing practices
420
+ Hands in and out Breathing
421
+ 5 rounds (2 min)
422
+ Hands Stretch Breathing
423
+ 5 rounds (2 min)
424
+ Ankle Stretch Breathing
425
+ 5 rounds (2 min)
426
+ 2.
427
+ Loosening practices in standing
428
+ Twisting
429
+ 5 rounds (2 min)
430
+ Side bending
431
+ 5 rounds (2 min) on each side
432
+ 3.
433
+ Loosening practices in sitting
434
+ Knee Cap Tightening
435
+ 5 rounds (2 min) each, both legs
436
+ Passive Patella Movement (Up and Down, In and Out, Rotation)
437
+ 10 rounds (4 min) both legs
438
+ Knee bending
439
+ 5 rounds (2 min) each, both legs
440
+ 4.
441
+ Loosening practices in Supine
442
+ Folded Leg Lumber Stretch (Left, Right, Both)
443
+ 5 rounds (2 min)
444
+ Cycling
445
+ 5 rounds (2 min) both legs
446
+ Straight Leg Raising (Left, Right and Both)
447
+ 5 rounds (2 min)
448
+ 5.
449
+ Yoga Posture- Sitting
450
+ Paschimottasana (Seated forward bend Pose)
451
+ 3 rounds (3 min)
452
+ Bh¯
453
+ un
454
+ . aman¯
455
+ asana (Earth Salutation Pose)
456
+ 3 rounds (3 min)
457
+ 6.
458
+ Yoga Posture-Prone
459
+ Bhuja ˙
460
+ ng¯
461
+ asana (Cobra Pose)
462
+ 3 rounds (3 min)
463
+ Salabh¯
464
+ asana (Locust Pose)
465
+ 3 rounds (1 min)
466
+ Vipareetkarani (Inverted Pose)
467
+ 2 min
468
+ 7.
469
+ Yoga posture- Supine
470
+ Setubandh¯
471
+ asana (Bridge Pose)
472
+ 2 rounds (1 min)
473
+ Markat
474
+ . ¯
475
+ asana (Lumbar Stretch Pose)
476
+ 2 rounds (1 min)
477
+ Sav¯
478
+ asana (Corpse Pose)
479
+ 5 min
480
+ 8.
481
+ Relaxation Techniques
482
+ Instant Relaxation Technique
483
+ 2 min
484
+ Quick Relaxation Technique
485
+ 5 min
486
+ Deep Relaxation Technique
487
+ 10 min
488
+ 9.
489
+ Kriyas (Cleansing techniques)
490
+ Jalaneti (Nasal Cleansing with Water)
491
+ 30 min
492
+ Vamanadhouti (Internal Cleansing by Water)
493
+ 15 min
494
+ Tr¯
495
+ at
496
+ .aka (Candle Light Gazing)
497
+ 10 min
498
+ Kap¯
499
+ alabh¯
500
+ ati (Frontal Brain Cleansing)
501
+ 5 min
502
+ 10.
503
+ Pr¯
504
+ an
505
+ . ayama (Yoga Breathing)
506
+ Vibh¯
507
+ ag¯
508
+ ıyaPr¯
509
+ an
510
+ . ayama (Sectional Breathing)
511
+ 3 rounds (3 min)
512
+
513
+ ad¯
514
+ ı´
515
+ suddh¯
516
+ ı (Alternate Breathing)
517
+ 9 rounds (3 min)
518
+ Brah¯
519
+ amar¯
520
+ ı (Humming Bee Breathing)
521
+ 9 rounds (3 min)
522
+ Bhastrik¯
523
+ a (Bellows Breathing)
524
+ 9 rounds (3 min)
525
+ 11.
526
+ Cooling Pr¯
527
+ an
528
+ . ayama
529
+ ´
530
+
531
+ ıtali (Rolling Tongue Breathing)
532
+ 9 rounds (3 min)
533
+ ´
534
+ Sitk¯
535
+ ar¯
536
+ ı (Folded Tongue Breathing)
537
+ 9 rounds (3 min)
538
+ Sadant¯
539
+ a (Clenched Teeth Breathing)
540
+ 9 rounds (3 min)
541
+ 12.
542
+ Meditation
543
+
544
+ ad¯
545
+ anusandh¯
546
+ ana (A,U,M and A-U-M Kara chanting)
547
+ 10 min
548
+ Om Meditation
549
+ 10 min
550
+ Cyclic Meditation
551
+ 30 min
552
+ Mind Sound Resonance Technique
553
+ 10 min
554
+ with Bonferroni correction, for two-time points of all the
555
+ outcome measures. All comparisons were made between
556
+ pre and post mean values of each outcome measure. If the
557
+ p-value was p ≤0.05, the results were considered statistically
558
+ significant.
559
+ RESULTS
560
+ The demographic data of recruited participants are given in
561
+ Table 1. The repeated measures of ANOVA were performed for
562
+ each outcome measure with two factors, i.e., groups (Yoga and
563
+ Frontiers in Psychiatry | www.frontiersin.org
564
+ 5
565
+ May 2018 | Volume 9 | Article 180
566
+ Deepeshwar et al.
567
+ Yoga Based Lifestyle Intervention for Osteoarthritis
568
+ TABLE 3 | Comparison of change in primary and secondary outcomes in IAYT and control groups.
569
+ Variables
570
+ Within group
571
+ Between-Group (p-value)
572
+ 2-Way repeated measures of ANOVA
573
+ Yoga group
574
+ Control group
575
+ F group (p-value) F time (p-value) F interaction (p-value)
576
+ Before
577
+ After
578
+ Before
579
+ After
580
+ PRIMARY OUTCOMES
581
+ Timed Up and Go Test (TUG)
582
+ 19.16 ± 5.99
583
+ 15.57 ± 5.23***
584
+ 18.56 ± 6.41
585
+ 19.02 ± 5.19*
586
+ 0.014
587
+ 2.500
588
+ 35.413$$$
589
+ 8.842$$
590
+ Sit-to-Stand (STS)
591
+ 18.35 ± 6.25
592
+ 14.22 ± 4.65***
593
+ 19.28 ± 5.69
594
+ 18.06 ± 5.71
595
+ 0.004
596
+ 4.72$
597
+ 30.973$$$
598
+ 9.092$$
599
+ Goniometer -
600
+ 177.58 ± 3.63
601
+ 179.36 ± 2.14*
602
+ 178.17 ± 3.25
603
+ 176.21 ± 3.05
604
+ NS
605
+ 0.912
606
+ 6.298$
607
+ 1.142
608
+ (i) Right Extension
609
+ (ii) Right Flexion
610
+ 45.52 ± 13.03
611
+ 37.23 ± 11.28***
612
+ 46.22 ± 13.40
613
+ 44.54 ± 14.32
614
+ 0.026
615
+ 2.38$
616
+ 28.910$$$
617
+ 12.671$$$
618
+ (iii) Left Extension
619
+ 176.52 ± 4.49
620
+ 179.32 ± 1.90***
621
+ 175.84 ± 4.22
622
+ 176.20 ± 5.19
623
+ 0.035
624
+ 0.887
625
+ 12.429$$
626
+ 7.927$$
627
+ (iv) Left Flexion
628
+ 46.39 ± 15.47
629
+ 39.84 ± 12.55***
630
+ 47.89 ± 16.24
631
+ 45.43 ± 15.12*
632
+ NS
633
+ 1.96
634
+ 31.435$$$
635
+ 6.488$
636
+ SECONDARY OUTCOMES
637
+ Falls Efficacy Scale (FES)
638
+ 39.13 ± 10.36
639
+ 41.58 ± 11.18
640
+ 37.53 ± 11.05
641
+ 36.21 ± 13.14
642
+ NS
643
+ 0.258
644
+ 2.180
645
+ 2.081
646
+ Hand Grip Strength (HGS)-
647
+ (i) Right Hand Grip Strength (RHGS)
648
+ 22.42 ± 6.28
649
+ 23.67 ± 6.05
650
+ 24.51 ± 7.35
651
+ 24.34 ± 5.75
652
+ NS
653
+ 0.886
654
+ 0.937
655
+ 1.779
656
+ (ii) Left Hand Grip Strength (LHGS)
657
+ 21.11 ± 6.32
658
+ 22.55 ± 6.88**
659
+ 22.11 ± 6.01
660
+ 20.2 ± 6.32
661
+ NS
662
+ 0.821
663
+ 7.625$$
664
+ 1.082
665
+ *p < 0.05; **p < 0.01; ***p < 0.001 significant difference before and after yoga intervention.
666
+ $ < 0.05; $$ < 0.01; $$$ < 0.001 showed main effect or interaction effect in 2-way repeated measures ANOVA.
667
+ Frontiers in Psychiatry | www.frontiersin.org
668
+ 6
669
+ May 2018 | Volume 9 | Article 180
670
+ Deepeshwar et al.
671
+ Yoga Based Lifestyle Intervention for Osteoarthritis
672
+ Control) and times of assessment (Pre and Post). The primary
673
+ and secondary outcome scores of within-group analysis are
674
+ shown in Table 3. The 2-way ANOVA results showed that there
675
+ was a significant interaction between “group” and “time” of (i)
676
+ TUG (F = 8.84; p < 0.01), (ii) STS (F = 9.09; p < 0.01), and
677
+ (iii) Goniometer (a) Right Flexion (F = 12.67; p < 0.001), (b)
678
+ Left Extension (F = 7.93; p < 0.01), and (c) Left Flexion (F
679
+ = 6.49; p < 0.05). Post-hoc analysis with Bonferroni correction
680
+ showed significant decrease in TUG (p < 0.001), STS (p < 0.001),
681
+ increased Right & Left Flexion (p < 0.001) and Right (p < 0.05)
682
+ & Left (p < 0.001) extension in primary outcomes.
683
+ Whereas in the secondary outcomes, handgrip strength showed
684
+ significant increase in LHGS (p < 0.01) in yoga group after 1 week
685
+ IAYT intervention and no changes falls efficacy score. In Control
686
+ group, we observed there was no relief of symptoms. After 1
687
+ week, we observed that the Control group had a significant
688
+ increase in TUG (p < 0.05) and a decrease in Left Flexion
689
+ (p < 0.05) suggesting worsened symptoms after 1 week with
690
+ conventional treatment alone. Between group analysis showed
691
+ there was significant difference in post assessments of TUG (p
692
+ < 0. 05), STS (p < 0.01), Right Flexion (p < 0.05), Left Extension
693
+ (p < 0.05) of Yoga and Control group as shown in Figures 2A–C.
694
+ DISCUSSION
695
+ The results of the present study of the 1-week integrated
696
+ approach of yoga therapy (IAYT) demonstrated significant
697
+ improvements in TUG and STS tests in the Yoga group and
698
+ no changes were observed in Control group. Yoga group
699
+ participants reported significantly shorter time taken to perform
700
+ different physical tests after 1-week yoga intervention which
701
+ suggest better functional performance. The TUG test assesses
702
+ multiple components of balance and mobility (35). The STS
703
+ movement is one function people frequently use as they change
704
+ from a sitting position to a standing position. STS requires
705
+ forward movement of the center of mass while still seated
706
+ (in preparation to stand), acceleration of the center-of-mass
707
+ both in the anterior, posterior, and vertical plane, push offand
708
+ stabilization once standing is achieved (36, 37). This movement
709
+ is defined as a transitional movement to the upright posture
710
+ requiring movement of the center of mass from a stable position
711
+ to a less stable position over extended lower extremities (38).
712
+ The HGS is a reliable measurement when standardized methods
713
+ and calibrated equipment are used, even when there are different
714
+ assessors or different brands of dynamometers (39, 40). Grip
715
+ strength is related to the predictive of other health conditions.
716
+ In the present study, right and left handgrip strength showed
717
+ improvement after 1 week IAYT intervention. Previous studies
718
+ reported that handgrip strength is positively related to normal
719
+ bone mineral density in postmenopausal women (41), and can be
720
+ used as a screening tool for women at risk of osteoporosis (42).
721
+ Additionally, in the present study, Yoga group patients
722
+ showed that there was a significant decrease in knee pain and
723
+ stiffness, and significant improvement in mobility, measured
724
+ through right and left leg extension and flexion test. These
725
+ results are consistent with previous findings of Schilke et al.
726
+ were 10 patients with knee pain, have undergone 8 weeks of
727
+ the isokinetic muscle-strength-training program and showed
728
+ a significant decrease in pain and stiffness. There was also a
729
+ significant decline in arthritis activity after intervention and an
730
+ increase in all strength measures of right-left flexion and left-leg
731
+ extension across the training period (14).
732
+ One study on rheumatoid arthritis (RA) patients aged 18
733
+ years and older, underwent 8 weeks of yoga (two 60-min
734
+ classes and one home practice/wk) reported higher physical
735
+ component summary (PCS), walking capacity, positive affect
736
+ and lower center for epidemiologic studies depression scale.
737
+ Improvements were also shown in SF-36 health-related quality
738
+ of life, role physical (work and daily activity impairment
739
+ due to physical health), pain, general health, vitality, and
740
+ mental health scale (43). Yoga showed a reduction in pain,
741
+ depression and more significant improvement in life satisfaction
742
+ after intervention (44). Yoga is mind-body interventions, that
743
+ impart stress management with physical activity may be well
744
+ suited for osteoarthritis and rheumatoid arthritis. Another
745
+ therapeutic intervention of Iyengar yoga in patients with knee
746
+ OA, EMG biofeedback showed a significant reduction in pain
747
+ and improvement in functional ability (19). This suggests that
748
+ yoga along with conventional therapy provides better results
749
+ in chronic knee osteoarthritis regarding pain and functional
750
+ disability. In a comparison of conventional therapy and add-
751
+ on yoga for 56 patients of knee rehabilitation after total knee
752
+ arthroplasty showed that there was a significant change for
753
+ pain, stiffness and functional subscales of Western Ontario and
754
+ McMaster Universities OA Index (WOMAC) Scale in both the
755
+ groups (45). This indicates that yoga asana protocol works better
756
+ than physiotherapy alone. The practice of yoga is doable, easy to
757
+ follow, safe and most important is useful for patients with knee
758
+ OA. There is evidence that Tai-Chi and yoga are safe and showed
759
+ significant reduction of pain and improvement of physical
760
+ function and quality of life in patients (46). The physical posture
761
+ (hatha yoga) practice also helps to reduce pain and symptoms
762
+ of OA and increase scores of daily activities, sports, spare-time
763
+ activities, and quality of life (17). The practice of yoga effects
764
+ on knee OA reported positive outcomes on symptoms including
765
+ pain, flexibility, functional disability, anxiety, and quality of life
766
+ (20). Earlier studies indicated subsided pain intensity in walking
767
+ scale and improvement in WOMAC and quality of life after yoga
768
+ practice. The resting pain and morning stiffness were studied in a
769
+ former study, and the current study is a continuation of the same
770
+ intervention (i.e., IAYT). The present study reported reduction
771
+ in Time Up and Go test, Sit To Stand test. These results show that
772
+ yoga practice improves muscular strength, better movement, and
773
+ flexibility.
774
+ The possible mechanism of yoga therapy-related changes in
775
+ symptoms of OA is not known. The multifactorial approach
776
+ of yoga therapy includes physical postures (asanas), breathing
777
+ practices (pranayama), meditation (dhyana), spiritual and
778
+ emotional cultures discourses may help to the amelioration of
779
+ OA symptoms. Yoga therapy intervention may increase cartilage
780
+ proteoglycan content and prevent cartilage degeneration (47).
781
+ This is helpful for the strengthening of periarticular muscles (i.e.,
782
+ quads and hamstrings) that normally contract to stabilize the
783
+ Frontiers in Psychiatry | www.frontiersin.org
784
+ 7
785
+ May 2018 | Volume 9 | Article 180
786
+ Deepeshwar et al.
787
+ Yoga Based Lifestyle Intervention for Osteoarthritis
788
+ FIGURE 2 | Comparison between yoga and control groups after intervention. (A) Time Up and Go Test(TUG) and Sit To Stand (STS). (B) Right and left extension
789
+ assessed with Goniometer. (C) Right and left flexion assessed with Goniometer. *p < 0.05, **p < 0.01.
790
+ Frontiers in Psychiatry | www.frontiersin.org
791
+ 8
792
+ May 2018 | Volume 9 | Article 180
793
+ Deepeshwar et al.
794
+ Yoga Based Lifestyle Intervention for Osteoarthritis
795
+ knee joint pain. Also, yoga practice may prevent synovial fluid
796
+ volume deterioration by stretching and strengthen different parts
797
+ of the body, massaging and bringing fresh blood to the internal
798
+ organs while rejuvenating the nervous system and lubricating the
799
+ joints, muscles, and ligaments. It is purported to have different
800
+ effects on the nervous and circulatory systems, coordination and
801
+ concentration and calming effect on the body. This also suggests
802
+ that yoga practice helps in reducing several psychological factors
803
+ such as stress, anxiety, depression, mood disturbances, and
804
+ enhance self-esteem and quality of life (43) in individuals with
805
+ chronic pain and arthritic conditions (48). It can be concluded
806
+ that yoga can be used as a complementary treatment along with
807
+ conventional treatment to improve the situation of people with
808
+ knee osteoarthritis.
809
+ There are several limitations to this study such as very
810
+ short duration of yogic intervention, confounding variables
811
+ such as diet, controlled environment, small sample size, etc.
812
+ Another limitation was no standard self-reported measure of
813
+ osteoarthritis symptoms was used. Further, sample was not
814
+ balanced by gender, so the outcome of the study cannot be
815
+ generalized and future study can be planned with equal number
816
+ of both the gender. Additionally, placebo is reported to be
817
+ effective for OA, especially for subjective outcomes such as pain,
818
+ stiffness, self-reported function, and physician global assessment
819
+ and in the current study no placebo group was taken. Hence,
820
+ the placebo effect on the outcome cannot be ruled out in
821
+ this study and further study can be planned with placebo
822
+ group. The strength of the present study is its cost-effectiveness
823
+ and use of non-invasive intervention and assessments. This
824
+ study comprises intensive lifestyle modification program with
825
+ self-corrective practice. The IAYT intervention could be used as
826
+ an add-on treatment of alternative and complementary therapy
827
+ for osteoarthritis.
828
+ CONCLUSION
829
+ In summary, the previous evidence and present study suggest that
830
+ yoga is an acceptable and safe intervention, which may result in
831
+ clinically relevant improvements in pain and functional outcome
832
+ associated with a range of musculoskeletal conditions such as
833
+ muscular dystrophy, osteoarthritis, rheumatoid arthritis, etc. The
834
+ present study would suggest that 1 week of IAYT may be useful
835
+ in decreasing pain and increasing functional mobility in these
836
+ patients over time.
837
+ AUTHOR CONTRIBUTIONS
838
+ SD helped in trial design, allocated participants, collected the
839
+ data, analysed, interpreted data, and wrote the manuscript; MT
840
+ performed the literature search and evaluated the outcomes
841
+ (blind assessor); VK data analysis; assisted in manuscript
842
+ compilation and RB editing; assisted in manuscript compilation
843
+ and correspondence.
844
+ ACKNOWLEDGMENTS
845
+ The authors would like to thank Yoga therapy center in
846
+ Bengaluru for providing participants and support for the conduct
847
+ of this study. The authors would also like to thank Dr. Vijay
848
+ Kumar for his guidance and support.
849
+ REFERENCES
850
+ 1. Mahajan A, Verma S, Tandon V. Osteoarthritis. J Assoc Phys India (2005)
851
+ 53:634–41.
852
+ 2. Cheung C, Wyman JF, Savik K. Adherence to a yoga program in older
853
+ women with knee osteoarthritis. J Aging Phys Act. (2016) 24:181–8.
854
+ doi: 10.1123/japa.2015-0048
855
+ 3. Dunlop DD, Song J, Semanik PA, Chang RW, Sharma L, Bathon
856
+ JM, et al. Objective physical activity measurement in the osteoarthritis
857
+ initiative: are guidelines being met? Arthritis Rheum. (2011) 63:3372–82.
858
+ doi: 10.1002/art.30562
859
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+ 10. Ebnezar J, Bali Y, Nagarathna R, Nagendra H. Effect of an integrated
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+ 11. Ferreira GE, Robinson CC, Wiebusch M, Viero CC, de M, da Rosa LHT, Silva
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+ MF. The effect of exercise therapy on knee adduction moment in individuals
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+ 12. Field T. Knee osteoarthritis pain in the elderly can be reduced by massage
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+ 13. Glickman-Simon R, Wallace J. Acupuncture for knee osteoarthritis,
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+ chasteberry for premenstrual syndrome, probiotics for irritable bowel
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+ 16. Cheung C, Wyman JF, Resnick B, Savik K. Yoga for managing knee
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+ 18. Nagarathna R, Nagendra H, Ebnezar J, Yogitha B. Effect of integrated
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+ 19. Nambi GS, Shah AAK. Additional effect of iyengar yoga and EMG biofeedback
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+ on pain and functional disability in chronic unilateral knee osteoarthritis. Int
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+ 20. Kolasinski SL, Garfinkel M, Tsai AG, Matz W, Van Dyke A, Schumacher HR.
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+ 22. Brosseau L, Pelland L, Wells G, Macleay L, Lamothe C, Michaud G, et al.
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+ 27. Nagarathna R, Nagendra HR. Integrated Approach of Yoga Therapy for Positive
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+ 28. Oliveira AM, Peccin MS, Silva KN, Teixeira LE, Trevisani VF. Impact
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+ osteoarthritis: a randomized clinical trial. Rev Bras Reumatol. (2012) 52:876–
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+ 82. doi: 10.1590/S0482-50042012000600006
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+ 29. Andersson EI, Lin CC, Smeets RJ. Performance tests in people with chronic
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+ 30. Wang TH, Liao HF, Peng Y.-C. Reliability and validity of the five-repetition
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+ 71. doi: 10.1177/0269215511426889
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+ 31. Kappetijn O, van Trijffel E, Lucas C. Efficacy of passive extension mobilization
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+ in addition to exercise in the osteoarthritic knee: an observational
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+ 32. Gogia PP, Braatz JH, Rose SJ, Norton BJ. Reliability and validity of goniometric
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+ 33. Skelton DA, Young A, Greig CA, Malbut KE. Effects of resistance training on
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+ strength, power, and selected functional abilities of women aged 75 and older.
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+ Go’ Test: more than meets the eye. Gerontology (2011) 57:203–10.
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+ 41. Kärkkäinen M, Rikkonen T, Kröger H, Sirola J, Tuppurainen M, Salovaara
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+ 44. Park J, McCaffrey R, Newman D, Cheung C, Hagen D. The effect of Sit “n”
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+ 45. Bedekar N, Shyam A, Sancheti P, Prabhu A, Sancheti K. Comparative
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+ additional
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+ knee
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+ rehabilitation after total knee arthroplasty. Int J Yoga (2012) 5:118–22.
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+ 46. Uhlig T. Tai Chi and yoga as complementary therapies in rheumatologic
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+ conditions.
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+ Pract
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+ Res
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+ Clin
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+ (2012)
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+ Exercise
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+ protects
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+ articular
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+ cartilage
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+ degeneration
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+ in
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+ the
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+ Conflict of Interest Statement: The authors declare that the research was
1071
+ conducted in the absence of any commercial or financial relationships that could
1072
+ be construed as a potential conflict of interest.
1073
+ Copyright © 2018 Deepeshwar, Tanwar, Kavuri and Budhi. This is an open-access
1074
+ article distributed under the terms of the Creative Commons Attribution License (CC
1075
+ BY). The use, distribution or reproduction in other forums is permitted, provided
1076
+ the original author(s) and the copyright owner are credited and that the original
1077
+ publication in this journal is cited, in accordance with accepted academic practice.
1078
+ No use, distribution or reproduction is permitted which does not comply with these
1079
+ terms.
1080
+ Frontiers in Psychiatry | www.frontiersin.org
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+ 10
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+ May 2018 | Volume 9 | Article 180
subfolder_0/Effect of Yoga as an Add-on Therapy in the Modulation of Heart Rate Variability in Children with Duchenne Muscular Dystrophy.txt ADDED
@@ -0,0 +1,308 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Int J Yoga. 2019 Jan-Apr; 12(1): 55–61.
2
+ doi: 10.4103/ijoy.IJOY_12_18
3
+ PMCID: PMC6329227
4
+ PMID: 30692784
5
+ Effect of Yoga as an Add-on Therapy in the Modulation of Heart Rate
6
+ Variability in Children with Duchenne Muscular Dystrophy
7
+ Dhargave Pradnya, Atchayaram Nalini, Raghuram Nagarathna, Trichur R Raju, Ragupathy Sendhilkumar,
8
+ Adoor Meghana, and Talakad N Sathyaprabha
9
+ Physiotherapy Center, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
10
+ Department of Neurology, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
11
+ Vivekananda Yoga Research Foundation, Bengaluru, Karnataka, India
12
+ Department of Neurophysiology, National Institute of Mental Health and Neurosciences, Bengaluru,
13
+ Karnataka, India
14
+ Address for correspondence: Dr. Talakad N. Sathyaprabha, Department of Neurophysiology, National
15
+ Institute of Mental Health and Neurosciences, Hosur Road, Bengaluru - 560 029, Karnataka, India. E-mail:
16
17
+ Received 2018 Feb; Accepted 2018 May.
18
+ Copyright : © 2018 International Journal of Yoga
19
+ This is an open access journal, and articles are distributed under the terms of the Creative Commons
20
+ Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the
21
+ work non-commercially, as long as appropriate credit is given and the new creations are licensed under the
22
+ identical terms.
23
+ Abstract
24
+ Background:
25
+ Duchene muscular dystrophy (DMD) is a progressive muscular disorder. Cardiac disorder is the
26
+ second-most common cause of death in children with DMD, with 10%–20% of them dying of cardiac
27
+ failure. Heart rate variability (HRV) is shown to be a predictor of cardio-autonomic function.
28
+ Physiotherapy (PT) is advised for these children as a regular treatment for maintaining their functional
29
+ status. The effect of yogic practices on the cardio-autonomic functions has been demonstrated in
30
+ various neurological conditions and may prove beneficial in DMD.
31
+ Materials and Methods:
32
+ In this study, 124 patients with DMD were randomized to PT alone or PT with yoga intervention.
33
+ Home-based PT and yoga were advised. Adherence was serially assessed at a follow-up interval of 3
34
+ months. Error-free, electrocardiogram was recorded in all patients at rest in the supine position. HRV
35
+ parameters were computed in time and frequency domains. HRV was recorded at baseline and at an
36
+ interval of 3 months up to 1 year. Repeated-measures ANOVA was used to analyze longitudinal
37
+ follow-up and least significant difference for post hoc analysis and P < 0.05 was considered
38
+ statistically significant.
39
+ Results:
40
+ In our study, with PT protocol, standard deviation of NN, root of square mean of successive NN, total
41
+ power, low frequency, high-frequency normalized units (HFnu), and sympathovagal balance improved
42
+ at varying time points and the improvement lasted up for 6–9 months, whereas PT and yoga protocol
43
+ 1
44
+ 2
45
+ 3
46
+ 4
47
+ 1
48
+ 4
49
+ 4
50
+ 1
51
+ 2
52
+ 3
53
+ 4
54
+ showed an improvement in HFnu during the last 3 months of the study period and all the other
55
+ parameters were stable up to 1 year. Thus, it is evident that both the groups improved cardiac functions
56
+ in DMD. However, no significant difference was noted in the changes observed between the groups.
57
+ Conclusion:
58
+ The intense PT and PT with yoga, particularly home-based program, is indeed beneficial as a
59
+ therapeutic strategy in DMD children to maintain and/or to sustain HRV in DMD.
60
+ Keywords: Duchene muscular dystrophy, heart rate variability, physiotherapy, yoga
61
+ Introduction
62
+ Duchenne muscular dystrophy (DMD) is a steadily progressive primary muscle disease and is the most
63
+ common form of neuromuscular disorder with an X-linked recessive pattern of inheritance that
64
+ ultimately leads to loss of ambulation and death at a young age.[1,2] The incidence of DMD is
65
+ approximately 15.9–19.5/100,000 live births.[3,4] In India, DMD has been found to account for 30% of
66
+ all reported forms of muscular dystrophies.[5] Respiratory failure and cardiac involvement are the most
67
+ common causes of death in children with DMD,[6] but with advancement in respiratory support
68
+ techniques, cardiac disorders remain an important problem in the late stages of the disease. Research in
69
+ this field reveals that there is an involvement of myocardium before the onset of clinically apparent
70
+ cardiomyopathy in DMD.[7] However, it has been observed that, in a routine management of DMD
71
+ children, assessment of cardiac function is not considered until the clinical manifestations are detected.
72
+ Nonrecognition of cardiac impairment and treatment at the early stages can lead to poor outcomes.
73
+ Hence, recognition and management of the cardiac autonomic dysfunction is an important strategy for
74
+ prolonged life expectancy and better quality of life in children with DMD.
75
+ Heart rate variability (HRV) assessment is an economical, noninvasive, and sensitive procedure for
76
+ investigating autonomic neurocardiac regulation.[8] HRV also provides a novel approach to the clinical
77
+ diagnosis and prognostic measures. Several authors have used HRV to assess cardiac neural regulation.
78
+ [9,10,11] Short-term HRV analysis is a good tool to investigate DMD children for evidence of cardiac
79
+ autonomic dysfunction.[12] Our previous study demonstrated the need for routine assessment of
80
+ cardiac functions using HRV measures, and short-term HRV analysis showed significant difference in
81
+ the cardio-autonomic parameters among the DMD children than the healthy volunteers.[12]
82
+ Apart from medical management, physiotherapy (PT) in the form of physical exercise is considered as
83
+ one of the vital rehabilitation strategies for the maintenance of physical function. The role of exercise
84
+ has been studied in the modulation of cardiac functions and found that training induces a resting
85
+ bradycardia accompanied by increased cardiac vagal modulation in healthy individuals.[13]
86
+ Yoga being the adjuvant therapy is considered as a simple practice that can be followed even at home
87
+ with prior training. Practicing yoga has shown improvement in cardio-autonomic functions in normal
88
+ individuals of different age groups.[14,15,16] Improvement in cardio-autonomic functions in healthy
89
+ volunteers using different yoga modules and physical exercise has been documented.[17] However, the
90
+ effect of yoga therapy to modulate HRV in DMD children has not been studied.
91
+ Materials and Methods
92
+ Subjects
93
+ This study was conducted at the National Institute of Mental Health and Neurosciences (NIMHANS).
94
+ Approval for this study was obtained from the Institutional Ethics Committee. Two hundred children
95
+ were screened, and 124 children with genetically confirmed DMD, in the age group of 5–10 years, who
96
+ were self-ambulant or required minimal assistance for walking, were recruited after obtaining written
97
+ assent and consent. Our cohort were drug naive at the time of evaluation and were recruited for the
98
+ study after genetic testing which was available within 3–4 weeks after clinical examination. Children
99
+ who had muscular dystrophy other than DMD, nonambulant children, and children/parents not willing
100
+ to participate in the study were excluded from the study.
101
+ Study design
102
+ Age matched randomized controlled repeated measure design.
103
+ The patients were paired for age and randomly allocated to Group 1 (PT only) and Group 2 (yoga and
104
+ PT [Y and PT]) using a computer-generated random table.
105
+ Assessment
106
+ HRV was used as the assessment tool in this study. Artifact-free, electrocardiograms were obtained for
107
+ all patients in the supine position. Recordings were analyzed for time and frequency domain parameters
108
+ according to the Taskforce report on HRV.[8] HRV parameters were computed in time and frequency
109
+ domains. Time domain measures include the standard deviation of NN (SDNN) interval and root of
110
+ square mean of successive NN (RMSSD) interval. Frequency domain consisted of total power (TP),
111
+ low frequency (LF), and high frequency (HF) power values. The ratio of LF/HF power values was
112
+ determined using the customized software. HRV assessments were done at the first presentation and
113
+ sequentially at intervals of 3, 6, 9, and 12 months. All participants were given a compliance notebook
114
+ to maintain exercise performance to make sure that children were practicing yoga and PT at home. Log
115
+ books were reviewed on every visit.
116
+ Intervention
117
+ All children received the standard approved therapy of oral prednisolone at 0.75 mg/kg/day from the
118
+ day of diagnosis and this was continued during the entire study period.
119
+ Physiotherapy
120
+ PT exercise was taught to children and parents in the Physiotherapy Department of NIMHANS. They
121
+ were made to practice it under the supervision of physiotherapists initially for a period of 1 week. Once
122
+ they learned the exercises, they were advised to carry it out at their homes. PT exercises were
123
+ performed twice daily by the participants, morning and evening for 45 min per session, and were
124
+ continued during the entire study period. Details of PT exercises are summarized in Table 1.
125
+ Table 1
126
+ Physiotherapy exercises
127
+ Yoga
128
+ Similarly, yoga practice was taught to the children and their parents by a trained, accredited yoga
129
+ therapist. They were made to perform the yoga under the supervision of the yoga therapist for 1 week.
130
+ Once they learned, they were advised to practice yoga in their homes. Children in this group performed
131
+ yoga in the morning and PT exercises in the evening, each session lasting for 45 min, and was
132
+ continued during the entire study period. Detail of yoga practices is summarized in Table 2.
133
+ Table 2
134
+ Yoga practices
135
+ Open in a separate window
136
+ Data extraction
137
+ All the data were documented in a standardized pro forma and later decoded.
138
+ Data analysis
139
+ Basic demographic details were analyzed using descriptive statistics. Groups were compared using
140
+ independent sample t-test for continuous variables. HRV data were square root transformed to produce
141
+ normal distributions. Values are expressed in (mean [standard deviation]). Level of significance was
142
+ kept at <0.05. RM ANOVA was used to analyze longitudinal follow-up and least significant difference
143
+ for post hoc analysis.
144
+ Results
145
+ The age of the children participated in this study ranged from 5 to 10 years. The mean age at
146
+ presentation was 7.9 ± 1.5 years. Mean height was 118.2 ± 8.4 cm (95–147 cm). Mean weight was 20.6
147
+ ± 4.3 kg (11–32 kg). Mean age at onset of DMD was 2.8 ± 0.6 years (1.5–4.0 years). Mean duration of
148
+ illness was 5.1 ± 1.5 years (1–8 years). At the end of the study, 45 children completed the scheduled
149
+ assessments in PT group and 43 children completed in Y and PT group. Details are explained in
150
+ CONSORT diagram [Figure 1].
151
+ Open in a separate window
152
+ Figure 1
153
+ CONSORT flow diagram
154
+ At baseline, DMD children showed significantly lower mean NN (PT: 606.1 ± 77.1 and Y and PT:
155
+ 605.7 ± 78.5), higher average heart rate (PT: 100.4 ± 12.0 and Y and PT: 100.8 ± 13.0), and
156
+ significantly reduced HF and HF normalized units (HFnu). The sympathovagal balance (SVB) was
157
+ tilted toward sympathetic limb in DMD children. The time and frequency domain findings of HRV
158
+ were similar in both the two study groups.
159
+ After the PT protocol, SDNN, RMSSD, TP, LF, HFnu, and SVB improved at varying time points and
160
+ the improvement lasted up for 6–9 months. Whereas the combined protocol of PT and yoga showed an
161
+ improvement in HFnu during the last 3 months of the study period and all the other parameters were
162
+ stable up to 1 year. When compared age wise with baseline values up to 1 year, in PT group, there was
163
+ no significant change in any of the HRV parameters, while, Y and PT group showed a significant
164
+ improvement in HFnu in 5–6 years’ group and mean NN and average HR in 7–8 years. However, no
165
+ significant difference was observed between PT and Y and PT groups in other parameters. We
166
+ observed that PT group demonstrated improvement in HRV parameters, but these effects were not long
167
+ lasting, whereas Y and PT combination is more helpful in improving cardiac function between 5–8
168
+ years of age. Detailed data are provided in Tables 3 and 4.
169
+ Table 3
170
+ Comparison of serial evaluation of heart rate variability values in the two study groups
171
+ Table 4
172
+ Age-wise difference between baseline and 1 year for heart rate variability values in the two
173
+ study groups
174
+ Open in a separate window
175
+ Strengths
176
+ Discussion
177
+ This study was conducted to know the added effect of yoga in the modulation of HRV among the
178
+ children with DMD. The HRV measures were used to assess the sympathetic and parasympathetic
179
+ nervous activities. In HRV measures, the HF component of the HRV indicates the vagal activity. In a
180
+ given point of time, any rise in the HF power, especially HFnu, indicates a vagal dominance. Similarly,
181
+ increased LF power indicates increased sympathetic activity. The LF-HF ratio indicates overall SVB.
182
+ High LF-HF ratio denotes increased sympathetic activity and a low LF-HF ratio indicates increased
183
+ parasympathetic activity.[18] In this study, the baseline HRV findings were showing predominant
184
+ sympathetic overactivity (increased SVB and reduced HF; HFnu) along with decreased mean NN.
185
+ Subsequently, the PT intervention showed noteworthy changes in HRV parameters. The
186
+ parasympathetic domination was very obvious during the intervention and lasted up to 6–9 months.
187
+ However, the added benefit of yoga showed further improvement in parasympathetic regulation
188
+ (HFnu). The age-wise improvement toward vagal balance was significant in our study. There was an
189
+ additional long-lasting improvement in autonomic modulation in 5–8 years of age of DMD children
190
+ with Y and PT group. All these findings confirm that DMD children have autonomic dysfunction and
191
+ these can be modulated by the interventions and stringent follow-ups. We also proved that yoga as an
192
+ adjuvant therapy has an additional benefit in enhancing the neuro-cardiac autonomic controls.
193
+ Studies showed that skeletal muscle training can be beneficial in patients with DMD.[19,20,21] Despite
194
+ the lack of studies addressing the use of yoga exercises as a complementary therapy for DMD patients,
195
+ there have been several other clinical studies of yoga on healthy volunteers. A study on healthy adults
196
+ aimed to find out the effect of yoga practice on HRV and showed increase in certain HRV parameters
197
+ such as mean RR interval, SDNN, HF power, and HFnu.[22] There was also reduction in the resting
198
+ heart rate, LF power, and LF/HF ratio. Several other studies on the effect of yoga on HRV exhibited an
199
+ increase in the parasympathetic tone which is reflected through the HRV measures.[14,23] To our
200
+ knowledge, the present study is the first to address and confirm the safety and efficacy of yogic
201
+ exercises along with PT in children with DMD. The yogic exercises used in the present study are
202
+ distinctive and were aimed at improving the muscular strength. Each school of yoga has various
203
+ physical postures (asanas), breathing practices (pranayama), and meditation as their components. In our
204
+ study, we used Sakthivikasaka (a practice aimed to improve the overall muscular function), selected
205
+ asanas, pranayama, and meditation (guided meditation). Although the effect of Sakthivikas has not
206
+ been studied, it can be considered as a practice equivalent to performing moderate-intensity exercise.
207
+ Since yoga comprises both physical activity in the form of sakhivikasakas and asanas and pranayama,
208
+ it has advantage in the modulation of HRV through mechanisms similar to practicing physical exercises
209
+ in addition to practicing pranayama and meditation.
210
+ The possible beneficiary effect of interventions on DMD may be due to several mechanisms. It
211
+ includes a reduction in the catecholamine, angiotensin II, and an increased bioavailability of nitric
212
+ oxide.[24] Complex neurophysiological mechanism, mediated through limbic, hypothalamic medullary
213
+ axis and the medullary cardiovascular center, is thought to be the reason for improvements in the HRV
214
+ after the practice of slow pranayamas.[18] On the other hand, HF yoga breathing practices such as
215
+ Kapalabhathi are found to enhance sympathetic activity by reducing the vagal tone.[25] Overall
216
+ relaxation and calming the mind through physical and breathing practices is the primary goal of yogic
217
+ practices. Finally, we could see that yoga does have a positive effect on skeleton muscle as well as
218
+ neuro-cardiac beneficiary with probable above-discussed mechanisms.
219
+ Strengths and limitations of our study
220
+ To our knowledge, this is the first study involving DMD children, with follow-up for 1 year,
221
+ with large samples, to study the effect of yoga. It was a longitudinal, prospective, age-matched, two-
222
+ group randomized study, with controlled RM design. The DMD being a progressive disease,
223
+ performing exercise and yoga might have reduced the deleterious effects on such patients. The primary
224
+ objective of the study was to show that yoga and exercises can be performed by patients with DMD.
225
+ Although there was 30.6% and 27.4% dropout in yoga and exercise groups, this study showed that
226
+ yoga exercises are feasible, harmless, and can actually improve HRV in DMD children.
227
+ Limitation
228
+ This study was not blinded for assessments and interventions.
229
+ Conclusion
230
+ Since modulation of HRV is an indicator of stable cardiac function and assessment of cardiac function
231
+ using HRV measure and therapeutic measures, we advised that combined PT and yoga can be initiated
232
+ as one of the rehabilitation strategies in children with DMD. This can also be a home-based PT, and
233
+ yoga programs appear to be beneficial and cost-effective in the management of patients with DMD if
234
+ started early.
235
+ Financial support and sponsorship
236
+ Nil.
237
+ Conflicts of interest
238
+ There are no conflicts of interest.
239
+ References
240
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+ Publications
subfolder_0/Effect of a diet enriched with fresh coconut saturated fats on plasma lipids and erythrocyte fatty acid composition in normal adults.txt ADDED
@@ -0,0 +1,760 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Full Terms & Conditions of access and use can be found at
2
+ http://www.tandfonline.com/action/journalInformation?journalCode=uacn20
3
+ Download by: [Cornell University Library]
4
+ Date: 18 May 2017, At: 09:36
5
+ Journal of the American College of Nutrition
6
+ ISSN: 0731-5724 (Print) 1541-1087 (Online) Journal homepage: http://www.tandfonline.com/loi/uacn20
7
+ Effect of a Diet Enriched with Fresh Coconut
8
+ Saturated Fats on Plasma Lipids and Erythrocyte
9
+ Fatty Acid Composition in Normal Adults
10
+ Rokkam Shankar Nagashree MSc, N. K. Manjunath, M. Indu, M. Ramesh, V.
11
+ Venugopal, P. Sreedhar, N. Pavithra & Hongasandra R. Nagendra
12
+ To cite this article: Rokkam Shankar Nagashree MSc, N. K. Manjunath, M. Indu, M. Ramesh, V.
13
+ Venugopal, P. Sreedhar, N. Pavithra & Hongasandra R. Nagendra (2017): Effect of a Diet Enriched
14
+ with Fresh Coconut Saturated Fats on Plasma Lipids and Erythrocyte Fatty Acid Composition in
15
+ Normal Adults, Journal of the American College of Nutrition, DOI: 10.1080/07315724.2017.1280713
16
+ To link to this article: http://dx.doi.org/10.1080/07315724.2017.1280713
17
+ Published online: 16 May 2017.
18
+ Submit your article to this journal
19
+ View related articles
20
+ View Crossmark data
21
+ Effect of a Diet Enriched with Fresh Coconut Saturated Fats on Plasma Lipids
22
+ and Erythrocyte Fatty Acid Composition in Normal Adults
23
+ Rokkam Shankar Nagashree, MSca, N. K. Manjunatha, M. Indub, M. Ramesha, V. Venugopala, P. Sreedhara, N. Pavithrab,
24
+ and Hongasandra R. Nagendraa
25
+ aSwami Vivekananda Yoga Anusandhana Samsthana, Department of Yoga and Life Sciences, Bengaluru, India; bSt. John’s Research Institute, Division of
26
+ Nutrition, Bengaluru, India
27
+ ARTICLE HISTORY
28
+ Received 8 November 2016
29
+ Accepted 5 January 2017
30
+ ABSTRACT
31
+ Objective: The objective of this study was to compare the effects of increased saturated fatty acid (SFA)
32
+ (provided by fresh coconut) versus monounsaturated fatty acid (MUFA) intake (provided by a combination
33
+ of groundnuts and groundnut oil) on plasma lipids and erythrocyte fatty acid (EFA) composition in healthy
34
+ adults.
35
+ Material and Methods: Fifty-eight healthy volunteers, randomized into 2 groups, were provided
36
+ standardized diet along with 100 g fresh coconut or groundnuts and groundnut oil combination for
37
+ 90 days in a Yoga University. Fasting blood samples were collected before and after the intervention
38
+ period for the measurement of plasma lipids and EFA profile.
39
+ Results: Coconut diet increased low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels
40
+ significantly. In contrast, the groundnut diet decreased total cholesterol (TC), mainly due to a decrease in
41
+ HDL levels. There were no differences in the major SFA of erythrocytes in either group. However, coconut
42
+ consumption resulted in an increase in C14:0 and C24:0 along with a decrease in levels of C18:1 n9 (oleic
43
+ acid). There was a significant increase in levels of C20:3 n6 (dihomo-gamma linolenic acid, DGLA).
44
+ Conclusions: Consumption of SFA-rich coconut for 3 months had no significant deleterious effect on
45
+ erythrocytes or lipid-related factors compared to groundnut consumption. On the contrary, there was an
46
+ increase in the anti-atherogenic HDL levels and anti-inflammatory precursor DGLA in erythrocyte lipids.
47
+ This suggests that coconut consumption may not have any deleterious effects on cardiovascular risk in
48
+ normal subjects.
49
+ Abbreviations: SFA, saturated fatty acid; MCSFA, medium-chain saturated fatty acids; MUFA, monounsaturated fatty
50
+ acid; HDL, high-density lipoprotein; TC, total cholesterol; TG , triglycerides; CAD, coronary artery disease; PUFA, poly-
51
+ unsaturated fatty acid; DGLA, dihomo-g-linolenic acid; VCO, virgin coconut oil; WHO, World Health Organization;
52
+ FAO, Food and Agriculture Organization
53
+ KEYWORDS
54
+ Coconut; saturated fat;
55
+ plasma lipid; erythrocyte
56
+ fatty acid; MUFA; gas
57
+ chromatography; groundnut
58
+ Introduction
59
+ Consumption of saturated fat is believed to increase the risk of
60
+ coronary artery disease mainly because of its effects on increas-
61
+ ing plasma total cholesterol (TC) levels. As early as the 1950s,
62
+ Keys et al. [1,2] and later Dietschy [3] and Hegsted et al. [4]
63
+ worked out equations that showed how dietary fatty acids influ-
64
+ enced plasma cholesterol levels. These equations suggested that
65
+ saturated fatty acids (SFAs) increased TC levels, whereas poly-
66
+ unsaturated fatty acids (PUFAs) decreased them and monoun-
67
+ saturated fats (MUFAs) were largely considered as neutral [5].
68
+ These studies were the basis of dietary recommendations that
69
+ advised reduced consumption of all types of SFAs [6].
70
+ Nearly one third of the world’s population depends on coco-
71
+ nut to some degree for their food [7]. Indian diets are relatively
72
+ low in fat; however, inclusion of fresh/dry coconut in the daily
73
+ diet is a common practice in many parts of the country. India
74
+ is the third largest producer of coconuts in the world [8] and
75
+ more than half of this (52%) is consumed in raw form as either
76
+ fresh or dry coconut [9]. Studies on the effect of coconut oil
77
+ consumption on plasma lipids are contradictory, with some
78
+ studies showing deleterious effects and others showing neutral
79
+ effects. However, there are almost no studies conducted on the
80
+ health effects of fresh coconut consumption. Fresh coconuts
81
+ contain 40%–50% moisture and, in addition to SFAs, they are
82
+ rich in fiber and protein and a number of vitamins, minerals,
83
+ and electrolytes [10]. Furthermore, the coconut SFA composi-
84
+ tion is unique in that it consists of over 50% of medium-chain
85
+ SFAs (MCSFAs) [11], whose properties and metabolism appear
86
+ to differ from longer chain SFAs commonly found in animal
87
+ products [12]. MCSFAs are rapidly oxidized in the liver to Ace-
88
+ tyl coenzyme A (acetyl CoA) and do not enter or alter the lipid
89
+ pool in the liver, thus remaining neutral with respect to regula-
90
+ tion of TC or low-density lipoprotein (LDL) levels [13].
91
+ The current study was therefore undertaken to study the
92
+ effects of daily consumption of fresh coconut on plasma lipids
93
+ CONTACT Rokkam Shankar Nagashree
94
95
+ Department of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana,
96
+ Eknath Bhavan, Gavipuram Circle, Kempegowda Nagar, Bengaluru - 560018, Karnataka, India.
97
+ © 2017 American College of Nutrition.
98
+ JOURNAL OF THE AMERICAN COLLEGE OF NUTRITION
99
+ https://doi.org/10.1080/07315724.2017.1280713
100
+ and erythrocyte fatty acid composition in healthy young men
101
+ and women.
102
+ Materials and methods
103
+ The study was carried out on 58 healthy adults who were
104
+ recruited following advertisement of the study at Swami Vive-
105
+ kananda Yoga Anusandhana Samstha University. Sample size
106
+ was calculated using SPSS software, Version 10 (IBM), where
107
+ the alpha was 0.05 and the power was 0.95. The effect size was
108
+ 0.570 and the sample size was 27. Subjects were aged 23.8 §
109
+ 4.8 years and had no known metabolic, endocrine, or hemato-
110
+ logical diseases; were not on any medications; and had high
111
+ physical activity levels. Subjects were nonsmokers and tee-
112
+ totalers residing on a residential campus of a university. The
113
+ study protocol was approved by the institutional ethics com-
114
+ mittee. This study has been registered with the Clinical Trial
115
+ Registry of India (CTRI/2016/07/007071). Signed informed
116
+ consent was obtained from the volunteers.
117
+ The subjects were randomized into 2 groups—the coconut
118
+ group (C) and the groundnut group (G). Randomization was
119
+ done using a computer-generated random number table (www.
120
+ randomizer.org). All subjects received a balanced diet based on
121
+ yogic principles of food (sativic, rajasic, and tamasic) blended
122
+ with modern medical nutrition (calorie requirements, composi-
123
+ tion of a balanced meal) and consumed this standard meal plus
124
+ intervention for a period of 90 days. Details of the diet are pro-
125
+ vided in Table 1. In addition to this standard meal, group C
126
+ consumed 100 g (444 kcal) of fresh coconut per day and group
127
+ G consumed 45 g (256 kcal) of groundnuts and 22 g (198 kcal)
128
+ of groundnut oil per day. A combination of groundnut and oil
129
+ was used to make the 2 study interventions isocaloric and to
130
+ ensure similar macronutrient compositions. Group C con-
131
+ sumed 2689 kcal, 392 g of carbohydrates (58.3%), 77 g of pro-
132
+ teins (11.4%), and 90 g (30.3%) of fat and group G consumed
133
+ 2699 kcal, 384 g of carbohydrates (57%), 89 g protein (13%),
134
+ and 90 g fats per day (30%).
135
+ Subjects were trained and requested to abstain from con-
136
+ suming anything other than the food and snacks provided by
137
+ the project kitchen, set up exclusively for the study.
138
+ Anthropometry
139
+ Subjects’ weight, height, waist and hip measurements, and body
140
+ mass index (BMI; weight in kilograms divided by height in
141
+ square meters) were determined. Body weight was measured
142
+ using a digital scale, height was measured with a stadiometer,
143
+ and waist and hip circumferences were assessed using a stan-
144
+ dard tape measure, performed by the same person.
145
+ Biochemical data and fatty acid analysis
146
+ Lipid profile was measured soon after sample collection using a
147
+ fully automated biochemistry analyzer (Mindray BS 390
148
+ Shenzhen, China). Blood samples for erythrocyte fatty acid
149
+ analysis were collected into EDTA tubes and centrifuged with
150
+ HiSep lymphocyte separation media (LSM 1077) at 1550 rpm
151
+ for 15 min. Erythrocytes were separated, washed 3 times with
152
+ phosphate-buffered saline, and centrifuged at 1400 rpm for
153
+ 10 min at 4C and stored at ¡80C until analysis.
154
+ Fatty acid profile of rbs through gas chromatography
155
+ Fatty acids in 300 mL erythrocytes were extracted using a chlo-
156
+ roform: methanol (1:2) mixture and transmethylated with 2%
157
+ concentrated H2SO4 in methanol. The different fatty acids were
158
+ separated using gas chromatography–flame ionization detec-
159
+ tion (Varian 3800; Varian, Palo Alto, CA; fused silica column–
160
+ fatty acid methyl ester (FAME), Varian 50 m, 0.2 mm capillary
161
+ column) with nitrogen as the carrier gas and quantified using
162
+ C17 as an internal standard. The total fatty acid content of the
163
+ samples was calculated and each identified fatty acid was
164
+ expressed as a percentage of total fatty acids.
165
+ Fatty acids profile of the meals
166
+ The fatty acid profile of coconut and groundnut meal for one
167
+ person for a whole day was obtained through gas chromatogra-
168
+ phy–flame ionization detection. Coconut meal contained 58%
169
+ SFA and 18% MUFA compared to 22% SFA and 41% MUFA
170
+ in the groundnut meal (Table 2).
171
+ Data analysis
172
+ Statistical analysis was done using SPSS Version 10 (IBM).
173
+ Each variable was first assessed for normality of distribution
174
+ using the Kolmogorov-Smirnov test. When the data were nor-
175
+ mally distributed with equal variance, parametric statistical
176
+ tests were selected for analysis. Within-group analysis was
177
+ done using a paired sample t test comparing the data collected
178
+ on day 90 with the respective day 1 values for each variable
179
+ Table 1. Diet composition of standard meal.
180
+ Food Group
181
+ No. of Exchanges Portion (g) Quantity(g) Energy(kcal)
182
+ Cereals and millets
183
+ 12
184
+ 30
185
+ 360
186
+ 1200
187
+ Pulses
188
+ 3
189
+ 30
190
+ 90
191
+ 300
192
+ Milk and its products
193
+ 3
194
+ 100
195
+ 300
196
+ 210
197
+ Roots and tubers
198
+ 1
199
+ 100
200
+ 100
201
+ 80
202
+ Green leafy vegetables
203
+ 2
204
+ 100
205
+ 200
206
+ 90
207
+ Other vegetables
208
+ 3
209
+ 100
210
+ 300
211
+ 90
212
+ Fruits
213
+ 2
214
+ 100
215
+ 200
216
+ 80
217
+ Jaggery/honey
218
+ 3
219
+ 5
220
+ 15
221
+ 60
222
+ Fat
223
+ 3
224
+ 5
225
+ 15
226
+ 135
227
+ Total
228
+ 2245
229
+ Table 2. Macronutrient and fatty acid composition of the 2 diets.
230
+ Coconut Group
231
+ Groundnut Group
232
+ Energy (kcal/day)
233
+ 2689
234
+ 2699
235
+ Carbohydrates (%)
236
+ 58.3 (392 g/d)
237
+ 57 (384 g/d)
238
+ Protein (%)
239
+ 11.4 (77 g/d)
240
+ 13 (89 g/d)
241
+ Fat (%)
242
+ 30.3 (90 g/d)
243
+ 30 (90 g/d)
244
+ Fatty acid composition (%)
245
+ MCSFAs
246
+ 39 (11.8%)
247
+ 0
248
+ Total SFAs
249
+ 58 (17.5%)
250
+ 22 (6.6%)
251
+ MUFAs
252
+ 18 (5.4%)
253
+ 41 (12.3%)
254
+ PUFAs
255
+ 24 (7.4%)
256
+ 37 (11.1%)
257
+ MCSFA D medium-chain saturated fatty acid, SFA D saturated fatty acid, MUFA D
258
+ monounsaturated fatty acid, PUFA D polyunsaturated fatty acid.
259
+ 2
260
+ R. S. NAGASHREE ET AL.
261
+ separately. Chi-square test was performed when the data were
262
+ nonparametric in nature. The between-group comparisons
263
+ were done to understand the significant differences between
264
+ groups C and G at baseline as well as at day 90 using an inde-
265
+ pendent sample t test.
266
+ Results
267
+ Table 2 provides details of the diet composition of the 2 groups.
268
+ Both groups consumed similar amounts of macronutrients;
269
+ however, the fatty acid compositions of the 2 diets were very
270
+ different. Group C consumed 17.5% as SFA, of which 11.8%
271
+ came from MCSFA, whereas group G consumed only 6.6% as
272
+ SFA, with no MCSFA. The MUFA as well as PUFA intake in
273
+ group G was double that of group C.
274
+ Physical activity levels of subjects in both groups were com-
275
+ parable (x2
276
+ 1
277
+ ð Þ D 1:16; p D 0:466Þ. Table 3 shows that the
278
+ baseline characteristics of the 2 groups were similar. A significant
279
+ decrease in weight was observed in group C; however, no changes
280
+ were observed in either BMI or in waist–hip ratio in either group.
281
+ The effect of coconut consumption on plasma lipids is pre-
282
+ sented in Table 4. It was seen that consumption of coconut for
283
+ 90 days resulted in an increase in both LDL as well as high-den-
284
+ sity lipoprotein (HDL) levels, although TC levels did not
285
+ increase significantly. On the other hand, groundnut consump-
286
+ tion for the same period resulted in a decrease in TC levels that
287
+ was mainly due to a significant decrease in HDL levels. No
288
+ changes were observed in any of the other lipids.
289
+ Erythrocyte fatty acid composition before and after the inter-
290
+ vention is detailed in Table 5. No significant changes were
291
+ observed in the major SFA composition in either group, although
292
+ significant changes were seen in minor fatty acids in both groups.
293
+ In the coconut group, an increase was seen in all of the minor
294
+ SFAs—14:0 and 24:0—whereas in the groundnut group, there
295
+ was a decrease in 14:0 and a corresponding increase in 22:0 and
296
+ 24:0. There was also a decrease in total n-3 PUFAs in the ground-
297
+ nut group. A significant increase was seen in the levels of 20:3 n-6
298
+ (dihomo-g-linolenic acid, DGLA) accompanied by a decrease in
299
+ the main MUFA (18:1 n-9) in the coconut group.
300
+ Discussion
301
+ In this carefully controlled diet study, we seek to shed light on
302
+ the impact of SFAs from fresh coconut (C) in comparison to
303
+ MUFAs from a groundnut and groundnut oil combination (G)
304
+ on some well-accepted indices of cardiovascular disease (CVD)
305
+ risk. The most important finding of the present study was that
306
+ despite much higher intakes of SFAs in the coconut group, the
307
+ effects on plasma TC and triglycerides were minimal. There
308
+ was a significant increase in LDL levels in the coconut group,
309
+ which is in line with a number of studies with coconut oil sup-
310
+ plementation [14,15]. This has been generally attributed to
311
+ either increased LDL synthesis or reduced LDL clearance. On
312
+ the other hand, a number of studies have reported beneficial
313
+ effects of virgin coconut oil on LDL and have attributed it to
314
+ the presence of high levels of polyphenols such as caffeic acid
315
+ [16], which play a key role in scavenging free radicals [17]. In
316
+ the current study, despite the use of fresh coconut rich in poly-
317
+ phenols, we observed an increase in LDL levels. However, it
318
+ was also seen that there was no significant increase in TC levels,
319
+ suggesting that this increase in LDL was well within physiologic
320
+ variability in the current study population of normal men and
321
+ women.
322
+ Groundnut was used as the control in this study because it is
323
+ a rich source of MUFA and is more commonly consumed than
324
+ Table 3. Basic characteristics of the 2 groups before and after dietary intervention.
325
+ Variables
326
+ Coconut Group (n D 27)
327
+ Groundnut Group (n D 31)
328
+ Age (years)
329
+ 23 § 4.1
330
+ 24.65 § 5.5
331
+ Gender (male/female)
332
+ 15/12
333
+ 16/15
334
+ Day 1
335
+ Day 90
336
+ Day 1
337
+ Day 90
338
+ Mean § SD
339
+ Mean § SD
340
+ Mean § SD
341
+ Mean § SD
342
+ Weight (kg)
343
+ 59.8 § 10.2
344
+ 59.1 § 9.6
345
+ 56.78 § 7.3
346
+ 56.2 § 7.9
347
+ BMI
348
+ 21.6 § 2.2
349
+ 21.4 § 2.1
350
+ 21.0 § 2.0
351
+ 20.80 § 1.9
352
+ Waist–hip ratio
353
+ 0.82 § 0.07
354
+ 0.79 § 0.12 0.82 § 0.06
355
+ 0.81 § 0.06
356
+ BMI D body mass index.
357
+ p < 0.05, paired sample t test; day 90 values compared to respective day 1 values.
358
+ Table 4. Biochemical measures recorded in both coconut and groundnut groups
359
+ on days 1 and 90.a
360
+ Coconut Group
361
+ Groundnut Group
362
+ Variable
363
+ Day 1
364
+ Day 90
365
+ Day 1
366
+ Day 90
367
+ TG (mg/dl)
368
+ 78.1 § 34.2
369
+ 79.7 § 25.3
370
+ 78.7 § 32.1
371
+ 70.1 § 24.8
372
+ LDL (mg/dl)
373
+ 85.9 § 20.1 97.96 § 23.8
374
+ 81.84 § 19.3 79.97 § 21.0
375
+ HDL (mg/dl)
376
+ 42.9 § 9.6
377
+ 46.74 § 11.4
378
+ 43.61 § 10.3 41.19 § 10.3
379
+ TC (mg/dl)
380
+ 150.5 § 22.6 157.6 § 27.9
381
+ 144.45 § 20.1 133.8 § 19.3
382
+ TG/HDL
383
+ 1.9 § 1
384
+ 1.8 § 0.8
385
+ 1.9 § 1
386
+ 1.8 § 0.9
387
+ apo-B/apo-A1
388
+ 0.63 § 0.16
389
+ 0.63 § 0.17
390
+ 0.63 § 0.16
391
+ 0.63 § 0.17
392
+ TG D triglycerides, LDL D low density lipoprotein, HDL D high density lipoprotein,
393
+ TC D total cholesterol, apo-A D apolipoprotein A, apo-B D apolipoprotein B.
394
+ aValues are group mean § standard deviation.
395
+ p < 0.05.p < 0.01.p < 0.001. Comparing day 90 values with day 1 values
396
+ using paired sample t test.
397
+ Table 5. Fatty acid profile of erythrocytes recorded in both coconut and ground-
398
+ nut groups on days 1 and 90.a
399
+ Coconut Group
400
+ Groundnut Group
401
+ Fatty Acid
402
+ Day 1
403
+ Day 90
404
+ Day 1
405
+ Day 90
406
+ 12:0
407
+ 0.01 § 0.04
408
+ 0.06 § 0.34
409
+ 0.09 § 0.31
410
+ 0.06 § 0.26
411
+ 14:0
412
+ 0.09 § 0.26
413
+ 0.43 § 0.55
414
+ 0.32 § 0.52
415
+ 0.11 § 0.33
416
+ 16:0
417
+ 24.5 § 2.1
418
+ 24.0 § 1.2
419
+ 24.6 § 1.8
420
+ 24.4 § 3.5
421
+ 18:0
422
+ 18.3 § 1.4
423
+ 18.0 § 1.23
424
+ 18.1 § 1.8
425
+ 18.2 § 1.5
426
+ 18:1
427
+ 13.4 § 1.5
428
+ 12.7 § 1.3
429
+ 13.6 § 1.7
430
+ 13.7 § 1.6
431
+ 18:2 n-6
432
+ 13.9 § 1.3
433
+ 14.3 § 1.4
434
+ 13.6 § 0.94
435
+ 13.4 § 1.5
436
+ 20:3 n-6
437
+ 1.63 § 0.33
438
+ 1.79 § 0.43
439
+ 1.60 § 0.31
440
+ 1.60 § 0.40
441
+ 20:4 n-6
442
+ 14.4 § 2.1
443
+ 14.4 § 1.5
444
+ 14.4 § 2.5
445
+ 14.1 § 3.1
446
+ 22:0
447
+ 0.68 § 0.54
448
+ 0.92 § 0.85
449
+ 0.63 § 0.52
450
+ 0.96 § 0.49
451
+ 22:04
452
+ 4.47 § 1.12
453
+ 4.35 § 1.12
454
+ 4.7 § 0.93
455
+ 4.66 § 1.13
456
+ 24:0
457
+ 2.8 § 1.1
458
+ 3.2 § 0.78
459
+ 2.7 § 1.0
460
+ 3.5 § 0.82
461
+ 22:5 n-6
462
+ 2.6 § 1.3
463
+ 2.8 § 0.7
464
+ 2.5 § 1.1
465
+ 2.5 § 0.72
466
+ 22:5 n-3
467
+ 1.1 § 0.58
468
+ 1.0 § 0.38
469
+ 1.1 § 0.55
470
+ 0.96 § 0.53
471
+ 22:6 n-3
472
+ 1.7 § 0.66
473
+ 1.6 § 0.55
474
+ 1.7 § 0.64
475
+ 1.6 § 0.72
476
+ Total SFA
477
+ 46.5 § 3.5
478
+ 46.7 § 2.4
479
+ 46.5 § 3.5
480
+ 47.3 § 5.6
481
+ Total MUFA
482
+ 13.4 § 1.5
483
+ 12.7 § 1.3
484
+ 13.6 § 1.8
485
+ 13.7 § 1.6
486
+ Total PUFA
487
+ 40.0 § 4.1
488
+ 40.4 § 2.4
489
+ 39.8 § 4.2
490
+ 38.9 § 6.6
491
+ Total n-6
492
+ 37.0 § 3.6
493
+ 37.7 § 2.3
494
+ 36.9 § 3.5
495
+ 36.4 § 5.7
496
+ Total n-3
497
+ 2.9 § 1.1
498
+ 2.7 § 0.81
499
+ 2.8 § 1.1
500
+ 2.5 § 1.2
501
+ SFA D saturated fatty acid, MUFA D monounsaturated fatty acid, PUFA D polyun-
502
+ saturated fatty acid.
503
+ aValues are group mean § standard deviation.
504
+ p < 0.05.p < 0.01.p < 0.001. Comparing day 90 values with day 1 values
505
+ using paired sample t test.
506
+ JOURNAL OF THE AMERICAN COLLEGE OF NUTRITION
507
+ 3
508
+ olive oil in India. We have enough evidence from several epide-
509
+ miologic studies that dietary MUFAs have a positive impact on
510
+ CVD risk factors by promoting a healthy blood lipid profile,
511
+ improving blood pressure, and decreasing inflammation and
512
+ oxidative stress [18,19]. MUFAs are also reported to improve
513
+ insulin sensitivity [19]. In the present study, there was a signifi-
514
+ cant decrease in TC levels in the groundnut group; however,
515
+ this appeared to be mainly due to a decrease in HDL levels
516
+ (Table 4). In contrast, the coconut group showed a significant
517
+ increase in HDL levels, which could be attributed to the high
518
+ MCSFA content of the diet [20].
519
+ Research from the past 30 years has shown that increased
520
+ levels of circulating HDL cholesterol are associated with a
521
+ reduced risk of coronary heart disease events, and HDL par-
522
+ ticles have properties that could provide protection against the
523
+ development of atherosclerosis [21–23]. Low levels of HDL
524
+ (<40 mg/dl) are not only an independent risk factor for CVD
525
+ [21] but are considered a higher risk factor than elevated levels
526
+ of LDL, mainly because HDL has important anti-atherogenic
527
+ effects like reverse cholesterol transport, inhibition of LDL oxi-
528
+ dation, and antiplatelet and anti-inflammatory actions [24].
529
+ Supplementation of as little as 2 g of coconut oil (8 weeks)
530
+ increased HDL levels significantly without harmful effects on
531
+ LDL or TC [25]. Older studies have shown that lauric and myr-
532
+ istic acids increase HDL levels [26,27]. Green and Pittman pro-
533
+ posed that a lower rate of Cholesteryl ester transfer protein
534
+ (CETP)-mediated transfer of lauric or myristic acid–rich cho-
535
+ lesteryl esters from HDL compared to longer chain saturated
536
+ fatty acids results in this increase in HDL levels [28].
537
+ However, increased HDL levels do not always ensure protec-
538
+ tion against atherosclerosis. It is not the level of HDL that
539
+ determines the innate ability for cholesterol efflux from macro-
540
+ phages [29]. Therefore, alternative markers have been proposed
541
+ to better reflect cardiovascular risk, such as the TC: HDL ratio
542
+ or TG: HDL or apolipoprotein ratios [30]. A recent review of
543
+ coconut oil studies points to this flaw; that is, in earlier research
544
+ the effect of coconut consumption on the ratio of TC or TG to
545
+ HDL was often not studied [31]. In the current study, there was
546
+ no significant change in the TG: HDL ratio in either group.
547
+ Therefore, it appears that daily consumption of 100 g of coco-
548
+ nut providing 16% as SFA does not have any deleterious effects
549
+ on plasma lipid profile.
550
+ The effect of dietary changes in fat intake are reflected well
551
+ in erythrocyte membrane fatty acid composition. Long-term fat
552
+ quality is best reflected in the fatty acid composition of adipose
553
+ tissue [32]. However, a number of studies confirm that erythro-
554
+ cytes fatty acid composition can serve as a reliable biomarker of
555
+ medium- to long-term dietary changes [33]. The results of the
556
+ current study show that daily consumption of coconut for 3
557
+ months had no deleterious effect on erythrocyte fatty acid com-
558
+ position compared to consumption of groundnut. Though the
559
+ dietary intake of SFAs was 2.6 times higher in the coconut
560
+ group compared to the groundnut group (58 g vs 22 g; Table 2),
561
+ there was no change in the levels of major SFAs such as pal-
562
+ mitic (16:0) and stearic (18:0) acid. This is logical because SFA
563
+ composition is more an index of de novo lipogenesis, and it is
564
+ likely that increasing intakes of dietary SFAs could result in a
565
+ downregulation of de novo fatty acid synthesis [34]. However,
566
+ significant changes were seen in minor fatty acids in both
567
+ groups. In the coconut group, an increase was seen in minor
568
+ saturated fatty acids C14:0 and C24:0. In the groundnut group,
569
+ there was a decrease in C14:0 and a corresponding increase in
570
+ C22:0 and C24:0.
571
+ The differences in the intakes of MUFAs (18 g vs 41 g),
572
+ however, appear to be reflected in the erythrocytes because
573
+ there was a significant decrease in oleic acid (18:1 n-9) lev-
574
+ els at the end of the intervention period in the coconut
575
+ group. Although there were no changes in the total PUFA
576
+ content in both groups, it was interesting to note that the
577
+ levels of DGLA (20:3 n-6) were significantly increased in
578
+ the coconut group. DGLA is also a substrate for both cyclo-
579
+ oxygenase as well as lipoxygenase, leading to the formation
580
+ of the 1-series prostaglandins and the 3-series leukotrienes,
581
+ respectively [35]. These molecules have been shown to be
582
+ anti-inflammatory in nature and also play a role in reducing
583
+ risk of thrombosis [36]. Taken together, it appears that con-
584
+ sumption of high SFAs from coconut does not have any
585
+ deleterious effects on erythrocyte fatty acids.
586
+ Recently, there have been some questions raised about die-
587
+ tary recommendations to reduce SFA consumption. A meta-
588
+ analysis of prospective epidemiologic studies in 2010 shows
589
+ that there is a lack of significant evidence on SFA intake and
590
+ CVD/coronary heart disease risk [37]. The 2010 Joint World
591
+ Health Organization/Food and Agriculture Organization rec-
592
+ ommendations continue to reiterate the previous recommenda-
593
+ tion to reduce SFAs to less than 10% of total calories [6]. This
594
+ needs to be better understood in regard to coconut saturated
595
+ fats. Even long-term coconut oil studies confirm that there is
596
+ no change in lipid-related cardiovascular risk factors and events
597
+ after 2 years of coconut oil consumption [38]. A recent study
598
+ has also suggested that PUFA-rich oils such as soybean oil
599
+ might be more deleterious to metabolic health compared to
600
+ SFA-rich coconut oil [39]. The current study shows that con-
601
+ sumption of fresh coconut, which is commonly consumed as
602
+ part of the daily diet in many parts of India, does not have any
603
+ deleterious effects on blood lipids or erythrocyte fatty acids but
604
+ may have some beneficial effects such as increasing levels of the
605
+ anti-atherogenic HDL as well as the anti-inflammatory fatty
606
+ acid DGLA.
607
+ Recent advances in nutritional science now allow assessment
608
+ of critical questions about the health effects of SFAs. Our find-
609
+ ings contradict the perspective that dietary saturated fat per se
610
+ is harmful and emphasize the importance of considering the
611
+ source of dietary SFAs. This is one of the first studies on fresh
612
+ coconut that supports the beneficial effects of coconut.
613
+ Conclusion
614
+ Fresh coconut, though rich in SFAs in comparison to a combi-
615
+ nation of groundnut and groundnut oil when used over a
616
+ period of 90 days, had no significant deleterious effect on eryth-
617
+ rocyte fatty acid composition and did not deleteriously change
618
+ lipid-related cardiovascular risk factors. On the whole, this
619
+ study suggests that regular consumption of 100 g of coconut,
620
+ containing high levels of SFAs, does not have any harmful
621
+ effect on plasma lipids and erythrocyte fatty acid composition.
622
+ The results of this work have particular relevance in suggesting
623
+ that individuals wishing to use fresh coconut in their diets can
624
+ 4
625
+ R. S. NAGASHREE ET AL.
626
+ do so safely, but more studies need to be conducted with larger
627
+ sample sizes.
628
+ Acknowledgments
629
+ The authors thank the SVYASA project kitchen, especially the man-
630
+ ager and staff of the kitchen for working together to share the main
631
+ kitchen space and endless hours of tasty food preparation. In addition,
632
+ we are grateful for the efforts of student volunteers of SVYASA for
633
+ working toward study-related tasks. St. John’s Research Institute and
634
+ “Anveshana” molecular biology lab at SVYASA is gratefully acknowl-
635
+ edged for analyzing all of our samples. Lastly, the authors thank the
636
+ research participants for their time and dedication in making this
637
+ study possible.
638
+ References
639
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640
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641
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+ 84:590–598, 2008.
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+ 22. Ali KM, Wonnerth A, Huber K, Wojta J: Cardiovascular disease risk
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+ reduction by raising HDL cholesterol—current therapies and future
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+ opportunities. Br J Pharmacol 167:1177–1194, 2012.
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+ 23. Barter P: HDL-C: role as a risk modifier. Atherosclerosis 12:267–270,
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+ 2011.
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+ 24. Eren E, Yilmaz N, Aydin O: High density lipoprotein and its dysfunc-
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+ tion. Open Biochem J 6:78–93, 2012.
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+ 25. Thompson-Felty C, Johnston CS, Ryder A: Coconut oil supplementa-
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+ tion an innovative strategy for cardiovascular disease risk reduction.
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+ FASEB J 30:904–919, 2016.
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+ 26. Mensink RP, Zock PL, Kester ADM, Katan MB: Effects of dietary fatty
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+ acids and carbohydrates on the ratio of serum total to HDL cholesterol
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+ and on serum lipids and apolipoproteins: a meta-analysis of 60 con-
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+ trolled trials. Am J Clin Nutr 77:1146–1155, 2003.
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+ 27. Temme EH, Mensink RP, Hornstra G: Effects of medium chain fatty
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+ acids (MCFA), myristic acid, and oleic acid on serum lipoproteins in
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+ healthy subjects. J Lipid Res 38:1746–1754, 1997.
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+ 28. Green SR, Pittman RC: Comparative acyl specificities for transfer and
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+ selective uptake of high-density-lipoprotein cholesteryl esters. J Lipid
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+ Res 32:457–467, 1991.
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+ 29. Rodrigues A, Burke MF, Jafri K, French BC, Phillips JA, Mucksavage
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+ ML, Wilensky RL, Mohler ER, Rothblat GH, Rader DJ: Cholesterol
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+ efflux capacity, high-density lipoprotein function, and atherosclerosis.
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+ N Engl J Med 364(2):127–135, 2011.
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+ 30. Di Angelantonio E, Sarwar N: Major lipids, apolipoproteins, and risk
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+ of vascular disease. J Am Med Assoc 302:1993–2000, 2009.
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+ 31. Eyres L, Eyres MF, Chisholm A, Brown RC: Coconut oil consumption
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+ and cardiovascular risk factors in humans. Nutr Rev 74:267–280,
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+ 2016.
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+ 32. Arab L: Biomarkers of fat and fatty acid intake. J Nutr 133
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+ (Suppl):925S–932S, 2003.
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+ 33. Caspar-Bauguil S, Garcia J, Galinier A, P
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+ eriquet B, Ferri
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+ eres J,
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+ Allenbach S, Morin N, H
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+ ericotte P, Salvayre R, Baudet M: Positive
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+ impact of long-term lifestyle change on erythrocyte fatty acid profile
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+ after acute coronary syndromes. Arch Cardiovasc Dis 103(2):106–114,
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+ 2010.
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+ 34. Papackova Z, Cahova M: Fatty acid signaling: the new function of
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+ intracellular lipases. Int J Mol Sci 16:3831–3855, 2015.
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+ 35. Wang X, Lin H, Gu Y: Multiple roles of dihomo-g-linolenic acid
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+ against proliferation diseases. Lipids Health Dis 11:25, 2012.
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+ 36. Yeung J, Tourdot B, Adili R, Green A, Freedman C, Fernandez-
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+ Perez P, Yu J, Holman T, Holinstat M: 12(S)-HETrE, a 12-lipoxy-
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+ genase oxylipin of dihomo-g-linolenic acid, inhibits thrombosis
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+ via Gas signaling in platelets. Arterioscler Thromb Vasc Biol
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+ 36:2068–2077, 2016.
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+ 37. Siri-tarino PW, Sun Q, Hu FB, Krauss RM: Meta-analysis of prospec-
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+ tive cohort studies evaluating the association of saturated fat with car-
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+ diovascular disease. Am J Clin Nutr 91:535–546, 2010.
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+ 38. Vijayakumar M, Vasudevan DM, Sundaram KR, Krishnan S, Vaidya-
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+ nathan K, Nandakumar S, Chandrasekhar R, Mathew N: A random-
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+ ized study of coconut oil versus sunflower oil on cardiovascular risk
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+ factors in patients with stable coronary heart disease. Indian Heart J
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+ 68:498–506, 2016.
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+ 39. Deol P, Evans JR, Dhahbi J, Chellappa K, Han DS, Spindler S, Sladek
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+ FM: Soybean oil is more obesogenic and diabetogenic than coconut
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+ oil and fructose in mouse: potential role for the liver. PLoS One 10:
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+ 5
subfolder_0/Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint A randomized control study.txt ADDED
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1
+ 8/12/2014
2
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
3
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
4
+ 1/9
5
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A
6
+ randomized control study
7
+ John Ebnezar, Raghuram Nagarathna, [...], and Hongasandra Ramarao Nagendra
8
+ Abstract
9
+ Aim:
10
+ This study was designed to evaluate the efficacy of addition of integrated yoga therapy to therapeutic exercises in osteoarthritis
11
+ (OA) of knee joints.
12
+ Materials and Methods:
13
+ This was a prospective randomized active control trial. A total of t participants with OA of knee joints between 35 and 80 years
14
+ (yoga, 59.56 ± 9.54 and control, 59.42 ± 10.66) from the outpatient department of Dr. John's Orthopedic Center, Bengaluru,
15
+ were randomly assigned to receive yoga or physiotherapy exercises after transcutaneous electrical stimulation and ultrasound
16
+ treatment of the affected knee joints. Both groups practiced supervised intervention (40 min per day) for 2 weeks (6 days per
17
+ week) with followup for 3 months. The module of integrated yoga consisted of shithilikaranavyayama (loosening and
18
+ strengthening), asanas, relaxation techniques, pranayama, meditation and didactic lectures on yama, niyama, jnana yoga,
19
+ bhakti yoga, and karma yoga for a healthy lifestyle change. The control group also had supervised physiotherapy exercises. A
20
+ total of 118 (yoga) and 117 (control) were available for final analysis.
21
+ Results:
22
+ Significant differences were observed within (P < 0.001, Wilcoxon's) and between groups (P < 0.001, Mann–Whitney U-test) on
23
+ all domains of the Short Form-36 (P < 0.004), with better results in the yoga group than in the control group, both at 15 day
24
+ and 90 day.
25
+ Conclusion:
26
+ An integrated approach of yoga therapy is better than therapeutic exercises as an adjunct to transcutaneous electrical stimulation
27
+ and ultrasound treatment in improving knee disability and quality of life in patients with OA knees.
28
+ Keywords: Knee disability, osteoarthritis, SF-36, yoga
29
+ INTRODUCTION
30
+ Osteoarthritis (OA) is the second most common rheumatological problem in India and has a prevalence rate of 22–39%.[1] It is
31
+ characterized primarily by articular cartilage degeneration and a secondary periarticular bone response.[2,3] Worldwide
32
+ prevalence rate of OA is 20% for men, 41% for women, and it causes pain or dysfunction in 20% of the elderly.[4] Relieving
33
+ pain stiffness and improving physical functions are the important goals of the present day therapy.[5,6]
34
+ The management of OA is still far from optimal, because the medications currently available provide limited symptomatic relief
35
+ and are fraught with a number of side-effect.[7] It is increasingly recognized that a key outcome measure for any health-care
36
+ intervention for OA is the change in health-related quality of life (QOL).[8,9] Although OA itself is not a life-threatening
37
+ disease, QOL can significantly deteriorate with pain and loss of mobility causing dependence and disability.[10] Health-related
38
+ QOL may be measured by disease-specific and generic health status questionnaires. Western Ontario and McMaster Universities
39
+ Osteoarthritis Index Score (WOMAC) is used to measure specific functional disability and SF-36 is used to measure general health
40
+ status that includes assessment of emotional functioning, energy level, and social functioning in addition to functional disability
41
+ th
42
+ th
43
+ 8/12/2014
44
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
45
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
46
+ 2/9
47
+ assessment. Aglamiş et al[11] Foley et al,[12] and Diracoglu et al.[13] observed greater increases in the SF-36 after the exercise
48
+ program of various durations for patients with OA knees. Kirkley et al.[14] showed that in patients assigned to arthroscopic
49
+ surgery, there was no improvement with health-related QOL. In a study by Tekur et al.[15] the role of yoga in the improvement
50
+ of QOL of patients with chronic low backache was discussed, and she showed that in the yoga group, there was significant
51
+ improvement in the scores of WHOQOL (WHO's Quality of life) brief on all domains. In a study by Sudheer et al.[16] about the
52
+ role of yoga about QOL in normal volunteers, 28% in physical, 16% in psychological, 10.17% in social, and 8.8% in the
53
+ environmental domain changed significantly after shifting to the control intervention in the second week.
54
+ There are no studies that have looked at disability and QOL measures in patients with OA knees after integrated yoga therapy
55
+ involving loosening, strengthening, asanas, etc. Hence, this study was planned with an aim to assess the effects of the integrated
56
+ approach of yoga therapy on QOL using a generic health-status tool involving SF-36 in patients with OA knee.
57
+ MATERIALS AND METHODS
58
+ A total of t patients with OA knees from the outpatient department of Dr John's Orthopedic Center, Bengaluru, were recruited
59
+ for the study. A sample size of 250 was obtained on G power software by fixing the alpha at 0.05 powered at 0.8 and an effect
60
+ size of 0.379 considering the mean and SD of an earlier study.[17] A total of t of both genders in the age group of 35–80 years
61
+ (59.56 ± 8.18) in the yoga group and (59.42 ± 10.66) control group with OA knees (one or both joints) satisfying theAmerican
62
+ College of Rheumatology (ACR) Guidelines[18] for diagnosis were included. The inclusion criteria were (i) persistent pain for 3
63
+ months prior to recruitment, (ii) moderate-to-severe pain on walking, (iii) Kellegren and Lawrence[19] radiologic grading of II-
64
+ IV in X-rays taken within 6 months prior to entry, and (iv) those fully ambulant, literate, and willing to participate in the study.
65
+ Those with (i) grade I changes in -ray, (ii) acute knee pain, (iii) secondary osteoarthritis due to rheumatoid arthritis, gout, septic
66
+ arthritis, tuberculosis, tumor, trauma, or hemophilia, and (iv)those with major medical or psychiatric disorders were excluded.
67
+ The study was approved by the institutional review board (IRB) and ethical committee of SVYASA (Swami Vivekananda Yoga
68
+ Anusandhana Samsthana) University. Signed informed consent was obtained from all the participants.
69
+ Design
70
+ This was a prospective randomized parallel active control study on patients with OA knees in the age range of 35-80 years.
71
+ Patients attending the outpatient department of Dr John's Orthopedic Center who satisfied the inclusion criteria were recruited
72
+ for the study. After the initial screening for selection criteria, they were assigned to either the yoga group or control group. A
73
+ computer-generated random number table (www.randomization.com) was used for randomization. Numbered envelopes were used
74
+ to conceal the sequence until the intervention was assigned. Both groups were given the conventional physiotherapy using
75
+ transcutaneous electrical stimulation and ultrasound for 15 days.
76
+ Both groups had supervised practices at the center for 40 min daily (6 days/week) after physiotherapy (20 min) for 2 weeks. The
77
+ yoga classes were conducted in the basement of the hospital where one hall is exclusively dedicated for yoga therapy. The study
78
+ group was taught integrated yoga and the control group was taught the non-yogic physiotherapy exercises by certified therapists.
79
+ After this, they were asked to practice daily at home for the next 3 months. Compliance was supervised by telephone calls once
80
+ in 3 days and a weekly review was conducted once a week for 3 months. The daily review cards were checked for the regularity
81
+ and doubts if any were clarified. The evaluation was conducted by the senior research fellow. All patients were asked to tick the
82
+ practices daily after the home practice in the diary provided for the purpose; at every visit their clinical progress and therapy
83
+ received on the day were documented. All assessments were carried out on 1 , 15 , and 90 days.
84
+ Blinding and masking
85
+ As this was an interventional study, double blinding was not possible. The answer sheets of the questionnaires were coded and
86
+ analyzed only after the study was completed. Here, the statistician who did the randomization, data analysts, and the researcher
87
+ who carried out the assessments were blinded to the treatment status of the subjects.
88
+ st
89
+ th
90
+ th
91
+ 8/12/2014
92
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
93
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
94
+ 3/9
95
+ Intervention for the yoga group
96
+ The daily routine practiced at the center in the yoga group included 40 min of integrated yoga therapy practice after 20 min of
97
+ physiotherapy with transcutaneous electrical stimulation and ultrasound for 2 weeks [Table 1]. The integrated yoga therapy
98
+ practice included shithilikaranavyayamas (loosening practices), saktivikasaka (strengthening practices) followed by yogasanas
99
+ and relaxation techniques with devotional songs. Later patients were advised to continue the integrated yoga therapy practice for
100
+ 40 min at home for the next 10 weeks.
101
+ Table 1
102
+ Yoga module for osteoarthritis knees
103
+ The concept used to develop a specific module of an integrated approach of yoga therapy for knee pain was taken from the
104
+ traditional yoga scriptures (patanjali yoga sutras, yoga vasishtha, and upanishads) that highlight a holistic lifestyle for positive
105
+ health at physical, mental, emotional, and intellectual levels.[20] Yoga is defined as the mastery over the modifications of mind
106
+ (chittavrittinirodhah—definition of yoga by patanjali). It helps to remove the unnecessary surges of neuromuscular activation
107
+ resulting from heightened stress responses that may contribute to aging.[21] The daily routine included a 40 min practice as
108
+ follows:
109
+ Yogic sukshmavyayamas (loosening and strengthening practices): These are safe, rhythmic, repetitive stretching
110
+ movements synchronized with breathing. These practices mobilize the joints and strengthen the periarticular muscles.
111
+ Relaxation techniques: Three types of guided relaxation techniques were interspersed between the physical practices of
112
+ sukshmavyayamas and asanas.
113
+ Asanas (physical postures): Asanas are featured by effortless maintenance in the final posture by internal awareness. We
114
+ selected asanas in standing, supine and prone positions that would relax and strengthen the knee joints.
115
+ Pranayama: The practice of voluntary regulated breathing while the mind is directed to the flow of breath is called
116
+ Pranayama. These practices promote autonomic balance through mastery over the mind.[22]
117
+ Meditation: Patanjali defines meditation (dhyana) as effortless flow of a single thought like OM in the mind without
118
+ distractions (pratyayaekataanatadhyanam). This has been shown to offer physiological benefits through alertful rest to
119
+ the mind body complex.[23]
120
+ Lectures and counseling: Yogic concepts of health and disease, yama, niyama, bhakti yoga, Jnana yoga, and karma yoga were
121
+ presented in the theory classes. These sessions were aimed at understanding the need for lifestyle change, weight management,
122
+ and prevent early aging by yogic self-management of psychosocial stresses.
123
+ Intervention for the control group
124
+ The daily routine practiced at the center in the control group included 40 min of therapeutic exercises after 20 min of
125
+ physiotherapy with transcutaneous electrical stimulation and ultrasound for 2 weeks [Table 2]. These therapeutic exercises
126
+ included loosening and strengthening practices for all the joints of the upper and lower limbs, brief period of rest, specific knee
127
+ practices, and supine rest followed by light music. Later patient was advised to continue the therapeutic exercise practice of 40
128
+ min at home for the next 12 weeks.
129
+ Table 2
130
+ Control module for OA knees
131
+ 8/12/2014
132
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
133
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
134
+ 4/9
135
+ Outcome variables
136
+ Short Form 36) was used to assess QOL after the intervention in both groups on day 15 and 90. SF-36 is one of the popularly
137
+ used self-evaluation questionnaire for the assessment of general.[24] It contains 36 questions aimed at assessment of the
138
+ participant's health under eight major categories: physical functioning, role limitations due to physical health, role limitations
139
+ due to mental health, energy or fatigue, emotional well-being, social functioning, pain, and general health. The scores are then
140
+ averaged accordingly under those headings.[25]
141
+ The increase in scores indicates better for domains physical functioning, role of limitations in physical health, role of limitations
142
+ in emotional problems, social functioning, pain reduction, general health, and for domains fatigue and emotional well-being the
143
+ decrease in scores indicates better QOL. The internal consistency of the SF-36 Health Survey Questionnaire as determined by
144
+ Cronbachs was high and ranged from 0.72-0.94.
145
+ Statistical methods
146
+ The data were analyzed using SPSS Version 16. The baseline values of the two groups were checked for normal distribution by
147
+ Shapiro–Wilk's test. Baseline matching was checked by the Mann–Whitney test. Wilcoxon's signed ranks test and MannWhitney
148
+ U-test were used for assessing ‘within’ and ‘between’ groups differences, respectively.
149
+ Tables 1 and 2 show the interventions of both study and control groups. Table 3 shows the baseline characteristics which were
150
+ similar between groups on all variables (P > 0.05, Mann–Whitney test for pre values).
151
+ Table 3
152
+ Demographic data
153
+ RESULTS
154
+ The trial profile of the study is shown in Figure 1. There were seven dropouts in the study group and eight in the control group.
155
+ Table 4 shows the results within the yoga group of 15 and 90 day. Table 5 shows the results within the control group of 15
156
+ and 90 day, and Table 6 shows the results between the yoga and control groups.
157
+ Figure 1
158
+ Trial profile of the study
159
+ Table 4
160
+ Results of variations of several parameters in SF-36 before and after integrated yoga therapy
161
+ Table 5
162
+ Results of variations of several parameters in SF-36 before and after therapeutic exercises
163
+ th
164
+ th
165
+ th
166
+ th
167
+ 8/12/2014
168
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
169
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
170
+ 5/9
171
+ Table 6
172
+ Results of SF-36 variables between groups (yoga and control groups)
173
+ Quality of life
174
+ Between and within group differences were highly significant on all domains of the SF-36 (P < 0.001) with better improvement
175
+ in the yoga group than the control group on 15 day and 90 day.
176
+ Physical functioning
177
+ This measures all the physical activities including bathing or dressing. In the yoga group, the physical function (P < .001)
178
+ increased from 12.03 ± 9.94 to 39.32 ± 11.24 and further to 67.50 ± 9.09 and in the control group from 12.82 ± 10.81 to 24.95
179
+ ± 13.93 and further to 50.94 ± 14.76 on 15 day and 90 days, respectively.
180
+ Role limitation in physical health
181
+ This measures problems with work or other daily activities as a result of physical health. The role limitation in physical health
182
+ (P < 0.001) improved by increase of scores from 52.33 ± 29.59 to 86.44 ± 15.55 in the yoga group and 35.47 ± 36.14 to 58.33
183
+ ± 44.52 in the control group on the 15th and 90th days, respectively, with significantly better results in the yoga group than the
184
+ control group (P = 0.001, Mann–Whitney U test).
185
+ Role limitation due to emotional health
186
+ This evaluates problems with work or other daily activities due to physical and emotional problems. The role limitation due to
187
+ emotional health (P < 0.001) improved from 56.17 ± 22.93 to 86.41 ± 17.59 in the yoga group and from 31.02 ± 26.86 to
188
+ 58.75 ± 38.94 in the control group on the 15th and 90th days, respectively, with significantly better results in the yoga group
189
+ than the control group (P = 0.001, Mann-Whitney U test).
190
+ Energy and fatigue level
191
+ These levels are evaluated by finding out whether a person feels tired and worn out or feels full of pep and energy all the time.
192
+ The energy and fatigue level improved in both groups (P <0.001, Wilcoxon's) with reduction of scores from 66.36 ± 5.66 to
193
+ 50.10 ± 6.30 and further to 36.35 ± 6.08 in the yoga group and from 64.91 ± 5.41 to 58.97 ± 5.6 and to 53.20 ± 6.8 in the
194
+ control group on 15 and 90 days, respectively, with significantly better results in the yoga group than the control group (P =
195
+ 0.001, Mann–Whitney U test).
196
+ Emotional well-being
197
+ This evaluates whether a person has problems or no problems with work or other daily activities as a result of emotional
198
+ problems. In the yoga group, the emotional well-being (P < 0.001, Wilcoxon's) improved with reduction in scores from 63.10 ±
199
+ 7.17 to 48.88 ± 7.01 and to 34.33 ± 5.46 and in the control group from 62.46 ± 6.61 to 57.43 ± 5.78 to 52.27 ± 5.91 on the
200
+ 15 and 90 days, respectively, with significantly better results in the yoga group than the control group (P = 0.001, Mann–
201
+ Whitney U test).
202
+ th
203
+ th
204
+ th
205
+ th
206
+ th
207
+ th
208
+ th
209
+ th
210
+ 8/12/2014
211
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
212
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
213
+ 6/9
214
+ Social functioning
215
+ This evaluates whether the social activities are limited due to physical and emotional problems. In the yoga group, the emotional
216
+ well-being (P <.001,Wilcoxon's) increased from 50.50 ± 6.82 to 57.83 ± 6.89 and to 64.04 ± 8.92 and in the control group from
217
+ 51.92 ± 9.37 to (52.67 ± 9.40) and to 57.15 ± 10.42 on the 15 and 90 days, respectively, with significantly better results in
218
+ the yoga group than the control group (P = 0.001, Mann–Whitney test).
219
+ Pain
220
+ This measures the severity of pain that limits the activities. Well-being on scores of pain improved in both groups (P < 0.001,
221
+ Wilcoxon's) from 11.54 ± 11.55 to 47.88 ± 11.33 and to 73.77 ± 12.67 in the yoga group and in the control group from 11.68
222
+ ± 9.11 to 30.21 ± 9.09 and to 46.93 ± 11.22 on the 15 and 90 days, respectively, with significantly better results in the yoga
223
+ group than the control group (P = 0.001, Mann–Whitney test).
224
+ General health
225
+ This evaluates the personal health of the individual. The general health increased in both groups (P < 0.001). It increased from
226
+ 36.91 ± 6.94 to 59.31 ± 12.24 to 77.47 ± 20.91 in the yoga group from 36.99 ± 11.08 to 48.75 ± 9.26 to 60.12 ± 12.57 in the
227
+ control group on the 15 and 90 days, respectively, with significantly better results in the yoga group than the control group (P
228
+ = 0.001, Mann–Whitney U test).
229
+ DISCUSSION
230
+ This randomized two armed parallel control trial on 250 participants included patients of both genders (F = 175) in age 35–80
231
+ years with osteoarthritis of knees. Results showed significantly better improvement in the yoga group than the control group on
232
+ all variables (P < 0.001, Mann–Whitney U test) of SF 36.
233
+ In a randomized controlled study on magnetic pulse treatment for knee osteoarthritis by Piptone et al. assessment of the patients
234
+ at week 6 revealed a statistically significant improvement in pain and disability of the WOMAC questionnaire (Western Ontario
235
+ and McMaster Universities) and EuroQol score (EuroQol or EQ-5D is a standardized measure of health status developed by the
236
+ EuroQol group in order to provide a simple, generic measure of health for clinical and economic appraisal) in the active
237
+ treatment group.[26]
238
+ Pain reduction
239
+ The reduction in pain observed in our study points to the beneficial effect of yoga as an add-on therapy to conventional
240
+ physiotherapy practices.
241
+ In pilot studies on OA knees involving yoga, Kolasinski et al.[27] Ranjita et al.[28] showed a better reduction of pain in the yoga
242
+ group than the control group. In our study, we added yoga after the standard physiotherapy and the degree of changes appears to
243
+ be similar in all the three yoga studies (37-47%). This may point to the efficacy of yoga when used with or without a session of
244
+ physiotherapy before the practice of yoga.
245
+ Similar effects of pain reduction ha been observed by Garfinkel et al.[29] in a randomized controlled trial on yoga for carpal
246
+ tunnel syndrome. Tekur et al.[15] studied the efficacy of the integrated approach of yoga therapy in patients with chronic low
247
+ back pain and documented 48.8% reduction in Numerical Rating Scale scores in the yoga group. Garfinkel et al.[30] studied the
248
+ effects of Iyengar yoga in patients with OA hands and found a better reduction in the pain during activity. Yogitha et al.[31]
249
+ showed a reduction in pain and tenderness in patients with common neck pain after integrated yoga. In a study by Aglamiş et al.
250
+ [11] there was a significant group differences in all domains of SF-36 (P < 0.004), while there were no group difference in
251
+ WOMAC domains (P > 0.004). Baker et al.[32] found increases in the SF-36 physical function, physical role, social and mental
252
+ health scores and physical performance scores and decreases in the WOMAC pain after a 4-month strength exercise program.
253
+ Foley et al.[12] stated that after a 6-week exercise program physical performance increased, the WOMAC score did not change,
254
+ th
255
+ th
256
+ th
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+ th
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+ th
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+ th
260
+ 8/12/2014
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+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
262
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
263
+ 7/9
264
+ and the physical component of the SF-12 increased after hydrotherapy. Diracoglu et al.[13] observed increases in the SF-36
265
+ physical function, physical role, and vitality scores and the WOMAC physical function scores and physical performance in a
266
+ kinesthetic group is greater than in a strength group after an 8 week exercise program. In a study by Kirkley et al.[14] in patients
267
+ assigned to arthroscopic surgery there was no improvement with respect to physical function, pain, or health-related than those
268
+ were assigned to the control group. In a study conducted at our center by Rangaji et al.[33] on the role of IAYT in the treatment
269
+ of osteoporosis, he showed that in the comparison between the groups, the exercise group showed a significant difference in
270
+ physical functioning component of SF-36 than the yoga group.
271
+ This study has revealed a statistically significant improvement in respect of all the domains of the SF 36 score with significantly
272
+ better improvements in the yoga and control groups.
273
+ Mechanisms
274
+ Several factors would have contributed to the beneficial effects observed in both groups in this study. As noted in several earlier
275
+ studies physiotherapy intervention may increase the blood glow. Better results in the yoga group could be due to its stress
276
+ reducing effect since yoga is meant to bring about better emotional stability. Yoga is defined as ‘samtvam yoga’ in
277
+ Bhagavadgita[34] which refers to ‘the balanced state of mind under any demanding life situation, be physical or psychological
278
+ (sheetaushnasukhaduhkheshusamah)’. This emotional stability is achieved by the multifactorial approach of yoga that includes
279
+ safe physical practices (asanas), breathing techniques (pranayama), meditation (dharana and dhyana), and introspective
280
+ corrections in one's cognitive errors by inputs at intellectual (jnana yoga) and emotional level (bhakti yoga).[35] This may have
281
+ contributed to better health behavior and improved QOL.
282
+ Strengths of the study
283
+ Good sample size, randomized control design, active supervised intervention for the control group for the same duration as the
284
+ experimental group and follow up for 3 months with good compliance (6% dropouts) are the strengths of this study. The result
285
+ of this study that has shown marked differences between groups on all variables offers strong evidence for incorporating this
286
+ module of IAYT for knees by the clinicians.
287
+ Suggestions for future work
288
+ A longer follow-up of ≥12 months is necessary to check for long-term efficacy and long-term acceptability. Studies using MRI
289
+ and biochemical variables may throw light on the mechanisms.
290
+ CONCLUSIONS
291
+ Adjunctive program of the integrated approach of yoga therapy for OA knees improves all components of QOL on SF36. IAYT
292
+ offers a good value addition as a nonpharmacological intervention in improving QOL in patients with OA knees.
293
+ Footnotes
294
+ Source of Support: Nil
295
+ Conflict of Interest: None declared
296
+ Article information
297
+ Int J Yoga. 2011 Jul-Dec; 4(2): 55–63.
298
+ doi: 10.4103/0973-6131.85486
299
+ PMCID: PMC3193655
300
+ John Ebnezar, Raghuram Nagarathna, Yogitha Bali, and Hongasandra Ramarao Nagendra
301
+ 1
302
+ 1
303
+ 8/12/2014
304
+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
305
+ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193655/
306
+ 8/9
307
+ Department of Orthopaedics, Dr. John's Orthopaedic Centre, Karnataka, Bengaluru, India
308
+ Division of Life Sciences, Swami Vivekananda Yoga Research Foundation (SVYASA), Karnataka, Bengaluru, India
309
+ Address for correspondence: Dr. John Ebnezar, Department of Orthopaedics, Dr. John's Orthopaedic Centre, Bilekahalli, Bannerghatta Road, Bengaluru,
310
+ Karnataka, India. E-mail: [email protected]
311
+ Copyright : © International Journal of Yoga
312
+ This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits
313
+ unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
314
+ This article has been cited by other articles in PMC.
315
+ Articles from International Journal of Yoga are provided here courtesy of Medknow Publications
316
+ REFERENCES
317
+ 1. Chopra A, Patil J, Bilampelly V, Relwani J, Tandle HS. Prevalence of rheumatic disease in rural population in Western India: A WHO-ILAR-
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+ 2. Felson DT. An update on the pathogenesis and epidemiology of osteoarthritis. Radiol Clin North Am. 2004;42:1–9. [PubMed]
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+ 3. Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, et al. Osteoarthritis: New insights.Part 1: The disease and its risk
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+ 5. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology
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+ 6. Pendleton A, Arden N, Dougados M, Doherty M, Bannwarth B, Bijlsma JW, et al. EULAR recommendations for the management of
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+ 8. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care. 1989;27:217–32. [PubMed]
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+ 11. Aglamiş B, Toraman NF, Yaman H. Change of quality of life due to exercise training in knee osteoarthritis: SF-36 and Womac. J Back
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+ 12. Foley A, Halbert J, Hewitt T, Crotty M. Does hydrotherapy improve strength and physical function in patients with osteoarthritis – a
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+ randomized controlled trial comparing a gym based and hydrotherapy based strengthening programme. Ann Rheum Dis. 2003;62:1162–7.
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+ [PMC free article] [PubMed]
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+ 13. Diracoglu D, Aydin R, Baskent A, Celik A. Effects of kinesthesia and balance exercises in knee osteoarthritis. J Clin Rheumatol. 2005;11:303–
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+ 10. [PubMed]
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+ 14. Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, et al. A randomized trial of arthroscopic surgery for osteoarthritis
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+ of the knee. N Eng J Med. 2008;359:1097–107. [PubMed]
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+ 15. Tekur P, Singhpow C, Nagarathna HR, Raghuram N. Effect of short term intensive yoga program on pain, functional disability, and spinal
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+ flexibility in chronic low back pain: A randomized control study. J Altern and Complement Med. 2008;14:637–44. [PubMed]
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+ 1
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+ 8/12/2014
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+ Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study
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+ 16. Deshpande S, Nagendra HR, Nagarathna R, Sudheer D, Nagendra HR, Nagarathna R. Effect of yoga on gunas (Personality) and health in normal
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+ healthy volunteers. Int J Yoga. 2008;2:13–21. [PMC free article] [PubMed]
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+ 17. Bookman AA, Williams KS, Shainhouse JZ. Effect of topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: A
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+ randomized controlled trial. CMAJ. 2004;171:333–8. [PMC free article] [PubMed]
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+ 18. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of
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+ osteoarthritis.Classification of the osteoarthritis of the knee. Arthritis Rheum. 1986;29:1039–49. [PubMed]
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+ 19. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494–502. [PMC free article] [PubMed]
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+ 20. Nagarathna R, Nagendra HR. Bangalore: Swami Vivekananda Yoga Prakashana; 2000. Yoga for promotion of positive health.
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+ 21. Nagarathna R, Nagendra HR. Bangalore: Swami Vivekananda Yoga Prakashana; 2001. Yoga for Arthritis.
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+ 22. Telles S, Nagarathna R, Nagendra HR. Breathing through a particular nostril can alter metabolism and autonomic activities. Indian J Physiol
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+ Pharmacol. 1994;38:133–7. [PubMed]
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+ 23. Telles S, Nagarathna R, Nagendra HR. Autonomic changes during Om meditation. Indian J Physiol Pharmacol. 1995;39:418–20. [PubMed]
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+ 24. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I.Conceptual framework and item selection. Med Care.
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+ 25. Jenkinson C, Layte R, Wright L, Coulter A. Oxford, U.K: Health services research unit, dept of public health and primary care, University of
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+ Oxford; 1996. The U.K. SF-36: An analysis and interpretation manual.
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+ 26. Pipitone N, Scott DL. Magnetic pulse treatment for knee osteoarthritis: a randomised, double-blind, placebo-controlled study. Curr Med Res
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+ Opin. 2001;17:190–6. [PubMed]
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+ 27. Kolasinski SL, Garfinkel M, Tsai AG, Matz W, Van Dyke A, Schumacher HR. Iyengar yoga for treating symptoms of osteoarthritis of the
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+ knees: A pilot study. J Altern Complement Med. 2005;11:689–93. [PubMed]
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+ 28. Ranjita R. Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru. Karnataka: 2008. Effect of yoga on pain, mobility, gait, and balance
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+ in patients with osteoarthritis of the knee.
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+ 29. Garfinkel MS, Singhal A, Katz WA, Allan DA, Reshetar R, Schumacher HR., Jr Yoga-based intervention for carpal tunnel syndrome.A
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+ randomized trial. JAMA. 1998;280:1601–3. [PubMed]
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+ 30. Garfinkel MS, Schumacher R, Husain A, Levy M, Reshetar RA. Evaluation of a yoga based regimen for treatment of osteoarthritis of the hands.
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+ J Rheumatol. 1994;21:2341–3. [PubMed]
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+ 31. Yogitha B, Nagarathna R, John E, Nagendra H. Complimentary effect of yogic sound resonance relaxation technique in patients with common
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+ neck pain. Int J Yoga. 2010;3:18–25. [PMC free article] [PubMed]
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+ 32. Baker KR, Nelson ME, Felson DT, Layne JE, Sarno R, Roubenoff R. The efficacy of home based progressive strength training in older adults
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+ with knee osteoarthritis: A randomized controlled trial. J Rheumatol. 2001;28:1655–65. [PubMed]
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+ 33. Rangaji . Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru. Karnataka: 2010. Role of IAYT in the treatment of osteoporosis.
382
+ 34. Goyandaka J. 19th ed. Gorakhpur: Gita press publications; 2004. Srimadbhagavadgita tattvavivecani.
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+ 35. Nagendra HR, Nagarathna R. An integrated approach of yoga therapy for bronchial asthma: a 3-54-month prospective study. J Asthma.
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+ 1986;23:123–37. [PubMed]
subfolder_0/Effect of holistic yoga program on anxiety symptoms in adolescent girls with polycysti.txt ADDED
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1
+
2
+
3
+
4
+ Journal of Alternative and Complementary Medicine: http://mc.manuscriptcentral.com/jaltcompmed
5
+
6
+
7
+
8
+ THE EFFECTS OF A HOLISTIC YOGA PROGRAM ON
9
+ ENDOCRINE PARAMETERS IN ADOLESCENTS WITH
10
+ POLYCYSTIC OVARIAN SYNDROME: A RANDOMIZED
11
+ CONTROL TRIAL
12
+
13
+
14
+ Journal: Journal of Alternative and Complementary Medicine
15
+ Manuscript ID: JACM-2011-0868.R2
16
+ Manuscript Type: Original Articles
17
+ Date Submitted by the Author: 25-Jan-2012
18
+ Complete List of Authors: Ram, Nidhi; SVYASA, Divison of Yoga and Life Sciences
19
+ Venkatram, Padmalatha
20
+ Raghuram, Nagarathna; SVYASA, Divison of yoga and life sciences
21
+ Ram, Amritanshu; SVYASA, Divison of yoga and life sciences
22
+ Keywords: endocrinology, mind/body, Ob/Gyn, yoga
23
+ Abstract:
24
+ THE EFFECTS OF A HOLISTIC YOGA PROGRAM ON ENDOCRINE
25
+ PARAMETERS IN ADOLESCENTS WITH POLYCYSTIC OVARIAN SYNDROME:
26
+ A RANDOMIZED CONTROL TRIAL
27
+
28
+
29
+ Authors: Nidhi R, Padmalatha V, Nagarathna R, Amritanshu R
30
+ ABSTRACT:
31
+ Objective: To compare the effects of a holistic yoga program with the
32
+ conventional exercise program in adolescent Polycystic Ovarian Syndrome
33
+ (PCOS).
34
+ Design: Prospective randomized active control trial
35
+ Setting: Ninety adolescent (15-18years) girls from a residential college in
36
+ Andhra Pradesh, who satisfied the Rotterdam criteria were randomized into
37
+ two groups.
38
+ Intervention: The yoga group practiced a holistic yoga module while the
39
+ control group practiced a matching set of physical exercises (1 hour/day,
40
+ for 12 weeks).
41
+ Outcome Measure: Anti-Mullerian Hormone (AMH-primary outcome), LH,
42
+ FSH, testosterone, prolactin, Body Mass Index (BMI), hirsutism and
43
+ menstrual frequency were measured at inclusion and after 12 weeks.
44
+ Results: Mann-Whitney test on difference score shows that changes in AMH
45
+ (Y= - 2.51, C= - 0.49, p=0.006), LH and LH/FSH ratio (LH: Y= - 4.09,
46
+ C=3.00, p=0.005; LH/FSH: Y= - 1.17, C= 0.49, p= 0.015) were
47
+ significantly different between the two intervention groups. Also changes in
48
+ testosterone (Y= - 6.01, C= 2.61, p=0.014) and mFG score (Y= -1.14, C=
49
+ +0.06, p=0.002) were significantly different between the two groups. On
50
+ the other hand, changes in FSH and prolactin post intervention were non-
51
+ significantly different between the two groups. Also, body weight and BMI
52
+ Mary Ann Liebert Inc., 140 Huguenot Street, New Rochelle, NY 10801
53
+ Journal of Alternative and Complementary Medicine
54
+ showed non-significantly different changes between the two groups while
55
+ changes in menstrual frequency were significantly different between the
56
+ two groups (Y=0.89, C= 0.49, p=0.049).
57
+ Conclusion: Holistic yoga program for 12 weeks is significantly better than
58
+ physical exercise in reducing AMH, LH and Testosterone, mFG score for
59
+ hirsutism and improving menstrual frequency with non significant changes
60
+ in body weight, FSH and prolactin in adolescent PCOS.
61
+ Clinical Trial Registration: REFCTRI-2008 000291
62
+ Key Words: adolescent PCOS, AMH, endocrine parameters, yoga
63
+
64
+
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+
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+ Page 1 of 24
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+ Mary Ann Liebert Inc., 140 Huguenot Street, New Rochelle, NY 10801
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+ Journal of Alternative and Complementary Medicine
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+ Original Article
130
+ Effects of a Holistic Yoga Program on Endocrine Parameters
131
+ in Adolescents with Polycystic Ovarian Syndrome:
132
+ A Randomized Controlled Trial
133
+ Ram Nidhi, MSc, Venkatram Padmalatha, MBBS, Raghuram Nagarathna, MBBS, MD,
134
+ and Ram Amritanshu, MSc
135
+ Abstract
136
+ Objectives: The objectives of this trial were to compare the effects of a holistic yoga program with the con-
137
+ ventional exercise program in adolescent polycystic ovarian syndrome (PCOS).
138
+ Design: This was a prospective, randomized, active controlled trial.
139
+ Setting: Ninety (90) adolescent (15–18 years) girls from a residential college in Andhra Pradesh who satisfied the
140
+ Rotterdam criteria were randomized into two groups.
141
+ Intervention: The yoga group practiced a holistic yoga module, while the control group practiced a matching set
142
+ of physical exercises (1 hour/day, for 12 weeks).
143
+ Outcome measures: Anti-mu
144
+ ¨ llerian hormone (AMH-primary outcome), luteinizing hormone (LH), follicle-
145
+ stimulating hormone (FSH), testosterone, prolactin, body–mass index (BMI), hirsutism, and menstrual frequency
146
+ were measured at inclusion and after 12 weeks.
147
+ Results: Mann-Whitney test on difference score shows that changes in AMH (Y = - 2.51, C = - 0.49, p = 0.006),
148
+ LH, and LH/FSH ratio (LH: Y = - 4.09, C = 3.00, p = 0.005; LH/FSH: Y = - 1.17, C = 0.49, p = 0.015) were signifi-
149
+ cantly different between the two intervention groups. Also, changes in testosterone (Y = - 6.01, C = 2.61, p = 0.014)
150
+ and Modified Ferriman and Gallway (mFG) score (Y = - 1.14, C = + 0.06, p = 0.002) were significantly different
151
+ between the two groups. On the other hand, changes in FSH and prolactin postintervention were nonsignifi-
152
+ cantly different between the two groups. Also, body weight and BMI showed nonsignificantly different changes
153
+ between the two groups, while changes in menstrual frequency were significantly different between the two
154
+ groups (Y = 0.89, C = 0.49, p = 0.049).
155
+ Conclusions: A holistic yoga program for 12 weeks is significantly better than physical exercise in reducing
156
+ AMH, LH, and testosterone, mFG score for hirsutism, and improving menstrual frequency with nonsignificant
157
+ changes in body weight, FSH, and prolactin in adolescent PCOS.
158
+ Introduction
159
+ P
160
+ olycystic ovarian syndrome (PCOS) is a highly prev-
161
+ alent female endocrine disorder with estimates ranging
162
+ from 2.2% to as high as 26%,1,2 depending on the diagnostic
163
+ criteria used and the ethnicity of the population studied. In a
164
+ recent survey, a 9.13% prevalence of PCOS was found in south
165
+ Indian adolescent girls.3
166
+ In recent years, excessive production of anti-mu
167
+ ¨llerian
168
+ hormone (AMH) has been implicated in the etiology of
169
+ PCOS. AMH is emerging as a diagnostic and screening tool
170
+ for PCOS.4 Several studies have shown highly increased
171
+ AMH levels in the serum, granulosa cells (75 times higher),5
172
+ and the follicular fluid of women with PCOS.5,6 AMH, a local
173
+ inhibitor
174
+ of
175
+ follicle-stimulating
176
+ hormone
177
+ (FSH)
178
+ action,7
179
+ shows positive correlation with luteinizing hormone (LH)8
180
+ and negative correlation with FSH.8–10 Dysregulation of
181
+ AMH function due to aberrant sensitivity to FSH leads to
182
+ accumulation of small antral follicles and failed ovulation
183
+ trigger. There is a positive correlation between AMH and
184
+ follicle number.6,9,11,12 Serum AMH levels correlate posi-
185
+ tively with androgen levels in PCOS.7 There are no effective
186
+ therapies for PCOS, although metformin and weight reduc-
187
+ tion have shown some benefits.13 Two (2) studies observed a
188
+ small reduction in AMH levels after prolonged treatment
189
+ with metformin.4,14 Of nonconventional therapies, one study
190
+ Svyasa University, Division of Yoga and Life Sciences, Bangalore, India.
191
+ THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
192
+ Volume 18, Number 00, 2012, pp. 1–8
193
+ ª Mary Ann Liebert, Inc.
194
+ DOI: 10.1089/acm.2011.0868
195
+ 1
196
+ ACM-2011-0868-ver9-Nidhi_1P
197
+ Type: research-article
198
+ ACM-2011-0868-ver9-Nidhi_1P.3d
199
+ 06/25/12
200
+ 12:46pm
201
+ Page 1
202
+ on obese women with PCOS showed no change in AMH
203
+ levels after a 20-week-long weight loss program, although
204
+ there was improvement in reproductive function.15
205
+ There are studies suggesting that chronic stimulation of
206
+ sympathetic activity, a result of stressful lifestyle, can induce
207
+ dysregulation of the hypothalamus–pituitary–ovarian axis
208
+ (HPO axis) in women with PCOS.16 This points to the need
209
+ for stress management–based lifestyle changes that reduce
210
+ sympathetic tone and influence the HPO axis.
211
+ Yogic lifestyle, a form of holistic mind–body medicine
212
+ developed thousands of years ago, is known to reduce
213
+ stress17 and sympathetic tone.18 Hence, it is hypothesized
214
+ that a holistic yoga program would be more effective in re-
215
+ ducing the AMH levels apart from improving all other
216
+ manifestations of PCOS in comparison to a conventional
217
+ exercise program.
218
+ There is a lack of randomized controlled trials analyzing the
219
+ efficacy of lifestyle intervention in PCOS, and to date there is
220
+ no published study on yoga in PCOS. Yogic lifestyle change
221
+ may contribute to a reduction/normalization of sympathetic
222
+ nervous system/hypothalamo-pituitary axis (HPA) activation
223
+ and therefore have beneficial effects on the endocrine system
224
+ in PCOS. Many women with PCOS show psychologic
225
+ distress, which may aggravate hormonal disturbances via
226
+ chronic SNS and/or HPA-axis activation. Thus, the present
227
+ study was designed to investigate the effect of yoga on AMH,
228
+ other endocrine measures, and clinical parameters in adoles-
229
+ cent PCOS in comparison to the physical exercise program.
230
+ Materials and Methods
231
+ Participants
232
+ The study was carried out on adolescent girls aged 15 to 18
233
+ years from a residential college in Anantapur, Andhra
234
+ Pradesh, India. Those who satisfied the Rotterdam criterion
235
+ (two thirds of the features) for PCOS were included in the
236
+ study. The following were the definitions of the three features.
237
+  Oligo/amenorrhea: absence of menstruation for 45 days
238
+ or more and/or less than eight menses per year.19
239
+  Clinical hyperandrogenism: Modified Ferriman and
240
+ Gallway (mFG) score of 6 or higher.1 Biochemical
241
+ hyperandrogenism: Serum testosterone level of > 82 ng/
242
+ dL in the absence of other causes of hyperandrogenism.
243
+  Polycystic ovaries: presence of > 10 cysts, 2–8 mm in
244
+ diameter, usually combined with increased ovarian
245
+ volume of > 10 cm3, and an echo-dense stroma in pelvic
246
+ ultrasound scan.20
247
+ Exclusion
248
+ criteria
249
+ were
250
+ use
251
+ of
252
+ oral
253
+ contraceptives/
254
+ hormone treatment/insulin-sensitizing agents within the
255
+ previous 6 weeks, smoking, hyperprolactinemia, thyroid
256
+ abnormalities, nonclassic adrenal hyperplasia, prior experi-
257
+ ence of yoga, and those who did not consent for the study.
258
+ The study was approved by the Institutional Ethical Com-
259
+ mittee of Swami Vivekananda Yoga Anusandhana Samsthana
260
+ (SVYASA) University. Signed informed consent was obtained
261
+ from the college authorities, the student, and one of the parents.
262
+ Outcome measures
263
+ We have used AMH as the primary outcome measure since
264
+ it is emerging as the most sensitive diagnostic and screening
265
+ tool for PCOS.4 The secondary outcome measures were chan-
266
+ ges in LH, FSH, testosterone, prolactin, mFG score, body–mass
267
+ index (BMI), and menstrual frequency between the groups.
268
+ Power calculation
269
+ Effect size of 0.61 was obtained by using the postintervention
270
+ mean difference between the two groups divided by the corre-
271
+ sponding pooled standard deviation for testosterone from the
272
+ study by Tang et al. on obese PCOS women that compared
273
+ 6 months of metformin and lifestyle modification with a
274
+ placebo.21 A sample size of 86 with 43 subjects in each arm was
275
+ calculated keeping this effect size of 0.61, with type1 error at 0.05
276
+ and power at 0.8. The actual recruitment was extended to 90.
277
+ Design
278
+ This was a prospective, randomized, active interventional
279
+ controlled trial in which 90 participants were randomly di-
280
+ vided into two study arms: one arm practiced yoga and the
281
+ other arm practiced conventional physical exercises for the
282
+ same duration.
283
+ Methods
284
+ All women students of standard 11 and 12 attended an
285
+ interactive introductory lecture where the purpose and de-
286
+ sign of the study were elucidated. They were asked to report
287
+ 1 week later after obtaining the signed consent from their
288
+ parents. After obtaining the written consent, a clinical ex-
289
+ amination was performed. All girls with oligomenorrhea
290
+ and/or hirsutism (as per the abovementioned definitions)
291
+ were asked to come for an ultrasound scan and blood tests.
292
+ Those who satisfied the Rotterdam criteria for PCOS were
293
+ then randomly assigned to two groups by a statistician using
294
+ a computer-generated random number table by the pre-
295
+ labeled sealed-envelope method. On the basis of a random
296
+ number table, participants were assigned to two interven-
297
+ tions. Anthropometric measurements (BMI, waist and hip
298
+ circumference), endocrine parameters, details of menstrual
299
+ frequency, diet pattern, and stress history were documented.
300
+ Two (2) different halls in the college premises were allot-
301
+ ted for yoga and control group practices. Both groups
302
+ practiced their respective set of practices, 1 hour daily, 7 days
303
+ a week for 12 weeks (total 90 sessions), under the supervision
304
+ of trained instructors. The daily routine in the class consisted
305
+ of lecture (5 minutes) followed by physical practices (40
306
+ minutes), pranayama (5 minutes), and relaxation (10minutes).
307
+ The instructors maintained the register of daily attendance
308
+ and the reason for absence, if any, for both of the groups.
309
+ Blinding and masking
310
+ Double blinding was not possible as this was an inter-
311
+ ventional study. The medical officer, ultrasonologist, and the
312
+ laboratory staff were blind to the groups. Also, the statisti-
313
+ cian who did the randomization and the final analysis was
314
+ blind to the source of the data.
315
+ Assessments
316
+ Abdominal ultrasound scanning of the pelvis with special
317
+ attention to the ovaries was carried out by a certified post-
318
+ graduate medical ultrasonologist using a Philips HD 11XE
319
+ ultrasound system. Vaginal ultrasound scanning was not
320
+ acceptable to the girls or the parents.
321
+ 2
322
+ NIDHI ET AL.
323
+ ACM-2011-0868-ver9-Nidhi_1P.3d
324
+ 06/25/12
325
+ 12:46pm
326
+ Page 2
327
+ A fasting sample of venous blood (10 mL) was drawn in the
328
+ morning (6:00 am–8:00 am) at the hostel premises. The samples
329
+ were packed in ice (3–4C) and transported to the laboratory
330
+ within 6 hours. Serum was separated by centrifugation and
331
+ stored at - 20C until it was analyzed at certified laboratories.
332
+ Hormone estimates including total testosterone, LH, FSH,
333
+ and prolactin were done by fully automated bidirectionally
334
+ interfaced chemiluminescent immunoassay. Thyroid-stimu-
335
+ lating hormone was measured by ultrasensitive sandwich
336
+ chemiluminescent immunoassay. Serum AMH levels were
337
+ assessed by using a second-generation enzyme immunoas-
338
+ say (AMH-EIA kit; Immunotech, a Beckman Coulter Com-
339
+ pany,
340
+ Marseilles,
341
+ France).
342
+ The
343
+ intra-
344
+ and
345
+ interassay
346
+ coefficients of variation were 5.1% and 6.6%, respectively for
347
+ AMH, 3.8% and 4.3% for FSH, 4.9% and 6.5% for LH, and
348
+ 4.0% and 5.6% for testosterone.
349
+ Intervention
350
+ The specific modules of intervention were developed by a
351
+ team of experts that included a physiatrist, a gynecologist,
352
+ and yoga therapy physician. Care was taken to match the
353
+ lectures, practical classes, and the type of relaxation tech-
354
+ nique used in the two modules.
355
+ Yoga intervention
356
+ The concepts for the intervention were taken from tradi-
357
+ tional yoga scriptures (Patanjali yoga sutras, Upanishads, and
358
+ Yoga Vasishtha) that highlight a holistic approach to health
359
+ management at physical, mental, emotional and intellectual
360
+ levels.22 The practices consisted of asanas (yoga postures),
361
+ pranayama, relaxation techniques, meditation, and lectures on
362
+ yogic lifestyle and stress management through yogic coun-
363
+ seling. The details of the protocol are given in Table 1. All
364
+ girls received at least one session (about one hour each) of
365
+ individualized counseling that was aimed at cognitive re-
366
+ structuring based on yoga philosophy.
367
+ Control intervention
368
+ Table 1 shows the hour-long module of practices for the
369
+ control group that consisted of a set of physical movements,
370
+ nonyogic safe breathing exercises, followed by supine rest
371
+ (without instructions) that were matched with the yoga
372
+ module. One (1) individualized counseling session was en-
373
+ sured for each student in the control group also. Care was
374
+ taken by the counselors not to introduce any of the yogic
375
+ concepts during these sessions.
376
+ Data analysis
377
+ All statistical analyses were performed using SPSS version
378
+ 17.0. The Kolmogorov–Smirnov test was used to check for
379
+ normal distribution. Because the hypothesis was to compare
380
+ the changes after yoga with that of exercise and the data were
381
+ not normally distributed, nonparametric analysis was done by
382
+ using the Mann-Whitney U test to compare difference scores (D
383
+ Table 1. Matched Practices Between Yoga and Control Groups
384
+ Yoga group
385
+ Time
386
+ Control group
387
+ Time
388
+ Group lecture
389
+ 8 min
390
+ Group Lecture
391
+ 15 min
392
+ Lectures, in the form of cognitive restructuring
393
+ based on the spiritual philosophy
394
+ underlying yogic concepts.
395
+ Lectures on conventional modern
396
+ medical concepts about a healthy
397
+ lifestyle including diet, exercise.
398
+ Surya Namaskara (Sun Salutation)
399
+ 10 min
400
+ Brisk walk
401
+ 15 min
402
+ Prone asanas
403
+ Prone exercises
404
+ Cobra pose (Bhujangasana)
405
+ 1 min
406
+ Prone head lift
407
+ 1 min
408
+ Locust pose (Salabhasana)
409
+ 1 min
410
+ Prone leg rising
411
+ 1 min
412
+ Bow pose (Dhanurasana)
413
+ 1 min
414
+ Tiger leg stretch
415
+ 1min
416
+ Standing asanas
417
+ Standing exercises
418
+ Triangle pose (Trikonasana)
419
+ 1 min
420
+ Spread-leg side bending
421
+ 1 min
422
+ Twisted angle pose (Parsva-konasana)
423
+ 1 min
424
+ Spread-leg twisted bending
425
+ 1 min
426
+ Spread-leg intense stretch (Prasarita padottanasana)
427
+ 1 min
428
+ Spread-leg forward bend
429
+ 1 min
430
+ Supine asanas
431
+ Supine exercises
432
+ Inverted pose (Viparita Karni)
433
+ 1 min
434
+ Straight-leg raising
435
+ 1 min
436
+ Shoulder stand (Sarvangasana)
437
+ 1 min
438
+ Straight-leg supine twist
439
+ 1 min
440
+ Plough pose (Halasana)
441
+ 1 min
442
+ Cycling (clockwise–counterclockwise)
443
+ bended-knee crunches
444
+ 1 min
445
+ Sitting asanas
446
+ Sitting exercises
447
+ Sitting forward stretch (Paschimottanasana)
448
+ 1 min
449
+ Spread-leg forward bend
450
+ 1 min
451
+ Fixed-angle pose (Baddha-konasana)
452
+ 1 min
453
+ Spread-leg alternate-toe touching
454
+ 1 min
455
+ Garland pose (Malasana)
456
+ 1 min
457
+ Squat pose
458
+ 1 min
459
+ Guided relaxation (Savasana)
460
+ 10 min
461
+ Supine rest
462
+ 10 min
463
+ Breathing techniques (Pranayama)
464
+ Normal breathing
465
+ 8 min
466
+ Sectional breathing (Vibhagiya-Pranayama)
467
+ 4 min
468
+ Forceful exhalation (Kapala Bhati)
469
+ 2 min
470
+ Right-nostril breathing (Suryanuloma Viloma)
471
+ 2 min
472
+ Alternate-nostril breathing (Nadi suddhi)
473
+ 2 min
474
+ OM meditation (OM Dhyana)
475
+ 10 min
476
+ YOGA EFFECTS ON ENDOCRINE PARAMETERS IN ADOLESCENT PCOS
477
+ 3
478
+ ACM-2011-0868-ver9-Nidhi_1P.3d
479
+ 06/25/12
480
+ 12:46pm
481
+ Page 3
482
+ change) between the two groups wherein difference score was
483
+ calculated by subtracting pre from post values for each variable.
484
+ Results
485
+ Figure 1 describes the trial profile. The recruitment was
486
+ carried out between December 2009 and January 2011. Of 986
487
+ girls who agreed to clinical examination, 154 girls with oligo-
488
+ menorrhea and/or hirsutism (as per the abovementioned
489
+ definitions) were asked to come for ultrasound and biochem-
490
+ ical investigations. After the laboratory evaluations, 90 girls
491
+ who satisfied Rotterdam criteria of PCOS were randomized
492
+ into two groups. Of these, there were a total of 18 dropouts: 8 in
493
+ the yoga group and 10 in the control group because of less than
494
+ 75% attendance. The reasons (not confirmed) given for with-
495
+ drawal were (1) sick leave and (2) unexpected events in the
496
+ family. The final analysis was done on 72 participants: 37 in the
497
+ yoga group and 35 in the control group.
498
+ Table 2 shows the demographic data. Of the 90 girls re-
499
+ cruited, 82.2% (74/90) were of normal weight (BMI = 18.5–23)
500
+ and only 17.78% (16/90) were overweight (BMI > 23), 31.11%
501
+ (28/90) had mFG score ‡ 6, and 34.44% (31/90) girls had LH/
502
+ FSH ‡ 2. Maximum 66.67% (60/90) numbers of the girls had
503
+ their menstrual cycle length between 60 and 90 days. Only
504
+ 45.56% (41/90) of the girls complained about the presence of
505
+ acne, while 54.44% (49/90) of the girls had no acne.
506
+ The baseline values were not significantly different be-
507
+ tween the yoga and control groups for all the variables in-
508
+ cluding age, BMI, menstrual frequency, serum FSH, serum
509
+ LH, LH/FSH ratio, serum prolactin, total testosterone, and
510
+ serum AMH (Table 2).
511
+ Mann-Whitney test on difference score shows that changes
512
+ in AMH were significantly different between the two inter-
513
+ vention groups (Y = - 2.51, C = - 0.49, p = 0.006). Similarly,
514
+ changes in LH and LH/FSH ratio were also significantly
515
+ different between the yoga and control groups (LH: Y = - 4.09,
516
+ C = 3.00, p = 0.005; LH/FSH: Y = - 1.17, C = 0.49, p = 0.015).
517
+ Also, changes in testosterone were significantly different be-
518
+ tween the two groups (Y = - 6.01, C = 2.61, p = 0.014). On the
519
+ other hand, changes in FSH and prolactin after the 3 months
520
+ of intervention were nonsignificantly different between the
521
+ two groups (FSH: p = 0.474, prolactin: p = 0.982) (Table 3).
522
+ The changes in the means between the groups were sig-
523
+ nificantly different (Y = - 1.14, C = + 0.06, p = 0.002) for mFG
524
+ score. Both body weight and BMI showed nonsignificantly
525
+ different changes between the two groups (weight: p = 0.882,
526
+ BMI: p = 0.910). Changes in menstrual frequency were sig-
527
+ nificantly
528
+ different
529
+ between
530
+ the
531
+ two
532
+ groups
533
+ (Y = 0.89,
534
+ C = 0.49, p = 0.049).
535
+ Discussion
536
+ This is the first randomized controlled trial comparing the
537
+ effect of a holistic yoga program with physical exercise on
538
+ adolescent PCOS, and to the authors’ knowledge this is the
539
+ first study proving the efficacy of a holistic therapy on en-
540
+ docrine parameters and menstrual frequency independent of
541
+ weight loss, within a short duration of 12 weeks.
542
+ The baseline mean AMH (6.01 ng/mL) in our population
543
+ was comparable to earlier observations that ranged from 3.3
544
+ to 15.3 ng/mL15,23 in normal weight and obese adult PCOS.
545
+ As this is the first study of AMH in adolescent PCOS, more
546
+ studies in different races and age groups may help in de-
547
+ fining the cutoff values for the diagnosis of PCOS.
548
+ After 3 months of intervention, there was better reduction
549
+ ( p = 0.006) in AMH levels after yoga (mean change 2.51) than
550
+ physical exercise (0.49). A well-designed randomized con-
551
+ trolled trial by Carlsen et al.23 on 50 women with PCOS
552
+ undergoing 26 weeks of diet, lifestyle, metformin, and an-
553
+ drogen suppression by dexamethasone showed no signifi-
554
+ cant change in AMH levels and on the contrary observed an
555
+ anomalous increase in AMH levels (12.6 ng/mL to 14.1 ng/
556
+ mL) in the group who were given dexamethasone. Thus, a
557
+ decrease in AMH after yoga, a nonsignificant change after a
558
+ 20-week weight-reduction program,15 and an increase after
559
+ dexamethasone therapy23 is noteworthy. Thus, it is interest-
560
+ ing to note that yoga therapy seems to offer better changes in
561
+ AMH than physical exercises or dexamethasone within a
562
+ short duration (3 months) which is similar to the effect with
563
+ metformin (6 months).
564
+ FIG. 1.
565
+ Trial profile.
566
+ 4
567
+ NIDHI ET AL.
568
+ ACM-2011-0868-ver9-Nidhi_1P.3d
569
+ 06/25/12
570
+ 12:46pm
571
+ Page 4
572
+ The baseline mean value for LH (9.7 mIU/mL) and FSH
573
+ (5.8 mIU/mL) in the current study’s population was lower
574
+ than a similar adolescent population of girls with PCOS from
575
+ Italy by De Leo et al.24 These differences between the study
576
+ groups could be due to ethnicity, BMI, and/or the timing of
577
+ hormonal assessment in relation to the menstrual cycle.
578
+ After 3 months of intervention, the current study showed
579
+ reduction in LH (actual mean change: Y = - 4.09, C = 3.00,
580
+ p = 0.005) and LH/FSH ratio (actual mean change: LH/FSH:
581
+ Y = - 1.17, C = 0.49, p = 0.015). This is similar to De Leo’s
582
+ study24 on the effect of metformin for 6 months in obese
583
+ teenage girls with PCOS. Although there was noteworthy
584
+ change after yoga, it is difficult to arrive at a conclusion with
585
+ certainty because of nonuniformity in the timing of hormonal
586
+ assessment in the current study’s population.
587
+ The results of increased menstrual frequency noted in both
588
+ yoga and control groups in the current study were compa-
589
+ rable to that reported by Tang et al. in their 6 months’ trial
590
+ through metformin and lifestyle modification.21
591
+ The mFG score to define clinical hyperandrogenism is
592
+ variable, ranging from 3 to 8. On the basis of a South Asian
593
+ study by Chen et al.,1 the current study used a score of 6 as
594
+ the upper normal limit. Accordingly, only a small proportion
595
+ (31.11 %) of girls had hirsutism. The reduction in mFG scores
596
+ in the yoga group was similar to the observation by Ganie
597
+ et al. after 12 weeks of metformin therapy in 82 adolescent
598
+ and young women with PCOS.25
599
+ Although it is known that a high androgen level is one of
600
+ the characteristic features in women with PCOS, the baseline
601
+ testosterone value in the current study group was well
602
+ within the normal range ( < 82 ng/dL). Since none of the girls
603
+ in this study had high testosterone levels, there was no need
604
+ to perform a 17-OHP test (to exclude the possibility of con-
605
+ genital adrenal hypertrophy) before inclusion in the study.
606
+ Wabitsch et al. observed much higher values (102.8 ng/dL)
607
+ of testosterone than those in the current group, which could
608
+ be due to higher BMI of girls in their study.26 Although the
609
+ baseline value of testosterone was well within the normal
610
+ range in the present study’s population, unlike many earlier
611
+ studies, a further decrease in its level after yogic intervention
612
+ may explain the significant reduction in mFG scores.
613
+ The possible mechanisms of action of yoga to explain the
614
+ above results are discussed below.
615
+ In the current study’s control group, the reduction ob-
616
+ served in FSH, prolactin, and AMH with improvement in
617
+ menstrual frequency adds evidence to the clinical benefits of
618
+ conventional exercises and lifestyle change, which is similar
619
+ to what has been observed in earlier studies.15 Thomson et al.
620
+ also observed that AMH expression may not be related to
621
+ weight reduction, although there were clinical benefits
622
+ traceable to weight reduction. The result of the current study
623
+ also seems to point to a similar conclusion, as a significant
624
+ reduction in AMH was found, although 82% of the girls were
625
+ in normal weight range and showed a nonsignificant change
626
+ in weight after the intervention in both groups.
627
+ The other factor that may influence the AMH levels seems
628
+ to be the serum androgen levels. Eldar-Geva et al. observed
629
+ that AMH is more elevated in hyperandrogenic compared
630
+ with normoandrogenic women with PCO despite compara-
631
+ ble numbers of small follicles.27 Thus, the yoga’s effect on
632
+ AMH may be related to the reduction in the androgen levels
633
+ in the girls in the current study.
634
+ Several studies have shown that women with PCOS
635
+ suffer with anxiety28 and depression.29 The beneficial effects
636
+ of yoga on stress-related disturbances are seen in anxiety.30
637
+ Cortisol levels are positively associated with stress and
638
+ anxiety.31 Yoga has also been shown to reduce cortisol
639
+ levels both in health32 and disease33 pointing to its effect on
640
+ the HPA axis. Furthermore, the increase in AMH after
641
+ dexamethasone observed by Carlsen et al. may point to the
642
+ relation between high cortisol levels, AMH, and HPA
643
+ axis.23
644
+ Thus, it appears that the beneficial effects of yoga in PCOS
645
+ could be mediated through both HPA and HPO axes based
646
+ on the observation that chronic stimulation of sympathetic
647
+ activity (HPA axis) can induce dysregulation of the HPO
648
+ axis in PCOS.16 There are some studies on other non-
649
+ pharmacologic therapies like acupuncture that have shown
650
+ beneficial effects on HPO axis. Electro-acupuncture restored
651
+ regular ovulation with reduction in LH/FSH ratio in more
652
+ than one third of anovulatory PCOS women.34
653
+ Table 2. Demographics of 90 Girls Recruited
654
+ Variables
655
+ Yoga group
656
+ (n = 45)
657
+ mean (SD)
658
+ Control group
659
+ (n = 45)
660
+ mean (SD)
661
+ Age, years
662
+ 16.22 (1.13)
663
+ 16.22 (0.93)
664
+ Height, m
665
+ 1.54 (0.06)
666
+ 1.56 (0.05)
667
+ Weight, kg
668
+ 48.42 (6.80)
669
+ 50.99 (7.25)
670
+ BMI, kg/m2
671
+ 20.36 (2.06)
672
+ 21.10 (2.98)
673
+ No. of girls with
674
+ BMI < 23a
675
+ 39 (86.7%)
676
+ 35 (77.8%)
677
+ No. of girls with
678
+ BMI ‡ 23a
679
+ 6 (13.3%)
680
+ 10 (22.2%)
681
+ mFG Score
682
+ 4.60 (2.02)
683
+ 4.20 (2.13)
684
+ No. of girls with
685
+ mFG score < 6a
686
+ 30 (66.7%)
687
+ 32 (71.1%)
688
+ No. of girls with
689
+ mFG score ‡ 6a
690
+ 15 (33.3%)
691
+ 13 (28.9%)
692
+ FSH, mIU/mL
693
+ 5.70 (1.91)
694
+ 5.80 (2.43)
695
+ LH, mIU/mL
696
+ 11.19 (8.11)
697
+ 8.29 (6.30)
698
+ LH/FSH ratio
699
+ 2.45 (4.27)
700
+ 1.46 (0.87)
701
+ No. of girls with
702
+ LH/FSH ‡ 2a
703
+ 21 (46.7%)
704
+ 10 (22.2%)
705
+ No. of girls with
706
+ LH/FSH < 2a
707
+ 24 (53.3%)
708
+ 35 (77.8%)
709
+ Prolactin, mg/mL
710
+ 9.76 (3.37)
711
+ 9.63 (3.92)
712
+ Total testosterone, ng/dL
713
+ 39.11 (21.58)
714
+ 32.43 (18.18)
715
+ AMH, ng/mL
716
+ 6.45 (3.91)
717
+ 5.57 (2.79)
718
+ Menstrual frequency
719
+ in months
720
+ 1.41 (0.84)
721
+ 1.47 (0.87)
722
+ No. of girls with cycle
723
+ length of 45–60 daysa
724
+ 9 (20%)
725
+ 10 (22.2%)
726
+ No. of girls with cycle
727
+ length of 60–90 daysa
728
+ 31 (68.9%)
729
+ 29 (64.4%)
730
+ No. of girls with cycle
731
+ length of > 90 daysa
732
+ 5 (11.1%)
733
+ 6 (13.3%)
734
+ No. of girls with
735
+ presence of acnea
736
+ 16 (35.6%)
737
+ 25 (55.6%)
738
+ No. of girls with
739
+ absence of acnea
740
+ 29 (64.4%)
741
+ 20 (44.4%)
742
+ aVariables = frequency (% values) are reported.
743
+ SD, standard deviation; BMI, body–mass index; mFG, Modified
744
+ Ferriman and Gallway; FSH, follicle-stimulating hormone; LH,
745
+ luteinizing hormone; AMH, anti-mu
746
+ ¨llerian hormone.
747
+ YOGA EFFECTS ON ENDOCRINE PARAMETERS IN ADOLESCENT PCOS
748
+ 5
749
+ ACM-2011-0868-ver9-Nidhi_1P.3d
750
+ 06/25/12
751
+ 12:46pm
752
+ Page 5
753
+ This study was on a captive adolescent population with a
754
+ highly selective age group, which raises the question of
755
+ generalizability of the conclusions of this study.
756
+ It could be speculated that a third arm in the randomized
757
+ controlled trial with a pure control group may have been
758
+ more informative. However, a study by Vigorito et al. on
759
+ exercise intervention in young females with PCOS that used
760
+ a pure control group (with no medications throughout the
761
+ study) had shown nonsignificant changes in weight, BMI,
762
+ and endocrine measures.35 Also, another study by Piltonen
763
+ et al.4 studying females with PCOS in six different age
764
+ range groups concluded that serum AMH levels are two- to
765
+ threefold higher in women with PCOS than in normal
766
+ women in all age groups (between 25 and 35 years).
767
+ Therefore, it is theorized that the addition of a pure control
768
+ group may not have added value to the conclusions of this
769
+ study.
770
+ Other limitations of the study were that LH and FSH
771
+ measurements were not carried out at the same phase of the
772
+ menstrual cycle and that cortisol levels were not measured.
773
+ The present study provides the scientific evidence for the
774
+ treatment of PCOS through yogic lifestyle modification that
775
+ may have an effect on HPO and HPA axes. Yoga not only
776
+ addresses the problems of PCOS but also is likely to prevent
777
+ the long-term sequelae such as cardiovascular disease, dia-
778
+ betes, and so on. Furthermore, yoga as a self-corrective
779
+ therapy is potentially more cost-effective and enduring.
780
+ Hence, the authors recommend yoga as both a primary
781
+ intervention and/or as adjunct to standard medical care.
782
+ This study in Asian population points to some unusual
783
+ racial differences (normal baseline values for testosterone
784
+ and BMI) that need to be confirmed by further studies.
785
+ Studies in other cultures using yoga from other schools
786
+ may throw light on the benefits of this nonpharmacologic
787
+ modality of management of PCOS. Future studies may be
788
+ designed to include longer duration of follow-up to observe
789
+ the changes in ovarian volume and follicular size. Also, fu-
790
+ ture studies may include objective and subjective measures
791
+ of stress that may help in understanding the mechanisms.
792
+ Conclusions
793
+ Twelve (12) weeks of a holistic yoga program in adoles-
794
+ cent PCOS is significantly better than a physical exercise
795
+ program in decreasing AMH, LH, testosterone, and mFG
796
+ scores and increasing menstrual frequency, with no change
797
+ in body weight, FSH, or prolactin.
798
+ Acknowledgments
799
+ We are thankful to the Central Council for Research in
800
+ Yoga and Naturopathy (C.C.R.Y.N.), Ministry of Health,
801
+ Government of India, New Delhi for funding this project. We
802
+ would like to place on record our gratitude for the support
803
+ provided by the Vice Chancellor, SVYASA University. We
804
+ gratefully acknowledge the cooperation of the staff and ad-
805
+ ministration of Sri Sai College in recruiting the students and
806
+ carrying out the study. We are also grateful to Dr. S. Jonna,
807
+ Director of Satyam Diagnostic Labs for his assistance with
808
+ ultrasound; Dr Sheela Kashi, Director, Suhruda Laboratory,
809
+ directors of Thyrocare Laboratories and Religare Labora-
810
+ tories for their assistance with blood assays. We thank many
811
+ others involved in the interviews, database construction, and
812
+ data entry. We extend our gratitude to Dr. Ravi Kulkarni for
813
+ his help in the statistical analysis. We are thankful to all the
814
+ yoga teachers, and the physical trainers who conducted the
815
+ classes for this project and the girls for their cooperation
816
+ during the study. Clinical Trial Registration: REFCTRI-2008
817
+ 000291.
818
+ Table 3. Comparison of Change Scores Between Groups After the Intervention
819
+ Variables
820
+ Groups
821
+ Pre mean – SD
822
+ Post mean – SD
823
+ Diff score mean – SD
824
+ Change score Mann-Whitney
825
+ Wt (kg)
826
+ Y
827
+ 48.24 – 6.53
828
+ 48.28 – 6.75
829
+ 0.04 – 1.34
830
+ 0.882
831
+ C
832
+ 51.83 – 7.66
833
+ 52.62 – 6.97
834
+ 0.79 – 4.13
835
+ BMI (kg/m2)
836
+ Y
837
+ 20.39 – 2.00
838
+ 20.41 – 2.07
839
+ 0.02 – 0.56
840
+ 0.910
841
+ C
842
+ 21.39 – 3.20
843
+ 21.70 – 2.88
844
+ 0.32 – 1.75
845
+ mFG score
846
+ Y
847
+ 4.51 – 2.12
848
+ 3.38 – 1.80
849
+ 1.14 – 1.44
850
+ 0.002*
851
+ C
852
+ 4.03 – 2.23
853
+ 4.09 – 2.06
854
+ 0.06 – 1.51
855
+ FSH (mIU/mL)
856
+ Y
857
+ 5.97 – 1.87
858
+ 5.58 – 1.90
859
+ 0.40 – 2.27
860
+ 0.474
861
+ C
862
+ 5.76 – 2.50
863
+ 5.45 – 1.73
864
+ 0.31 – 2.70
865
+ LH (mIU/mL)
866
+ Y
867
+ 11.94 – 8.32
868
+ 7.84 – 6.13
869
+ 4.09 – 9.99
870
+ 0.005*
871
+ C
872
+ 7.26 – 5.18
873
+ 10.26 – 8.66
874
+ 3.00 – 7.48
875
+ LH/FSH ratio
876
+ Y
877
+ 2.59 – 4.67
878
+ 1.42 – 0.91
879
+ 1.17 – 4.83
880
+ 0.015**
881
+ C
882
+ 1.33 – 0.82
883
+ 1.82 – 1.35
884
+ 0.49 – 1.15
885
+ Prl (mg/mL)
886
+ Y
887
+ 9.61 – 3.29
888
+ 8.73 – 5.08
889
+ 0.88 – 5.07
890
+ 0.982
891
+ C
892
+ 10.00 – 4.19
893
+ 8.35 – 4.49
894
+ 1.64 – 4.67
895
+ TT (ng/dL)
896
+ Y
897
+ 39.55 – 21.40
898
+ 33.55 – 19.93
899
+ 6.01 – 15.88
900
+ 0.014**
901
+ C
902
+ 29.48 – 15.27
903
+ 32.09 – 16.46
904
+ 2.61 – 13.14
905
+ AMH (ng/mL)
906
+ Y
907
+ 6.25 – 3.79
908
+ 3.73 – 2.25
909
+ 2.51 – 2.92
910
+ 0.006*
911
+ C
912
+ 4.79 – 2.33
913
+ 4.30 – 2.88
914
+ 0.49 – 2.20
915
+ Mens freq
916
+ Y
917
+ 1.49 – 0.87
918
+ 2.38 – 0.64
919
+ 0.89 – 0.66
920
+ 0.049**
921
+ C
922
+ 1.49 – 0.89
923
+ 1.97 – 0.79
924
+ 0.49 – 0.98
925
+ Y, yoga (n = 37); C, control (n = 35); Wt, weight; BMI, body–mass index; mFG, Modified Ferriman Gallway Score; FSH, follicle-stimulating
926
+ hormone; LH, luteinizing hormone; Prl, prolactin; TT, total testosterone; AMH, anti-mu
927
+ ¨llerian hormone; Mens freq, menstrual frequency.
928
+ *Significance at < 0.01 level.
929
+ **Significance at < 0.05 level.
930
+ 6
931
+ NIDHI ET AL.
932
+ ACM-2011-0868-ver9-Nidhi_1P.3d
933
+ 06/25/12
934
+ 12:46pm
935
+ Page 6
936
+ Disclosure Statement
937
+ It is declared that none of the authors involved in this
938
+ study have any conflict of interest and that all authors of this
939
+ article have contributed to their fullest capacities.
940
+ References
941
+ 1. Chen X, Yang D, Mo Y, et al. Prevalence of polycystic ovary
942
+ syndrome in unselected women from southern China. Eur J
943
+ Obstet Gynecol Reprod Biol 2008;139:59–64.
944
+ 2. Michelmore KF, Balen AH, Dunger DB, Vessey MP. Poly-
945
+ cystic ovaries and associated clinical and biochemical
946
+ features in young women. Clin Endocrinol (Oxf) 1999;51:
947
+ 779–786.
948
+ 3. Nidhi R, Padmalatha V, Nagarathna R, Amritanshu R.
949
+ Prevalence of polycystic ovarian syndrome in Indian ado-
950
+ lescents. J Pediatr Adolesc Gynecol 2011;24:223–227.
951
+ 4. Piltonen T, Morin-Papunen L, Koivunen R, et al. Serum anti-
952
+ Mullerian hormone levels remain high until late reproduc-
953
+ tive age and decrease during metformin therapy in women
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+ with polycystic ovary syndrome. Hum Reprod 2005;20:
955
+ 1820–1826.
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+ 5. Pellatt L, Hanna L, Brincat M, et al. Granulosa cell produc-
957
+ tion of anti-Mullerian hormone is increased in polycystic
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+ ovaries. J Clin Endocrinol Metab 2007;92:240–245.
959
+ 6. Cook CL, Siow Y, Brenner AG, Fallat ME. Relationship
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+ between serum mu
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+ ¨llerian-inhibiting substance and other
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+ 9. Pigny P, Merlen E, Robert Y, et al. Elevated serum level of
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+ anti-mullerian hormone in patients with polycystic ovary
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+ 5957–5962.
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+ 10. La Marca A, Pati M, Orvieto R, et al. Serum anti-mullerian
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+ hormone levels in women with secondary amenorrhea.
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+ Fertil Steril 2006;85:1547–1549.
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+ 11. Fallat ME, Siow Y, Marra M, et al. Anti Mullerian-inhibiting
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+ substance in follicular fluid and serum: A comparison of
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+ patients with tubal factor infertility, polycystic ovary syn-
984
+ drome, and endometriosis. Fertil Steril 1997;67:962–965.
985
+ 12. Laven JS, Mulders AG, Visser JA, et al. Anti-Mullerian
986
+ hormone serum concentrations in normoovulatory and an-
987
+ ovulatory women of reproductive age. J Clin Endocrinol
988
+ Metab 2004;89:318–323.
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+ 13. Norman RJ, Noakes M, Wu R, et al. Improving reproduc-
990
+ tive performance in overweight/obese women with effec-
991
+ tive weight management. Hum Reprod Update 2004;10:
992
+ 267–280.
993
+ 14. Fleming R, Harborne L, MacLaughlin DT, et al. Metformin
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+ reduces serum mullerian-inhibiting substance levels in
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+ women with polycystic ovary syndrome after protracted
996
+ treatment. Fertil Steril 2005;83:130–136.
997
+ 15. Thomson RL, Buckley JD, Moran LJ, et al. The effect of
998
+ weight loss on anti-Mu
999
+ ¨llerian hormone levels in overweight
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+ and obese women with polycystic ovary syndrome and re-
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+ productive impairment. Hum Reprod 2009;24:1976–1981.
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+ 16. Diamanti-Kandarakis E. PCOS in adolescents. Best Pract Res
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+ Clin Obstet Gynaecol 2009;24:173–183.
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+ 17. Sahajpal P, Ralte R. Impact of induced yogic relaxation
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+ training (IYRT) on stress-level, self-concept and quality of
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+ sleep among minority group individuals. J Indian Psychol
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+ 2000;18:66–73.
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+ 18. Manjunath NK, Telles S. Effects of sirsasana (headstand)
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+ practice on autonomic and respiratory variables. Indian
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+ J Physiol Pharmacol 2003;47:34–42.
1011
+ 19. Kumarapeli V, Seneviratne RD, Wijeyaratne CN, et al. A
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+ simple screening approach for assessing community preva-
1013
+ lence and phenotype of polycystic ovary syndrome in a
1014
+ semiurban population in Sri Lanka. Am J Epidemiol
1015
+ 2008;168:321–328.
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+ 20. Franks S, Gharani N, Waterworth D, et al. The genetic basis
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+ of
1018
+ polycystic
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+ ovary
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+ Hum
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+ Reprod
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+ 1997;12:
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+ 2641–2648.
1025
+ 21. Tang T, Glanville J, Hayden CJ, et al. Combined lifestyle
1026
+ modification and metformin in obese patients with poly-
1027
+ cystic ovary syndrome: A randomized, placebo-controlled,
1028
+ double-blind multicentre study. Hum Reprod 2006;21:80–89.
1029
+ 22. Nagendra HR, Nagarathna R. Breath-the Bridge-Breathing
1030
+ Practices. RN, ed. Bangalore, India: Swami Vivekananda
1031
+ Yoga Prakashan, 2004.
1032
+ 23. Carlsen SM, Vanky E, Fleming R. Anti-Mu
1033
+ ¨llerian hormone
1034
+ concentrations in androgen-suppressed women with poly-
1035
+ cystic ovary syndrome. Hum Reprod 2009;24:1732–1738.
1036
+ 24. De Leo V, Musacchio MC, Morgante G, et al. Metformin
1037
+ treatment is effective in obese teenage girls with PCOS. Hum
1038
+ Reprod 2006;21:2252–2256.
1039
+ 25. Ganie MA, Khurana ML, Eunice M, et al. Comparison of
1040
+ efficacy of spironolactone with metformin in the manage-
1041
+ ment of polycystic ovary syndrome: An open-labeled study.
1042
+ J Clin Endocrinol Metab 2004;89:2756–2762.
1043
+ 26. Wabitsch M, Hauner H, Heinze E, et al. Body fat distribution
1044
+ and steroid hormone concentrations in obese adolescent
1045
+ girls before and after weight reduction. J Clin Endocrinol
1046
+ Metab 1995;80:3469–3475.
1047
+ 27. Eldar-Geva T, Margalioth EJ, Gal M, et al. Serum anti-
1048
+ Mullerian hormone levels during controlled ovarian hyper-
1049
+ stimulation in women with polycystic ovaries with and
1050
+ without hyperandrogenism. Hum Reprod 2005;20:1814–
1051
+ 1819.
1052
+ 28. Benson S, Hahn S, Tan S, et al. Prevalence and implications
1053
+ of anxiety in polycystic ovary syndrome: Results of an In-
1054
+ ternet-based
1055
+ survey
1056
+ in
1057
+ Germany.
1058
+ Hum
1059
+ Reprod
1060
+ 2009;
1061
+ 24:1446–1451.
1062
+ 29. Kerchner A, Lester W, Stuart SP, Dokras A. Risk of de-
1063
+ pression and other mental health disorders in women with
1064
+ polycystic ovary syndrome: A longitudinal study. Fertil
1065
+ Steril 2009;91:207–212.
1066
+ 30. Telles S, Gaur V, Balkrishna A. Effect of a yoga practice
1067
+ session and a yoga theory session on state anxiety. Percept
1068
+ Mot Skills 2009;109:924–930.
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+ 31. Van Eck M, Berkhof H, Nicolson N, Sulon J. The effects of
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+ perceived stress, traits, mood states, and stressful daily
1071
+ events on salivary cortisol. Psychosom Med 1996;58:447–458.
1072
+ 32. Kamei T, Toriumi Y, Kimura H, et al. Decrease in serum
1073
+ cortisol during yoga exercise is correlated with alpha wave
1074
+ activation. Percept Mot Skills 2000;90(3 pt 1):1027– 1032.
1075
+ 33. Vadiraja HS, Raghavendra RM, Nagarathna R, et al. Effects
1076
+ of a yoga program on cortisol rhythm and mood states in
1077
+ early breast cancer patients undergoing adjuvant radio-
1078
+ therapy: A randomized controlled trial. 2009;8:37–46.
1079
+ YOGA EFFECTS ON ENDOCRINE PARAMETERS IN ADOLESCENT PCOS
1080
+ 7
1081
+ ACM-2011-0868-ver9-Nidhi_1P.3d
1082
+ 06/25/12
1083
+ 12:46pm
1084
+ Page 7
1085
+ 34. Stener-Victorin E, Waldenstrom U, Tagnfors U, et al. Effects of
1086
+ electro-acupuncture on anovulation in women with polycystic
1087
+ ovary syndrome. Acta Obstet Gynecol Scand. 2000;79:180–188.
1088
+ 35. Vigorito C, Giallauria F, Palomba S, et al. Beneficial effects of
1089
+ a three-month structured exercise training program on car-
1090
+ diopulmonary 10 functional capacity in young women with
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+ polycystic
1092
+ ovary
1093
+ syndrome.
1094
+ J
1095
+ Clin
1096
+ Endocrinol
1097
+ Metab.
1098
+ 2007;92:1379–1384.
1099
+ Address correspondence to:
1100
+ Ram Nidhi, MSc
1101
+ #19, Eknath Bhavan
1102
+ Gavipuram Cirlce Kempegowdanagar
1103
+ Bangalore 560 019
1104
+ India
1105
+ E-mail: [email protected]
1106
+ 8
1107
+ NIDHI ET AL.
1108
+ ACM-2011-0868-ver9-Nidhi_1P.3d
1109
+ 06/25/12
1110
+ 12:46pm
1111
+ Page 8
subfolder_0/Effect of integrated approach of Yoga therapy on chronic constipation.txt ADDED
The diff for this file is too large to render. See raw diff
 
subfolder_0/Effect of integrated yoga therapy on nerve conduction velocity in type -2 diabetics a cross sectional clinical study.txt ADDED
@@ -0,0 +1,712 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ EFFECT OF INTEGRATED YOGA THERAPY ON NERVE CONDUCTION
2
+ VELOCITY IN TYPE -2 DIABETICS A CROSS SECTIONAL CLINICAL STUDY
3
+ C Nagraj1
4
+ N K Manjunath2
5
+ H R Nataraj3
6
+ 1Research fellow, S-VYASA Bengaluru, 2Associate professor, S-VYASA Bengaluru,
7
+ 3Research associate, Jindal nature cure institute, Bengaluru, Karnataka, India
8
+ INTRODUCTION
9
+ Notably, there is growing evidence that yoga
10
+ practices may aid in the prevention and
11
+ management of DM 2. By attenuating the
12
+ symptoms and signs of those with clinical
13
+ DM 2, with improved glycaemic control,
14
+ improve lipid profile and reduce insulin
15
+ resistance and thus improve its prognosis. A
16
+ study of effect of forty days of yoga done in
17
+ twenty-four type 2 DM cases provides
18
+ metabolic
19
+ and
20
+ clinical
21
+ evidence
22
+ of
23
+ improvement in glycaemic control and
24
+ autonomic functions. There was a significant
25
+ decrease in fasting blood glucose level,
26
+ postprandial blood glucose and glycosylated
27
+ hemoglobin. Also the pulse rate, systolic and
28
+ diastolic
29
+ blood
30
+ pressure
31
+ decreased
32
+ significantly. Four uncontrolled studies
33
+ targeting adults with diabetes.[i,ii] and/or
34
+ other chronic conditions,[iii,iv] demonstrated
35
+ Research Study
36
+ International Ayurvedic Medical Journal
37
+ ISSN:2320 5091
38
+ ABSTRACT
39
+ Background: Type 2diabetes mellitus comprises an array of dysfunctions resulting from the
40
+ combination of resistance to insulin action and inadequate insulin secretion. It is characterized by
41
+ hyperglycemia and associated with micro vascular i.e., retinal, renal, possibly neuropathic,
42
+ macro vascular i.e., coronary, peripheral vascular, and neuropathic i.e., (autonomic, peripheral)
43
+ complications. Yoga has been shown to reduce the hyperglycemia and thereby reducing the
44
+ underlying nerve damages in diabetics. Objectives: To observe the nerve conduction velocity
45
+ variation among practitioners and non practitioners of yoga. And propose yoga as a better
46
+ method to manage neuropathies in type 2 diabetics. Materials and methods: Across sectional
47
+ clinical study was conducted among type 2 Diabetic patients, two groups i.e. yoga practitioners
48
+ and non yoga practitioners were made with a sample size of 30 in each group and yoga group
49
+ was prescribed with different yogic practices and both group analyzed for nerve conduction
50
+ velocity and data analyzed using Independent t-test.Results: Results were encouraging and
51
+ Independent sample t-test showed significantly higher means in yoga group for nerve conduction
52
+ velocity in right (P= 0.004), and left wrist (P=0.017). Mann-Whitney test showed similarly
53
+ significantly higher mean in
54
+ yoga group for the variable F-wave in right hand
55
+ (P=0.004).Conclusion: People practicing yoga seems to have better nerve conduction parameters
56
+ compare to control group, hence yoga can be used as useful supporting palliative treatment for
57
+ managing diabetes mellitus type 2 induced nerve damage. Keywords: Yoga therapy, Type 2
58
+ Diabetes, Nerve conduction velocity
59
+ EFFECT OF INTEGRATED YOGA THERAPY ON NERVE CONDUCTION
60
+ VELOCITY IN TYPE -2 DIABETICS A CROSS SECTIONAL CLINICAL STUDY
61
+ C Nagraj1
62
+ N K Manjunath2
63
+ H R Nataraj3
64
+ 1Research fellow, S-VYASA Bengaluru, 2Associate professor, S-VYASA Bengaluru,
65
+ 3Research associate, Jindal nature cure institute, Bengaluru, Karnataka, India
66
+ INTRODUCTION
67
+ Notably, there is growing evidence that yoga
68
+ practices may aid in the prevention and
69
+ management of DM 2. By attenuating the
70
+ symptoms and signs of those with clinical
71
+ DM 2, with improved glycaemic control,
72
+ improve lipid profile and reduce insulin
73
+ resistance and thus improve its prognosis. A
74
+ study of effect of forty days of yoga done in
75
+ twenty-four type 2 DM cases provides
76
+ metabolic
77
+ and
78
+ clinical
79
+ evidence
80
+ of
81
+ improvement in glycaemic control and
82
+ autonomic functions. There was a significant
83
+ decrease in fasting blood glucose level,
84
+ postprandial blood glucose and glycosylated
85
+ hemoglobin. Also the pulse rate, systolic and
86
+ diastolic
87
+ blood
88
+ pressure
89
+ decreased
90
+ significantly. Four uncontrolled studies
91
+ targeting adults with diabetes.[i,ii] and/or
92
+ other chronic conditions,[iii,iv] demonstrated
93
+ Research Study
94
+ International Ayurvedic Medical Journal
95
+ ISSN:2320 5091
96
+ ABSTRACT
97
+ Background: Type 2diabetes mellitus comprises an array of dysfunctions resulting from the
98
+ combination of resistance to insulin action and inadequate insulin secretion. It is characterized by
99
+ hyperglycemia and associated with micro vascular i.e., retinal, renal, possibly neuropathic,
100
+ macro vascular i.e., coronary, peripheral vascular, and neuropathic i.e., (autonomic, peripheral)
101
+ complications. Yoga has been shown to reduce the hyperglycemia and thereby reducing the
102
+ underlying nerve damages in diabetics. Objectives: To observe the nerve conduction velocity
103
+ variation among practitioners and non practitioners of yoga. And propose yoga as a better
104
+ method to manage neuropathies in type 2 diabetics. Materials and methods: Across sectional
105
+ clinical study was conducted among type 2 Diabetic patients, two groups i.e. yoga practitioners
106
+ and non yoga practitioners were made with a sample size of 30 in each group and yoga group
107
+ was prescribed with different yogic practices and both group analyzed for nerve conduction
108
+ velocity and data analyzed using Independent t-test.Results: Results were encouraging and
109
+ Independent sample t-test showed significantly higher means in yoga group for nerve conduction
110
+ velocity in right (P= 0.004), and left wrist (P=0.017). Mann-Whitney test showed similarly
111
+ significantly higher mean in
112
+ yoga group for the variable F-wave in right hand
113
+ (P=0.004).Conclusion: People practicing yoga seems to have better nerve conduction parameters
114
+ compare to control group, hence yoga can be used as useful supporting palliative treatment for
115
+ managing diabetes mellitus type 2 induced nerve damage. Keywords: Yoga therapy, Type 2
116
+ Diabetes, Nerve conduction velocity
117
+ EFFECT OF INTEGRATED YOGA THERAPY ON NERVE CONDUCTION
118
+ VELOCITY IN TYPE -2 DIABETICS A CROSS SECTIONAL CLINICAL STUDY
119
+ C Nagraj1
120
+ N K Manjunath2
121
+ H R Nataraj3
122
+ 1Research fellow, S-VYASA Bengaluru, 2Associate professor, S-VYASA Bengaluru,
123
+ 3Research associate, Jindal nature cure institute, Bengaluru, Karnataka, India
124
+ INTRODUCTION
125
+ Notably, there is growing evidence that yoga
126
+ practices may aid in the prevention and
127
+ management of DM 2. By attenuating the
128
+ symptoms and signs of those with clinical
129
+ DM 2, with improved glycaemic control,
130
+ improve lipid profile and reduce insulin
131
+ resistance and thus improve its prognosis. A
132
+ study of effect of forty days of yoga done in
133
+ twenty-four type 2 DM cases provides
134
+ metabolic
135
+ and
136
+ clinical
137
+ evidence
138
+ of
139
+ improvement in glycaemic control and
140
+ autonomic functions. There was a significant
141
+ decrease in fasting blood glucose level,
142
+ postprandial blood glucose and glycosylated
143
+ hemoglobin. Also the pulse rate, systolic and
144
+ diastolic
145
+ blood
146
+ pressure
147
+ decreased
148
+ significantly. Four uncontrolled studies
149
+ targeting adults with diabetes.[i,ii] and/or
150
+ other chronic conditions,[iii,iv] demonstrated
151
+ Research Study
152
+ International Ayurvedic Medical Journal
153
+ ISSN:2320 5091
154
+ ABSTRACT
155
+ Background: Type 2diabetes mellitus comprises an array of dysfunctions resulting from the
156
+ combination of resistance to insulin action and inadequate insulin secretion. It is characterized by
157
+ hyperglycemia and associated with micro vascular i.e., retinal, renal, possibly neuropathic,
158
+ macro vascular i.e., coronary, peripheral vascular, and neuropathic i.e., (autonomic, peripheral)
159
+ complications. Yoga has been shown to reduce the hyperglycemia and thereby reducing the
160
+ underlying nerve damages in diabetics. Objectives: To observe the nerve conduction velocity
161
+ variation among practitioners and non practitioners of yoga. And propose yoga as a better
162
+ method to manage neuropathies in type 2 diabetics. Materials and methods: Across sectional
163
+ clinical study was conducted among type 2 Diabetic patients, two groups i.e. yoga practitioners
164
+ and non yoga practitioners were made with a sample size of 30 in each group and yoga group
165
+ was prescribed with different yogic practices and both group analyzed for nerve conduction
166
+ velocity and data analyzed using Independent t-test.Results: Results were encouraging and
167
+ Independent sample t-test showed significantly higher means in yoga group for nerve conduction
168
+ velocity in right (P= 0.004), and left wrist (P=0.017). Mann-Whitney test showed similarly
169
+ significantly higher mean in
170
+ yoga group for the variable F-wave in right hand
171
+ (P=0.004).Conclusion: People practicing yoga seems to have better nerve conduction parameters
172
+ compare to control group, hence yoga can be used as useful supporting palliative treatment for
173
+ managing diabetes mellitus type 2 induced nerve damage. Keywords: Yoga therapy, Type 2
174
+ Diabetes, Nerve conduction velocity
175
+ C Nagraj et;aAl: Effect of Integrated Yoga Therapy on Nerve Conduction Velocity In Type -2 Diabetics A Cross Sectional Clinical
176
+ Study
177
+ 120
178
+ www.iamj.in IAMJ: Volume 1; Issue 6; Nov– Dec2013
179
+ significant positive changes in blood lipid
180
+ levels following yoga-based interventions
181
+ that ranged from 8 days to 3 months,
182
+ [v] in
183
+ duration.
184
+ Yoga and nerve conduction: A study with
185
+ yogic intervention has shown that yoga
186
+ asana have a beneficial effect on glycaemic
187
+ control and improve nerve function in mild
188
+ to moderate type 2 diabetes with sub-clinical
189
+ neuropathy.[vi]
190
+ Aims and Objectives: Hence the present
191
+ study is conducted with an objective of
192
+ nerve
193
+ conduction
194
+ variation
195
+ among
196
+ practitioners and non practitioners of yoga.
197
+ And to propose yoga as a better method to
198
+ manage neuropathies in type 2 Diabetics.
199
+ Materials and Methods:
200
+ Recruitment was done through public
201
+ announcements made at different yoga
202
+ therapy centers and advertisements. Those
203
+ volunteers who fulfilled the inclusion
204
+ criteria were selected for the study. The
205
+ signed informed consent of subjects was
206
+ obtained before the data recording.
207
+ Study Design
208
+ Subjects belonging to two groups (yoga and
209
+ non yoga) were assessed under standard
210
+ experimental conditions. Since this was a
211
+ two group comparative study with onetime
212
+ assessment, the present study followed a
213
+ cross sectional design.
214
+ The two groups were:
215
+ 1. The patients with type two Diabetes, on
216
+ allopathic
217
+ medication
218
+ with
219
+ yoga
220
+ relearning.
221
+ 2.
222
+ The patients with type two Diabetes, on
223
+ allopathic medication
224
+ Selection Criteria
225
+ A
226
+ Inclusion Criteria
227
+
228
+ HbA1c >7
229
+
230
+ Fasting Bold Glucose < 270 mg/dl
231
+
232
+ Subject with history of type 2dm who
233
+ have been on diet and exercise.
234
+
235
+ Willing to participate by giving a written
236
+ informed consent.
237
+
238
+ Medication-
239
+ any
240
+ anti-diabetic
241
+ medication.
242
+
243
+ Women and men between 40-70 years
244
+ (married or singles)
245
+
246
+ Those who are not practicing yoga since
247
+ last 3months (for non yoga group).
248
+
249
+ Those who are practicing yoga since last
250
+ 6 months (for yoga group).
251
+
252
+ Patients with the history of DM Type-2
253
+ for minimum of 1 year.
254
+ B Exclusion Criteria
255
+
256
+ Renal dysfunction
257
+
258
+ Congestive heart failure.
259
+
260
+ BMI < 20 or > 40
261
+
262
+ Hypersensitive to Metformin
263
+
264
+ Women of child bearing
265
+
266
+ Uncontrolled hypertension
267
+
268
+ Alcohol abuse
269
+
270
+ Type I DM
271
+
272
+ Retinopathy requiring laser therapy
273
+
274
+ Recent myocardial infarction less than 3
275
+ months.
276
+ Outcome measures:
277
+ Primary outcome measures
278
+
279
+ Motor nerve conduction velocity.
280
+
281
+ Sensory nerve conduction velocity
282
+
283
+ F- wave: F-waves reflect the antidromic
284
+ conduction of the compound neural
285
+ volley to the ventral spinal cord, and the
286
+ postsynaptic activation of a portion of
287
+ the muscle fibers in the innervated
288
+ muscle. [vii]
289
+
290
+ Amplitudes: Peak amplitude driven by
291
+ maximal stimulation reflects the number
292
+ C Nagraj et;aAl: Effect of Integrated Yoga Therapy on Nerve Conduction Velocity In Type -2 Diabetics A Cross Sectional Clinical
293
+ Study
294
+ 121
295
+ www.iamj.in IAMJ: Volume 1; Issue 6; Nov– Dec2013
296
+ of responding fibers and the synchrony
297
+ of their activity. [viii]
298
+ Nerve
299
+ Conduction
300
+ Velocity
301
+ Testing
302
+ (NCV)
303
+ Definition
304
+ A nerve conduction study is a test that
305
+ measures the movement of an impulse
306
+ through a nerve after the deliberate stimula-
307
+ tion of the nerve. The time it takes to travel
308
+ to the other end of the nerve is measured. [ix]
309
+ Recording procedure:
310
+ Subjects have reported to the laboratory with
311
+ prior appointment which was taken with the
312
+ consent. They were made to understand the
313
+ nature of the test and they were asked to sit
314
+ on a comfortable chair and electrodes were
315
+ placed on their palms and median nerve was
316
+ stimulated in various places, through an
317
+ electrical
318
+ stimulator
319
+ with
320
+ appropriate
321
+ amount of current. Then actual values of
322
+ NCV viz, motor nerve conduction velocity,
323
+ sensory nerve conduction velocity, and F-
324
+ wave were noted for further analysis.
325
+ The nerve conduction velocity was recorded
326
+ using RMS.EMG.EP.MARK- machine of
327
+ recorders and Medicare systems pvt. Ltd
328
+ company, haryana. The equipment has an
329
+ inbuilt amplifier with digital filters along
330
+ with electrical stimulator. These filters are
331
+ mathematical filters that can distinguish
332
+ random, background electrical signals from
333
+ the actual signal produced by an activated
334
+ nerve.
335
+ Before placing electrodes in place it is very
336
+ important to apply gel on the points where
337
+ electrodes are to be placed, then electrodes
338
+ are placed in the belly and tendon method
339
+ that is, active electrode was placed on the
340
+ belly of adductor brevis muscle and refer-
341
+ ence electrode was placed on tendon of the
342
+ same muscle just below the thumb finger.
343
+ Then grounding was placed around 3 cm
344
+ away from the active electrode i.e. middle of
345
+ the palm.
346
+ Analysis
347
+ The analysis of the nerve signal involves the
348
+ study of the movement of the signal through
349
+ the nerve from one point to another. Using
350
+ characteristics such as the speed of the im-
351
+ pulse, and the shape, wavelength, and height
352
+ of the signal wave, an examiner can assess
353
+ whether the nerve is functional or defective.
354
+ Data Extraction
355
+ The measurement for motor nerve conduc-
356
+ tion study includes the onset latency, dura-
357
+ tion, and amplitude of CMAP and nerve
358
+ conduction velocity. The onset latency is the
359
+ time in milli seconds from the stimulus arti-
360
+ fact to the first negative deflection of
361
+ CMAP. For the better visualization of the
362
+ take off the latency should be measured at a
363
+ higher gain than the one used for the CMAP
364
+ amplitude measurement. The onset latency
365
+ is a measure of conduction in the fastest
366
+ conducting motor fibers. It also includes
367
+ neuromuscular transmission time and the
368
+ propagation time along the muscle mem-
369
+ brane which constitutes residual latency.
370
+ The amplitude of CMAP is measured from
371
+ baseline to the negative peak (base to peak)
372
+ the amplitude correlates with the number of
373
+ nerve fibers. The duration of CMAP is
374
+ measured from the onset to the negative or
375
+ positive peak or the final return of waveform
376
+ to the baseline. Duration correlated with the
377
+ density of small fibers. The area under the
378
+ CMAP can also be measured. However it
379
+ needs computer analysis.
380
+ Motor nerve conduction velocity is calcu-
381
+ lated by measuring the distance in millime-
382
+ ter between two points of stimulation, which
383
+ is divided by the latency difference in milli-
384
+ C Nagraj et;aAl: Effect of Integrated Yoga Therapy on Nerve Conduction Velocity In Type -2 Diabetics A Cross Sectional Clinical
385
+ Study
386
+ 122
387
+ www.iamj.in IAMJ: Volume 1; Issue 6; Nov– Dec2013
388
+ second. The nerve conduction velocity is
389
+ expressed as m/s. Measurement of latency
390
+ between the two points of stimulation elimi-
391
+ nates the effect of residual latency.
392
+ Conduction Velocity= D/PL-DL M/S
393
+ Where PL is The Proximal Latency and DL is
394
+ the Distal Latency in ms, and D is the distance
395
+ between proximal and distal stimulation in mm.
396
+ Plan of Analysis
397
+ The data were analyzed by using Statistical
398
+ Package for Social Sciences (SPSS) version
399
+ 10.0. Following statistical steps were fol-
400
+ lowed for all types of variables.
401
+
402
+ Descriptive statistics
403
+
404
+ Measures of central tendency and dis-
405
+ persion
406
+
407
+ Tests for normal distribution: Box
408
+ whisker plot, stem and leaf plot
409
+
410
+ Test for variance: F test
411
+
412
+ Inferential statistics
413
+
414
+ Data type : Ratio scale
415
+
416
+ Mann-Whitney test was done in case of
417
+ non-parametric data and independent t-
418
+ test was done in case of parametric data.
419
+ INTERVENTION
420
+ Patients in group II were practicing a par-
421
+ ticular format of yoga practices (prescribed
422
+ by their Diabetologist and yoga therapist)
423
+ [Table -1] one hour per day, for the period
424
+ of 6 months.
425
+ RESULTS
426
+ Data were found to be normally distributed
427
+ except for the following variables: in yoga
428
+ group, nerve conduction velocity in right
429
+ hand elbow, nerve conduction velocity in
430
+ left hand elbow, and f-wave in right hand.
431
+ Hence non-parametric test (Mann Whitney
432
+ test) was performed on these variables and
433
+ also f-wave in left hand, which being the
434
+ counterpart of f-wave in right hand. For re-
435
+ maining variables parametric test was per-
436
+ formed (independent sample t-tests). Vari-
437
+ ances were found to be equal for all pa-
438
+ rameters in parametric tests. [Table-2]
439
+ Nerve Conduction Velocity in Right hand
440
+ Wrist (p=0.004) and Nerve Conduction Ve-
441
+ locity in Left hand Wrist (p=0.017) were
442
+ found to be statistically significant across
443
+ yoga and non yoga groups. Higher means
444
+ were observed for yoga group. Also there
445
+ was a significantly higher means noticed in
446
+ yoga group as compared to non yoga group,
447
+ F-Wave in Right hand (p=0.004). [Table-3]
448
+ DISCUSSION
449
+ The result of this cross sectional two group
450
+ comparative study on 60 patients with dia-
451
+ betes type 2 have showed statistically sig-
452
+ nificant difference in nerve conduction vari-
453
+ ables nerve conduction velocity in right
454
+ hand wrist (p=0.004) and nerve conduction
455
+ velocity in left hand wrist (p=0.017) be-
456
+ tween yoga and non yoga groups. Higher
457
+ means were observed for yoga group. Also
458
+ there was a significantly higher means no-
459
+ ticed in yoga group as compared to non yoga
460
+ group, f-wave in right hand(p=0.004). Dif-
461
+ ferences in all other parameters were found
462
+ to be statistically insignificant. In addition to
463
+ the DCCT,[x] three much smaller but long-
464
+ term prospective studies have confirmed that
465
+ maintained near-normal glycaemia prevents
466
+ the development and retard the progression
467
+ of DPN as assessed electro-physiologically.
468
+ These include the Stockholm Diabetes
469
+ Intervention Study (7.5 years), [xi] and 10
470
+ years), [xii] the Oslo Study (8 years), [xiii] and,
471
+ in type 2 diabetes, the Kumamato Study (6
472
+ years). [xiv] Thus these results are suggestive
473
+ of efficiency of yoga to reduce the nerve
474
+ damage occurred due to hyperglycemic
475
+ condition.The observed differences found in
476
+ the nerve conduction parameters seems to
477
+ C Nagraj et;aAl: Effect of Integrated Yoga Therapy on Nerve Conduction Velocity In Type -2 Diabetics A Cross Sectional Clinical
478
+ Study
479
+ 123
480
+ www.iamj.in IAMJ: Volume 1; Issue 6; Nov– Dec2013
481
+ support some of the existing ideas that yoga
482
+ asana have a beneficial effect on glycaemic
483
+ control and improve nerve function in mild
484
+ to moderate Type 2 diabetes with sub-
485
+ clinical neuropathy.[xv]
486
+ CONCLUSION
487
+ People practicing yoga seems to have better
488
+ nerve
489
+ conduction
490
+ parameters
491
+ hence
492
+ suggesting yoga as a useful means for
493
+ managing diabetes mellitus type 2 induced
494
+ nerve damage.
495
+ CORRESPONDING AUTHOR
496
+ C Nagraj
497
+ Research fellow, S-VYASA Bengaluru
498
+ Source of support: Nil
499
+ Conflict of interest: None Declared
500
+ REFERENCES
501
+ i ) Divekar M, Bhat M, Mulla A. Effect of yoga therapy in diabetes and obesity. J Diabet Assoc
502
+ India 1978; 17:75-8.
503
+ ii) Shembakar A, Kate S. Yogic exercise in the management of diabetes mellitus. J Diabet Assoc
504
+ India 1980; 20:167-71.
505
+ iii) Khare K, Jain D. Effect of yoga on plasma glucose and serum fructosamine level in NIDDM.
506
+ In: Yoga Mimamsa; 1999. p. 1-9.
507
+ iv ) Koertge J, Weidner G, Elliott-Eller M, Scherwitz L, Merritt-Worden TA, Marlin R, et al.
508
+ Improvement in medical risk factors and quality of life in women and men with coronary artery
509
+ disease in the Multicenter Lifestyle Demonstration Project. Am J Cardiol 2003; 91:120-22.
510
+ v ) Ornish D. Avoiding revascularization with lifestyle changes: The Multicenter Lifestyle
511
+ Demonstration Project. Am J Cardiol 1998:82:26
512
+ vi ) Malhotra V, Singh S, Tandon OP, Madhu SV, Prasad A, Sharma SB Effect of Yoga asanas
513
+ on nerve conduction in type 2 diabetes. Indian J Physiol Pharmacol. 2002 Jul; 46 3):298-306.
514
+ vii ) Kohara N, Kimura J, Kaji R, Goto Y, Ishii J, Takiguchi M, Nakai M: F-wave latency serves
515
+ as the most reproducible measure in nerve conduction studies of diabetic polyneuropathy:
516
+ multicentre analysis in healthy subjects and patients with diabetic polyneuropathy. Diabetologia
517
+ 43:915–921, 2000
518
+ viii ) Veves A, Malik RA, Lye, RH, Masson EA, Sharma AK, Schady W, Boulton AJM: The
519
+ relationship between sural nerve morphometric findings and measures of peripheral nerve
520
+ function in mild diabetic neuropathy. Diabet Med 8:917–921, 1991
521
+ ix ) Mosby's Manual of Diagnostic and Laboratory Tests, 1998
522
+ x ) DCCT Research Group: The effect of intensive diabetes therapy on the development and
523
+ progression of neuropathy. Ann Int Med 122:561–568, 1995
524
+ xi ) Reichard P, Nilsson BY, Rosenqvist CL: The effect of long-term intensified insulin
525
+ treatment on the development of microvascular complications of diabetes. N Engl J Med
526
+ 329:304–309, 1993
527
+ xii Reichard P, Pihl M, Rosenqvist U, Sule J: Complications of IDDM are caused by elevated
528
+ blood glucose levels, the Stockholm Diabetes Intervention study at 10 year follow-up.
529
+ Diabetologia 39:1383–1488, 1996
530
+ C Nagraj et;aAl: Effect of Integrated Yoga Therapy on Nerve Conduction Velocity In Type -2 Diabetics A Cross Sectional Clinical
531
+ Study
532
+ 124
533
+ www.iamj.in IAMJ: Volume 1; Issue 6; Nov– Dec2013
534
+ xiii ) Amthor KF, Dahl-Jorgensen K, Berg TJ, Sandvik L, Hanssen KF: The effect of 8 years of
535
+ strict glycaemic control on peripheral nerve function in IDDM patients: the Oslo study.
536
+ Diabetologia 37:579–586, 1994
537
+ xiv ) Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N,
538
+ Shichiri M: Intensive insulin therapy prevents the progression of diabetic microvascular
539
+ complications in Japanese patients with non-insulin-dependent diabetes: a randomized
540
+ prospective 6-year study. Diabetes Res Clin Pract 28:103–117, 1995
541
+ xv ) Malhotra V, Singh S, Tandon OP, Madhu SV, Prasad A, Sharma SB Effect of Yoga asana on
542
+ nerve conduction in type 2 diabetes. Indian J Physiol Pharmacol. 2002 Jul; 46(3):298-306.
543
+ LIST OF TABLES :Table-1 List of Yoga Practices Prescribed For Group-II
544
+ Sl.no
545
+ Name of the practice
546
+ Number of Repetitions
547
+ Breathing practices
548
+ 1
549
+ Shashankasana breathing
550
+ 5
551
+ 2
552
+ Tiger breathing
553
+ 5
554
+ Shithili karana vyayama
555
+ 1
556
+ Jogging
557
+ 3mins
558
+ 2
559
+ Forward and backward bending
560
+ 11 rounds
561
+ 3
562
+ Side bending
563
+ 11 rounds
564
+ 4
565
+ Dhanurasana swing
566
+ 11 rounds
567
+ 5
568
+ Uddiyana
569
+ 11 rounds
570
+ 6
571
+ Surya namaskar 12 rounds
572
+ 3 rounds
573
+ YOGASANA
574
+ 1
575
+ Parivritta trikonasana
576
+ 1 mins
577
+ 2
578
+ Pada hastasana
579
+ 3 mins
580
+ 3
581
+ Ardha chakrasana
582
+ 3 mins
583
+ 4
584
+ Ardha matsyendrasana
585
+ 3 mins
586
+ 5
587
+ Ushtrasana
588
+ 3 mins
589
+ 6
590
+ QRT
591
+ 3 mins
592
+ Kriyas
593
+ 1
594
+ Jalaneti
595
+ 1/week
596
+ 2
597
+ Sutranet
598
+ 1/week
599
+ C Nagraj et;aAl: Effect of Integrated Yoga Therapy on Nerve Conduction Velocity In Type -2 Diabetics A Cross Sectional Clinical
600
+ Study
601
+ 125
602
+ www.iamj.in IAMJ: Volume 1; Issue 6; Nov– Dec2013
603
+ 3
604
+ Vamana dhouti
605
+ 1/week
606
+ 4
607
+ Laghu
608
+ shankha
609
+ prakshalana
610
+ 1/week
611
+ Pranayama
612
+ 1
613
+ Vibhagiya pranayama
614
+ 11 rounds
615
+ 2
616
+ Nadi shudhi
617
+ 9 rounds
618
+ 3
619
+ Bhramari
620
+ 9 rounds
621
+ Meditation
622
+ 5mins
623
+ Table: 2 Motor nerve conduction velocities recorded at wrist, elbow and axilla in both yoga
624
+ and non yoga group.
625
+ Variable
626
+ (m/s)
627
+ Yoga
628
+ Non-yoga
629
+ p-value
630
+ Mean(m/
631
+ s)
632
+ Std .dev (m/s)
633
+ Mean(m/s)
634
+ Std .dev(m/s)
635
+ MNC_RT_W
636
+ 53.7053
637
+ 7.46156
638
+ 48.0407
639
+ 7.03811
640
+ .004
641
+ MNC_LT_W
642
+ 52.6873
643
+ 6.71670
644
+ 48.3497
645
+ 6.95866
646
+ .017
647
+ MNC_RT_ELⱡ
648
+ 62.4690
649
+ 11.63628
650
+ 66.1430
651
+ 8.75384
652
+ .280
653
+ MNC_LT_ELⱡ
654
+ 57.6677
655
+ 12.70624
656
+ 63.2080
657
+ 11.20706
658
+ .066
659
+ Table: 3 Sensory nerve conduction velocity of median nerve in right and left hand.
660
+ Variable
661
+ Yoga
662
+ Non-yoga
663
+ p-value
664
+ Mean(m/s)
665
+ Std. dev(m/s)
666
+ Mean(m/s)
667
+ Std. dev(m/s)
668
+ SNC_RT
669
+ 51.3627
670
+ 6.85947
671
+ 48.3190
672
+ 10.50064
673
+ .189
674
+ SNC_LT
675
+ 52.5860
676
+ 8.04264
677
+ 48.5060
678
+ 9.30390
679
+ .074
680
+ Table: 3 f-wave recorded from median nerve in left and right hand.
681
+ Variable
682
+ Yoga
683
+ Non-yoga
684
+ p-value
685
+ Mean(m/s)
686
+ St. dev (m/s)
687
+ Mean(m/s)
688
+ St. dev(m/s)
689
+ FW_RTⱡ
690
+ 30.3140
691
+ 3.65324
692
+ 33.1017
693
+ 3.94996
694
+ .004
695
+ FW_LTⱡ
696
+ 31.0700
697
+ 3.91277
698
+ 32.6500
699
+ 3.29375
700
+ .143
701
+ Table: 4 Demographic data
702
+ Non Yoga
703
+ yoga
704
+ Male
705
+ Female
706
+ 17
707
+ 13
708
+ 23
709
+ 7
710
+ Mean Age
711
+ 53.3
712
+ 55.36
subfolder_0/Effect of pranayama and meditation as an add-on therapy in rehabilitation of patients with Guillain-Barré syndrome.txt ADDED
@@ -0,0 +1,704 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ 1
2
+ Disability & Rehabilitation, 2012; Early Online: 1–6
3
+ © 2012 Informa UK, Ltd.
4
+ ISSN 0963-8288 print/ISSN 1464-5165 online
5
+ DOI: 10.3109/09638288.2012.687031
6
+ Objective: To study the add-on effects of pranayama and
7
+ meditation in rehabilitation of patients with Guillain-Barré
8
+ syndrome (GBS). Patients and Method: This randomized
9
+ control pilot study was conducted in neurological
10
+ rehabilitation unit of university tertiary research hospital.
11
+ Twenty-two GBS patients, who consented for the study and
12
+ satisfied selection criteria, were randomly assigned to yoga
13
+ and control groups. Ten patients in each group completed
14
+ the study. The yoga group received 15 sessions in total over a
15
+ period of 3 weeks (1 h/session), one session per day on 5 days
16
+ per week that consisted of relaxation, Pranayama (breathing
17
+ practices) and Guided meditation in addition to conventional
18
+ rehabilitation therapeutics. The control group received usual
19
+ rehabilitation care. All the patients were assessed using
20
+ Pittsburgh Sleep Quality Index, Numeric pain rating scale,
21
+ Hospital anxiety and Depression scale and Barthel index
22
+ score. Mann–Whitney U test and Wilcoxon’s signed rank test
23
+ were used for statistical analysis. Results: Quality of sleep
24
+ improved significantly with reduction of PSQI score in the
25
+ yoga group (p = 0.04). There was reduction of pain scores,
26
+ anxiety and depression in both the groups without statistical
27
+ significance between groups (pain p > 0.05, anxiety p > 0.05
28
+ and depression p > 0.05). Overall functional status improved
29
+ in both groups without significant difference (p > 0.05).
30
+ Conclusions: Significant improvement was observed in quality
31
+ of sleep with yogic relaxation, pranayama, and meditation in
32
+ GBS patients.
33
+ Keywords:  Guillain-Barré syndrome, yoga
34
+ Background
35
+ Guillain-Barré Syndrome (GBS) is an inflammatory,
36
+ demyelinating disease affecting multiple peripheral nerves.
37
+ The disease onset is acute or sub acute in nature. The
38
+ clinical features include flaccid ascending symmetrical limb
39
+ weakness/paralysis, absence of deep tendon reflexes, cranial
40
+ nerve palsies, autonomic nervous system disturbances, pain
41
+ and paraesthesia [1,2]. It has an annual incidence varying
42
+ from 0.16 to 4 cases per 100 000 populations [3–5]. There
43
+ are four clearly defined subtypes of GBS: AIDP (acute
44
+ inflammatory
45
+ demyelinating
46
+ polyradiculoneuropathy),
47
+ AMAN (acute motor axonal neuropathy), AMSAN (acute
48
+ motor and sensory axonal neuropathy) and Miller–Fisher
49
+ syndrome [6]. In general the disease outcome is expected to
50
+ be good. Wide variations are observed during the long term
51
+ RESEARCH PAPER
52
+ 
53
+ “Effect of pranayama and meditation as an add-on therapy in
54
+ rehabilitation of patients with Guillain-Barré syndrome—a
55
+ randomized control pilot study”
56
+ Ragupathy Sendhilkumar1, Anupam Gupta1, Raghuram Nagarathna2 & Arun B. Taly3
57
+ 1Neurological Rehabilitation Division, Department of Psychiatric and Neurological Rehabilitation, National
58
+ Institute of Mental Health and Neuro-Sciences (NIMHANS), Bangalore, India, 2Division of yoga and physical sciences, Swamy
59
+ Vivekanandha Yoga Anusndhana Samsthana (SVYASA), (Yoga research foundation), Kempegowda Nagar, Bangalore India,
60
+ and 3Department of Neurology, National Institute of Mental Health and Neuro-Sciences (NIMHANS), Bangalore, India
61
+ Correspondence: Dr. Anupam Gupta, Associate professor, Neurological Rehabilitation Division, Department of Psychiatric and Neurological
62
+ Rehabilitation, National Institute of Mental Health and Neuro-Sciences (NIMHANS), Hosur Road, Bangalore-560029, India. Tel: +91 080 26995282
63
+ (H), +91 87626 89540 (M). Fax: +91 80 2656 4830. E-mail: [email protected]
64
+ • GBS is an inflammatory demyelinating polyneuro
65
+ radiculopathy with multiple complications requiring
66
+ long term care.
67
+ • Yoga and other rehabilitation measures contribute in
68
+ improving functional abilities, pain and sleep quality
69
+ in GBS patients.
70
+ • This randomized control trial showed that short term
71
+ yoga practice can improve the quality of sleep as com-
72
+ pare to other rehabilitation measures in GBS patients
73
+ Implications for Rehabilitation
74
+ (Accepted April 2012)
75
+ Disabil Rehabil Downloaded from informahealthcare.com by Allied Publishers Subscription Agency on 05/24/12
76
+ For personal use only.
77
+ 2  R. Sendhilkumar et al.
78
+
79
+
80
+ Disability & Rehabilitation
81
+ follow up with persistent sensory and motor impairments as
82
+ common sequelae [7,8].
83
+ Multiple complications occur during the course of the
84
+ disease with several long term sequelae. Apart from physi-
85
+ cal disability persistent pain, fatigue, paraesthesia, mood
86
+ changes, anxiety, depression [2,7,9] and sleep disturbances are
87
+ common during rehabilitation [10,11]. A multidisciplinary
88
+ approach is required for the rehabilitation of the GBS patients
89
+ which includes pharmacotherapy, nutrition management,
90
+ carefully modified exercises using gentle range of motion,
91
+ assisted range of motion, manual resistance, positioning
92
+ and orthotic management [12,13]. Therapeutic methods like
93
+ cognitive behavior therapy in the management of pain [14],
94
+ and psychological education programs designed specifically
95
+ for patients and the family members have been found to be
96
+ beneficial in managing pain and psychological sequelae of
97
+ GBS [15,16].
98
+ Integrated yoga that includes postures, pranayama, relax-
99
+ ation and meditation have been found to be effective in the
100
+ long term rehabilitation of diseases like rheumatoid arthritis
101
+ [17], bronchial asthma [18] and major depression [19]. Yoga
102
+ as an add-on to physiotherapy has shown benefits in patients
103
+ with chronic neck pain [20]. Addition of yogic prana ener-
104
+ gization technique hastens the callus formation in fracture
105
+ of long bones [21]. Many other studies have shown demon-
106
+ strable benefits of yoga after short duration of intensive inte-
107
+ grated programs either as inpatient [22] or out patient [23]
108
+ with better quality of sleep in the elderly [24] and in cancer
109
+ patients [25] have been documented. There are no studies
110
+ in the literature that have tried to observe the effect of yogic
111
+ relaxation techniques during rehabilitation of GBS patients.
112
+ The aim of the present pilot study was to examine the effect of
113
+ yoga as an add-on therapy in patients with GBS undergoing
114
+ in-patient rehabilitation.
115
+ Patients and methods
116
+ In this randomized control trial, 44 GBS patients who were
117
+ admitted in the neurological rehabilitation unit in the uni-
118
+ versity hospital after their initial treatment with either plas-
119
+ mapheresis or intravenous immunoglobulin therapy in the
120
+ acute care neurological ward or in the ICU, from April 2010
121
+ to March 2011 were screened for our study. The inclusion
122
+ criteria were: (a) age group of 15–60 year of both gender, (b)
123
+ patients with stage 3 (able to walk 5 feet with assistance) and
124
+ 4 (bed bound) of Hughes scale, (c) weaned off from venti-
125
+ lator, (d) medically stable, (e) those with fair to good trunk
126
+ balance and (f) admitted in the unit for inpatient rehabilita-
127
+ tion. The exclusion criteria were: (a) GBS with Hughes grade
128
+ 1 (able to run) and 2 (able to walk independently), (b) those
129
+ with severe respiratory distress, (c) with poor trunk control,
130
+ (d) Miller–Fisher variant of GBS and (e) chronic inflamma-
131
+ tory demyelinating polyneuropathy (CIDP) patients. Patients
132
+ with grade 5 and 6 according to Hughes scale would not be
133
+ able to perform yoga whereas patients with grade 1 and 2 on
134
+ Hughes scale would not agree for 3 weeks inpatient rehabilita-
135
+ tion program as they would be independent for most of the
136
+ ADL including locomotion. This was the reason for including
137
+ patients’ only with Hughes grade 3 and 4 in the study. Twenty-
138
+ five (10 AIDP, 12 AMAN, 3 AMSAN) patients met with the
139
+ eligibility criteria. The sample size calculation for the trial not
140
+ done as it was a pilot study only. Eleven patients were recruited
141
+ in each group. The study protocol was approved by the insti-
142
+ tutes’ ethical committee. Informed consent was obtained
143
+ from all patients. Out of the total 25 patients, 22 patients who
144
+ consented to participate were recruited for the study (Figure
145
+ 1). The patients from rehabilitation consultant were sent to
146
+ therapy section using serially numbered referral forms, then
147
+ they were randomly allocated to yoga or control group using a
148
+ computer generated random table. The random table was cre-
149
+ ated using software from www.Randomizer.org. It was single
150
+ blind study with blinding of outcome assessor who would
151
+ assess all patients (both the groups) at the beginning and after
152
+ end of therapy sessions (after 3 weeks) without knowing the
153
+ group of the patient (Yoga vs. conservative therapy).
154
+ Rehabilitation program
155
+ All patients in both the groups (yoga and control) received
156
+ regular rehabilitation care which included pharmacotherapy,
157
+ physiotherapy, occupational therapy and orthotic manage-
158
+ ment as per the need of individual patients. Physiotherapy
159
+ included active assisted range of motion, passive range of
160
+ motion, stretching of tight muscles, strengthening exercises
161
+ using weight cuffs, breathing exercises and gait training with
162
+ or without assistive devices. Functional ability training was
163
+ provided in the occupational therapy section which included
164
+ hand function training, trunk stability training and care
165
+ giver’s education about transfer techniques etc.
166
+ Yoga intervention
167
+ Patients in yoga group received 15 sessions of yoga (1 hour/
168
+ day) in addition to the regular rehabilitation therapeutics by a
169
+ qualified post graduate yoga therapist. Five sessions per week
170
+ were conducted with no sessions on Saturdays and Sundays.
171
+ Patients completed sessions over a period of 3 weeks. The yoga
172
+ intervention was carried out in a place near the in-patient
173
+ neurological rehabilitation unit between 5 to 6 PM daily.
174
+ There was no scientific reason behind this particular time of
175
+ the day for conducting session. This time schedule was con-
176
+ venient for the participant to attend after their routine regular
177
+ therapy sessions like physiotherapy and occupational therapy
178
+ etc. During this time, the patients in the control group were
179
+ allowed to relax with their friends or relatives in the adjacent
180
+ open lawn.
181
+ The specific yoga module developed for GBS patients
182
+ included Quick relaxation technique (QRT), pranayama
183
+ and guided meditation (Mind Sound Resonance Technique-
184
+ MSRT) that could be practiced in supine posture in bed
185
+
186
+ (Table I). Quick relaxation technique (QRT) could be prac-
187
+ ticed in three phases in a comfortable supine position with
188
+ eyes closed that involves synchronization of breathing with
189
+ abdominal movement and energization of the whole body as
190
+ they chant ‘aaa’ slowly during exhalation.
191
+ Pranayama, as defined by sage patanjali(swasa praswayoh
192
+ gatir vicchedah pranayamah [26]), is aimed at calming down
193
+ the mind by reducing the rate of breathing voluntarily while
194
+ Disabil Rehabil Downloaded from informahealthcare.com by Allied Publishers Subscription Agency on 05/24/12
195
+ For personal use only.
196
+ Role of yoga in rehabilitation of GBS patients  3
197
+ © 2012 Informa UK, Ltd.
198
+ maintaining the mindful awareness of the touch of the air
199
+ flowing in and out of the air passages.
200
+ MSRT is an eight stepped guided meditation technique
201
+ where the participants are guided to experience the soothing
202
+ sound resonance in the whole body during repeated slow chant-
203
+ ing of the Vedic syllables (a, u, m and om, etc) in a low pitch.
204
+ Measurements
205
+ Assessment for sleep, anxiety, depression and pain was done
206
+ before and after the period of intervention using Pittsburg
207
+ Sleep Quality Index (PSQI [27]), Hospital Anxiety and
208
+ Depression Scale (HADS [28]) and Numeric pain rating scale
209
+ (NPRS [29]), respectively. Functional status was recorded
210
+ using Barthel Index (BI [30]) at admission and at discharge.
211
+ Pittsburg Sleep Quality Index [27] assesses the quality of
212
+ sleep in the previous 2 weeks through seven areas: subjective
213
+ sleep quality, sleep latency, sleep duration, habitual sleep
214
+ efficiency, sleep disturbances, use of sleeping medication, and
215
+ daytime dysfunction. The client self-rates each of these seven
216
+ areas of sleep. Scoring of answers is based on a 0–3 scale,
217
+ whereby 3 reflect the negative extreme on the Likert Scale.
218
+ The responses are added to give composite global PSQI [27],
219
+ score. A global sum of “5” or greater indicates a “poor” sleeper.
220
+ Hospital Anxiety and Depression Scale [28], is used as a
221
+ screening scale to assess anxiety and depression level of the
222
+ patients. It contains a total of 14 questions related to anxiety
223
+ and depression, 7 questions each for anxiety and depression.
224
+ Each question is scored using 0–3 response, 0 being lowest
225
+ Figure 1  CONSORT flow diagram. *Reasons: age group not matching, medically unstable (e.g. uncontrolled diabetes), Hughes grades not matching.
226
+ Table I  Daily yoga practice schedule.
227
+ Name of the practice
228
+ Duration
229
+ (in minutes)
230
+ A
231
+ Pranayama
232
+ 1.
233
+ Vibhagiya pranayama (sectional breathing)
234
+ 5
235
+ 2.
236
+ Ujjayi pranayama (psychic breath)
237
+ 5
238
+ 3.
239
+ Sheetali pranayama (cooling breath)
240
+ 5
241
+ 4.
242
+ Seetkari pranayama (hissing breath)
243
+ 5
244
+ 5.
245
+ Sadanta pranayama (clenched teeth breath)
246
+ 5
247
+ 6.
248
+ Bhramari pranayama (humming bee breath)
249
+ 5
250
+ B.
251
+ QRT
252
+ 5
253
+ C.
254
+ MSRT
255
+ 25
256
+ QRT, quick relaxation technique; MSRT, mind sound resonance technique.
257
+ Disabil Rehabil Downloaded from informahealthcare.com by Allied Publishers Subscription Agency on 05/24/12
258
+ For personal use only.
259
+ 4  R. Sendhilkumar et al.
260
+
261
+
262
+ Disability & Rehabilitation
263
+ level of response and 3 being the highest level response. Scores
264
+ are added to get total anxiety score and depression scores
265
+ separately. A score between 0 and 7 is normal, 8–10 is bor-
266
+ derline abnormal and 11–21 is abnormal for both anxiety and
267
+ depression.
268
+ Numeric pain rating scale [29] evaluates the level of pain
269
+ marked by the patients in a scale containing numbers from
270
+ 0 to 10, 0 being ‘No’ pain and 10 being the worst maximum
271
+ pain.
272
+ BI [30] consists of 10 items (bladder and bowel in the
273
+ preceding week, grooming, in preceding 24–48 h, toilet use,
274
+ feeding, transfers, mobility, dressing, stairs and bathing)with
275
+ scores ranging from 0 to 100.
276
+ Data analysis
277
+ Analysis was done using SPSS version 15.0 (SPSS Inc.,
278
+ Chicago, IL). Descriptive statistics was made for the variables
279
+ showing the demographic details and Shapiro–Wilk’s test was
280
+ done for all the outcome measures for both groups to find out
281
+ normality of distribution. Assessment of effect of additional
282
+ yoga therapy was done by comparing the scores PSQI, HADS,
283
+ and Numeric pain rating scale at the time of starting therapy
284
+ and after the completion of 15 sessions between both the
285
+ groups using Mann–Whitney U test. Effect of therapy within
286
+ group was analyzed using Wilcoxon signed rank test.
287
+ Results
288
+ There were 11 subjects in each group with two drop outs, as
289
+ these two patients took discharge before the study completed
290
+ at their will due to their personal reasons. Age ranged from
291
+ 20 to 55 years (32.30 ± 9.911) in yoga group. In the control
292
+ group age ranged from 15 to 58 years (31.30 ± 14.317). There
293
+ were eight (80%) male patients and two (20%) female patients
294
+ in the yoga group whereas five (50%) male and five (50%)
295
+ female patients in control group. Three patients (30%) had
296
+ typical AIDP, four patients (40%) had AMAN variant and
297
+ three patients (30%) had AMSAN variant in yoga group. In
298
+ the control group four (40%) had typical AIDP and six (60%)
299
+ patients had AMAN variant. The mean length of stay in the
300
+ rehabilitation unit in yoga group was 43 ± 3.8 days and in
301
+ control group was 40.70 ± 3.2 day. The baseline data did not
302
+ differ significantly between groups (p > 0.05, Shapiro–Wilk
303
+ test) although there were more males in the yoga group as
304
+ compare to control group (8 vs. 5).
305
+ Yoga schedule of the patients has been shown in Table I.
306
+ Results after 15 sessions of intervention are shown in Table II.
307
+ There was significant difference between groups (p = 0.048,
308
+ Mann–Whitney U test) in the quality of sleep. The global PSQI
309
+ [27] score in yoga group improved from 8.70 ± 4.24 to 4.00 ±
310
+ 3.36 (p < 0.05, Wilcoxon’s test) with no significant change (p =
311
+ 0.21) in control group from 9.30 ± 4.37 to 7.20 ± 3.49.
312
+ The anxiety score of HADS [28] showed a reduction in
313
+ yoga group from 2.90 ± 2.18 to 1.60 ± 1.64 (p < 0.05) and in
314
+ control group from 6.60 ± 4.50 to 4.20 ± 4.51 (p < 0.05). No
315
+ significant difference observed between both group (p > 0.05).
316
+ The depression score of HADS [28] also showed a reduction
317
+ in yoga group from 4.70 ± 3.59 to 1.20 ± 1.22 (p < 0.05) and
318
+ in control group from 4.90 ± 2.84 to 3.20 ± 2.70 (p < 0.05).
319
+ No significant change between the groups existed (p > 0.05).
320
+ There was a reduction in the level of pain in Numeric pain
321
+ rating scale [29] in yoga group with a shift from 3.5 ± 2.42 to
322
+ 2.20 ± 1.47 (p < 0.05) and in control group from 5.90 ± 2.28
323
+ to 3.50 ± 2.46 (p < 0.05).There was no significant difference
324
+ observed between the groups (p > 0.05).
325
+ Functional status improved in BI 30 from 33.50 ± 15.64 to
326
+ 59 ± 24.58 (p < 0.05) in yoga group and from 32 ± 8.88 to 69
327
+ ± 22.82 (p < 0.05) in control group. No significant difference
328
+ observed between the groups (p > 0.05). Sub group analysis
329
+ based on gender was not done because of the unequal number
330
+ of male and female patients in yoga group.
331
+ Discussion
332
+ To our knowledge, this is the first randomized control
333
+ study using yoga techniques (QRT, pranayama and MSRT
334
+ meditation) as adjuvant therapy for rehabilitation of GBS
335
+ patients. The results showed that the patients in the yoga
336
+ Table II  Results of intervention.
337
+ Variables
338
+ Within groups
339
+ Between groups
340
+ (Mann–whitney
341
+ U test)
342
+ p Value
343
+ Yoga (Wilcoxon signed rank test)
344
+ Control (Wilcoxon signed rank test)
345
+ Median
346
+ Inter quartile
347
+ range
348
+ p Value
349
+ Median
350
+ Inter quartile
351
+ range
352
+ p Value
353
+ PSQI
354
+ Pre
355
+ 9.00
356
+ 7
357
+ 0.005
358
+ 10.00
359
+ 6
360
+ 0.210
361
+ 0.048*
362
+ Post
363
+ 3.00
364
+ 2
365
+ 8.00
366
+ 7
367
+ NPRS
368
+ Pre
369
+ 4.00
370
+ 3.50
371
+ 0.048
372
+ 6.50
373
+ 2.50
374
+ 0.026
375
+ 0.167
376
+ Post
377
+ 2.50
378
+ 2.50
379
+ 3.50
380
+ 3.50
381
+ HADS (anx)
382
+ Pre
383
+ 2.50
384
+ 2
385
+ 0.033
386
+ 6.50
387
+ 7
388
+ 0.017
389
+ 0.133
390
+ Post
391
+ 1.00
392
+ 2
393
+ 3.00
394
+ 6
395
+ HADS (dep)
396
+ Pre
397
+ 4.50
398
+ 7
399
+ 0.012
400
+ 4.00
401
+ 5
402
+ 0.036
403
+ 0.070
404
+ Post
405
+ 1.00
406
+ 2
407
+ 3.50
408
+ 4
409
+ BI
410
+ Admission
411
+ 25.00
412
+ 17.50
413
+ 0.007
414
+ 27.50
415
+ 15
416
+ 0.008
417
+ 0.402
418
+ Discharge
419
+ 57.50
420
+ 50
421
+ 75.00
422
+ 36.25
423
+ PSQI, Pittsburg Sleep Quality Index; NPRS, Numeric pain rating scale; HADS (anx), Hospital Anxiety Depression Scale-anxiety domain; HADS (dep), Hospital Anxiety Depression
424
+ Scale-Depression domain; BI, Barthel Index.
425
+ *Mann–Whitney U test; significance with p < 0.05.
426
+ Disabil Rehabil Downloaded from informahealthcare.com by Allied Publishers Subscription Agency on 05/24/12
427
+ For personal use only.
428
+ Role of yoga in rehabilitation of GBS patients  5
429
+ © 2012 Informa UK, Ltd.
430
+ group had significantly better (p < 0.05, between groups on
431
+ Mann–Whitney) improvement in quality of sleep than the
432
+ control group, while there were significant improvements in
433
+ functional status, pain, anxiety and depression in both groups
434
+ with statistically insignificant differences between groups.
435
+ However, the results should be interpreted with caution
436
+ because its’ a pilot study only with relatively small sample size.
437
+ In one of the studies continuous sleep monitoring among
438
+ the GBS patients admitted in ICU revealed some sleep abnor-
439
+ malities in the form of reduced REM sleep latency, REM sleep
440
+ without atonia and NREM sleep with rapid eye movements.
441
+ These changes were observed even in patients staying out of
442
+ ICU [10]. Disordered breathing pattern leading to hypoxia
443
+ and hypercarbia and fragmented sleep pattern have also been
444
+ observed among GBS patients [11]. High (Global PSQI > 5)
445
+ baseline scores on PSQI [27], (Yoga = 8.70 ± 4.24, control =
446
+ 9.30 ± 4.37) observed in our study reflects these observations.
447
+ The improvement in the median scores after yoga reached a
448
+ value of 4.00 ± 3.36 indicating that these patients slept nor-
449
+ mally, while the patients in control group also showed some
450
+ improvement in their scores (7.20 ± 3.49) that did not reach
451
+ normalcy. Studies using meditation and chanting similar to
452
+ the techniques used in this study showed improved quality of
453
+ sleep in the form of appearance of theta rhythm during slow
454
+ wave sleep along with low EMG and enhanced REM duration
455
+ following Transcendental Meditation(TM) among healthy
456
+ volunteers [31,32] and enhanced slow wave sleep and REM
457
+ sleep state among different age groups of healthy Vipassana
458
+ meditation practitioners [33,34]. This improved quality of
459
+ sleep may be due to the improved REM sleep and slow wave
460
+ sleep by meditation practice and regularization of breathing
461
+ through pranayama practices.
462
+ Pain control through pranayama and meditation (MSRT)
463
+ techniques in chronic pain conditions like low back pain
464
+ and neck pain was found to be significant in some studies
465
+ [20,22]. In this present study, the pain in GBS patients showed
466
+ improvement in both the groups and add on yoga techniques
467
+ did not have additional benefits. This may be due to the dif-
468
+ ficult nature of GBS pain which includes both nociceptive
469
+ and neuropathic components. In one of the earlier studies in
470
+ neurological rehabilitation unit, it was reported that about
471
+ 80% admitted GBS patients had neuropathic pain and 34.3%
472
+ of these patients required more than one medications and the
473
+ pain persisted for longer duration [13]. As the neuropathic
474
+ pain is more difficult to treat, 15 yoga sessions might not have
475
+ been sufficient and the results could have been different with
476
+ more yoga therapy sessions.
477
+ The baseline median anxiety and depression scores in both
478
+ the group, showed that the anxiety and depression level were
479
+ in normal range. This can be attributed to natural history of
480
+ illness, nature of the disease progression and prognosis being
481
+ explained routinely to all patients including GBS patients in
482
+ rehabilitation unit and this might have contributed in improv-
483
+ ing relaxation and allaying mood disorders in this popula-
484
+ tion. Similar observation has been reported in a qualitative
485
+ analysis of the patients’ experiences during the acute stage
486
+ of GBS [35]. Though there was a significant improvement in
487
+ the post session scores in both anxiety and depression(less
488
+ score) there was no statistical significance existed between the
489
+ groups. When comparing the depression scores according to
490
+ HADS in our trial between yoga group and control group, we
491
+ observed a trend suggestive of better improvement in depres-
492
+ sion in yoga group as compare to control group, although it
493
+ did not reach significant levels (p = 0.07). A future trail com-
494
+ prising of healthier sample size using the same scale might
495
+ come up with some interesting findings.
496
+ Some positive findings have been reported in the manage-
497
+ ment of anxiety and depression levels with the use hyperven-
498
+ tilating type of pranayama like kapalabathi and Bashthrika or
499
+ combination of Aasanas (physical postures)and pranayama [36].
500
+ Hyperventilation techniques are difficult to practice by the GBS
501
+ patients because of the intercostals and abdominal muscles weak-
502
+ ness. Similarly some physical postures also cannot be practiced
503
+ because of the motor paralysis of both trunk and limb muscles.
504
+ Significant functional recovery found in both groups at
505
+ discharge time without statistical significance on comparison.
506
+ In one of the earlier study similar improvement in the func-
507
+ tional status has been reported [13].
508
+ Although study has a small sample size, it highlights the
509
+ importance of yoga in managing a number of co-morbidities
510
+ (complications) occurring as a result of GBS. Training para-
511
+ medical staff to carry out these practices or hiring trained
512
+ yoga instructors to take care of such patient group could prove
513
+ be a cost-effective method of rehabilitation. Further, although
514
+ patients showed trend for improvement across all the domains
515
+ (functional ability, sleep quality, anxiety and depression) in
516
+ both the groups, a longer duration of yoga program should be
517
+ worth exploring in future studies.
518
+ Conclusions
519
+ Significant improvement in quality of sleep was observed
520
+ in GBS patients in yoga group as compare to control group
521
+ with yogic relaxation, pranayama, and meditation. There
522
+ was reduction of pain scores, anxiety and depression in both
523
+ the groups without statistical significance between groups.
524
+ Similarly overall functional status improved in both groups
525
+ without significant difference between the groups.
526
+ Pranayama and meditation practices are simple and effec-
527
+ tive techniques, which do not require any special equipment
528
+ or space, can be used in GBS patients to improve their quality
529
+ of sleep, anxiety, depression and level of pain during their stay
530
+ in the hospital for rehabilitation. Yoga practices can also be
531
+ incorporated as home-based programs with recorded materi-
532
+ als with little direct contact training for the GBS patients. This
533
+ would also benefit many such patients, who are not able to
534
+ avail in-patient rehabilitation for various reasons.
535
+ There were some limitations of this study like it was a
536
+ single blind study. The number of yoga therapy sessions was
537
+ confined to 15 only. More sessions would have provided better
538
+ insight on the role of yoga in improving other problem areas
539
+ and issues in GBS patients during in-patient rehabilitation.
540
+ Sleep recordings and pulmonary function test can be added in
541
+ future study with healthier sample size, increased frequency
542
+ and duration of yoga practice and adequate follow up to see
543
+ the lasting effects.
544
+ Disabil Rehabil Downloaded from informahealthcare.com by Allied Publishers Subscription Agency on 05/24/12
545
+ For personal use only.
546
+ 6  R. Sendhilkumar et al.
547
+
548
+
549
+ Disability & Rehabilitation
550
+ Declaration of interest: The authors declare no conflict of
551
+ interest. The authors alone are responsible for the content
552
+ and writing of the paper. No funding was received from any
553
+ source for this project.
554
+ References
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+
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+   1. Ropper AH. The Guillain-Barré syndrome. N Engl J Med
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+ 3. Barzegar M, Dastgiri S, Karegarmaher MH, Varshochiani A.
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+ Epidemiology of childhood Guillan-Barre syndrome in the north west
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+ 4. Alter M. The epidemiology of Guillain-Barré syndrome. Ann Neurol
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+ 7. Forsberg A, Press R, Einarsson U, de Pedro-Cuesta J, Widén Holmqvist
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+ 8. Koeppen S, Kraywinkel K, Wessendorf TE, Ehrenfeld CE, Schürks M,
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+ 9. Chan A, Gold R. Neuropsychological/-psychiatric deficits in immune-
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+ 10. Cochen V, Arnulf I, Demeret S, Neulat ML, Gourlet V, Drouot X,
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+ Moutereau S, et al. Vivid dreams, hallucinations, psychosis and REM
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+ 11. Chokroverty S. Sleep dysfunction in neuromuscular disorders. Schwiez
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+ Arch Neurol Psychiatr. 2003; 154: 400–406.
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+ 12. Hughes RA, Wijdicks EF, Benson E, Cornblath DR, Hahn AF,
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+ Meythaler JM, Sladky JT, et al.; Multidisciplinary Consensus Group.
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+ Supportive care for patients with Guillain-Barré syndrome. Arch Neurol
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+ 13. Gupta A, Taly AB, Srivastava A, Murali T. Guillain-Barre Syndrome-
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+ rehabilitation outcome, residual deficits and requirement of lower
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+ limb orthosis for locomotion at 1 year follow-up. Disabil Rehabil
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+ 2010;32:1897–1902.
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+
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+ 14. Sternbach RA. Psychophysiology of pain. Int J Psychiatry Med
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+ 1975;6:63–73.
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+
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+ 15. Dattilio FM. Educating patients about symptoms of anxiety in the wake of
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+ neurological illness. J Neuropsychiatry Clin Neurosci 2002;14:354–355.
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+
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+ 16. Eisendrath SJ, Matthay MA, Dunkel JA, Zimmerman JK, Layzer
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+ RB. Guillain-Barré syndrome: psychosocial aspects of management.
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+ Psychosomatics 1983;24:465–475.
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+
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+ 17. Haslock I, Monro R, Nagarathna R, Nagendra HR, Raghuram NV.
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+ Measuring the effects of yoga in rheumatoid arthritis. Br J Rheumatol
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+ 1994;33:787–788.
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+ 18. Nagarathna R, Nagendra HR. Yoga for bronchial asthma: a controlled
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+ study. Br Med J (Clin Res Ed) 1985;291:1077–1079.
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+
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+ 19. Woolery A, Myers H, Sternlieb B, Zeltzer L. A yoga intervention for
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+ young adults with elevated symptoms of depression. Altern Ther Health
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+ Med 2004;10:60–63.
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+
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+ 20. Yogitha B, Nagarathna R, John E, Nagendra H. Complimentary effect of
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+ yogic sound resonance relaxation technique in patients with common
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+ neck pain. Int J Yoga 2010;3:18–25.
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+
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+ 21. Oswal P, Nagarathna R, Ebnezar J, Nagendra HR. The effect of add-
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+ on yogic prana energization technique (YPET) on healing of fresh
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+ fractures: a randomized control study. J Altern Complement Med
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+ 2011;17:253–258.
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+
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+ 22. Tekur P, Singphow C, Nagendra HR, Raghuram N. Effect of short-term
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+ intensive yoga program on pain, functional disability and spinal flex-
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+ ibility in chronic low back pain: a randomized control study. J Altern
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+ Complement Med 2008;14:637–644.
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+
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+ 23. Vempati R, Bijlani RL, Deepak KK. The efficacy of a comprehensive
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+ lifestyle modification programme based on yoga in the management
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+ of bronchial asthma: a randomized controlled trial. BMC Pulm Med
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+ 2009;9:37.
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+
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+ 24. Manjunath NK, Telles S. Influence of Yoga and Ayurveda on self-rated
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+ sleep in a geriatric population. Indian J Med Res 2005;121:683–690.
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+
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+ 25. Cohen L, Warneke C, Fouladi RT, Rodriguez MA, Chaoul-Reich A.
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+ Psychological adjustment and sleep quality in a randomized trial of
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+ the effects of a Tibetan yoga intervention in patients with lymphoma.
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+ Cancer 2004;100:2253–2260.
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+
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+ 26. Vivekananda S. Raja Yoga: Swami Bodhasarananda, Advaita Ashrama;
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+ 2008.p 214.
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+
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+ 27. Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The
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+ Pittsburgh Sleep Quality Index: a new instrument for psychiatric prac-
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+ tice and research. Psychiatry Res 1989;28:193–213.
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+
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+ 28. Herrmann C. International experiences with the Hospital Anxiety
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+ and Depression Scale–a review of validation data and clinical results. J
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+ Psychosom Res 1997;42:17–41.
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+
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+ 29. Straford PW, Spadoni G. The reliability, consistency and clinical applica-
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+ tion of pain rating scale. Physiother Canada. 2001; 51:88–91.
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+
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+ 30. Mc Dowell I, Newell C. Measuring health: A guide to rating scales and
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+ questionnaires. 2nd edition. 1996. pp 56–63.
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+ 31. Travis F, Wallace RK. Autonomic and EEG patterns during eyes-closed
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+ rest and transcendental meditation ™ practice: the basis for a neural
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+ model of TM practice. Conscious Cogn 1999;8:302–318.
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+
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+ 32. Mason LI, Alexander CN, Travis FT, Marsh G, Orme-Johnson DW,
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+ Gackenbach J, Mason DC, et al. Electrophysiological correlates of higher
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+ states of consciousness during sleep in long-term practitioners of the
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+ Transcendental Meditation program. Sleep 1997;20:102–110.
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+
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+ 33. Sulekha S, Thennarasu K, Vedamurthachar A, Raju TR, Kutty BM.
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+ Evaluation of sleep architecture in practitioners of Suddharshan
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+ kriya
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+ yoga
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+ and
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+ Vipassana
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+ Meditation.
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+ Sleep
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+ Biol
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+ Rhythm.
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+ 2006; 4:207–214.
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+
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+ 34. Ravindra P, Sulekha S, Sathyaprabha T, Pradhan N, Raju T, Bindu MK.
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+ Practitioners of vipassana meditation exhibit enhanced slow wave sleep
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+ and REM sleep states across different age groups. Sleep Biol Rhythm.
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+ 2010; 8:34–41.
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+
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+ 35. Forsberg A, Ahlström G, Holmqvist LW. Falling ill with Guillain-Barré
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+ syndrome: patients’ experiences during the initial phase. Scand J Caring
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+ Sci 2008;22:220–226.
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+
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+ 36. Saeed SA, Antonacci DJ, Bloch RM. Exercise, yoga, and medi-
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+ tation for depressive and anxiety disorders. Am Fam Physician
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+ 2010;81:981–986.
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+ For personal use only.
subfolder_0/Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity..txt ADDED
@@ -0,0 +1,944 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ E
2
+ n
3
+ d
4
+ o
5
+ c
6
+ r
7
+ i
8
+ n
9
+ o
10
+ l
11
+ o
12
+ g
13
+ y
14
+
15
+ &
16
+
17
+ M
18
+ e
19
+ t
20
+ a
21
+ b
22
+ o
23
+ l
24
+ i
25
+ c
26
+
27
+ S
28
+ y
29
+ n
30
+ d
31
+ r
32
+ o
33
+ m
34
+ e
35
+ ISSN: 2161-1017
36
+ Endocrinology & Metabolic Syndrome
37
+ Rathi et al., Endocrinol Metab Syndr 2018, 7:5
38
+ DOI: 10.4172/2161-1017.1000292
39
+ Research Article
40
+ Open Access
41
+ Endocrinol Metab Syndr, an open access journal
42
+ ISSN: 2161-1017
43
+ Volume 7 • Issue 5 • 1000292
44
+ Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent
45
+ Obesity
46
+ Sunanda S Rathi1*, Ruchira R Joshi2, Padmini Tekur3, Nagaratna RN4 and Nagendra HR5
47
+ 1Swami Vivekananda Yoga Anusandhana Samsthana, Yoga and Life sciences 404 Pinnacle Pride Tilak Road, Pune, Maharashtra, India
48
+ 2Chiranjiv Foundation, Pune, Maharashtra, India
49
+ 3S-VYASA, Banglore, India
50
+ 4Yoga consulting Physician, S-VYASA, Bangalore, India
51
+ 5S-VYASA, University Campus: Prashanti Kutiram, Vivekananda Road,  Kalluballu Post, Jigani, Anekal, Bengaluru, India
52
+ Abstract
53
+ Background: Adolescent Obesity is causing serious public health concern and in many countries threatening
54
+ the viability of basic health care delivery. Many co-morbid conditions are seen in association with adolescent obesity.
55
+ Interventions based on Yoga principles are found to have effective solutions for adolescent obesity.
56
+ Aim: To evaluate the effect of the Yoga based intervention on anthropometric and physical assessments in
57
+ Adolescent Obesity.
58
+ Methods: RCT (Randomized Controlled Trial) was conducted on 53 obese adolescents for 40 days. Special
59
+ yoga based training Program was conducted for yoga group. Parameters like weight, Body Mass Index (BMI)
60
+ parameters, pulse rate, blood pressure, MAC (Mid Upper Arm Circumferences), Ac (Abdominal Circumference), Waist
61
+ Circumference (WC), HC (Hip Circumference) along with physical tests like sit ups and Flamingo balance tests were
62
+ assessed before and after intervention for both yoga and control groups. Within and between groups analyses of the
63
+ variables were analysed.
64
+ Result: The study showed significant reduction in weight, body mass index, Hip circumference, and total body
65
+ fat percentage, subcutaneous fat throughout the body in yoga group and percentage of improvement is more in yoga
66
+ group than that of control group.
67
+ Conclusion: Yoga based intervention is effective to reduced obesity in adolescent children with respect to
68
+ anthropometric and physical assessments.
69
+ *Corresponding author: Rathi SS, Swami Vivekananda Yoga Anusandhana
70
+ Samsthana Yoga and Life sciences 404 Pinnacle Pride Tilak Road, Sadhashiv
71
+ Peth, 411030, Pune, Maharashtra, India, Tel: 9860100251; 020-24330251; E-mail:
72
73
+ Received September 22, 2018; Accepted October 05, 2018; Published October
74
+ 12, 2018
75
+ Citation: Rathi SS, Joshi RR, Tekur P, Naratna RN, Nagendra HR (2018) Effect
76
+ of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity.
77
+ A Case Report. Endocrinol Metab Syndr 7: 292. doi:10.4172/2161-1017.1000292
78
+ Copyright: © 2018 Rathi SS, et al. This is an open-access article distributed under
79
+ the terms of the Creative Commons Attribution License, which permits unrestricted
80
+ use, distribution, and reproduction in any medium, provided the original author and
81
+ source are credited.
82
+ Keywords: Obesity; Adolescence; Yoga
83
+ Introduction
84
+ Adolescent obesity
85
+ Overweight and obesity are metabolic conditions in which abnormal
86
+ or excessive fat accumulation is found to impair health. In 2016, more
87
+ than 1.9 billion adults aged 18 years and older were overweight. Of these
88
+ over 650 million adults were obese. The worldwide prevalence of obesity
89
+ nearly tripled between 1975 and 2016. The prevalence of overweight
90
+ and obesity among children and adolescents aged 5-19 years has risen
91
+ dramatically from just 4% in 1975 to just over 18% in 2016. The rise has
92
+ occurred similarly among both boys and girls: in 2016 18% of girls and
93
+ 19% of boys were overweight [1]. Obesity leads to adverse impacts on
94
+ physical as well as psychological functions of the person. Energy-dense
95
+ overeating, nutrient-poor foods and a sedentary lifestyle have led to an
96
+ epidemic of obesity all over the world. Apart from physical problems
97
+ there are issues which affect psychological well-being of an individual
98
+ [2]. Children in low- and middle-income countries are more prone to
99
+ inadequate pre-natal, infant and young child nutrition. At the same
100
+ time, they are exposed to high-fat, high-sugar, high-salt, energy-dense,
101
+ micronutrient-poor foods. These dietary patterns in conjunction with
102
+ lower levels of physical activity, result in sharp increases in childhood
103
+ obesity while under nutrition issues remain unsolved [3].
104
+ Assessment of obesity in adolescence
105
+ Obesity is a commonly used term with a wide range of meanings
106
+ with no widely accepted diagnostic definitions or cut-off points are
107
+ available for children. Mean body fat percentages and percentile curves
108
+ are available for children 5 to 18 years of age [4]. Several studies have
109
+ recommended BMI as the preferred measure for evaluating obesity
110
+ among adolescents 2 to 19 years of age. BMI can be correlated strongly
111
+ with body fat percentage as it is associated weakly with height, and it
112
+ identifies the fattest individuals correctly, with acceptable accuracy
113
+ at the upper end of the distribution like 85th or 95th percentile for age
114
+ and gender. In 1994, the Expert Committee on Clinical Guidelines
115
+ for Overweight in Adolescent Preventive Services recommended that
116
+ children whose BMI exceeds 30 kg/m2 or is more than 95th percentile
117
+ for age and gender should be considered obese [5].
118
+ BMI is a fairly reliable indicator of body fatness for most people.
119
+ BMI does not measure boy fat directly, but research has shown that
120
+ BMI correlates to direct measures of body fat. BMI can be considered
121
+ an alternative for direct measures of body fat. Additionally, BMI is
122
+ an inexpensive and easy-to-perform method for screening for weight
123
+ categories that may lead to health problems. Measuring children’s BMI
124
+ regularly is the first step to maintaining a healthy weight. BMI being an
125
+ important variable, the full body sensor, composition monitor and scale
126
+ is used to calculate BMI and other BMI parameters. Full Body Sensing
127
+ provides a comprehensive understanding of the body composition. The
128
+ BMI machine calculates the estimated values for body fat percentage,
129
+ skeletal muscle percentage, resting metabolism and subcutaneous fat in
130
+ Research Article
131
+ Citation: Rathi SS, Joshi RR, Tekur P, Naratna RN, Nagendra HR (2018) Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity. A Case
132
+ Report. Endocrinol Metab Syndr 7: 292. doi:10.4172/2161-1017.1000292
133
+ Page 2 of 6
134
+ Volume 7 • Issue 5 • 1000292
135
+ Endocrinol Metab Syndr, an open access journal
136
+ ISSN: 2161-1017
137
+ Endocrinol Metab Syndr, an open access journal
138
+ ISSN: 2161-1017
139
+ different body parts like arms, trunk, and legs using the BI (Bioelectrical
140
+ Impedance) Method. The monitor also calculates the BMI (Body Mass
141
+ Index) and body age as well as weight. Resting metabolism is the energy
142
+ required to maintain vital functions. The total amount of energy used
143
+ by the body in a typical day contributes resting metabolism (60%-70%),
144
+ daily activity metabolism (20%-30%) and diet-induced thermogenesis
145
+ (10%). If less energy is consumed by resting metabolism that can be
146
+ consumed by daily activity metabolism. Percentage of subcutaneous
147
+ fat and skeletal muscles are inversely proposal to each other. Skeletal
148
+ muscle is the type of muscle that can see and feel. Building skeletal
149
+ muscle can help prevent rebound weight gain. The maintenance and
150
+ increase of skeletal muscle is closely linked to resting metabolism rate.
151
+ Along with BMI, waist circumference in children provides a better
152
+ estimate of visceral adipose tissue [6,7]. Alternative measures that
153
+ account for fat distribution include abdominal circumference, hip
154
+ circumference and mid arm circumference. EUROFIT tests are also one
155
+ of the assessment tools in adolescent obesity to check physical fines. The
156
+ measurement of physical fitness for each child helps them to develop
157
+ positive attitudes towards their bodies and get information about their
158
+ physical status [8]. Handgrip strength, standing broad jump, flexed
159
+ arm hang, sit‐ups, sit‐and‐reach and Flamingo balance tests are few
160
+ EUROFIT tests out of which sit‐ups and Flamingo balance tests are
161
+ significant in adolescent obesity.
162
+ Yoga for adolescent obesity
163
+ A study consisted of 709 healthy children (with mean age=8.9
164
+ ± 1.6 years) suggest that overweight and obesity are limiting factors
165
+ for fitness performance in  adolescence. Interventions promoting
166
+ children’s health should, ideally, begin early in life and involve
167
+ measures that simultaneously improve fitness and lower fatness [9].
168
+ Yoga is widely recognized as an effective tool in maintaining a healthy
169
+ lifestyle resulting as a vaccine against lifestyle related disorders [10].
170
+ According to a study of effect of aerobic & resistance exercise on
171
+ physical fitness conducted on 60 adolescent obese participants in
172
+ Karnataka (India), aerobic and resistance exercise in combination
173
+ reduces fat significantly [11]. But only physical activity has limited
174
+ scope of correcting the causes of obesity in preadolescence. Other than
175
+ physical causes like lack of physical exercise, genetic and sedentary
176
+ lifestyle there are few psychological causes of obesity like low self-
177
+ esteem, depression, failures to cope up to demanding situations are also
178
+ not uncommon. The negative experiences in school and at home leads
179
+ to lower self-esteem found in childhood obesity [12]. Home, child care
180
+ centre, school, and community environments can influence children's
181
+ behaviours related to food intake and physical activity also which is a
182
+ contributing factor of causes of obesity [13]. Along with this, increasing
183
+ academic stress is also a contributing factor in causes of obesity [14].
184
+ Any form of physical activity having limited scope to manage this
185
+ supportive cause of obesity can manage weight for short duration but
186
+ fails to provide long termed constant impacts in preadolescence obesity.
187
+ Whereas Yoga based programs have a wider impact on body, mind,
188
+ habits, perception and cognition also.
189
+ In one month randomized control trial of impact of Yoga on self-
190
+ esteem in 44 adolescent participants in Hardwar (India), it is noted that
191
+ the level of self-esteem has significantly increased with experimental
192
+ group [15]. Yoga lays great significance on strengthening inherent
193
+ defensive mechanisms of human body and mind. It develops immunity
194
+ and resistance in human body and helps the body and mind in attaining
195
+ homeostatic balance. The strengthening of defence mechanism and
196
+ harmony between mind and body prevents causes of psychosomatic
197
+ disorders like obesity. The aim of yoga therefore is also the attainment
198
+ of physical, mental, social and spiritual health [16]. A study conducted
199
+ on Effect of yoga and physical exercise on physical, cognitive and
200
+ emotional measures in 98 school children, it is observed that Physical
201
+ exercise and yoga have different ways of influencing physical fitness,
202
+ cognitive performance and self-esteem. Both ways showed significant
203
+ improvements in tests for physical fitness [17]. But, this study has
204
+ two independent groups without control group and represents
205
+ geographically north part of India. The findings could be the possible
206
+ effects of the two interventions, with a degree of uncertainty due to the
207
+ absence of a control group. There was a need to check generalizability of
208
+ the findings in a sample drawn from diverse geo-graphical and cultural
209
+ backgrounds with control group. So, current study was designed to
210
+ evaluate the effect of validated and feasible yoga based intervention on
211
+ anthropometric and physical assessments in Adolescent Obesity.
212
+ Methods
213
+ The complete study has been approved by ethical committee of
214
+ Swami Vivekananda Yoga Anusandhan Samsthana, Bangalore (Figure
215
+ 1). 1400 students including both genders were screened from age of 9
216
+ year to 14 year (standard 5 to 9) in one of the reputed school in Pune
217
+ city of Maharashtra state in India. Height, weight and BMI of all the
218
+ students were recorded and obese participants (Figure 2) having BMI
219
+ >95th percentile were included who were ready to participate in the
220
+ study with written consent. Participants having any physical disability,
221
+ any psychosomatic disorder, consuming any medical drugs and
222
+ exposed to yoga within last 6 months were excluded from the study.
223
+ All the participants are randomly divided in two groups. Yoga group
224
+ (n=30) and control group (n=30). RCT (Randomized Controlled Trial)
225
+ was conducted on 60 obese adolescents for 40 days. Special yoga based
226
+ training Program was conducted for yoga group. Yoga intervention
227
+ was consisting of specially designed and validated yoga protocol of 60
228
+ minutes duration which included set of loosening exercises, asanas,
229
+ pranayamas, suryanamskara, breathing practises and meditation.
230
+ This intervention was conducted for 5 days a week for 40 days. 4
231
+ sessions of chanting, Karmayoga, Yoga counselling was also provided.
232
+ Participants of Yoga group were regular in throughout the intervention
233
+ and maintained 90 percent of attendance. Control group was under
234
+ observation with normal routine. The diet regulation was only provided
235
+ for both yoga and control group in order to acquire uniform base with
236
+ respect to diet. Parameters like weight, pulse rate, blood pressure, MAC
237
+ (Mid Upper Arm Circumferences), AC (Abdominal Circumference),
238
+ WC (Waist Circumference), HC (Hip Circumference) along with
239
+ physical tests like sit ups per minute and Flamingo balance test were
240
+ assessed before and after intervention for both yoga and control groups.
241
+ Body Mass Index (BMI) parameters like total body fat percentage,
242
+ resting metabolism, subcutaneous fat and muscle percentage of
243
+ whole body, arms, trunk and legs region also calculated using Body
244
+ composition monitor Model HBF-701 before and after intervention
245
+ for both yoga and control groups. In yoga group, there were 5 drop
246
+ outs and from control group 2 children were absent for post parameter
247
+ collection.
248
+ Statistical Analysis
249
+ The data was analysed using SPSS software 20 version. Normality
250
+ test was done using Shapiro Wilk test. The paired sample t test was
251
+ conducted for pre & post variables which were found normally
252
+ distributed for both the groups. For not normally distributed variables,
253
+ Wilcoxon signed ranks test was done. Between groups analysis was
254
+ done using independent sample t test for the post values of both the
255
+ groups.
256
+ Citation: Rathi SS, Joshi RR, Tekur P, Naratna RN, Nagendra HR (2018) Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity. A Case
257
+ Report. Endocrinol Metab Syndr 7: 292. doi:10.4172/2161-1017.1000292
258
+ Page 3 of 6
259
+ Volume 7 • Issue 5 • 1000292
260
+ Endocrinol Metab Syndr, an open access journal
261
+ ISSN: 2161-1017
262
+ Endocrinol Metab Syndr, an open access journal
263
+ ISSN: 2161-1017
264
+ Results
265
+ The baseline demographic data of age and height of the yoga
266
+ and control group is described in Table 1. Results of within group
267
+ analysis of Yoga group are given in Table 2. Parameters like abdominal
268
+ circumference, waist circumference, hip circumference, total body
269
+ fat percentage, trunk subcutaneous fat, trunk muscle percentage,
270
+ legs subcutaneous fat, legs muscle percentage and situps per minute
271
+ were normally distributed. Hip circumference (p=0.001), total
272
+ body fat percentage (p=0.001), trunk subcutaneous fat (p=0.005)
273
+ and legs subcutaneous fat (p=0.03) reduced significantly whereas
274
+ abdominal circumference (p=0.376) reduced but without significance.
275
+ Trunk muscle percentage (p=0.021) increased significantly. Waist
276
+ circumference (p=0.553) increased but without significance. Whole
277
+ body muscle percentage (p=0.076) and legs muscle percentage
278
+ (p=0.187) increased but without significance. Number of situps per
279
+ minute (p=0.566) is decreased but without significance.
280
+ Parameters like weight, BMI, mid arm circumference, pulse rate,
281
+ systolic blood pressure, diastolic blood pressure, resting metabolism,
282
+ whole body subcutaneous fat, arm subcutaneous fat, arm muscle
283
+ percentage and flamingo balance test were not normally distributed.
284
+ Weight (p=0.018), BMI (p=0.001), whole body subcutaneous fat
285
+ (p=0.01), arm subcutaneous fat (p=0.021) reduced significantly whereas
286
+ systolic blood pressure (p=0.30), diastolic blood pressure (p=0.087) and
287
+ mid arm circumference (p=0.474) reduced but without significance.
288
+ Muscle percentage of arms (p=0.042) increased significantly whereas
289
+ pulse rate (p=0.597), Flamingo balance test (p=0.065) increased but
290
+ without significance.
291
+ A result of within group analysis of Control group is given in
292
+
293
+ Table 3. Parameters like abdominal circumference, waist circumference,
294
+ Figure 1: Flow chart of group formation for intervention.
295
+ Figure 2: Body Mass Index for age percentile.
296
+ NO.
297
+ GROUP
298
+ YOGA
299
+ CONTROL
300
+ 1
301
+ Gender
302
+ Male
303
+ Female
304
+ Male
305
+ Female
306
+ 13
307
+ 17
308
+ 14
309
+ 16
310
+ 2
311
+ Average Age (years)
312
+ 11 ± 1.4
313
+ 11 ± 1.3
314
+ 3
315
+ Average Height (cm)
316
+ 152.91 ± 6.97
317
+ 152.71 ± 9.18
318
+ 4
319
+ Average Weight (Kg)
320
+ 63.86 ± 15.52
321
+ 62.39 ± 14.21
322
+ 5
323
+ Average BMI (Kg/m2)
324
+ 27.16 ± 5.04
325
+ 26.43 ± 3.53
326
+ Table 1: The baseline demographic data of age and height of the yoga and control
327
+ group.
328
+ Citation: Rathi SS, Joshi RR, Tekur P, Naratna RN, Nagendra HR (2018) Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity. A Case
329
+ Report. Endocrinol Metab Syndr 7: 292. doi:10.4172/2161-1017.1000292
330
+ Page 4 of 6
331
+ Volume 7 • Issue 5 • 1000292
332
+ Endocrinol Metab Syndr, an open access journal
333
+ ISSN: 2161-1017
334
+ Endocrinol Metab Syndr, an open access journal
335
+ ISSN: 2161-1017
336
+ hip circumference, total body fat percentage, trunk subcutaneous fat,
337
+ trunk muscle percentage, legs subcutaneous fat, legs muscle percentage
338
+ and sit ups per minute were normally distributed. Number of sit ups
339
+ per minute (p=0.023) decreased significantly whereas abdominal
340
+ circumference (p=0.730), hip circumference (p=0.226), total body
341
+ fat percentage (p=0.876), trunk subcutaneous fat (p=0.186) and legs
342
+ subcutaneous fat (p=0.162) reduced but without significance. Waist
343
+ circumference (p=0.244), trunk muscle percentage (p=0.427) and legs
344
+ muscle percentage (p=0.270) increased but without significance.
345
+ Parameters like weight, BMI, mid arm circumference, pulse rate,
346
+ systolic blood pressure, diastolic blood pressure, resting metabolism,
347
+ whole body subcutaneous fat, arm subcutaneous fat, arm muscle
348
+ percentage and flamingo balance test were not normally distributed.
349
+ No.
350
+ Variable
351
+ Mean (Pre)
352
+ Mean (Post)
353
+ t/z value
354
+ p value
355
+ 1
356
+ Weight
357
+ 63.86 ± 15.52
358
+ 63.14 ± 15.28
359
+ 2.359a
360
+ 0.018*
361
+ 2
362
+ BMI
363
+ 27.16 ± 5.04
364
+ 26.47 ± 4.85
365
+ 3.344a
366
+ 0.001*
367
+ 3
368
+ Pulse rate
369
+ 95.5 ± 11.7
370
+ 97.37 ± 14.48
371
+ 0.529a
372
+ 0.597
373
+ 4
374
+ Systolic blood pressure
375
+ 125.16 ± 11.06
376
+ 122.87 ± 13.42
377
+ 1.037a
378
+ 0.30
379
+ 5
380
+ Diastolic blood pressure
381
+ 81 ± 6.83
382
+ 77.26 ± 17.63
383
+ 1.712a
384
+ 0.087
385
+ 6
386
+ Mid arm circumference
387
+ 11.23 ± 1.03
388
+ 11.07 ± 0.93
389
+ 0.716a
390
+ 0.474
391
+ 7
392
+ Abdominal circumference
393
+ 35.89 ± 3.69
394
+ 35.5 ± 3.77
395
+ 0.902b
396
+ 0.376
397
+ 8
398
+ Waist circumference
399
+ 37.65 ± 4.48
400
+ 37.77 ± 4.81
401
+ 0.602b
402
+ 0.553
403
+ 9
404
+ Hip circumference
405
+ 39.49 ± 4.63
406
+ 38.21 ± 4.71
407
+ 3.68b
408
+ 0.001*
409
+ 10
410
+ Total body fat percentage
411
+ 29.83 ± 3.46
412
+ 27.76 ± 2.72
413
+ 4.40b
414
+ 0.001*
415
+ 11
416
+ Resting metabolism
417
+ 1382.83 ± 205.34
418
+ 1404.33 ± 263.73
419
+ 1.33a
420
+ 0.183
421
+ 12
422
+ Subcutaneous fat (Whole body)
423
+ 25.57 ± 5.58
424
+ 21.96 ± 4.32
425
+ 2.57a
426
+ 0.01∞
427
+ 13
428
+ Muscle percentage (Whole body)
429
+ 27.13 ± 3.51
430
+ 28.26 ± 2.89
431
+ 1.77b
432
+ 0.076
433
+ 14
434
+ Subcutaneous fat (Arms)
435
+ 39.23 ± 8.58
436
+ 34.62 ± 6.47
437
+ 2.315a
438
+ 0.021∞
439
+ 15
440
+ Muscle percentage (Arms)
441
+ 31.01± 6.78
442
+ 33.98 ± 5.07
443
+ 2.032a
444
+ 0.042∞
445
+ 16
446
+ Subcutaneous fat (Trunk)
447
+ 22.21 ± 5.35
448
+ 19.23 ± 3.29
449
+ 3.085b
450
+ 0.005∞
451
+ 17
452
+ Muscle percentage (Trunk)
453
+ 20.58 ± 2.97
454
+ 21.55 ± 2.20
455
+ 2.480b
456
+ 0.021∞
457
+ 18
458
+ Subcutaneous fat (Legs)
459
+ 38.35 ± 8.27
460
+ 34.27 ± 6.29
461
+ 2.307b
462
+ 0.03∞
463
+ 19
464
+ Muscle percentage (Legs)
465
+ 41.94 ± 5.21
466
+ 43.94 ± 4.65
467
+ 1.359b
468
+ 0.187
469
+ 20
470
+ Sit ups
471
+ 32.95 ± 7.02
472
+ 31.5 ± 9.38
473
+ 0.582b
474
+ 0.566
475
+ 21
476
+ Flamingo Balance test
477
+ 60.70 ± 37.07
478
+ 65.75 ± 38.48
479
+ 1.845 a
480
+ 0.065
481
+ aWilcox test
482
+ bPaired sample t test
483
+ *significant at 0.01
484
+ ∞significant at 0.05
485
+ Table 2: Result of within group analysis of Yoga group (n= 25).
486
+ No.
487
+ Variable
488
+ Mean Pre value
489
+ Mean Post value
490
+ t value
491
+ p value
492
+ 1
493
+ Weight
494
+ 62.39 ± 14.21
495
+ 62.8 ± 14.73
496
+ 1.646a
497
+ 0.100
498
+ 2
499
+ BMI
500
+ 26.43 ± 3.53
501
+ 26.82 ± 3.58
502
+ 0.108a
503
+ 0.914
504
+ 3
505
+ Pulse rate
506
+ 95.07 ± 12.7 7
507
+ 93.85 ± 11.31
508
+ 0.781a
509
+ 0.435
510
+ 4
511
+ Systolic blood pressure
512
+ 125.96 ± 18.54
513
+ 119.25 ± 13.68
514
+ 2.596a
515
+ 0.009∞
516
+ 5
517
+ Diastolic blood pressure
518
+ 83.71 ± 9.78
519
+ 77.5 ± 8.05
520
+ 2.90a
521
+ 0.004∞
522
+ 6
523
+ Mid arm circumference
524
+ 11.21 ± 1.37
525
+ 11.35 ± 1.42
526
+ 1.160a
527
+ 0.246
528
+ 7
529
+ Abdominal circumference
530
+ 35.51 ± 3.27
531
+ 35.42 ± 3.28
532
+ 0.348b
533
+ 0.730
534
+ 8
535
+ Waist circumference
536
+ 36.50 ± 3.01
537
+ 36.99 ± 3.67
538
+ 1.192b
539
+ 0.244
540
+ 9
541
+ Hip circumference
542
+ 38.84 ± 3.71
543
+ 38.57 ± 3.93
544
+ 1.240b
545
+ 0.226
546
+ 10
547
+ Total body fat percentage
548
+ 29.02 ± 2.65
549
+ 28.96 ± 2.17
550
+ 0.157b
551
+ 0.876
552
+ 11
553
+ Resting metabolism
554
+ 1369.25 ± 218.60
555
+ 1388.33 ± 238.43
556
+ 1.287a
557
+ 0.198
558
+ 12
559
+ Subcutaneous fat (Whole body)
560
+ 24.80 ± 5.11
561
+ 22.75 ± 4.56
562
+ 1.150a
563
+ 0.250
564
+ 13
565
+ Muscle percentage (Whole body)
566
+ 27.20 ± 3.06
567
+ 28.12 ± 2.93
568
+ 1.059a
569
+ 0.290
570
+ 14
571
+ Subcutaneous fat (Arms)
572
+ 38.90 ± 8.16
573
+ 36.02 ± 7.03
574
+ 0.997a
575
+ 0.319
576
+ 15
577
+ Muscle percentage (Arms)
578
+ 30.62 ± 7.27
579
+ 33.47 ± 6.61
580
+ 1.261a
581
+ 0.207
582
+ 16
583
+ Subcutaneous fat (Trunk)
584
+ 21.34 ± 4.32
585
+ 20.07 ± 3.52
586
+ 1.359b
587
+ 0.186
588
+ 17
589
+ Muscle percentage (Trunk)
590
+ 20.87 ± 2.40
591
+ 21.2 ± 2.08
592
+ 0.806b
593
+ 0.427
594
+ 18
595
+ Subcutaneous fat (Legs)
596
+ 38.75 ± 8.81
597
+ 35.92 ± 7.71
598
+ 1.439b
599
+ 0.162
600
+ 19
601
+ Muscle percentage (Legs)
602
+ 42.06 ± 4.94
603
+ 43.78 ± 4.95
604
+ 1.128b
605
+ 0.270
606
+ 20
607
+ Sit ups
608
+ 30.21 ± 8.74
609
+ 26.78 ± 7.36
610
+ 2.419b
611
+ 0.023∞
612
+ 21
613
+ Flamingo Balance test
614
+ 72.17 ± 56.41
615
+ 91.89 ± 58.65
616
+ 1.173a
617
+ 0.241
618
+ aWilcox test
619
+ bPaired sample t test
620
+ ∞significant at 0.05
621
+ Table 3: Result of within group analysis of Control group (n=28).
622
+ Citation: Rathi SS, Joshi RR, Tekur P, Naratna RN, Nagendra HR (2018) Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity. A Case
623
+ Report. Endocrinol Metab Syndr 7: 292. doi:10.4172/2161-1017.1000292
624
+ Page 5 of 6
625
+ Volume 7 • Issue 5 • 1000292
626
+ Endocrinol Metab Syndr, an open access journal
627
+ ISSN: 2161-1017
628
+ Endocrinol Metab Syndr, an open access journal
629
+ ISSN: 2161-1017
630
+ Systolic blood pressure (p=0.009), diastolic blood pressure (p=0.004)
631
+ reduced significantly whereas pulse rate (p=0.435), whole body
632
+ subcutaneous fat (p=0.250), arm subcutaneous fat (p=0.319) reduced
633
+ but without significance. Weight (p=0.100), BMI (p=0.914), mid arm
634
+ circumference (p=0.246), resting metabolism (p=0.198), whole body
635
+ muscle percentage (p=0.290) and Flamingo balance test (p=0.241)
636
+ increased but without significance.
637
+ Analysis of in between Yoga and control group states that
638
+ abdominal circumference of Yoga group is decreased significantly than
639
+ that of Control group (p=0.05). Weight, BMI, mid-arm circumference,
640
+ hip circumference, total body fat percentage, subcutaneous fat of whole
641
+ body, arm, trunk and legs has been reduced more in Yoga group than that
642
+ of Control group but without significance. Number of situps, systolic
643
+ blood pressure and diastolic blood pressure is decreased in control
644
+ group more than that of Yoga group but without significance. Pulse rate
645
+ is found to be increased in Yoga group whereas that of control group
646
+ is reduced but without significance. Waist circumference is increased
647
+ more in control group than that of Yoga group but without significance.
648
+ Resting metabolism, muscle percentage of whole body, arm, trunk and
649
+ legs are increased more in Yoga group than that of Control group but
650
+ without significance. Flamingo balance test has been increased more in
651
+ control group than that of Yoga group but without significance.
652
+ Discussion
653
+ Obesity especially abdominal is related to academic achievement
654
+ and cognitive functions in children. Visceral adipose tissues  have
655
+ negative impact on cognitive functions leading to academic decrease
656
+ among children with obesity because of its dangerous metabolic nature
657
+ [18].
658
+ Excessive adipose tissue also affects the physical inactivity leading
659
+ to psychological increased sensitivity. These childhoods obesity leaded
660
+ poorer cognitive function results in decreased measures of intra
661
+ individual response, even after accounting for intellectual abilities,
662
+ aerobic fitness [19]. So focus of this study was to evaluate the yoga
663
+ based validated intervention on anthropometric and physical variables
664
+ in adolescent Obesity [20]. Specific anthropometric and physical tests
665
+ are selected as variables were selected in order to conserve comfort and
666
+ convenience of the participants with average age of 11 ± 1.4 years. Hip
667
+ circumference, total body fat percentage, subcutaneous fat of trunk
668
+ and legs whereas these parameters are reduced in control group but
669
+ without significance. Subcutaneous fat reduction leads to significant
670
+ increase of muscle percentage of trunk and leg region. This provides
671
+ evidence of efficacy of validated yoga based intervention on reduction
672
+ of adipose tissues in hip, trunk and leg region resulting in reduction
673
+ of total body fat percentage and overall body weight. Abdominal
674
+ circumference is reduced significantly in Yoga group and without
675
+ significance in control group. Yoga group has improved significantly
676
+ better in this parameter than control group. Yoga intervention practices
677
+ like dynamic surya namaskara, asana, loosening practices are focused
678
+ to reduced abdominal adipose tissue. According to one RCT, yoga
679
+ intervention had moderately strong positive effects on anthropometric
680
+ variables in women with abdominal obesity. Yoga is safe in women and
681
+ can be recommended as a technique for combating abdominal obesity
682
+ in women [21]. Our study provides efficacy of Yoga in same concern in
683
+ adolescent population. Yoga improves emotional wellbeing in children.
684
+ The mechanisms underlying these benefits have not been clearly worked
685
+ out and may involve complex neuro-chemical changes and modified
686
+ functioning of brain areas within the limbic circuit. Physical activities
687
+ of control group was not monitored and compared with test group. This
688
+ is limitation of the study.
689
+ Conclusion
690
+ Yoga based intervention is effective to reduced obesity in adolescent
691
+ No.
692
+ Variable
693
+ Yoga Group
694
+ (n= 25)
695
+ Control Group
696
+ (n= 28)
697
+ t value
698
+ p value
699
+ Pre
700
+ Post
701
+ Pre
702
+ Post
703
+ 1
704
+ Weight
705
+ 63.86 ± 15.52
706
+ 63.14 ± 15.28
707
+ 62.39 ± 14.21
708
+ 62.8 ± 14.73
709
+ 0.517a
710
+ 0.60
711
+ 2
712
+ BMI
713
+ 27.16 ± 5.04
714
+ 26.47 ± 4.85
715
+ 26.43 ± 3.53
716
+ 26.82 ± 3.58
717
+ 0.053a
718
+ 0.95
719
+ 3
720
+ Pulse rate
721
+ 95.5 ± 11.7
722
+ 97.37 ± 14.48
723
+ 95.07 ± 12.7 7
724
+ 93.85 ± 11.31
725
+ 1.052 a
726
+ 0.29
727
+ 4
728
+ Systolic blood pressure
729
+ 125.16 ± 11.06
730
+ 122.87 ± 13.43
731
+ 125.96 ± 18.54
732
+ 119.25 ± 13.68
733
+ 0.883a
734
+ 0.37
735
+ 5
736
+ Diastolic blood pressure
737
+ 81 ± 6.83
738
+ 76.95 ± 8.79
739
+ 83.71 ± 9.78
740
+ 77.5 ± 8.05
741
+ 0.330a
742
+ 0.74
743
+ 6
744
+ Mid arm circumference
745
+ 11.23 ± 1.03
746
+ 11.07 ± 0.93
747
+ 11.21 ± 1.37
748
+ 11.35 ± 1.42
749
+ 0.027a
750
+ 0.97
751
+ 7
752
+ Abdominal circumference
753
+ 35.89 ± 3.69
754
+ 35.5 ± 3.77
755
+ 35.51 ± 3.27
756
+ 35.42 ± 3.28
757
+ 0.530b
758
+ 0.05∞
759
+ 8
760
+ Waist circumference
761
+ 37.65 ± 4.48
762
+ 37.77 ± 4.81
763
+ 36.50 ± 3.01
764
+ 36.99 ± 3.67
765
+ 0.593b
766
+ 0.79
767
+ 9
768
+ Hip circumference
769
+ 39.49 ± 4.63
770
+ 38.21 ± 4.71
771
+ 38.84 ± 3.71
772
+ 38.57 ± 3.93
773
+ 2.479b
774
+ 0.54
775
+ 10
776
+ Total body fat percentage
777
+ 29.83 ± 3.46
778
+ 27.76 ± 2.72
779
+ 29.02 ± 2.65
780
+ 28.96 ± 2.17
781
+ 3.236b
782
+ 0.92
783
+ 11
784
+ Resting metabolism
785
+ 1382.83 ± 205.34
786
+ 1404.33 ± 263.33
787
+ 1369.25 ± 218.60
788
+ 1388.33 ± 238.43
789
+ 0.579 a
790
+ 0.56
791
+ 12
792
+ Subcutaneous fat (Whole body)
793
+ 25.57 ± 5.58
794
+ 21.96 ± 4.32
795
+ 24.80 ± 5.11
796
+ 22.75 ± 4.56
797
+ 0.606 a
798
+ 0.54
799
+ 13
800
+ Muscle percentage (Whole body)
801
+ 27.13 ± 3.51
802
+ 28.26 ± 2.89
803
+ 27.20 ± 3.06
804
+ 28.12 ± 2.93
805
+ 0.036a
806
+ 0.97
807
+ 14
808
+ Subcutaneous fat (Arms)
809
+ 39.23 ± 8.58
810
+ 34.62 ± 6.47
811
+ 38.90 ± 8.16
812
+ 36.02 ± 7.03
813
+ 0.383a
814
+ 0.70
815
+ 15
816
+ Muscle percentage (Arms )
817
+ 31.01± 6.78
818
+ 33.98 ± 5.07
819
+ 30.62 ± 7.27
820
+ 33.47 ± 6.61
821
+ 0.330a
822
+ 0.74
823
+ 16
824
+ Subcutaneous fat (Trunk)
825
+ 22.21 ± 5.35
826
+ 19.23 ± 3.29
827
+ 21.34 ± 4.32
828
+ 20.07 ± 3.52
829
+ 1.241b
830
+ 0.88
831
+ 17
832
+ Muscle percentage (Trunk)
833
+ 20.58 ± 2.97
834
+ 21.55 ± 2.20
835
+ 20.87 ± 2.40
836
+ 21.2 ± 2.08
837
+ -1.637b
838
+ 0.36
839
+ 18
840
+ Subcutaneous fat (Legs)
841
+ 38.35 ± 8.27
842
+ 34.27 ± 6.29
843
+ 38.75 ± 8.81
844
+ 35.92 ± 7.71
845
+ - 0.278b
846
+ 0.77
847
+ 19
848
+ Muscle percentage (Legs)
849
+ 41.94 ± 5.21
850
+ 43.94 ± 4.65
851
+ 42.06 ± 4.94
852
+ 43.78 ± 4.95
853
+ - 0.701b
854
+ 0. 14
855
+ 20
856
+ Sit ups
857
+ 32.95 ± 7.02
858
+ 31.5 ± 9.38
859
+ 30.21 ± 8.74
860
+ 26.78 ± 7.36
861
+ - 0.942b
862
+ 0.09
863
+ 21
864
+ Flamingo Balance test
865
+ 60.70 ± 37.07
866
+ 65.75 ± 38.48
867
+ 72.17 ± 56.41
868
+ 91.89 ± 58.65
869
+ 1.568a
870
+ 0.11
871
+ aMann-Whitney U test
872
+ bIndependent samples t-test
873
+ ∞significant at 0.05
874
+ Table 4: Result of In between group analysis.
875
+ Citation: Rathi SS, Joshi RR, Tekur P, Naratna RN, Nagendra HR (2018) Effect of the Yoga on Anthropometric and Physical Assessments in Adolescent Obesity. A Case
876
+ Report. Endocrinol Metab Syndr 7: 292. doi:10.4172/2161-1017.1000292
877
+ Page 6 of 6
878
+ Volume 7 • Issue 5 • 1000292
879
+ Endocrinol Metab Syndr, an open access journal
880
+ ISSN: 2161-1017
881
+ Endocrinol Metab Syndr, an open access journal
882
+ ISSN: 2161-1017
883
+ children with respect to anthropometric and physical assessments. This
884
+ study provides evidence to prove efficacy of Yoga to manage increased
885
+ subcutaneous adiposity in trunk, hip and leg region resulting in weight
886
+ reduction in adolescent children.
887
+ Acknowledgement
888
+ We are thankful to Mr. Ramkumar Rathi and Rathi foundation for
889
+ his support. We also acknowledge the kind cooperation of Kaveri group
890
+ of education, Pune.
891
+ References
892
+ 1. WHO (2017) Obesity and overweight.
893
+ 2. Batch JA, Baur L (2005) Management and prevention of obesity and its
894
+ complications in children and adolescents. Med J Aust 182: 130-135.
895
+ 3. WHO (2015) Obesity and overweight.
896
+ 4. Krebs NF, Himes JH, Jacobson D, Nicklas TA, Guilday P, et al. (2007)
897
+ Assessment of Child and Adolescent Overweight and Obesity. Pediatrics 120:
898
+ S193-228.
899
+ 5. Koplan JP, Liverman CT, Kraak VI, (2005) Preventing Childhood Obesity:
900
+ Health in the Balance. Washington, DC: National Academies Press, Institute
901
+ of Medicine (US) Committee on Prevention of Obesity in Children and Youth.
902
+ 6. Brambilla P, Bedogni G, Moreno LA, Goran MI, Gutin B, et al. (2006)
903
+ Crossvalidation of anthropometry against magnetic resonance imaging for the
904
+ assessment of visceral and subcutaneous adipose tissue in children. Int J Obes
905
+ (Lond) 30: 23-30.
906
+ 7. Lofgren I, Herron K, Zern T, West K, Patalay M, et al. (2004) Waist circumference
907
+ is a better predictor than body mass index of coronary heart disease risk in
908
+ overweight premenopausal women. J Nutr 134: 1071-1076.
909
+ 8. Erikoglu O, Guzel NA, Pense M, Orer GE (2015) Comparison of Physical
910
+ Fitness Parameters with EUROFIT Test Battery of Male Adolescent Soccer
911
+ Players and Sedentary Counterparts. Int JSCS. 3: 43-52.
912
+ 9. Tokmakidis SP, Kasambalis A, Christodoulos AD (2006) Fitness levels of Greek
913
+ primary schoolchildren in relationship to overweight and obesity. Eur J Pediatr
914
+ 165: 867-874.
915
+ 10. Agarwal BB (2010) Yoga and Medical Sciences. JIMSA 23: 69-70.
916
+ 11. Subhadra S, Jayable T (2017) Effect of aerobic & resistance exercise
917
+ on physical fitness components of Adolescent boys. Journal of Exercise
918
+ Rehabilitation 13: 95-100.
919
+ 12. Pierce JW, Wardle J (1997) Cause and Effect Beliefs and Self-esteem of
920
+ Overweight Children. J Child Psychol Psychiatry 38: 645-650.
921
+ 13. https://www.cdc.gov/chronicdisease/index.htm
922
+ 14. Garcia DM (1986) The transactional model of stress and coping: Its implication
923
+ to young adolescents. University of Denver.
924
+ 15. Bhardwaj KA, Agrawal G (2013) Yoga Practice Enhances the Level of Self-
925
+ Esteem in Pre-Adolescent School Children. International Journal of Physical
926
+ and Social Sciences 10: 189-199.
927
+ 16. Kumar P (2016) Effects of Yoga on Mental Health. International Journal of
928
+ Science and Consciousness 2: 6-12.
929
+ 17. Telles S, Singh N, Bhardwaj AK, Kumar A, Balkrishna A (2013) Effect of yoga or
930
+ physical exercise on physical, cognitive and emotional measures in children: a
931
+ randomized controlled trial. Child Adolesc Psychiatry Ment Health 7: 37.
932
+ 18. Raine L, Drollette E, Kao SC, Westfall D, Chaddock-Heyman L (2018) The
933
+ Associations between Adiposity, Cognitive Function, and Achievement in
934
+ Children. Med Sci Sports Exerc 50: 1868-1874.
935
+ 19. Chojnacki MR, Raine LB, Drollette ES, Scudder MR, Kramer AF, et al. (2018)
936
+ The Negative Influence of Adiposity Extends to Intraindividual Variability in
937
+ Cognitive Control among Adoloscent Children. Obesity (Silver Spring) 26:
938
+ 405-411.
939
+ 20. Rathi SS, Raghuaram N, Tekur P, Joshi RR, Ramarao NH (2018) Development
940
+ and validation of integrated yoga module for obesity in adolescents. Int J Yoga
941
+ 11: 231-238.
942
+ 21. Cramer H, Thoms MS, Anheyer D, Lauche R, Dobos G (2016) Yoga in Women
943
+ With Abdominal Obesity a Randomized Controlled Trial. Dtsch Arztebl Int 113:
944
+ 645-652.
subfolder_0/Effect of yoga on self-rated visual discomfort in computer users.txt ADDED
@@ -0,0 +1,571 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ BioMed
2
+ Central
3
+ Page 1 of 6
4
+ (page number not for citation purposes)
5
+ Head & Face Medicine
6
+ Open Access
7
+ Research
8
+ Effect of yoga on self-rated visual discomfort in computer users
9
+ Shirley Telles*, KV Naveen†, Manoj Dash†, Rajendra Deginal† and
10
+ NK Manjunath†
11
+ Address: Swami Vivekananda Yoga Research Foundation, No. 19, Eknath Bhavan, K.G. Nagar, Bangalore 560 019, India
12
+ Email: Shirley Telles* - [email protected]; KV Naveen - [email protected]; Manoj Dash - [email protected];
13
+ Rajendra Deginal - [email protected]; NK Manjunath - [email protected]
14
+ * Corresponding author †Equal contributors
15
+ Abstract
16
+ Background: 'Dry eye' appears to be the main contributor to the symptoms of computer vision
17
+ syndrome. Regular breaks and the use of artificial tears or certain eye drops are some of the
18
+ options to reduce visual discomfort. A combination of yoga practices have been shown to reduce
19
+ visual strain in persons with progressive myopia. The present randomized controlled trial was
20
+ planned to evaluate the effect of a combination of yoga practices on self-rated symptoms of visual
21
+ discomfort in professional computer users in Bangalore.
22
+ Methods: Two hundred and ninety one professional computer users were randomly assigned to
23
+ two groups, yoga (YG, n = 146) and wait list control (WL, n = 145). Both groups were assessed at
24
+ baseline and after sixty days for self-rated visual discomfort using a standard questionnaire. During
25
+ these 60 days the YG group practiced an hour of yoga daily for five days in a week and the WL
26
+ group did their usual recreational activities also for an hour daily for the same duration. At 60 days
27
+ there were 62 in the YG group and 55 in the WL group.
28
+ Results: While the scores for visual discomfort of both groups were comparable at baseline, after
29
+ 60 days there was a significantly decreased score in the YG group, whereas the WL group showed
30
+ significantly increased scores.
31
+ Conclusion: The results suggest that the yoga practice appeared to reduce visual discomfort,
32
+ while the group who had no yoga intervention (WL) showed an increase in discomfort at the end
33
+ of sixty days.
34
+ Background
35
+ Nowadays most people have some contact with comput-
36
+ ers either at work or at home. This change has been asso-
37
+ ciated with an increase in complaints of a number of
38
+ health problems associated with working at visual display
39
+ terminals (VDTs) [1]. Eye problems are the single most
40
+ common complaints [2]. The main visual symptoms
41
+ which VDT users report are eyestrain, irritation, tired eyes,
42
+ a burning sensation, redness, blurred vision, and double
43
+ vision [2-5]. The symptoms collectively constitute compu-
44
+ ter vision syndrome [6]. The main contributor to the
45
+ symptoms of computer vision syndrome appears to be
46
+ 'dry eye'.
47
+ These symptoms are widely recognized as temporary,
48
+ however the individual does experience considerable dis-
49
+ Published: 03 December 2006
50
+ Head & Face Medicine 2006, 2:46
51
+ doi:10.1186/1746-160X-2-46
52
+ Received: 15 June 2006
53
+ Accepted: 03 December 2006
54
+ This article is available from: http://www.head-face-med.com/content/2/1/46
55
+ © 2006 Telles et al; licensee BioMed Central Ltd.
56
+ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
57
+ which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
58
+ Head & Face Medicine 2006, 2:46
59
+ http://www.head-face-med.com/content/2/1/46
60
+ Page 2 of 6
61
+ (page number not for citation purposes)
62
+ comfort [7]. Reducing visual discomfort appears to
63
+ improve productivity at work [8]. This was indirectly
64
+ inferred, as adding regular breaks to the work schedule
65
+ improved the efficiency between breaks and compensated
66
+ for the extra time spent in breaks. Apart from breaks other
67
+ options which have been tried to reduce discomfort are
68
+ modifying the computer location, the lighting and reflec-
69
+ tion, increasing humidity, the use of artificial tears [9] or
70
+ certain eye drops [10].
71
+ Yoga is an ancient Indian science which includes the prac-
72
+ tice of specific postures, cleansing practices, regulated
73
+ breathing and meditation [11]. A combination of yoga
74
+ practices reduced symptoms of visual strain in persons
75
+ with progressive myopia [12]. Among software develop-
76
+ ment organizations worldwide, several are in Bangalore
77
+ city [13]. Hence the present randomized controlled trial
78
+ was planned to evaluate the effect of a combination of
79
+ yoga practices on self-rated symptoms of visual discom-
80
+ fort in professional computer users in Bangalore.
81
+ Methods
82
+ Participants
83
+ The participants were 291 persons working in a software
84
+ company in Bangalore, India. There was no attempt to cal-
85
+ culate the sample size when planning the study. However
86
+ based on the effect size obtained in the present study
87
+ [0.66 with 0.9 power to detect a significant difference at
88
+ alpha level 0.05], 50 subjects were required for each group
89
+ while in fact at baseline there were 146 subjects in the
90
+ yoga group and 145 in the control group.
91
+ All of them used a computer for at least 6 hours each day,
92
+ for 5 days in a week. Persons of both sexes participated in
93
+ the trial and their ages ranged between 21 and 49 years.
94
+ The participants were screened to exclude those who: (i)
95
+ had consulted a specialist for their visual symptoms, (ii)
96
+ had uncorrected errors of refraction, (iii) had clinical con-
97
+ ditions such as Sjögren's syndrome or kerato-conjunctivi-
98
+ tis sicca and (iv) used medication associated with drying
99
+ of the eyes (e.g., anti-histaminics). None of the partici-
100
+ pants had to be excluded based on these criteria. The
101
+ details of the study were described to the participants and
102
+ their consent to participate was obtained. The project was
103
+ approved by the ethics committee of the yoga research
104
+ foundation and had the approval of the human resource
105
+ department of the software company.
106
+ Design of the study
107
+ 291 participants were randomized prior to assessment as
108
+ two groups using a standard random number table by the
109
+ researchers responsible. The two groups were then desig-
110
+ nated as (i) intervention (i.e., yoga, n = 146) and (ii) wait
111
+ list control (n = 145) by an office assistant from the soft-
112
+ ware company who had no other role in the study. The
113
+ yoga (YG) and wait list control (WL) groups were compa-
114
+ rable with respect to age (group average (± S.D.) 32.8 (±
115
+ 8.6) years and 31.9 (± 10.2) years, respectively) and gen-
116
+ der-distribution (11 females in YG group and 13 in WL
117
+ group).
118
+ Both groups were assessed at baseline and after 60 days.
119
+ During the 60 days the YG group practiced yoga for an
120
+ hour per day, for five days in a week. While the YG group
121
+ practiced yoga the WL group spent the time in the recrea-
122
+ tion center of the software company where 60 percent of
123
+ them talked to their friends, 12 percent spent time playing
124
+ indoor games, 12 percent worked out in the gym and 16
125
+ percent watched television. The WL group had already
126
+ been spending this time each day doing the same activities
127
+ and hence during the 60 day period they were following
128
+ their usual routine. During the 60 days there were 84 drop
129
+ outs from the trial in the YG group and 90 from the WL
130
+ group. The large number of drop outs was mainly due to
131
+ the fact that the participants had demanding work sched-
132
+ ules which interfered with their participating in: (i) the
133
+ intervention (YG group) or recreational activities (WL
134
+ group) and/or (ii) the assessments (both groups). To be
135
+ considered as regular in their participation the YG group
136
+ had to have a minimum of 38 days of attendance during
137
+ the 60 day period. The trial profile is given in Figure 1.
138
+ Assessments
139
+ Visual discomfort including dryness, irritation, burning,
140
+ redness, photo-sensitivity and possible remedial measures
141
+ (e.g., the use of lubricating eye drops) were determined
142
+ using a questionnaire [14]. It had 12 items, each of which
143
+ had 4 possible choices. These were: (i) absent, (ii) rarely
144
+ present (meaning one or two days per week), (iii) often
145
+ (meaning more than two days per week) and (iv) contin-
146
+ uous. The symptoms were considered during the week
147
+ before assessment and the four alternatives (i-iv) were
148
+ graded as '0', '1', '2' and '3', respectively. The person who
149
+ administered the questionnaire and scored the response
150
+ sheets was not aware to which group the subjects
151
+ belonged.
152
+ Intervention (yoga)
153
+ The 60 minute yoga program included yoga postures
154
+ (asanas, 15 minutes), regulated breathing (pranayamas, 10
155
+ minutes), exercises for the joints (sithilikarana vyayama, 10
156
+ minutes), visual cleansing exercises (trataka, 10 minutes),
157
+ and guided relaxation (15 minutes).
158
+ The practice of trataka involves two sets of eye exercises. (i)
159
+ Shifting the gaze (by moving the eyes alone) in eight
160
+ directions. During this exercise, practitioners are asked to
161
+ use their right thumb (and when gazing to the left, their
162
+ left thumb) as a cue to direct their gaze. The directions are
163
+ up, down, up to the left, down to the left, up to the right,
164
+ Head & Face Medicine 2006, 2:46
165
+ http://www.head-face-med.com/content/2/1/46
166
+ Page 3 of 6
167
+ (page number not for citation purposes)
168
+ down to the right and rotation of the eyes clock-wise and
169
+ anti clock-wise. (ii) During the second exercise, practition-
170
+ ers gaze at a flame placed at eye level without blinking.
171
+ While gazing at the flame, practitioners are instructed to
172
+ focus their gaze on the flame and subsequently defocus
173
+ while keeping their gaze on the flame. Throughout the
174
+ practice practitioners should sit upright and should avoid
175
+ moving their head to shift their gaze.
176
+ These techniques were selected either because previous
177
+ research showed that they reduced physiological arousal
178
+ [15,16] or based on our unpublished clinical observa-
179
+ tions.
180
+ Data analysis
181
+ The data were analyzed using SPSS Version 10.0. Repeated
182
+ measures analyses of variance (ANOVA) were carried out
183
+ with one Between-subjects factor, viz., Groups (with two
184
+ levels, i.e., YG and WL groups) and one Within-subjects
185
+ factor, viz., Assessments (with two levels, i.e., baseline and
186
+ day 60). Post-hoc analyses for multiple comparisons
187
+ between mean values were done with Bonferroni adjust-
188
+ ment.
189
+ Results
190
+ 291 participants attended their respective interventions
191
+ [yoga and control] in three blocks across 18 months from
192
+ October 2004 to April 2005.
193
+ The repeated measures analyses of variance (ANOVA)
194
+ showed a significant difference between YG and WL
195
+ groups (F = 15.369, DF = 1,115, P < .001). There was no
196
+ significant difference between assessments taken at base-
197
+ line and on day 60. The interaction between groups and
198
+ assessments was significant (F = 178.607, DF = 1,115, P <
199
+ .001), suggesting that the two factors (groups, assess-
200
+ ments) were not independent of each other.
201
+ Post-hoc assessments with multiple comparisons of mean
202
+ values showed a significant decrease in scores of self-rated
203
+ visual discomfort for the YG group on day 60 compared
204
+ to baseline (P < .001). In contrast, there was a significant
205
+ increase in scores of self rated visual discomfort for the WL
206
+ group on day 60 compared to baseline (P < .001).
207
+ The groups mean values with 95% C.I. are given in Table
208
+ 1. The details of the ANOVA are given in Table 2.
209
+ Discussion
210
+ In the present single blind, randomized, prospective trial
211
+ 291 persons working in a software company were evalu-
212
+ ated for self-rated symptoms of visual discomfort. They
213
+ were randomized as yoga (YG) and wait list (WL) control
214
+ groups. Both groups showed comparable discomfort at
215
+ baseline. At the end of sixty days the YG group showed
216
+ decreased scores, whereas the WL group showed an
217
+ increase in visual discomfort.
218
+ Trial profile of the randomized controlled study
219
+ Figure 1
220
+ Trial profile of the randomized controlled study.
221
+ Total number selected & randomly assigned to two groups=291
222
+ Yoga
223
+ Group
224
+ Pre
225
+ (n=146)
226
+ Pre
227
+ (n=145)
228
+ Post
229
+ (n= 62)
230
+ Post
231
+ (n= 55)
232
+ Drop outs, unable to
233
+ regularly attend:
234
+ 1. Recreational
235
+ activities (n=59)
236
+ 2. Assessments (n=31)
237
+ Drop outs, unable to
238
+ regularly attend:
239
+ 1. Intervention (n=57)
240
+ 2. Assessments (n=27)
241
+ Control
242
+ Group
243
+ Head & Face Medicine 2006, 2:46
244
+ http://www.head-face-med.com/content/2/1/46
245
+ Page 4 of 6
246
+ (page number not for citation purposes)
247
+ Visual discomfort in professional computer users is con-
248
+ tributed to by various factors such as lighting, glare, dis-
249
+ play quality, ergonomic positioning of the monitor and
250
+ regularity of work breaks [6]. The symptom which largely
251
+ contributes to subjectively rated visual discomfort is 'dry
252
+ eye'. Dry eye is itself contributed to by various factors,
253
+ including certain diseases (e.g., Sjögren's syndrome, use of
254
+ certain medication (e.g., anti-histaminics), gender (being
255
+ more common in females)), and individual factors [17].
256
+ Individual factors include blink rate and completeness of
257
+ blinking which significantly affect tear film dynamics and
258
+ ocular surface health [18,19]. Blink rate especially has
259
+ been shown to vary with the task performed [20]. The
260
+ mean (± S.D.) rate of blinking was 22 (± 9) per minute
261
+ under relaxed conditions, 10 (± 6) per minute while the
262
+ subjects were reading a book at table level, and 7 (± 7) per
263
+ minute while working at a video display terminal. Hence
264
+ the frequency of blinking reduces while mentally alert and
265
+ with gaze focused.
266
+ Specific yoga practices have been found to bring about
267
+ physiological changes suggestive of 'alertful rest' [21]. This
268
+ description was based on a simultaneous decrease in heart
269
+ rate and oxygen consumption along with a reduction in
270
+ peripheral cutaneous blood flow. Also the visual cleans-
271
+ ing practices used in the present trial have been shown to
272
+ facilitate visual perceptual sensitivity in terms of a
273
+ decrease in optical illusion [22]. A reduction in anxiety
274
+ has been found to be associated with better visual percep-
275
+ tual sensitivity [23]. A relaxed state (as described above) is
276
+ associated with a higher frequency of blinking. Yoga prac-
277
+ tice has been associated with better self rated relaxation
278
+ [24] as well as with physiological relaxation [25]. Hence
279
+ the reduction in visual discomfort in the yoga group in the
280
+ present study may be attributed to an improvement in the
281
+ ability to focus while remaining relaxed which may have
282
+ increased the blink rate.
283
+ In contrast to the yoga group the control group showed an
284
+ increase in self rated visual discomfort. These differences
285
+ between the groups could be due to psychological bene-
286
+ fits that are reported with 'additional care' [26]. In the
287
+ present study the frequent meetings which the yoga group
288
+ had with the instructor could serve as additional care and
289
+ may have contributed to the benefits seen in the yoga
290
+ group. The absence of this psychological support and the
291
+ yoga practice in the control group may have contributed
292
+ to increased visual discomfort at follow-up.
293
+ A main limitation of the study is that well recognized
294
+ objective indicators of visual discomfort (especially dry-
295
+ ness) were not measured. It would have been ideal to have
296
+ carried out a semi-quantitative estimation of the superfi-
297
+ cial lipid layer or have measured the tear breakup time
298
+ [27]. However another variable which is an objective indi-
299
+ cator of VDT related fatigue was measured in these sub-
300
+ jects, and the results were reported elsewhere [28]. This is
301
+ the critical flicker fusion frequency (CFF), which is the
302
+ flicker frequency rate beyond which one can no longer
303
+ perceive the flicker. Flicker related changes in the visual
304
+ system from working at a cathode ray tube (CRT) compu-
305
+ ter screen have also been measured [29]. A group of sub-
306
+ jects worked for 3 hours at simulated CRT displays with
307
+ different flicker rates. The CFF was found to decrease. A
308
+ similar result was obtained when the effect of performing
309
+ the same task on a CRT was compared with the perform-
310
+ ance on a back slide projection system (BPS) [30]. The
311
+ CFF of the group decreased after working on the CRT com-
312
+ puter screen while it did not change when working on the
313
+ BPS. These studies suggest that the visual system possibly
314
+ gets fatigued as a result of viewing supra-threshold flicker.
315
+ Table 2: Analysis of variance for scores in the 'Dry Eye Questionnaire'
316
+ Source
317
+ df
318
+ MS
319
+ F
320
+ P' values
321
+ Within subjects factor (Assessments)
322
+ 1
323
+ 0.133
324
+ 3.221
325
+ 0.075
326
+ Between subjects factor (Groups)
327
+ 1
328
+ 8.326
329
+ 15.369
330
+ 0.001
331
+ Interaction (Assessments and Groups)
332
+ 1
333
+ 7.381
334
+ 178.607
335
+ 0.001
336
+ Error (Within subjects factor)
337
+ 115
338
+ 4.133
339
+ Error (Between subjects factor)
340
+ 115
341
+ 0.542
342
+ Greenhouse-Geisser epsilon = 1.000, hence Sphericity Assumed
343
+ Table 1: Scores of the questionnaire for visual discomfort for yoga and control groups at baseline [BL] and day 60.
344
+ Descriptive values
345
+ YOGA [n = 62]
346
+ CONTROL [n = 55]
347
+ BL
348
+ Day 60
349
+ BL
350
+ Day 60
351
+ Mean (95 % C.I.)
352
+ 1.03 (.91–1.15)
353
+ 0.7*** (.58–.94)
354
+ 1.05 (.89–1.21)
355
+ 1.5*** (1.34–1.66)
356
+ *** P < .001, post-hoc test for multiple comparisons
357
+ Head & Face Medicine 2006, 2:46
358
+ http://www.head-face-med.com/content/2/1/46
359
+ Page 5 of 6
360
+ (page number not for citation purposes)
361
+ In the subjects of this study critical flicker fusion fre-
362
+ quency was measured using a standard electronic appara-
363
+ tus [28]. Each subject was assessed in 10 trials (5 each,
364
+ ascending and descending, given alternately). The fre-
365
+ quency of flicker for the ascending trials was gradually
366
+ increased from a minimum of 8 Hz, with 1 Hz incre-
367
+ ments, till the subjects reported that the light appeared
368
+ "fused" or steady. This was the fusion threshold. For
369
+ descending trials, the frequency was gradually reduced (1
370
+ Hz per step) from 49 Hz, till the subject perceived the
371
+ stimulus as "flickering". This was the flickering threshold.
372
+ The average value of the ascending and descending trials
373
+ was used for statistical analysis.
374
+ After sixty days the yoga group showed an increase in CFF
375
+ from a group average (± SD) of 31.8 (± 2.6) at baseline to
376
+ an average of 33.6 (± 2.5) after sixty days. In contrast, the
377
+ wait list control group showed a decrease in CFF, from a
378
+ group average of 32.5 (± 2.5) at baseline to a group aver-
379
+ age of 31.4 (± 2.5) at the end of sixty days. Hence the yoga
380
+ group showed an average increase of 1.8 Hz in the CFF,
381
+ compared with an average decrease of 1.1 Hz in the wait
382
+ list control. This may suggest that the wait-list control
383
+ group might have remained prone to visual fatigue,
384
+ whereas the yoga group was not.
385
+ These results suggest that sixty days of yoga practice may
386
+ have reduced visual fatigue based on the self-rated symp-
387
+ toms presented in this study and the CFF findings
388
+ reported earlier [28]. However other factors may have
389
+ influenced the subjective assessment of visual dryness. For
390
+ example, certain personality traits were reported to be
391
+ higher in contact lens wearers who had dryness of the eyes
392
+ [31]. This study subjectively evaluated personality traits
393
+ using the Yatabe Guilford Personality Test. No personality
394
+ assessment was carried out in the participants studied
395
+ here, which can be considered a limitation of the study.
396
+ Also, it has been shown that for yoga practice to be effec-
397
+ tive participants should be motivated to learn and practice
398
+ yoga [32]. Hence it would also have been useful to assess
399
+ levels of motivation in the yoga group and correlate them
400
+ with the reduction in self-rated visual discomfort which
401
+ was found.
402
+ Conclusion
403
+ The results of the present study suggest that a combination
404
+ of yoga techniques practiced for 60 days improves self-
405
+ rated visual discomfort in computer professionals. In con-
406
+ trast, the wait list control group who continued with their
407
+ usual routine showed an increase in self-rated visual dis-
408
+ comfort. Hence the practice of yoga can be a potential
409
+ non-pharmacological intervention for visual discomfort
410
+ related to working at visual display terminals (VDTs).
411
+ Competing interests
412
+ The principal author and four co-authors declare that they
413
+ have no competing interests.
414
+ Authors' contributions
415
+ ST conceived and designed the study and prepared the
416
+ manuscript. NKV participated in the conception and
417
+ design of the study and in compiling the manuscript. MD
418
+ co-ordinated the project and supervised the intervention
419
+ and data collection. RD participated in the recruitment of
420
+ subjects, data collection and assisted in statistical analysis.
421
+ MNK carried out data extraction and analysis. All authors
422
+ read and approved the final manuscript.
423
+ Acknowledgements
424
+ The research was funded by the Central Council for Research in Yoga and
425
+ Naturopathy, Department of AYUSH, Ministry of Health and Family Wel-
426
+ fare, Government of India, New Delhi, India.
427
+ References
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+ 1.
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+ Smith MJ, Cohen BG, Stammerjohn WL Jr: An investigation of
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+ health complaints and job stress in Video Display operations.
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+ Hum Factors 1981, 23:387-400.
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+ Collins MJ, Brown B, Bowman KJ: Visual Discomfort and VDTs.
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+ Report for National Occupational Health and Safety Commission (Australia)
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+ Lie I, Watten RG: VDT work, Oculomotor strain and subjec-
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+ Bergqvist UO, Knave BG: Eye discomfort work with visual dis-
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+ play terminals. Scand J Work Environ Health 1994, 20:27-33.
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+ Cole BL, Maddocks JD, Sharpe K: Effect of VDUs on the eyes –
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+ Yeow PT, Taylor SP: Effect of short-term VDT usage on visual
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+ Grandjean E: Fitting the task to the man London: Taylor and Francis;
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+ Sheedy JE, Shaw-McMinn PG: Diagnosing and treating computer related
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+ vision problems Burlington, MA: Butterworth-Heinemann; 2003.
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+ Apostol S, Filip M, Dragne C, Filip A: Dry eye syndrome. Etiolog-
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+ ical and therapeutic aspects. Oftalmologia 2003, 59:28-31.
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+ 11.
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+ Visweswaraiah NK, Telles S: Randomized trial of yoga as a com-
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+ plementary therapy for pulmonary tuberculosis. Respirology
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+ 2004, 9:96-101.
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+ Nagendra HR, Vaidehi S, Nagarathna R: Integrated approach of yoga
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+ Killcrece G, Kossakowski K-P, Ruefle R: Organizational models for com-
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+ puter security incident response teams (CSIRTs). Pittsburgh: SEI: Hand book
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+ HB-001-15213-3890 2003.
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+ 14.
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+ Bandeen-Roche K, Munoz B, Tielsch JM, West SK, Schein OD: Self-
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+ reported assessment of dry eye in a population-based set-
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+ Tran MD, Holly RG, Lashbrook J, Amsterdam EA: Effects of hatha
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+ 16.
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+ sympathetic activity in subjects based on baseline levels. Psy-
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+ Salisbury Eye Evaluation Project Team. Photochem Photobiol
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+ 1997, 66:701-709.
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+ Central
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+ and
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+ every
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+ scientist can read your work free of charge
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+ "BioMed Central will be the most significant development for
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+ disseminating the results of biomedical research in our lifetime."
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+ Sir Paul Nurse, Cancer Research UK
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+ Your research papers will be:
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+ available free of charge to the entire biomedical community
503
+ peer reviewed and published
504
+ immediately upon acceptance
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+ cited in PubMed and archived on PubMed Central
506
+ yours — you keep the copyright
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+ Submit your manuscript here:
508
+ http://www.biomedcentral.com/info/publishing_adv.asp
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+ BioMedcentral
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+ Head & Face Medicine 2006, 2:46
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+ http://www.head-face-med.com/content/2/1/46
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+ Tsubota K, Nakamori K: Dry eyes and Video Display Terminals.
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+ N Engl J Med 1993, 328:584.
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+ Telles S, Nagarathna R, Nagendra HR: Improvement in visual per-
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+ ception following yoga training. J Indian Psychol 1995, 13:30-32.
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+ Vani PR, Nagarathna R, Nagendra HR, Telles S: Progressive
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+ increase in critical flicker fusion frequency following yoga
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+ training. Indian J Physiol Pharmacol 1997, 41:71-74.
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+ 23.
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+ Brown D, Forte M, Dysart M: Differences in visual sensitivity
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+ among mindfulness meditators and non-meditators. Percept
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+ Mot Skills 1984, 58(3):727-733.
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+ Manjunath NK, Telles S: Influence of Yoga and Ayurveda on self
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+ rated sleep in a geriatric population. Indian J Med Res 2005,
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+ 121:683-690.
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+ 26.
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+ Delbanco T: The healing roles of doctor and patient. Healing and the mind
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+ 27.
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+ Brasche S, Bullinger M, Petrovich A, Mayer E, Gebhardt H, Herzog V,
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+ Bischof W: Self reported eye symptoms and related diagnos-
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+ tic findings-comparison of risk factor profiles. Indoor Air
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+ 2005:56-64.
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+ 28.
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+ Telles S, Dash M, Manjunath NK, Deginal R, Naveen KV: Effect of
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+ yoga on visual perception and visual strain. Opt Acta (Lond) [cur-
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+ 29.
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+ Laubli T, Hunting W, Grandjean E, Fellmann T, Brauninger U, Gierer
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+ R: Load factors at visual display terminals. Klin Monatsbl Augen-
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+ Chikama T, Ueda K, Nishida T: Clinical interpretation of the sub-
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+ col 1999, 43(2):225-229.
subfolder_0/Effect of yoga on somatic indicators of distress in professional computer users.txt ADDED
@@ -0,0 +1,238 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ PERS
2
+ ON
3
+ Effect of yoga on somatic indicators of distress in profes-
4
+ sional computer users
5
+ Comments to:
6
+ Association between occupational asthenopia and psycho-phy-
7
+ siological indicators of visual strain in workers using video dis-
8
+ play terminals
9
+ Ruta Ustinaviciene, Vidmantas Januskevicius
10
+ Med Sci Monit, 2006; 12(7): CR296–301
11
+ Dear Editor,
12
+ Ophthalmologic and psycho-physiological indicators con-
13
+
14
+ rmed the subjective perception of visual strain due to vi-
15
+ sual display terminal [VDT] work in two hundred and eight
16
+ professional computer users [1]. The report also mentio-
17
+ ned that easily accessible and simple examinations could
18
+ be used to evaluate strain at the work place related to pre-
19
+ ventive programs or interventional studies.
20
+ Various interventions have been used to reduce visu-
21
+ al discomfort, including breaks during work, modifying
22
+ the computer location, lighting and refl
23
+ ection, modify-
24
+ ing the indoor environment, and the use of certain eye
25
+ drops [2].
26
+ Yoga is an ancient Indian science which includes the practi-
27
+ ce of specifi
28
+ c postures, cleansing practices, regulated bre-
29
+ athing, and meditation [3]. A controlled trial was carried
30
+ out to evaluate the effect of a combination of yoga practi-
31
+ ces on self-rated symptoms of visual discomfort in profes-
32
+ sional computer users in India [4]. At the end of sixty days
33
+ of yoga practice there was a signifi
34
+ cant decrease in self-ra-
35
+ ted visual discomfort, while the non-yoga control group
36
+ showed an increase.
37
+ Apart from visual strain, VDT workers experienced a grea-
38
+ ter subjective perception of stress than offi
39
+ ce workers [5].
40
+ Stress is related to high work load, high work pressure,
41
+ diminished job control and stress related to the use of new
42
+ technology. The practice of yoga has been shown to redu-
43
+ ce psycho-physiological indicators of mental stress in per-
44
+ sons with high baseline stress levels associated with a phy-
45
+ sical disability [6], their social circumstances [7] or their
46
+ occupation [8].
47
+ Somatic indicators of distress were assessed in two hundred
48
+ and ninety one professional computer users with ages be-
49
+ tween 21 and 49 years, who were randomly assigned to two
50
+ groups, yoga (YG, n=146) and wait-list control (WL, n=145).
51
+ The participants were from a software company in Bangalore
52
+ city (India) and they all used a computer for more than six
53
+ LE21
54
+ Electronic PDF security powered by IndexCopernicus.com
55
+ opy is for personal use only - distribution prohibited. This copy is for personal use only - distribution prohibited. This copy is for p
56
+ PERSONAL USE
57
+ ONLY
58
+ hours each day, for fi
59
+ ve days a week. All of them had normal
60
+ health based on a clinical history and examination. Both
61
+ groups had comparable job assignments and responsibili-
62
+ ties as rated by the human resource personnel from the sof-
63
+ tware company. Both groups were assessed at baseline and
64
+ after sixty days. At the end of sixty days there were 62 per-
65
+ sons in the YG group and 56 in the WL group.
66
+ The YG group (average age of 32.8 years (±8.6 S.D.); 11 fe-
67
+ males) practiced yoga for sixty minutes each day for fi
68
+ ve days
69
+ in a week. The practice consisted of joint loosening tech-
70
+ niques (shithilikarana vyayama) for 10 minutes, physical po-
71
+ stures (asanas, 15 minutes), regulated breathing practices
72
+ (pranayamas, 10 minutes), eye cleansing exercises (trataka,
73
+ 10 minutes) and guided relaxation techniques (15 minu-
74
+ tes). The WL group (average age of 31.9 years (±10.2 S.D.);
75
+ 13 females) spent the same time talking to friends (60%),
76
+ watching television (16%), playing indoor games (12%)
77
+ or exercising in the gym (12%). This was how they usual-
78
+ ly spent the time allotted as a work break. Hence they were
79
+ carrying on with their usual routine.
80
+ A section of the symptom checklist 90 – Revised [SCL-90-R]
81
+ specifi
82
+ c to ‘somatization’ with 12 items was administered
83
+ to both groups at baseline and after two months of the in-
84
+ terventions. The checklist was administered and scored by
85
+ the investigator who was blind to the allocation of subjects
86
+ to YG and WL groups. Each item was rated on a 0 to 4 sca-
87
+ le for distress. The sum of the scores for the 12 items was
88
+ analyzed using a repeated measures analysis of variance
89
+ (ANOVA) followed by post hoc analyses with Bonferroni ad-
90
+ justment (SPSS version 10).
91
+ Both groups (YG and WL) had comparable baseline sco-
92
+ res for the somatization dimension of the SCL-90-R as fol-
93
+ lows: group average of 12.03 (±6.62 S.D.) and 9.93 (±7.38
94
+ S.D.), respectively (p>0.05). At the end of two months the
95
+ YG group showed a decrease in scores [average score of
96
+ 6.34 (±6.13 S.D.)], (p<0.001) whereas the WL group sho-
97
+ wed an increase in the score [average score of 12.82 (±8.24
98
+ S.D.)], (p=0.003).
99
+ The somatization dimension of the SCL-90-R refl
100
+ ects distress
101
+ related to the way physical sensations are perceived [9]. The
102
+ cardiovascular, gastrointestinal, respiratory, and other sy-
103
+ stems with autonomic mediation are included. It has alrea-
104
+ dy been reported that physical and psychological symptoms
105
+ have signifi
106
+ cantly decreased following a 10 week behavio-
107
+ ral medicine intervention, with a greater reduction in tho-
108
+ se who were ‘high somatizers’ at baseline [10].
109
+ Hence in the present study practicing yoga for sixty days
110
+ reduced somatic indicators of distress in professional com-
111
+ puter users. Based on these results it may be interesting
112
+ to determine whether yoga practice prevents the develop-
113
+ ment of actual somatic illness in asymptomatic professio-
114
+ nal computer users.
115
+ Sincerely,
116
+ Shirley Telles and Naveen K.V.,
117
+ Swami Vivekananda Yoga Research Foundation,
118
+ No. 19, K.G. Nagar, Bangalore 560 019, India,
119
+ e-mail: [email protected]
120
+ REFERENCES:
121
+ 1. Ustinaviciene R, Januskevicius V: Association between occupational asthe-
122
+ nopia and psycho-physiological indicators of visual strain in workers using
123
+ video display terminals. Med Sci Monit, 2006; 12(7): CR296–301
124
+ 2. Sheedy JE, Shaw-McMinn PG: Diagnosing and treating computer rela-
125
+ ted vision problems. Burlington, MA, Butterworth-Heinemann, 2003
126
+ 3. Visweswaraiah NK, Telles S: Randomized trial of yoga as a complemen-
127
+ tary therapy for pulmonary tuberculosis. Respirology, 2004, 9: 96–101
128
+ 4. Telles S, Dash M, Manjunath NK et al: Effect of yoga on visual percep-
129
+ tion and visual strain. J Mod Optics, 2006; in press
130
+ 5. Tomei G, Rosati MV, Martini A et al: Assessment of subjective stress in
131
+ video display terminal workers. Ind Health, 2006; 44(2): 291–95
132
+ 6. Telles S, Srinivas RB: Autonomic and respiratory measures in children
133
+ with impaired vision following yoga and physical activity programs. Int
134
+ J Rehab Health, 1999; 4(2): 117–22
135
+ 7. Telles S, Narendran S, Raghuraj P et al: Comparison of changes in au-
136
+ tonomic and respiratory parameters of girls after yoga and games at a
137
+ community home. Percept Mot Skills, 1997; 84: 251–57
138
+ 8. Vempati RP, Telles S: Baseline occupational stress levels and physiologi-
139
+ cal responses to a two day stress management program. J Indian Psychol,
140
+ 2000; 18(1–2): 33–37
141
+ 9. Holi MM, Marttunen M, Aalberg V: Comparison of the GHQ – 36, the
142
+ GHQ – 12 and the SCL – 90 as psychiatric screening instruments in the
143
+ Finnish population. Nord J Psychiatry, 2003; 57(3): 233–38
144
+ 10. Nakao M, Myers P, Fricchione G et al: Somatization and symptom re-
145
+ duction through a behavioral medicine intervention in mind/body me-
146
+ dicine clinic. Behav Med, 2001; 26(4): 169–76
147
+ Received: 2006.08.25
148
+ LE22
149
+ Electronic PDF security powered by IndexCopernicus.com
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1
+ Official Publication of
2
+ Academy of Advanced Dental Research
3
+ Journal of
4
+ Health Research & Reviews
5
+ Volume 3| Issue 2 | May-Aug 2016
6
+ www.jhrr.org
7
+ ISSN 2394-2010
8
+ © 2016 Journal of Health Research and Reviews | Published by Wolters Kluwer - Medknow
9
+ 48
10
+ Effect of yoga therapy on quality of life and depression
11
+ in premenopausal nursing students with mastalgia:
12
+ A randomized controlled trial with 6‑month follow‑up
13
+ Sukanya Raghunath, Nagarathna Raghuram, Sandhya Ravi1, Nidhi C Ram, Amritanshu Ram
14
+ Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana University, 1Prameya Wellness Private Limited,
15
+ Bengaluru, Karnataka, India
16
+ INTRODUCTION
17
+ Mastalgia or breast pain is a common problem[1,2] with a
18
+ prevalence of 41–79%.[3‑5] Although the etiology of mastalgia is
19
+ not clearly understood, several factors including stress, anxiety,
20
+ and depression[6,7] have been a concern. A review of several
21
+ randomized controlled trials (RCTs) concluded that yoga was
22
+ better than many control interventions in reducing pain in
23
+ different parts of the body.[8,9]
24
+ Literature says that there has been no research on yoga in
25
+ mastalgia. Hence, this study was planned to assess the role of
26
+ yoga therapy on the quality of life (QoL) and depression among
27
+ subjects with mastalgia through an randomized controlled
28
+ trial (RCT).
29
+ Introduction: Mastalgia is a common problem and disturbs women’s reproductive lives. There is no known organic etiology
30
+ for mastalgia and also no definitive treatment. Considering the impact of mastalgia on the quality of life (QoL), it appears
31
+ that mind–body interventions such as yoga would play an important role. Yoga has shown a beneficial effect in reducing
32
+ pain, anxiety, and depression, thereby improving the QoL. Objective: To compare the benefits of yoga with the physical
33
+ activity in improving the QoL in nursing students with mastalgia. Materials and Methods: An institutional ethical committee
34
+ approved this randomized active control trial (RCT) with a follow‑up of 6 months on premenopausal women above 18 years
35
+ with breast pain (pain score >2) of more than 3 months duration. Women already practicing yoga, on hormonal treatment,
36
+ or diagnosed with malignancy were excluded. Eighty consenting nursing students were randomized into the yoga therapy
37
+ or control (brisk walk) arm (for 12 weeks). QoL and Beck Depression Inventory (BDI) questionnaires were administered prior
38
+ to the intervention and 3 months and 6 months after the intervention. Results: RM‑ANOVA group effect was significant in
39
+ BDI, F (1, 67) = 2632.72, P (<0.001) and in overall QoL, F (1, 67) =6881.41, (P < 0.001). Post hoc test (paired sample t‑test)
40
+ showed better improvement in the yoga group (0–3 months, 0–6 months) in both QoL (P < 0.001) (in all the four domains)
41
+ and depression scores (P < 0.001) compared to the control group. Conclusion: QoL and depression scores improved with
42
+ yoga in nursing students with mastalgia.
43
+ Keywords: Depression, mastalgia, nursing students, quality of life, yoga
44
+ ABSTRACT
45
+ Access this article online
46
+ Quick Response Code:
47
+ Website:
48
+ www.jhrr.org
49
+ DOI:
50
+ 10.4103/2394-2010.184229
51
+ Address for correspondence: Mrs. Sukanya Raghunath,
52
+ 324, 5th Cross, 1st Block Jayanagar, Bangalore ‑ 560 011,
53
+ Karnataka, India.
54
+ E‑mail: [email protected]
55
+ How to cite this article: Raghunath S, Raghuram N, Ravi S, Ram NC, Ram A.
56
+ Effect of yoga therapy on quality of life and depression in premenopausal
57
+ nursing students with mastalgia: A randomized controlled trial with 6-month
58
+ follow-up. J Health Res Rev 2016;3:48-54.
59
+ This is an open access article distributed under the terms of the Creative
60
+ Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
61
+ others to remix, tweak, and build upon the work non‑commercially, as long as the
62
+ author is credited and the new creations are licensed under the identical terms.
63
+ For reprints contact: [email protected]
64
+ Original Article
65
+ Raghunath, et al.: Yoga in improving women’s quality of life with mastalgia/yoga in improving quality of life in women with mastalgia
66
+ Journal of Health Research and Reviews | May ‑ August 2016 | Volume 3 | Issue 2
67
+ 49
68
+ MATERIALS AND METHODS
69
+ Female students between 18 years and 25 years of age, from two
70
+ residential nursing colleges, namely, IKON College of Nursing
71
+ in Bidadi and Sri Rajarajeswari College of Nursing in Bengaluru,
72
+ both in Karnataka in South India were the subjects of the study.
73
+ All the students lived in the hostel and had come from semi‑urban
74
+ and rural areas of six different states of India  (Karnataka,
75
+ Andhra Pradesh, Tamil Nadu, Maharashtra, and Kashmir) and
76
+ some parts of Nepal. They all had breast pain (cyclical or acyclical)
77
+ of more than 3 months.
78
+ To ascertain the optimum sample size for the study, effect size
79
+ values obtained from our pilot study on 10 women with breast
80
+ pain in the same setting was used. Severity of pain, QoL, anxiety,
81
+ and depression were measured before and after 12  weeks of
82
+ yoga therapy practice. Results of seven women who completed
83
+ the study indicated reduction in pain [effect size (ES) =3.09],
84
+ anxiety (ES = 1.59) and depression (ES = 2.21), and increase in
85
+ QoL (ES = 0.80). Using these ES values of QoL powered at 0.95
86
+ for two‑tailed analysis a sample size of 23/arm was obtained;
87
+ anticipating an attrition rate of 70% due to the forthcoming
88
+ academic year, it was planned that 40 subjects would be recruited
89
+ in each arm.
90
+ Inclusion criteria were: Premenopausal women 18  years and
91
+ above, breast pain more than 3 months requiring reassurance
92
+ and/or nondrug therapy, breast pain cyclical or acyclical,
93
+ unilateral or bilateral, with or without fibrocystic disease
94
+ of the breast, and those who satisfied 
95
+   Cleeland’s Breif pain
96
+ inventory with a pain score of >2. Women with malignancy,
97
+ postmenopausal women, those with hypothyroidism, those who
98
+ were on hormonal treatment or oral contraceptive pills, and those
99
+ already practicing yoga were excluded from the study.
100
+ The trial started after the approval from the Institutional Ethical
101
+ Committee of Swami Vivekananda Yoga Anusandhana Samsthana
102
+ (SVYASA) University  (RES/IEC‑SVYASA/16/201). The written
103
+ approval was also obtained from the administrative heads of
104
+ both the colleges. This study was registered with the Clinical
105
+ Trial Registry of India (CTRI/2014/08/004911).
106
+ After giving an introductory lecture, all the students were
107
+ asked to give signed informed consent, along with a filled
108
+ checklist of symptoms, which included questions regarding
109
+ their breast health, breast pain cyclical or acyclical, history of
110
+ fibroadenoma, fibrocystic disease, history of breast cancer, age
111
+ of menarche, menstrual cycle, information about past diagnosis,
112
+ management, scanning, surgery, other illness, their stress level,
113
+ happiness scores, diet, shifts in work, lifestyle pattern, along with
114
+ anthropometric and demographic data.
115
+ The Research Medical Officer and a breast surgeon educated
116
+ the girls about the procedure and the importance of screening in
117
+ detail to make them comfortable. Along with four female medical
118
+ officers from the state government, the breast surgeon conducted
119
+ a detailed physical/clinical examination (breast screening) to look
120
+ for the features/signs and symptoms. Uniformity was maintained
121
+ by all the medical officers during the screening. Counseling and
122
+ educating them with regard to breast care were done during this
123
+ individual interaction. The screening was conducted in a hygienic
124
+ environment (biology laboratory of the college) providing them
125
+ privacy and comfort.
126
+ This was a randomized, active control interventional trial wherein
127
+ 80 participants were randomly divided into two arms. Concealed
128
+ envelope procedure was performed for randomization. One group
129
+ underwent yoga therapy and the control arm did brisk walk under
130
+ supervision for the same duration.
131
+ This was an interventional study, and so double blinding was not
132
+ possible. Computer (www.randomizer.org)‑generated random
133
+ number table was used and the allocation of the subjects was
134
+ done by the prelabeled sealed envelope method. The research
135
+ medical officer and four gynecologists, ultrasonologists, and the
136
+ laboratory team were blind to the groups. The statistician had to
137
+ be blind as randomization and the final analysis was done by him.
138
+ The coded answer sheets of the questionnaires were decoded
139
+ only after completion of the scoring.
140
+ The yoga group followed the precise list of practices 75 min
141
+ daily, 6 days a week for 3 months. During the 1st month, the
142
+ yoga sessions were taught by the certified yoga therapist for all
143
+ the 6 days. After this, the supervised 1‑h sessions were given
144
+ 3  days a week by the therapist and subjects were asked to
145
+ do self‑practice for the other 3 days of the week for the next
146
+ 2 months. After 3 months, they were asked to practice daily
147
+ on their own with weekly follow‑up classes when the therapist
148
+ reviewed their diary of daily practice and clarified the queries
149
+ of both groups. The detailed list of yoga therapy practices is
150
+ given in Table 1.
151
+ The control group subjects did brisk walk for 1.5 h followed by
152
+ supine rest for 6 days 1 week under supervision. Lectures were
153
+ given on breast health, medical concept of a healthy lifestyle,
154
+ and benefits of diet and exercise. Attendance was taken for both
155
+ the groups.
156
+ Sociodemographic details were obtained with the screening check
157
+ list. Cleeland’s Breif pain inventory and body mass index (BMI)
158
+ were documented after the clinical examination by the clinician.
159
+ Ultrasound scanning of the breast to look for fibroadenoma/cysts
160
+ and blood test to look for hypothyroidism were performed before
161
+ starting the intervention. Psychological assessments were done
162
+ by administering QoL and Beck Depression Inventory  (BDI)
163
+ questionnaires before and at 3 months and 6 months after the
164
+ intervention.
165
+ BDI, developed by Dr. Beck in 1961,[10] aims to evaluate the
166
+ risk of depression and level of depressive symptoms objectively.
167
+ The inventory consists of 21 questions, each with four possible
168
+ answers scored between 0 and 3, with the total score ranging
169
+ 0–63. The total score demonstrates the level of depression.
170
+ The score for each item ranges 0–3 and the range of total
171
+ score is 0–63. A score of 0 ≤ 9: No depression, 10–19: Mild
172
+ depression, 20–25: Moderate depression, and 26 and above:
173
+ Severe depression. BDI has been used widely and has Cronbach’s
174
+ alpha coefficient of 0.80 and r 0.74. This instrument has a
175
+ reliability of 0.48–0.86 and validity of 0.67 with the Diagnostic
176
+ Raghunath, et al.: Yoga in improving women’s quality of life with mastalgia/yoga in improving quality of life in women with mastalgia
177
+ Journal of Health Research and Reviews | May ‑ August 2016 | Volume 3 | Issue 2
178
+ 50
179
+ and Statistical Manual of Mental Disorders (DSM) diagnostic
180
+ criteria for depression.[11]
181
+ BDI questionnaire attempts to measure the intensity, severity,
182
+ and depth of depression. It is commonly used in a clinical setting
183
+ as a novel way of diagnosing and categorizing depression in
184
+ psychiatric settings.
185
+ QoL reflects the psychological imbalances that result from amplified
186
+ responses to incorrectly perceived environmental situations. The
187
+ World Health Organization quality of life‑BREF (WHOQOL‑BREF),
188
+ which is the short version of the WHOQOL‑100, is widely used.
189
+ WHOQOL‑BREF consists of 26 items assessing the QoL in four
190
+ domains (Physical health, Psychological health, Social relationships
191
+ and Environment) and a general evaluative facet (overall QoL and
192
+ general health). The psychometric properties of the WHOQOL‑BREF
193
+ is considered good for assessment of QoL in women with benign
194
+ breast disease.[12] Higher the scores in WHOQOL‑BREF, higher is
195
+ the QoL. Chronbach’s alpha being >0.70.
196
+ Statistical analysis
197
+ Data was analyzed using 
198
+ “R” software (ver. 3.1.0). Although the
199
+ data were not distributed normally, parametric tests were conducted
200
+ because of the large sample size. The paired and independent t‑tests
201
+ were used to compare within and between group differences. The
202
+ data for the 6 month follow‑up were compared using repeated
203
+ measures analysis of variance (ANOVA). All tests were two‑tailed,
204
+ with an alpha level of 0.05 and the power maintained at 0.8.
205
+ RESULTS
206
+ Detailed participant flow chart is given in Figure 1.
207
+ The recruitment for the trial, data collection, and the baseline to
208
+ the 3rd month intervention, along with postdata collection were
209
+ from October 2013 to February 2014. Six months follow‑up was
210
+ done from March 2014 to August 2014.
211
+ All the 80 residential subjects were unmarried [Mean (M) =19.84,
212
+ standard deviation (SD) =1.15] (range: 18–25 years), the onset of
213
+ menarche was M = 12.66, SD = 0.97 (range: 11–15 years), the
214
+ duration of breast pain was M = 13.13, SD = 10.06 (range: 4–60
215
+ months), and the BMI was M = 20.61, SD = 3.23. The breast pain
216
+ score in the pain analog scale was M = 3.67, SD = 1.11 (range:
217
+ 3–6), a majority of the students, i.e., 58 (72.5%) had cyclical
218
+ mastalgia while 22  (27%) students had acyclical mastalgia.
219
+ Practice sessions varied from 56.89 ± 4.29 (out of 72 sessions)
220
+ in the yoga group and 54.83 ± 4.4 in the control group.
221
+ Average scores in QoL were 87.28 ± 6.16 in the yoga group and
222
+ 86.88 ± 7.07 in the control group. BDI scores were 15.28 ± 6.75
223
+ in the yoga group and 14.48 ± 4.67 in the control group. Detailed
224
+ sociodemographic data, along with psychological variables, are
225
+ shown in Table 2.
226
+ Results after the intervention
227
+ In QoL, comparison of means of the two groups by repeated
228
+ measures ANOVA 
229
+   showed highly significant between group
230
+ Table 1: List of yoga practices
231
+ Sl.
232
+ No
233
+ List of practices
234
+ Time (1 h 15 min)
235
+ I
236
+ Breathing exercises
237
+ Hands in and out breathing
238
+ Saśanka (moon) breathing
239
+ Tiger breathing/stretch
240
+ Bhujanga (cobra) breathing
241
+ Salabha (plough) breathing
242
+ II
243
+ Loosening exercises
244
+ Upper body twist
245
+ 4 min
246
+ Lateral bend
247
+ Forward-backward bend
248
+ III
249
+ Sun salutation (ṣūrya namaskāra)
250
+ 10 min
251
+ IV
252
+ Postures (āsanaās)
253
+ Standing poses
254
+ Half‑waist wheel pose (ardha kati cakrāsana)
255
+ 1 min
256
+ Half‑wheel pose (ārdha cakrāsana)
257
+ 1 min
258
+ Triangle pose (trikonāsana)
259
+ 1 min
260
+ Tree pose (vrkśāsana)
261
+ 1 min
262
+ Sitting poses
263
+ Cow face pose (gomukhāsana)
264
+ 1 min
265
+ Camel pose (uśtrāsana)
266
+ 1 min
267
+ Moon pose (ṣaśankāsana)
268
+ 1 min
269
+ Twisted pose (vakrāsana)
270
+ 1 min
271
+ Prone poses
272
+ Cobra pose (bhujangāsana)
273
+ 1 min
274
+ Bow pose (dhanurāsana)
275
+ 1 min
276
+ Plough pose (ṣalabhāsana)
277
+ 1 min
278
+ Supine poses
279
+ Shoulder stand (sarvāngāsana)
280
+ 1 min
281
+ V
282
+ Altered breathing (pranāyāma) and cleansing
283
+ technique (kriya)
284
+ Kriya
285
+ Active exhalation (kapāla bhāti)
286
+ 1 min
287
+ Sectional breathing
288
+ Abdominal, thoracic, clavicular, full yogic
289
+ breathing (vibhāgīya prānāyāma)
290
+ 2 min
291
+ Alternate nostril breathing (anuloma‑viloma)
292
+ 3 min
293
+ VI
294
+ Deep relaxation (śavāsana)
295
+ 10 min
296
+ VII
297
+ Meditation
298
+ Chanting of A, U, M, and Om (nādānusandhāna)
299
+ 4 min
300
+ Observing silence (dhyāna)
301
+ 5 min
302
+ VIII
303
+ Lectures
304
+ About culturing emotions, sātvik diet and
305
+ yogic counseling
306
+ 20 min
307
+ Figure 1: Participant flowchart
308
+ Raghunath, et al.: Yoga in improving women’s quality of life with mastalgia/yoga in improving quality of life in women with mastalgia
309
+ Journal of Health Research and Reviews | May ‑ August 2016 | Volume 3 | Issue 2
310
+ 51
311
+ effect, F (1, 67) =6881.41 (P < 0.001) in overall QoL. The
312
+ post hoc test (paired sample t‑test) showed highly significant
313
+ improvement at 3 months, t (37) =‑9.08, (P <.001) *** and
314
+ 6 months, t (37) = ‑7.34, (P <.001) *** in the yoga group as
315
+ compared to the control group. The detailed results of all the four
316
+ domains are presented in Table 3.
317
+ In BDI, comparison of means of the two groups by repeated
318
+ measures ANOVA showed highly significant reduction in
319
+ depression scores group effect: F (1, 67) =2632.72, P (<0.001).
320
+ The post hoc test (paired sample t‑test) showed significantly better
321
+ reduction at both 3 months: t (37) =12.96, (P <.001) *** and
322
+ 6 months: t (37) =8.90, (P <.001) *** in the yoga group as
323
+ compared to the control group [Table 3]. Degrees of depression
324
+ before and after intervention in both the groups are presented
325
+ in Table 4.
326
+ DISCUSSIONS
327
+ The present RCT on 80 nursing students in the age range of
328
+ 18–25 years with nonorganic breast pain looked at the effect
329
+ of yoga on QoL and depression in a 6‑month period. Results
330
+ of repeated measures ANOVA showed significant group time
331
+ interaction  (P  <  0.001). Post hoc tests revealed significant
332
+ improvement within the yoga group at the 3rd month and 6th month
333
+ follow‑up on all four domains of QoL and BDI [Figures 2 and 3].
334
+ Although some studies point to a negative association of pain and
335
+ depression with QoL in women with nonorganic mastalgia,[13]
336
+ very few interventional studies have measured QoL. Those
337
+ that did look at QoL after pharmacotherapy did not show a
338
+ significant change in QoL as many of them were associated with
339
+ adverse effects.[14] Looking at nonpharmacological therapies,
340
+ Table 2: Baseline characteristics of both the groups
341
+ Variables
342
+ Yoga (n=40)
343
+ Control (n=40)
344
+ Total (n=80)
345
+ Mean or N
346
+ SD or %
347
+ Mean or N
348
+ SD or %
349
+ Mean or N
350
+ SD or %
351
+ Age (years)
352
+ 20.10
353
+ 1.28
354
+ 19.58
355
+ 0.96
356
+ 19.84
357
+ 1.15
358
+ Height (cm)
359
+ 155.08
360
+ 7.35
361
+ 155.95
362
+ 4.50
363
+ 155.51
364
+ 6.07
365
+ Weight (kg)
366
+ 48.90
367
+ 6.86
368
+ 50.85
369
+ 9.72
370
+ 49.88
371
+ 8.42
372
+ BMI
373
+ 20.33
374
+ 2.43
375
+ 20.90
376
+ 3.88
377
+ 20.61
378
+ 3.23
379
+ Age at menarche
380
+ 12.48
381
+ 1.06
382
+ 12.85
383
+ 0.83
384
+ 12.66
385
+ 0.97
386
+ Numberof students
387
+ I BSc
388
+ 3
389
+ 7.5
390
+ 3
391
+ 7.5
392
+ 6
393
+ 7.5
394
+ II BSc
395
+ 13
396
+ 16.25
397
+ 11
398
+ 27.5
399
+ 24
400
+ 30
401
+ III BSc
402
+ 13
403
+ 16.25
404
+ 12
405
+ 30
406
+ 25
407
+ 31.25
408
+ I GNM
409
+ 8
410
+ 20
411
+ 8
412
+ 20
413
+ 16
414
+ 20
415
+ II GNM
416
+ 3
417
+ 7.5
418
+ 6
419
+ 15
420
+ 9
421
+ 11.25
422
+ Regular menstrual cycle (n)
423
+ 28
424
+ 70
425
+ 33
426
+ 82.5
427
+ 61
428
+ 76.25
429
+ Irregular menstrual cycle (n)
430
+ 12
431
+ 30
432
+ 7
433
+ 17.5
434
+ 19
435
+ 23.75
436
+ Menstrual pain (n)
437
+ 2
438
+ 5
439
+ 30
440
+ 75
441
+ 32
442
+ 40
443
+ Mastalgia (n)
444
+ Cyclical
445
+ 30
446
+ 75
447
+ 28
448
+ 70
449
+ 58
450
+ 72.5
451
+ Acyclical
452
+ 10
453
+ 25
454
+ 12
455
+ 30
456
+ 22
457
+ 27.5
458
+ Breast pain: Duration in months (mean)
459
+ 13.78
460
+ 11.05
461
+ 12.38
462
+ 8.97
463
+ 13.13
464
+ 10.06
465
+ Breast pain score (mean)
466
+ 3.85
467
+ 1.17
468
+ 3.63
469
+ 1.10
470
+ 3.67
471
+ 1.11
472
+ Family history of breast cancer
473
+ 2
474
+ 5
475
+ 0
476
+ 0
477
+ 2
478
+ 5
479
+ BMI: Body mass index, BSC: Bachelor of Science, GNM: General nursing midwifery, SD: Standard deviation. The two groups were matched on all variables
480
+ (P>0.05 in independent samples t‑test)
481
+ Table 3: Results after intervention in both the groups
482
+ Variable
483
+ Group
484
+ Baseline
485
+ 3 Months
486
+ Sig within groups
487
+ (0-3 months)
488
+ 6 Months
489
+ Sig within groups
490
+ (0‑6 months)
491
+ RM ANOVA
492
+ between groups
493
+ Mean
494
+ SD
495
+ Mean
496
+ SD
497
+ T (p)
498
+ Mean
499
+ SD
500
+ T (p)
501
+ QoL D1
502
+ Yoga
503
+ 26.45
504
+ 2.82
505
+ 30.84
506
+ 3.96
507
+ 7.08 (<0.01)
508
+ 30.39
509
+ 3.07
510
+ 5.71 (<0.001)
511
+ 1045.01(<0.001)
512
+ Control
513
+ 25.61
514
+ 3.21
515
+ 24.4
516
+ 2.45
517
+ 2.92 (=0.01)
518
+ 27.2
519
+ 3.61
520
+ 2.28 (0.02)
521
+ QoL D2
522
+ Yoga
523
+ 21.16
524
+ 2.15
525
+ 25.6
526
+ 2.55
527
+ −7.88 (<0.001)
528
+ 25.6
529
+ 3.42
530
+ 6.3 (<0.001)
531
+ 471.58(<0.001)
532
+ Control
533
+ 20.55
534
+ 1.8
535
+ 20.4
536
+ 2.06
537
+ 0.31 (=0.75)
538
+ 22.9
539
+ 3.25
540
+ 3.77 (0.001)
541
+ QoL D3
542
+ Yoga
543
+ 11.5
544
+ 1.43
545
+ 13.4
546
+ 1.64
547
+ −5.68 (<0.001)
548
+ 12.7
549
+ 2.42
550
+ 2.79 (0.008)
551
+ 167.96(<0.001)
552
+ Control
553
+ 12.16
554
+ 1.0
555
+ 11.6
556
+ 0.99
557
+ 2.53 (=0.01)
558
+ 11.8
559
+ 1.24
560
+ 1.07 (0.29)
561
+ QoL D4
562
+ Yoga
563
+ 28.37
564
+ 3.16
565
+ 34.7
566
+ 3.79
567
+ −8.06 (<0.001)
568
+ 34.2
569
+ 4.71
570
+ 6.91 (<0.001)
571
+ 1087.42(<0.001)
572
+ Control
573
+ 29.13
574
+ 3.03
575
+ 28.1
576
+ 2.65
577
+ 1.87 (=0.07)
578
+ 30
579
+ 3.94
580
+ 1.05 (0.30)
581
+ QoL total
582
+ Yoga
583
+ 87.47
584
+ 6.25
585
+ 105
586
+ 11.0
587
+ −9.08 (<0.001)
588
+ 103
589
+ 11.6
590
+ 7.34 (<0.001)
591
+ 6881.41(<0.001)
592
+ Control
593
+ 87.45
594
+ 7.22
595
+ 84.5
596
+ 6.19
597
+ 2.60 (=0.01)
598
+ 91.9
599
+ 10.7
600
+ 2.19 (0.03)
601
+ BDI
602
+ Yoga
603
+ 15.11
604
+ 6.88
605
+ 1.08
606
+ 1.22
607
+ 12.96 (<0.001)
608
+ 3.21
609
+ 5.79
610
+ 8.90 (<0.001)
611
+ 2632.72(<0.001)
612
+ Control
613
+ 15.19
614
+ 4.94
615
+ 12.1
616
+ 5.61
617
+ 2.60 (=0.01)
618
+ 19.1
619
+ 4.74
620
+ 3.72 (=0.001)
621
+ BDI: Beck depression inventory, ANOVA: Analysis of variance, D1 to D4: Domain 1 to domain 4, RM: Repeated measures, QoL: Quality of life
622
+ Raghunath, et al.: Yoga in improving women’s quality of life with mastalgia/yoga in improving quality of life in women with mastalgia
623
+ Journal of Health Research and Reviews | May ‑ August 2016 | Volume 3 | Issue 2
624
+ 52
625
+ a pilot study of acupuncture on 37 women with noncyclic
626
+ breast pain gave four acupuncture sessions over two weeks,
627
+ with 3 months follow‑up showing no significant improvement
628
+ in any of the domains (mental, physical, emotional, social, or
629
+ spiritual well‑being) of QoL although there was a significant
630
+ reduction (P < 0.05) in the pain scores by about 67% and pain
631
+ interference by about 56%.
632
+ A randomized pre‑post intervention study on 98 (66 experimental
633
+ and 32 control) Turkish patients with nonorganic mastalgia
634
+ looked at the effect of a session of psychoeducation on QoL and
635
+ pain [visual analog scale (VAS)]. While the baseline QOL in both
636
+ groups was poorer than the normative values for Turkish women,
637
+ the QoL of those who had psychoeducation was significantly
638
+ better (SF‑36) after 2 months as compared to the control group.[15]
639
+ As there are no published studies on yoga in patients with
640
+ mastalgia, we have made an attempt to compare the effect
641
+ of integrated yoga (similar yoga module in a similar setting)
642
+ with that of other nonorganic pain conditions. In patients with
643
+ mechanical chronic lower back pain admitted for yoga therapy,[16]
644
+ the baseline mean QoL (12 to 13) was much lower in all domains
645
+ of WHOQOL‑BREF than our study (22 to 29) except the social
646
+ domain in which it was 11.5 in our study. The improvement
647
+ observed was highly significant in both studies (16–28% in back
648
+ pain study and 10– 20% in the present study) although the groups
649
+ were different in their demography (both genders and higher age
650
+ in the back pain study). A similar work by Deshpande et al. on
651
+ normal volunteers also looked at the QoL, which showed similar
652
+ improvements after 3 months intervention on all domains of
653
+ WHOQOL‑100.[17]
654
+ Results of integrated yoga in patients with osteoarthritis of the
655
+ knee showed about 20–30% increase in (SF36) QoL.[18]
656
+ In the survey on 105 Turkish women with mastalgia with a mean
657
+ score of 5 on VAS (1–10), 58% were depressive, 30% were
658
+ anxious, and 4% were depressive and anxious.[13] Yilmaz, Enver
659
+ Demirel et al. showed that anxiety, depression, harm avoidance,
660
+ self‑directedness, and self‑transcendence scores were significantly
661
+ higher in premenopausal women with mastalgia in comparison
662
+ with the age‑matched healthy control group of premenopausal
663
+ women.[19]
664
+ A BDI score [Table 4] less than 9 indicates no depression and that
665
+ between 10 and 19 indicates mild depression. The mean baseline
666
+ scores in our sample (around 15) showed that both the groups
667
+ were in this range of mild depression and the yoga group moved
668
+ to normal values (<9) at 3 months. In the control group, there
669
+ were a good number (16) of subjects with reduced depression
670
+ scores at the 3rd month who reverted back to depression in the
671
+ 6th month although they had the same instructions, monitoring,
672
+ and counseling by the therapists at regular intervals; the BDI
673
+ scores in the back pain study also showed similar trends with
674
+ significant reduction in mean scores moving from mild depression
675
+ zone (12.13) to no depression zone (6.43).[16]
676
+ The various domains of the WHOQOL‑BREF assessed in this
677
+ study are described below.
678
+ The physical health domain deals with features such as
679
+ mobility, fatigue, pain, sleep, and work capacity. The observed
680
+ improvement can be attributed to better physical stamina that
681
+ Table 4: BDI-Number of subjects in different degrees of depression before and after intervention (n yoga-38; control-31)
682
+ BDI
683
+ scores
684
+ Depression
685
+ Baseline
686
+ 3 months
687
+ 6 months
688
+ Y
689
+ C
690
+ Y
691
+ C
692
+ Y
693
+ C
694
+ n
695
+ %
696
+ n
697
+ %
698
+ n
699
+ %
700
+ n
701
+ %
702
+ N
703
+ %
704
+ n
705
+ %
706
+ 0-9
707
+ Nil
708
+ 7
709
+ 18.42
710
+ 0
711
+ 0
712
+ 38
713
+ 100
714
+ 16
715
+ 51.61
716
+ 32
717
+ 84.21
718
+ 0
719
+ 0
720
+ 10-19
721
+ Mild
722
+ 22
723
+ 57.89
724
+ 27
725
+ 71.05
726
+ 0
727
+ 0
728
+ 9
729
+ 29.03
730
+ 5
731
+ 13.16
732
+ 14
733
+ 45.16
734
+ 20-25
735
+ Moderate
736
+ 9
737
+ 23.68
738
+ 4
739
+ 10.53
740
+ 0
741
+ 0
742
+ 6
743
+ 19.35
744
+ 1
745
+ 2.63
746
+ 17
747
+ 54.84
748
+ >26
749
+ Severe
750
+ 0
751
+ 0
752
+ 0
753
+ 0
754
+ 0
755
+ 0
756
+ 0
757
+ 0
758
+ 0
759
+ 0
760
+ 0
761
+ 0
762
+ BDI: Beck depression inventory
763
+ 0.00
764
+ 5.00
765
+ 10.00
766
+ 15.00
767
+ 20.00
768
+ 25.00
769
+ 30.00
770
+ 35.00
771
+ Baseline (0)
772
+ 3 month
773
+ 6 month
774
+ Quality Of Life Yoga
775
+ Quality Of Life Control
776
+ Figure 2: Bar graph for QoL mean shift from the baseline, intervention
777
+ at the end of 3 months, and follow-up after 6 months between the yoga
778
+ group (n = 38) and control group (n = 31)
779
+ 0
780
+ 5
781
+ 10
782
+ 15
783
+ 20
784
+ 25
785
+ Baseline (0)
786
+ 3 month
787
+ 6 month
788
+ BDI Yoga
789
+ BDI Control
790
+ Figure 3: Bar graph for Beck Depression Inventory (BDI) mean shift from
791
+ the baseline, intervention at the end of 3 months, and follow-up after 6
792
+ months between the yoga group (n = 38) and control group (n = 31)
793
+ Raghunath, et al.: Yoga in improving women’s quality of life with mastalgia/yoga in improving quality of life in women with mastalgia
794
+ Journal of Health Research and Reviews | May ‑ August 2016 | Volume 3 | Issue 2
795
+ 53
796
+ occurs after maintained stretches followed by deep rest. Other
797
+ studies on integrated yoga in healthy children and adults have
798
+ shown better physical stamina.[20] Better quality and duration of
799
+ sleep after yoga have been reported in the elderly too.[21]
800
+ In the psychological health domain, the improvement seen
801
+ deals with questions relating to feelings, self‑esteem, spirituality,
802
+ thinking, learning, memory, etc., may be attributed to a reduction
803
+ in depression. Yoga is defined as “mastery over the modifications
804
+ of the mind” (Patañjali),[22] which is the goal of our integrated
805
+ yoga program; several studies have shown the effect of yoga in
806
+ reducing anxiety,[23] depression,[24] and stress,[25] with enhanced
807
+ mental health as observed by improved perceptual sharpness[26]
808
+ and memory.[27]
809
+ Social health domain has questions relating to problems with
810
+ interpersonal relationships, social support, etc., which could
811
+ be the main source of stress contributing to mastalgia. In this
812
+ domain, the baseline scores [Table 3] were lesser than the other
813
+ three domains in both the groups of students, which improved
814
+ significantly after the intervention. These were addressed during
815
+ lectures and at a personal level in yoga counseling sessions. They
816
+ were aimed at achieving an introspective cognitive change by
817
+ recognizing the psychological freedom “to react, not to react or
818
+ change the usual pattern of reaction to situations” highlighted
819
+ in yoga texts.[28]
820
+ Environmental health domain has questions that deal with
821
+ problems relating to financial resources, physical safety, and
822
+ adaptability to physical environment such as pollution, noise,
823
+ and climate. One of the definitions of yoga (Bhagavad Gīta) says
824
+ that yoga results in equanimity and balance (samatvam) that can
825
+ help in better tolerance to environmental changes.[29]
826
+ Studies have shown that yoga changes the physiological
827
+ responses to stressors by improving autonomic stability with
828
+ better parasympathetic tone in normal adults.[30]
829
+ There is evidence to suggest that cyclical mastalgia is caused
830
+ by a latent stress‑induced hormonal imbalance as indicated
831
+ by hyper prolactinemia.[31] It is observed that patients with
832
+ cyclic mastalgia and noncyclic mastalgia have increased
833
+ catecholamine and decreased baseline dopamine level, which
834
+ suggests that catecholamine may be released due to stress,
835
+ resulting in altered abnormal sensitivity of the breast tissue.[32]
836
+ Yoga may improve the QoL by promoting voluntary reduction
837
+ in violence and aggressiveness.[33] Mastery over the emotional
838
+ reactions of anxiety[34] or depression[24] is achieved through restful
839
+ awareness during all the practices in general and meditation
840
+ in particular.[35] Kundalini yoga is found to be beneficial in
841
+ cases of depression. It stimulates the various autonomic nerve
842
+ plexus  (chakras) and activates pineal organ, which in turn
843
+ brings homeostasis between sympathetic and parasympathetic
844
+ activities.[36] This mastery over emotional surges leads to
845
+ controlled and need‑based physiological responses that may
846
+ reduce the overtones of hypothalamus‑pituitary‑adrenal (HPA)
847
+ axis[37] during chronic pain. Yoga has an influence on the HPA
848
+ axis as evidenced by a reduction in cortisol levels in normal[38]
849
+ and sick individuals.[39,40]
850
+ Hence, it appears that the beneficial effects of yoga in mastalgia
851
+ could be mediated through HPA axis by stabilizing the HPA axis
852
+ and promoting autonomic balance. We may hypothesize that
853
+ yoga helps in restoring the normal biorhythm of reproductive
854
+ hormones in cases of cyclical or noncyclical mastalgia and thus,
855
+ improve the QoL .
856
+ Strength of the study
857
+ To the best of our knowledge, this is the first randomized
858
+ controlled study (RCT) on the role of yoga therapy in measuring
859
+ QoL and depression in nursing students with mastalgia. The
860
+ strengths of this RCT study are adequate sample size, supervised
861
+ practice sessions, randomization, and the 6 months follow‑up
862
+ with very few dropouts. The uniqueness of the results was the
863
+ highly significant reduction in depression scores and improved
864
+ QoL scores. This offers the first evidence to introduce yoga as
865
+ a noninvasive and cost‑effective therapy in treating mastalgia.
866
+ Limitations of the study
867
+ This study only addressed mastalgia as a solicited symptom.
868
+ Further study on patients presenting with mastalgia with or
869
+ without associated fibroadenosis and fibrocystic breast condition
870
+ will provide an insight into the use and acceptability of yoga as
871
+ an intervention in a clinical setting.
872
+ CONCLUSION
873
+ This randomized control study of 12 weeks of integrated yoga
874
+ therapy with 6 months follow‑up has shown that nursing students
875
+ with mastalgia showed a good improvement in QoL and the
876
+ decreased depression scores than physical therapy exercises for
877
+ mastalgia.
878
+ Acknowledgements
879
+ We are thankful to the Research Officer and the Vice Chancellor,
880
+ SVYASA, Bengaluru, Karnataka, India for funding and supporting
881
+ this project. We extend our gratitude to the Principal of the
882
+ college for permitting us to carry out the trial and the teachers
883
+ and the staff for assisting us in data collection and supervising
884
+ both the trial groups. We thank Dr. Judu Ilavarasu for his help
885
+ in the statistical analysis. We also thank the yoga therapists
886
+ for giving the sessions. We also extend our heartfelt thanks to
887
+ all the nursing students for their wholehearted participation in
888
+ the study.
889
+ Financial support and sponsorship
890
+ Institutional funding, SVYASA, Bangalore, Karnataka, India.
891
+ Conflicts of interest
892
+ We do not have any conflicts of interest.
893
+ REFERENCES
894
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895
+ Naz N, Sohail S, Memon MA. Utility of breast imaging in mastalgia.
896
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898
+ Saeed Na. Is oil of evening primrose effective for mastalgia: A comparison
899
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+ Deschamps M, Band PR, Coldman AJ, Hislop TG, Longley DJ. Clinical
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+ determinants of mammographic dysplasia patterns. Cancer Detect Prev
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+ Raghunath, et al.: Yoga in improving women’s quality of life with mastalgia/yoga in improving quality of life in women with mastalgia
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+ Journal of Health Research and Reviews | May ‑ August 2016 | Volume 3 | Issue 2
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908
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910
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912
+ Ader DN, South‑Paul J, Adera T, Deuster PA. Cyclical mastalgia:
913
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916
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920
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923
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929
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930
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931
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933
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934
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936
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939
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940
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942
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944
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945
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948
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952
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954
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956
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959
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960
+ Ebnezar J, Nagarathna R, Bali Y, Nagendra HR. Effect of an integrated
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962
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964
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965
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966
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967
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968
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970
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972
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977
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978
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979
+ Michalsen A, Jeitler M, Brunnhuber S, Lüdtke R, Büssing A, Musial F, et al.
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+ Iyengar yoga for distressed women: A 3‑armed randomized controlled
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+ 24.
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+ Sharma VK, Das S, Mondal S, Goswampi U, Gandhi A. Effect of Sahaj
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+ Yoga on depressive disorders. Indian J Physiol Pharmacol 2015;49:462‑8.
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+ 25.
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+ Carmody J, Baer RA. Relationships between mindfulness practice
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+ and levels of mindfulness, medical and psychological symptoms and
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+ well‑being in a mindfulness‑based stress reduction program. J Behav
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+ Telles S, Nagarathna R, Nagendra HR. Improvement in visual perception
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+ following yoga training. J Indian Psychol 1995;13:30‑2.
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+ Naveen KV, Nagarathna R, Nagendra HR, Telles S. Yoga breathing
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+ through a particular nostril increases spatial memory scores without
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+ lateralized effects. Psychol Rep 1997;81:555‑61.
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+ Bangalore: Swami Vivekananda Yoga Prakashana; 2001.
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+ Tapasyānanda S. Srimad Bhagavad Gita. Mylapore: Sri Ramakrishna
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+ Math; 2000.
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+ Telles S, Nagarathna R, Nagendra HR. Breathing through a particular
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+ nostril can alter metabolism and autonomic activities. Indian J Physiol
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+ Pharmacol 1994;38:133‑7.
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+ Deshpande S, Nagendra HR, Raghuram N. A randomized control trial of
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+ Int J Yoga 2008;1:76‑82.
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+ Miller JJ, Fletcher K, Kabat‑Zinn J. Three‑year follow‑up and clinical
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+ Devi SK, Chansauria JP, Udupa KN. Mental depression and kundalini
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+ yoga. Anc Sci Life 1986;6:112‑8.
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+ Leonard BE. HPA and immune axes in stress: Involvement of the
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+ 38.
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+ Kamei T, Toriumi Y, Kimura H, Ohno S, Kumano H, Kimura K. Decrease
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+ in serum cortisol during yoga exercise is correlated with alpha wave
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+ activation. Percept Mot Skills 2000;90:1027‑32.
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+ 39.
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+ Vadiraja HS, Raghavendra RM, Nagarathna R, Nagendra HR, Rekha M,
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+ Vanitha N, et al. Effects of a yoga program on cortisol rhythm and mood
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+ states in early breast cancer patients undergoing adjuvant radiotherapy:
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+ A randomized controlled trial. Integr Cancer Ther 2009;8:37‑46.
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+ 40.
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+ Curtis K, Osadchuk A, Katz J. An eight‑week yoga intervention is
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+ associated with improvements in pain, psychological functioning and
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+ J Pain Res 2011;4:189‑201.
subfolder_0/Effects of an integrated yoga program on chemotherapy induced nausea and emesis in breast cancer patients..txt ADDED
@@ -0,0 +1,1710 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ © 2007 The Authors
2
+ Journal compilation © 2007 Blackwell Publishing Ltd
3
+ European Journal of Cancer Care, 2007, 16, 462–474
4
+ Original article
5
+ Effects of an integrated yoga programme on chemotherapy-
6
+ induced nausea and emesis in breast cancer patients
7
+ R.M. RAGHAVENDRA, bnys, phd, Department of Life Sciences, Swami Vivekananda Yoga Anusandhana Samst-
8
+ hana, R. NAGARATHNA, md, frcp (edin), Department of Life Sciences, Swami Vivekananda Yoga Anusandhana
9
+ Samsthana, H.R. NAGENDRA, phd, Department of Life Sciences, Swami Vivekananda Yoga Anusandhana Sam-
10
+ sthana, K.S. GOPINATH, ms, Department of Surgical Oncology, Bangalore Institute of Oncology, B.S. SRINATH,
11
+ ms, Department of Surgical Oncology, Bangalore Institute of Oncology, B.D. RAVI, md, Department of Medical
12
+ Oncology, Bangalore Institute of Oncology, S. PATIL, md, Department of Medical Oncology, Bangalore Institute
13
+ of Oncology, B.S. RAMESH, md, Department of Radiation Oncology, Bangalore Institute of Oncology, &
14
+ R. NALINI, md, Department of Radiation Oncology, Bangalore Institute of Oncology, Bangalore, India
15
+ RAGHAVENDRA R.M., NAGARATHNA R., NAGENDRA H.R., GOPINATH K.S., SRINATH B.S.,
16
+ RAVI B.D., PATIL S., RAMESH B.S. & NALINI R. (2007) European Journal of Cancer Care 16, 462–474
17
+ Effects of an integrated yoga programme on chemotherapy-induced nausea and emesis in breast cancer patients
18
+ This study examined the effect of an integrated yoga programme on chemotherapy-related nausea and emesis
19
+ in early operable breast cancer outpatients. Sixty-two subjects were randomly allocated to receive yoga (n = 28)
20
+ or supportive therapy intervention (n = 34) during the course of their chemotherapy. Both groups had similar
21
+ socio-demographic and medical characteristics. Intervention consisted of both supervised and home practice
22
+ of yoga sessions lasting for 60 min daily, while the control group received supportive therapy and coping
23
+ preparation during their hospital visits over a complete course of chemotherapy. The primary outcome
24
+ measure was the Morrow Assessment of Nausea and Emesis (MANE) assessed after the fourth cycle of
25
+ chemotherapy. Secondary outcomes included measures for anxiety, depression, quality of life, distressful
26
+ symptoms and treatment-related toxicity assessed before and during the course of chemotherapy. Following
27
+ yoga, there was a significant decrease in post-chemotherapy-induced nausea frequency (P = 0.01) and nausea
28
+ intensity (P = 0.01), and intensity of anticipatory nausea (P = 0.01) and anticipatory vomiting (P = 0.05) as
29
+ compared with the control group. There was a significant positive correlation between MANE scores and
30
+ anxiety, depression and distressful symptoms. In conclusion, the results suggest a possible use for stress
31
+ reduction interventions such as yoga in complementing conventional antiemetics to manage chemotherapy-
32
+ related nausea and emesis.
33
+ Keywords: yoga, meditation, nausea, vomiting, complementary therapies, supportive care, stress.
34
+ Correspondence address: Raghuram Nagarathna, Dean, Division of Life
35
+ Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, No-19,
36
+ Eknath Bhavan, Gavipuram Circle, K.G Nagar, Bangalore-560019, India
37
+ (e-mail: [email protected]).
38
+ Accepted 18 September 2006
39
+ DOI: 10.1111/j.1365-2354.2006.00739.x
40
+ INTRODUCTION
41
+ Nausea and emesis are two of the most distressing side
42
+ effects of chemotherapy and are experienced by as many as
43
+ 66–91% of patients receiving chemotherapy (Rhodes &
44
+ McDaniel 2001). Complete control of emesis (i.e. no vom-
45
+ iting with currently available antiemetic agents) is achiev-
46
+ able in a majority of patients in the first 24 h and in only
47
+ Yoga for CINV
48
+ © 2007 The Authors
49
+ 463
50
+ Journal compilation © 2007 Blackwell Publishing Ltd
51
+ 45% of patients during the first 5–7 days of chemotherapy
52
+ (Gralla et al. 1999; Roila et al. 2005). However, chemo-
53
+ therapy-induced nausea occurs at a greater frequency than
54
+ vomiting and, despite the use of new-generation antiemet-
55
+ ics, complete control rates for nausea remain low as com-
56
+ pared with those for emesis (Perez et al. 1998). Another
57
+ significant problem is that a substantial gap remains
58
+ between antiemetic guidelines and practice and that most
59
+ of these guidelines may not be widely implemented even
60
+ in developed countries (De Angelis et al. 2003). This is
61
+ even more so for developing countries such as India and
62
+ other countries where nausea and emesis following che-
63
+ motherapy are not adequately managed because of low
64
+ affordability of new-generation antiemetic medications.
65
+ However, various psychological techniques, such as cog-
66
+ nitive behaviour therapy, biofeedback, relaxation, sup-
67
+ portive therapy and coping preparation interventions,
68
+ have been shown to complement antiemetics in managing
69
+ chemotherapy-related nausea and emesis (Burish et al.
70
+ 1991; Burish & Tope 1992). We therefore evaluated the
71
+ benefits of using traditional intervention strategies such
72
+ as yoga and meditation in comparison with standard
73
+ supportive care and coping preparation in managing
74
+ chemotherapy-related nausea and emesis.
75
+ There is a high prevalence of nausea and emesis follow-
76
+ ing chemotherapy. This is attributed to high doses of eme-
77
+ togenic antineoplastic agents and anticipatory nausea and
78
+ emesis (King 1997). Distressing symptoms (such as nau-
79
+ sea, vomiting, retching, anorexia, motion sickness, head-
80
+ aches, etc.) commonly occur after chemotherapy and
81
+ antiemetogenic administration. These distressing symp-
82
+ toms can impede the ability of patients to perform normal
83
+ household tasks, enjoy meals, and maintain daily function
84
+ and recreation, thereby reducing their quality of life
85
+ (Osoba et al. 1997). Some patients may even see the treat-
86
+ ment and resulting distress worse than the disease itself
87
+ (Rimer et al. 1983), while some may even discontinue the
88
+ prescribed course of chemotherapy (Burish & Tope 1992),
89
+ thereby reducing hope of recovery and life expectancy
90
+ (Gilbar 1991).
91
+ Studies have shown that some of these side effects that
92
+ develop after chemotherapy may be partly psychological
93
+ rather than purely pharmacological in nature (Burish &
94
+ Tope 1992). Nearly 70% of patients who experience ant-
95
+ icipatory nausea and emesis attribute these side effects to
96
+ a psychological aetiology (Morrow 1982). This may be
97
+ because the information from the vomiting centre in the
98
+ brain to higher brain centres is involved in the perception
99
+ of nausea and vice versa (Hawthorn 1995). Various studies
100
+ have shown risk factors such as motion sickness, vomit-
101
+ ing related to particular foods, and pre-treatment anxiety
102
+ and expectations (Jacobsen et al. 1988; Morrow et al.
103
+ 1991)
104
+ to
105
+ have
106
+ a
107
+ strong
108
+ predisposition
109
+ for
110
+ post-
111
+ chemotherapy and anticipatory nausea and vomiting, and
112
+ these can further exacerbate the responses to conditioned
113
+ stimuli in these subjects (Mattes et al. 1987). Therefore,
114
+ these strong relationships between psychosocial variables,
115
+ nausea and emesis justify the need for integrating mind/
116
+ body therapies with pharmacological interventions in
117
+ managing treatment-related nausea and emesis (Schwartz
118
+ et al. 1996).
119
+ Studies show that complementary and alternative med-
120
+ icine (CAM) and mind/body approaches such as hypnosis,
121
+ progressive muscle relaxation training with guided imag-
122
+ ery, music therapy, acupuncture, acupressure, systematic
123
+ desensitization, biofeedback and distraction are useful in
124
+ reducing nausea and emesis either alone or in combina-
125
+ tion with antiemetics and anxiolytic medications (Redd
126
+ et al. 2001; Mundy et al. 2003). Of these, relaxation with
127
+ guided imageries has been studied extensively, and has
128
+ been shown to reduce the duration and frequency of both
129
+ acute and delayed nausea and emesis following chemo-
130
+ therapy in subjects with poor control of nausea and vom-
131
+ iting (Burish & Tope 1992; Arakawa 1997; Molassiotis
132
+ et al. 2002). Most of these techniques reduce anxiety,
133
+ physiological arousal and psychological distress in cancer
134
+ patients through stress reduction (Morrow & Rosenthal
135
+ 1996). A growing interest in the use of these therapies
136
+ reflects a need for a more holistic approach to cancer treat-
137
+ ment (Cassileth 1999).
138
+ Yoga as a complementary modality is being practised
139
+ increasingly in both Indian and western population. Yoga
140
+ practices have been used for therapeutic benefits in
141
+ numerous health-care concerns, such as asthma (Nagar-
142
+ athna & Nagendra 1985), diabetes (Sahay & Sahay 2002),
143
+ hypertension (Sainani 2003), heart disease (Jayasinghe
144
+ 2004), musculoskeletal disorders (Raub 2002), cancer
145
+ (Cohen et al. 2004) and others in which mental stress
146
+ (Gimbel 1998; Bijlani 2004) was believed to play a role.
147
+ These practices include several techniques, such as
148
+ asanas (postures done with awareness), pranayama (vol-
149
+ untarily regulated nostril breathing), yoga nidra (guided
150
+ relaxation with imagery) and meditation, which promote
151
+ physical well-being and mental calmness. These practices
152
+ are known to build inner awareness and attention of men-
153
+ tal phenomena. This is thought to alter the perceptions
154
+ and mental responses to both external and internal stim-
155
+ uli, slow down reactivity and responses to such stimuli,
156
+ and instill a greater control over stressful situations. This
157
+ could be particularly useful in cancer patients who per-
158
+ ceive cancer as a threat. Recent randomized waitlist con-
159
+ trolled studies using meditation and mindfulness yoga
160
+ RAGHAVENDRA et al.
161
+ 464
162
+ © 2007 The Authors
163
+ Journal compilation © 2007 Blackwell Publishing Ltd
164
+ components (Mindfulness-Based Stress Reduction pro-
165
+ gramme) have found beneficial effects in terms of
166
+ improved affective states; decrease in mood disturbance,
167
+ stress symptoms and disturbed sleep; improved quality of
168
+ life; and benefits in terms of improved immune responses
169
+ in early breast (Speca et al. 2000; Targ & Levine 2002) and
170
+ prostate cancer patients (Carlson et al. 2003). However,
171
+ most of these studies involve heterogeneous cancer pop-
172
+ ulations at varying stages of their disease and treatment,
173
+ and evaluate quality of life and psychosocial outcomes.
174
+ However, studies reviewed using yoga/meditation com-
175
+ ponents do not address issues pertaining to conventional
176
+ treatment toxicity and chemotherapy-related nausea and
177
+ vomiting.
178
+ The purpose of this trial was to study whether a support
179
+ intervention based on mind/body and psycho-spiritual
180
+ interventions such as yoga might be a viable alternative to
181
+ standard supportive therapy and coping preparation in
182
+ reducing the frequency and intensity of nausea and emesis
183
+ in chemotherapy-naïve stage II and III breast cancer
184
+ patients receiving adjuvant chemotherapy.
185
+ METHODS
186
+ Subjects
187
+ This study is a part and continuation of the original ran-
188
+ domized control study that recruited 98 recently diag-
189
+ nosed women with stage II and III operable breast cancer
190
+ to assess the effect of a yoga programme on mood, quality
191
+ of life, distressful symptoms, toxicity and immune
192
+ responses in early breast cancer patients undergoing con-
193
+ ventional treatment. These patients were recruited from
194
+ Bangalore Institute of Oncology, a comprehensive cancer
195
+ care centre in Bangalore, India, over a 2.5-year period from
196
+ January 2000 to June 2002. Only subjects who were on
197
+ adjuvant chemotherapy were included for analysis in this
198
+ study. Patients were eligible to participate in this study if
199
+ they met the following selection criteria at the start of the
200
+ study: (1) recently diagnosed operable breast cancer; (2)
201
+ aged between 30 and 70 years; (3) Zubrod’s performance
202
+ status 0–2 (ambulatory >50% of time); (4) high-school edu-
203
+ cation; (5) having a treatment plan with surgery followed
204
+ by adjuvant chemotherapy or by both adjuvant radiother-
205
+ apy and chemotherapy; and (6) consenting to participate in
206
+ the study. Subjects were excluded if they had any concur-
207
+ rent medical condition that was likely to interfere with
208
+ the treatment, major psychiatric, neurological illness or
209
+ autoimmune disorders, and any known metastases. Sub-
210
+ jects were excluded from analyses in the current study if
211
+ they had a history of intestinal obstruction and any
212
+ known sensitivity to any class of antiemetics (such as
213
+ 5HT3 receptor antagonists or dopamine receptor antago-
214
+ nists) and corticosteroids (such as dexamethasone). Of the
215
+ 98 subjects who were randomized to yoga and supportive
216
+ therapy initially at the start of the study, 62 subjects (yoga
217
+ n = 28; control n = 34) completed their prescribed chemo-
218
+ therapy cycles. There were 29 dropouts immediately fol-
219
+ lowing surgery, and seven subjects did not receive
220
+ chemotherapy (see trial profile, Fig. 1). The reasons for
221
+ dropouts were migration to other hospitals, use of other
222
+ complementary therapies (e.g. homeopathy or ayurveda),
223
+ lack of interest, time constraints and other concurrent
224
+ illness.
225
+
226
+ Randomization
227
+
228
+ Subjects consenting to participate in this study to com-
229
+ pare two interventions, ‘yoga versus supportive therapy
230
+ and coping preparation’, were randomly allocated to
231
+ receive either one of these interventions prior to their pri-
232
+ mary treatment or surgery, using random numbers gener-
233
+ ated by a random number table. These subjects were then
234
+ followed up with interventions and assessments during
235
+ their adjuvant treatment (radiotherapy and chemother-
236
+ apy). Randomization was performed using opaque enve-
237
+ lopes with group assignments. The envelopes were opened
238
+ sequentially in the order of assignment during rec-
239
+ ruitment, with the names and registration numbers of
240
+ the participants written on the covers. The order of ran-
241
+ domization was verified with the hospital date of admis-
242
+ sion records for surgery at study intervals to make sure
243
+ that field personnel had not altered the sequence of ran-
244
+ domization to suit the allocation of consenting partici-
245
+ pants into two study arms.
246
+ Procedure
247
+ This study evaluated the effects of yoga intervention ver-
248
+ sus supportive therapy and coping preparation in chemo-
249
+ therapy-naïve early stage II and III breast cancer patients
250
+ undergoing adjuvant chemotherapy. The subjects in the
251
+ study were prescribed four to eight cycles of FAC or CMF
252
+ or both as adjuvant chemotherapy protocols following
253
+ surgery, which was the standard care in the hospital
254
+ during the study period. The FAC protocol consisted of
255
+ 5-fluorouracil (600 mg/m2), adriamycin (60 mg/m2) and
256
+ cyclophosphamide (600 mg/m2), and the CMF protocol
257
+ consisted of cyclophosphamide (600 mg/m2), methotrex-
258
+ ate (50 mg/m2) and 5-fluorouracil (600 mg/m2). The stan-
259
+ dard approach to chemotherapy-related nausea and emesis
260
+ in the hospital when the study was conducted was 8-mg
261
+ Yoga for CINV
262
+ © 2007 The Authors
263
+ 465
264
+ Journal compilation © 2007 Blackwell Publishing Ltd
265
+ intravenous odansetron, with 8-mg dexamethasone given
266
+ as a bolus injection 30 min before chemotherapy. This
267
+ was followed by per-oral administration of either 8-mg
268
+ odansetron (Emeses) bid for the next 3 days after chemo-
269
+ therapy or 10-mg domperidone (Doomster) qid for 2 days
270
+ to control delayed nausea and vomiting. Some subjects in
271
+ the study were also prescribed anxiolytic medication,
272
+ such as lorazepam (Aprazolam 0.5 mg o.d.), by the medical
273
+ oncologists, who were blinded to the intervention.
274
+ During the chemotherapy protocol, subjects in both
275
+ groups were given intervention before starting their first
276
+ adjuvant chemotherapy cycle. Subjects who were on che-
277
+ motherapy were given a bolus injection of dexamethasone
278
+ 8 mg, with odansetron 8 mg intravenous 30 min before
279
+ chemotherapy. Thereafter, subjects in the yoga group were
280
+ taught bedside yoga relaxation by the instructor for the
281
+ next 30 min, while the participants and their spouses in
282
+ the control group were educated about chemotherapy-
283
+ related nausea and vomiting, food aversions, nutrition,
284
+ etc., and were counselled by the same yoga instructor,
285
+ who was trained in counselling cancer patients. Thereaf-
286
+ ter, subjects in the yoga group were provided with audio
287
+ and video cassettes of the yoga modules for home practice
288
+ and were asked to practise them every day for 1 h. Their
289
+ practice was also supervised once in 10 days by their
290
+ trainer through house visits. The supportive counselling
291
+ and coping preparation sessions were of 60-min duration
292
+ initially and lasted 30 min for the control group, given
293
+ during their hospital visits for chemotherapy and investi-
294
+ gations (once in 10 days). After each chemotherapy infu-
295
+ sion, patients were prescribed antiemetic regimens as
296
+ described above. They were asked to note down the epi-
297
+ sodes of vomiting and nausea duration after every cycle of
298
+ chemotherapy and, at the fourth cycle, they were asked to
299
+ complete the Morrow Assessment of Nausea and Emesis
300
+ (MANE) questionnaire, State Trait Anxiety Inventory
301
+ Figure 1. Patient flow chart. CT, chemo-
302
+ therapy; RT, radiotherapy.
303
+ 174 patients screened
304
+ 44 refused
305
+ 32 not eligible
306
+ 98 randomized
307
+ Yoga
308
+ 12 discontinued
309
+ Surgery
310
+ Supportive therapy
311
+ 17 discontinued
312
+ Post surgery 33 completed
313
+ /analysed
314
+ Post RT 32 completed/
315
+ analysed/
316
+ I did not receive RT
317
+ Number of CT cycles received
318
+ 4 cycles. 6 cycles. 8 cycles
319
+ (n = 3).
320
+ (n = 22).
321
+ (n = 3).
322
+ Exclusions due to
323
+ sensitivity ot CT
324
+ or antienetics in
325
+ both groups = Nil
326
+ Mid CT (4th cycle) 28
327
+ completed/analysed
328
+ 5 did not receive CT
329
+ Mid CT (4th cycle)
330
+ 34 completed/analysed
331
+ 2 did not receive CT
332
+ Number of CT cycles received
333
+ 4 cycles. 6 cycles. 8 cycles
334
+ (n = 3).
335
+ (n = 27).
336
+ (n = 4).
337
+ Post RT 35 completed/
338
+ analysed
339
+ I did not receive RT
340
+ Post surgery 36 completed
341
+ /analysed
342
+ (RT)
343
+ (CT)
344
+ RAGHAVENDRA et al.
345
+ 466
346
+ © 2007 The Authors
347
+ Journal compilation © 2007 Blackwell Publishing Ltd
348
+ (STAI), Beck’s Depression Inventory (BDI), Functional
349
+ Living Index for Cancer (FLIC) and symptom checklist
350
+ questionnaires.
351
+ Sixty-two patients (yoga n = 28; control n = 34) contrib-
352
+ uted data for the current analysis during chemotherapy.
353
+ Signed
354
+ informed
355
+ consent
356
+ was
357
+ obtained
358
+ from
359
+ all
360
+ participants.
361
+ Measures
362
+ During the initial visit, demographic information, includ-
363
+ ing age, marital status, education, occupation, obstetric
364
+ and gynaecological history, medical history and intake
365
+ of medications, was obtained, and clinical data were
366
+ abstracted on the history of breast cancer, investigative
367
+ notes and chemotherapy treatment regimen. The follow-
368
+ ing self-report questionnaires were distributed to the sub-
369
+ jects during the study.
370
+ The primary outcome measures were frequency and
371
+ intensity of both post-chemotherapy and anticipatory
372
+ nausea and vomiting assessed using the MANE scale. The
373
+ test–retest reliability of this descriptive scale has been
374
+ reported to range from 0.72 to 0.96 with different cancer
375
+ patient samples and different chemotherapy protocols
376
+ (Morrow 1992). Subjects were administered this question-
377
+ naire after the fourth chemotherapy cycle as anticipatory
378
+ nausea and emesis, which are learned responses to che-
379
+ motherapy, develop by about the fourth cycle in 25% of
380
+ the patients (Morrow & Rosenthal 1996).
381
+ The secondary outcome measures were anxiety state
382
+ and trait assessed using standard instruments such as
383
+ Spielberger’s STAI (Spielberger et al. 1970), depression
384
+ using BDI (Beck et al. 1961) and global quality of life
385
+ assessed using FLIC (Schipper et al. 1984). Subjective
386
+ symptom checklist was developed during the pilot phase
387
+ to assess treatment-related side effects, problems with
388
+ sexuality and image, and relevant psychological and
389
+ somatic symptoms. The checklist consisted of 31 items,
390
+ each evaluated on two dimensions: severity, graded from
391
+ no to very severe (0–4), and distress, graded from not at all
392
+ to very much (0–4). This scale measured the total number
393
+ of symptoms experienced, total and mean severity and dis-
394
+ tress, and was evaluated previously in a similar breast
395
+ cancer population (Bhaskaran 1996). Finally, treatment-
396
+ related toxicity and side effects were objectively analysed
397
+ by the investigators using the World Health Organization
398
+ (WHO, 1979) Toxicity Criteria during chemotherapy.
399
+ These secondary outcome measures were used to study
400
+ relationships between the psychological states, frequency
401
+ and intensity of post-chemotherapy and anticipatory nau-
402
+ sea and vomiting. Assessments were carried out before
403
+ starting the first cycle of chemotherapy, during the mid-
404
+ cycle and after chemotherapy, except for MANE and WHO
405
+ Toxicity Criteria, which was assessed following the fourth
406
+ cycle of chemotherapy.
407
+ Interventions
408
+ The intervention group received an ‘integrated yoga pro-
409
+ gramme’ and the control group received ‘supportive coun-
410
+ seling and coping preparation’. The yoga intervention
411
+ consisted of a set of asanas (postures done with awareness)
412
+ breathing exercises, pranayama (voluntarily regulated
413
+ nostril breathing), meditation and yogic relaxation tech-
414
+ niques with imagery. These practices were based on prin-
415
+ ciples of attention diversion, mindful awareness and
416
+ relaxation to cope with day-to-day stressful experiences.
417
+ The yoga intervention was tailored to the patient’s needs
418
+ during chemotherapy infusion and home practice. The
419
+ yoga session was conducted 30 min before the start of che-
420
+ motherapy infusion. This session consisted of yogic relax-
421
+ ation, meditation using breath awareness and impulses of
422
+ touch emanating from palms and fingers, or chanting a
423
+ mantra from a Vedic text for 30 min. These sessions were
424
+ administered by an instructor at the subject’s bedside
425
+ before chemotherapy infusion. Subjects were also pro-
426
+ vided with audiotapes of these exercises for home prac-
427
+ tice, using the instructor’s voice, so that a familiar voice
428
+ could be heard on the cassette. The subjects were asked to
429
+ practise daily for 1 h for 6 days/week as homework during
430
+ the intervals between chemotherapy cycles. They were
431
+ required to practise a minimum of 3 h per week, but were
432
+ told to practise for 6 h per week in their homes. These
433
+ home sessions started with a few easy yoga postures,
434
+ breathing exercises and pranayama (voluntarily regulated
435
+ nostril breathing), and yogic relaxation. After this prepa-
436
+ ratory practice for about 20 min, the subjects were guided
437
+ through any one of the meditation practices for the next
438
+ 30 min, which included focusing awareness on sounds and
439
+ chants from Vedic texts, or breath awareness and impulses
440
+ of touch emanating from palms and fingers while practis-
441
+ ing yogic mudras, or a dynamic form of meditation that
442
+ involved practising with eyes closed of four yoga postures
443
+ interspersed with relaxation while supine, thus achieving
444
+ a combination of both ‘stimulating’ and ‘calming’ prac-
445
+ tice. These sessions were followed by informal individual
446
+ counselling sessions, which focused on problems related
447
+ to impediments in home practice, clarification of the par-
448
+ ticipant’s doubts, motivation, education and supportive
449
+ interaction with spouses. The participants were also
450
+ informed about practical day-to-day application of aware-
451
+ ness and relaxation to attain a state of equanimity during
452
+ Yoga for CINV
453
+ © 2007 The Authors
454
+ 467
455
+ Journal compilation © 2007 Blackwell Publishing Ltd
456
+ stressful situations, and were given homework in learning
457
+ to adapt to such situations in their daily life by applying
458
+ these principles.
459
+ The subjects were encouraged to practise one of these
460
+ meditation techniques daily, were given booklets and
461
+ instructions on these practices, and were encouraged to
462
+ pursue relevant themes and gain greater depth through
463
+ proficiency in practice. Their homework was monitored
464
+ daily by their instructor, who conducted house visits
465
+ (once in 10 days), and participants were encouraged to
466
+ maintain a daily log, listing the yoga practices done, use of
467
+ audiovisual aids for practice, duration of practice, experi-
468
+ ence of distressful symptoms, intake of medication and
469
+ diet history.
470
+ The control intervention consisted of a psychodynamic
471
+ supportive–expressive therapy with coping preparation.
472
+ Supportive–expressive counselling sessions also included
473
+ education as an important component. We chose to have
474
+ this as a control intervention mainly to control for the
475
+ non-specific effects of the yoga programme that may be
476
+ associated with adjustment, such as attention, support
477
+ and a sense of control. We also incorporated coping
478
+ preparation sessions as a control intervention along with
479
+ supportive–expressive therapy to enhance patients’
480
+ knowledge of their disease and treatment options, thereby
481
+ reducing any apprehensions and anxiety regarding their
482
+ treatment. This coping preparation consisted of a single
483
+ 60-min session held at the treatment clinic before the
484
+ start of the first chemotherapy cycle. Family members
485
+ were invited to join the patient during the session, which
486
+ included a tour of the oncology clinic and treatment area,
487
+ describing the chemotherapy procedure, providing infor-
488
+ mation about a variety of common questions, showing a
489
+ patient coping successfully with the treatment, and
490
+ finally, providing dietary advice and taking questions and
491
+ answers. These didactic educational interventions are
492
+ known to serve as an effective coping preparation in con-
493
+ trolling chemotherapy-related side effects (Burish & Tope
494
+ 1992).
495
+ This counselling was extended over the course of the
496
+ patients’ chemotherapy cycles during their hospital visits
497
+ (30-min sessions, once in 10 days). Subjects in the sup-
498
+ portive therapy group also completed daily logs or diaries
499
+ on episodes of nausea and vomiting. This therapy mainly
500
+ involved preparing the patient to adequately cope with
501
+ chemotherapy side effects, such as nausea and emesis.
502
+ Similar supportive sessions have been used successfully as
503
+ a control comparison group to evaluate psychotherapeutic
504
+ interventions (Jacobs et al. 1983; Greer et al. 1992), and
505
+ similar coping preparations have been effective in control-
506
+ ling chemotherapy-related nausea and emesis (Burish
507
+ et al. 1991). All subjects had received either yoga inter-
508
+ vention or supportive counselling and coping preparation
509
+ earlier during their surgery and radiotherapy period, and
510
+ were followed up with their respective interventions dur-
511
+ ing chemotherapy.
512
+ Data analysis
513
+ Data were analysed using Statistical Package for Social
514
+ Sciences version 10.0. Descriptive statistics were used
515
+ with all questionnaires of the study to summarize the
516
+ data. Wherever differences between groups were sought,
517
+ independent samples t-tests were used for analysis. Pear-
518
+ son correlation coefficient was used to study the relation-
519
+ ship and associations between various primary and
520
+ secondary outcome measures.
521
+ RESULTS
522
+ Sixty-two subjects (yoga n = 28; control n = 34) received
523
+ their prescribed chemotherapy cycles. The age, stages of
524
+ disease, grade and node status were similar in the yoga and
525
+ control groups, which received chemotherapy. The mean
526
+ years of education were 10.4 ± 5 and 13.5 ± 3 years in the
527
+ yoga and control groups respectively. Subjects were put on
528
+ a chemotherapy treatment protocol of either FAC, CMF or
529
+ CMF + FAC, conforming to the standard clinical protocol
530
+ followed during that time at the hospital. All subjects
531
+ were ambulatory and had a Zubrod’s performance status
532
+ score of 0–2. All patients had prior mastectomy, 38 sub-
533
+ jects had received radiotherapy before chemotherapy, and
534
+ 24 subjects received chemotherapy as the first adjuvant
535
+ following mastectomy. A majority of the subjects (90.3%)
536
+ received six or more cycles of chemotherapy, and six
537
+ (9.7%) received only four cycles of chemotherapy. The two
538
+ groups did not differ with respect to age, stage of disease,
539
+ tumour grade, menopausal status, chemotherapy regimen,
540
+ number of chemotherapy cycles and antiemetic regimen.
541
+ Twenty-nine (47%) subjects were on antidopaminergics
542
+ (domperidone), and 33 (53%) were on odansetron. Medical
543
+ oncologists who were blinded to the intervention pre-
544
+ scribed anxiolytic medication (lorazepam) (Alprazolam)
545
+ 0.5 mg bid to 22 subjects: 12 (35.3%) in controls and 10
546
+ (28%) in the experimental group. A goodness-of-fit test
547
+ between the socio-demographic and medical characteris-
548
+ tics of the study sample revealed no significant differences
549
+ between the two groups in any of the characteristics
550
+ examined (P > 0.05) (Table 1).
551
+ Overall, the administration of anxiolytic medication,
552
+ chemotherapy treatment regimens (CMF/FAC) and
553
+ antiemetic regimens (antidopaminergics/5-HT3 receptor
554
+ RAGHAVENDRA et al.
555
+ 468
556
+ © 2007 The Authors
557
+ Journal compilation © 2007 Blackwell Publishing Ltd
558
+ antagonists) had no significant influence on measures of
559
+ nausea and emesis as assessed using the MANE question-
560
+ naire. Overall, there was a significant influence only for
561
+ age group on nausea frequency, with subjects aged less
562
+ than 50 years having a greater frequency of nausea than
563
+ those more than 50 years old (Table 2).
564
+ Post-chemotherapy-related nausea and vomiting
565
+ The severity of post-chemotherapy-related vomiting was
566
+ mild to moderate in both the groups, and nausea severity
567
+ was moderate to severe in controls and mild to moderate
568
+ in the yoga group. Anticipatory vomiting was very mild in
569
+ both groups, and nausea was mild to moderate in controls
570
+ and very mild in the yoga group as seen with any moder-
571
+ ately emetogenic treatment. Both the groups received
572
+ antiemetics for an average of 2.6 ± 0.5 days.
573
+ Independent samples t-tests on MANE scores showed that
574
+ yoga intervention significantly reduced post-chemotherapy
575
+ nausea frequency (t = 2.587, P = 0.01) and nausea severity
576
+ (t = −2.670, P = 0.01), but not frequency of vomiting and
577
+ severity, even though they tended to decrease more so in the
578
+ yoga group as compared with controls (Table 3).
579
+ Pearson correlation analysis was performed to see the
580
+ relationship between MANE scores, anxiety states,
581
+ depression, symptom number, severity and distress,
582
+ chemotherapy-related toxicity and global quality-of-life
583
+ scores during the mid-cycle of chemotherapy. Post-
584
+ chemotherapy-related nausea frequency, nausea severity,
585
+ vomiting frequency and severity correlated significantly
586
+ and positively with anxiety state, depression, chemother-
587
+ apy-related toxicity and distressful symptoms, and
588
+ inversely with quality of life. The correlation was not sig-
589
+ nificant for chemotherapy regimen and number of chemo-
590
+ therapy cycles (Table 4).
591
+ Anticipatory nausea and vomiting (Tables 2,4,5)
592
+ Independent samples t-tests on anticipatory nausea and
593
+ vomiting showed a significant reduction in anticipatory
594
+ Table 1. Medical characteristics of the study population
595
+ Yoga group
596
+ (n = 28)
597
+ n (%)
598
+ Control group
599
+ (n = 34)
600
+ n (%)
601
+ All subjects
602
+ (n = 62)
603
+ n (%)
604
+ P-value
605
+ Stage of breast cancer
606
+ II
607
+ 16 (57.1)
608
+ 14 (41.1)
609
+ 30 (48.4)
610
+ NS
611
+ III
612
+ 12 (42.9)
613
+ 20 (58.8)
614
+ 32 (51.6)
615
+ Grade of tumour
616
+ I
617
+ 1 (3.5)
618
+ 0 (0)
619
+ 1 (1.6)
620
+ NS
621
+ II
622
+ 5 (17.8)
623
+ 2 (5.9)
624
+ 7 (11.2)
625
+ III
626
+ 22 (78.6)
627
+ 32 (94.1)
628
+ 54 (87.1)
629
+ Menopausal status
630
+ Pre-menopausal
631
+ 18 (64.2)
632
+ 13 (38.2)
633
+ 31 (50.0)
634
+ NS
635
+ Post-menopausal
636
+ 8 (28.6)
637
+ 20 (58.8)
638
+ 28 (45.2)
639
+ Perimenopausal
640
+ 1(3.5)
641
+ 0 (0)
642
+ 1 (1.6)
643
+ Post-hysterectomy
644
+ 1 (3.5)
645
+ 1 (2.9)
646
+ 2 (3.2)
647
+ CT regimen
648
+ FAC
649
+ 17 (60.7)
650
+ 18 (52.9)
651
+ 35 (56.4)
652
+ NS
653
+ CMF
654
+ 10 (35.7)
655
+ 11 (32.4)
656
+ 21 (33.9)
657
+ FAC + CMF
658
+ 1 (3.5)
659
+ 5 (14.7)
660
+ 6 (9.7)
661
+ Number of CT cycles
662
+ 6
663
+ 22 (78.6)
664
+ 27 (79.4)
665
+ 49 (79.0)
666
+ NS
667
+ 8
668
+ 3 (10.7)
669
+ 4 (11.8)
670
+ 7 (11.3)
671
+ 4
672
+ 3 (10.7)
673
+ 3 (8.8)
674
+ 6 (9.7)
675
+ Treatment regimen
676
+ S + RT + CT
677
+ 18 (64.2)
678
+ 20 (58.8)
679
+ 38 (61.3)
680
+ NS
681
+ S + CT + RT
682
+ 2 (7.1)
683
+ 2 (5.9)
684
+ 4 (6.5)
685
+ S + CT3 + RT + CT3
686
+ 7 (25.0)
687
+ 10 (29.4)
688
+ 17 (27.4)
689
+ S + CT
690
+ 1 (3.5)
691
+ 2 (5.9)
692
+ 3 (4.8)
693
+ Antiemetic regimen
694
+ 5-HT3 receptor antagonists
695
+ 15 (54)
696
+ 18 (53)
697
+ 33 (53)
698
+ NS
699
+ Antidopaminergic
700
+ 13 (46)
701
+ 16 (47)
702
+ 29 (47)
703
+ NS
704
+ Anxiolytic administration
705
+ Yes
706
+ 13 (46.4)
707
+ 17 (50)
708
+ 30 (48.4)
709
+ NS
710
+ No
711
+ 15 (53.6)
712
+ 17 (50)
713
+ 32 (51.6)
714
+ NS, not significant for goodness-of-fit test.
715
+ CT, chemotherapy; RT, radiotherapy; S, surgery.
716
+ Yoga for CINV
717
+ © 2007 The Authors
718
+ 469
719
+ Journal compilation © 2007 Blackwell Publishing Ltd
720
+ Table 2. Influence of age group (<50 years or >50 years), chemotherapy treatment regimen, class of antiemetic treatment regimen and
721
+ days of oral antiemetic administration following chemotherapy on measures of Morrow Assessment of Nausea and Emesis (MANE)
722
+ MANE outcome measure
723
+ Nausea
724
+ intensity
725
+ Nausea
726
+ frequency
727
+ Vomiting
728
+ frequency
729
+ Vomiting
730
+ intensity
731
+ An Nau
732
+ frequency
733
+ An Nau
734
+ intensity
735
+ An Vom
736
+ frequency
737
+ An Vom
738
+ intensity
739
+ Age group
740
+ <50 years (n = 33), mean ± SD
741
+ 2.79 ± 1.2
742
+ 4.45 ± 1.2
743
+ 2.76 ± 1.4
744
+ 1.94 ± 1.3
745
+ 1.79 ± 1.2
746
+ 1.13 ± 1.5
747
+ 1.33 ± 0.96
748
+ 0.63 ± 1.2
749
+ >50 years (n = 29), mean ± SD
750
+ 2.97 ± 1.3
751
+ 3.72 ± 1.4
752
+ 2.45 ± 1.4
753
+ 1.86 ± 1.3
754
+ 1.45 ± 1.1
755
+ 1.21 ± 1.3
756
+ 0.97 ± 0.5
757
+ 0.57 ± 0.9
758
+ t-value
759
+ d.f.
760
+ −0.56
761
+ 60
762
+ 2.25
763
+ 60
764
+ 0.87
765
+ 60
766
+ 0.24
767
+ 60
768
+ 1.14
769
+ 60
770
+ −0.24
771
+ 58
772
+ 1.86
773
+ 58
774
+ 0.22
775
+ 56
776
+ P-value
777
+ 0.58
778
+ 0.028
779
+ 0.39
780
+ 0.81
781
+ 0.26
782
+ 0.81
783
+ 0.07
784
+ 0.83
785
+ CT regimen
786
+ FAC (n = 35), mean ± SD
787
+ 2.94 ± 1.2
788
+ 4.11 ± 1.3
789
+ 2.56 ± 1.2
790
+ 1.86 ± 1.13
791
+ 1.58 ± 1
792
+ 1.08 ± 1.3
793
+ 1.06 ± 0.5
794
+ 0.48 ± 0.83
795
+ CMF (n = 21), mean ± SD
796
+ 2.7 ± 1.3
797
+ 3.95 ± 1.5
798
+ 2.55 ± 1.5
799
+ 1.75 ± 1.3
800
+ 1.80 ± 1.4
801
+ 1.47 ± 1.5
802
+ 1.4 ± 1.19
803
+ 0.89 ± 1.5
804
+ t-value
805
+ 0.70
806
+ 0.42
807
+ 0.02
808
+ 0.33
809
+ −0.66
810
+ −0.97
811
+ −1.76
812
+ −1.28
813
+ d.f.
814
+ 54
815
+ 54
816
+ 54
817
+ 54
818
+ 54
819
+ 53
820
+ 54
821
+ 50
822
+ P-value
823
+ 0.49
824
+ 0.68
825
+ 0.99
826
+ 0.75
827
+ 0.51
828
+ 0.36
829
+ 0.084
830
+ 0.28
831
+ Class of antiemetic treatment
832
+ 5HT3 receptor antagonists
833
+ (n = 33), mean ± SD
834
+ 2.94 ± 1.3
835
+ 4.09 ± 1.3
836
+ 2.52 ± 1.4
837
+ 1.7 ± 1.9
838
+ 1.55 ± 1
839
+ 124 ± 1.4
840
+ 1.03 ± 0.5
841
+ 0.55 ± 0.89
842
+ Antidopaminergics (n = 29),
843
+ mean ± SD
844
+ 2.8 ± 1.2
845
+ 4.14 ± 1.5
846
+ 2.72 ± 1.4
847
+ 2.14 ± 1.3
848
+ 1.72 ± 1.4
849
+ 1.07 ± 1.5
850
+ 1.31 ± 1.0
851
+ 0.67 ± 1.3
852
+ t-value
853
+ 0.46
854
+ −0.14
855
+ −0.59
856
+ −1.39
857
+ −0.59
858
+ 0.46
859
+ −1.39
860
+ −0.49
861
+ d.f.
862
+ 60
863
+ 60
864
+ 60
865
+ 60
866
+ 60
867
+ 60
868
+ 60
869
+ 56
870
+ P-value
871
+ 0.64
872
+ 0.89
873
+ 0.56
874
+ 0.17
875
+ 0.56
876
+ 0.65
877
+ 0.17
878
+ 0.68
879
+ No. of days of antiemetic administration
880
+ 2 days (n = 25), mean ± SD
881
+ 2.64 ± 1.3
882
+ 4.28 ± 1.3
883
+ 2.6 ± 1.4
884
+ 2 ± 1.4
885
+ 1.76 ± 1.5
886
+ 1.09 ± 1.6
887
+ 1.28 ± 1.06
888
+ 0.63 ± 1.4
889
+ 3 days (n = 37), mean ± SD
890
+ 3.03 ± 1.2
891
+ 4.0 ± 1.33
892
+ 2.62 ± 1.4
893
+ 1.84 ± 1.1
894
+ 1.54 ± 0.96
895
+ 1.22 ± 1.3
896
+ 1.08 ± 0.55
897
+ 0.59 ± 0.89
898
+ t-value d.f
899
+ −1.21
900
+ 60
901
+ 0.82
902
+ 60
903
+ −0.059
904
+ 60
905
+ 0.49
906
+ 60
907
+ 0.72
908
+ 60
909
+ −0.34
910
+ 58
911
+ 0.97
912
+ 60
913
+ 0.13
914
+ 60
915
+ P-value
916
+ 0.23
917
+ 0.42
918
+ 0.95
919
+ 0.64
920
+ 0.51
921
+ 0.73
922
+ 0.39
923
+ 0.90
924
+ An Nau, anticipatory nausea; An Vom, anticipatory vomiting; CT, chemotherapy; RT, radiotherapy; SD, standard deviation.
925
+ Table 3. Independent samples t-test on measures of Morrow Assessment of Nausea and Emesis scores between yoga and control groups
926
+ during CT
927
+ Groups
928
+ Yoga group
929
+ (n = 28)
930
+ Mean ± SD
931
+ Control group
932
+ (n = 34)
933
+ Mean ± SD
934
+ t-value (d.f.)
935
+ P-value
936
+ Post-CT nausea frequency
937
+ 3.6 ± 1.6
938
+ 4.5 ± 0.9
939
+ −2.67 (60)
940
+ 0.01
941
+ Post-CT nausea intensity
942
+ 2.3 ± 1.2
943
+ 3.4 ± 1.1
944
+ −3.71 (57)
945
+ <0.001
946
+ Post-CT vomiting frequency
947
+ 2.3 ± 1.4
948
+ 2.9 ± 1.4
949
+ −1.9 (58)
950
+ 0.06
951
+ Post-CT vomiting intensity
952
+ 1.6 ± 1.0
953
+ 2.2 ± 1.4
954
+ −1.99 (60)
955
+ 0.05
956
+ Anticipatory nausea frequency
957
+ 1.3 ± 0.98
958
+ 1.9 ± 1.3
959
+ −1.9 (60)
960
+ 0.06
961
+ Anticipatory nausea intensity
962
+ 0.6 ± 1.03
963
+ 1.7 ± 1.5
964
+ −3.17 (55)
965
+ 0.003
966
+ Anticipatory vomiting frequency
967
+ 1.1 ± 0.88
968
+ 1.2 ± 0.73
969
+ −0.476 (53)
970
+ 0.63
971
+ Anticipatory vomiting intensity
972
+ 0.3 ± 0.67
973
+ 0.87 ± 1.3
974
+ −2.05 (56)
975
+ 0.04
976
+ CT, chemotherapy; SD, standard deviation.
977
+ Table 4. Pearson correlation between Morrow Assessment of Nausea and Emesis measures, mood states, quality of life and toxicity
978
+ scores during chemotherapy
979
+ All subjects (n = 62)
980
+ Pearson correlation coefficient values, r
981
+ Nausea
982
+ frequency
983
+ Nausea
984
+ intensity
985
+ Vomiting
986
+ frequency
987
+ Vomiting
988
+ intensity
989
+ An Nau
990
+ frequency
991
+ An Nau
992
+ intensity
993
+ An Vom
994
+ frequency
995
+ An Vom
996
+ intensity
997
+ STAI score
998
+ 0.29*
999
+ 0.56**
1000
+ 0.42**
1001
+ 0.43**
1002
+ 0.50**
1003
+ 0.59**
1004
+ 0.27*
1005
+ 0.50*
1006
+ BDI score
1007
+ 0.38**
1008
+ 0.53**
1009
+ 0.441**
1010
+ 0.41**
1011
+ 0.38**
1012
+ 0.39**
1013
+ 0.14
1014
+ 0.33*
1015
+ Symptom distress score
1016
+ 0.50**
1017
+ 0.62**
1018
+ 0.44**
1019
+ 0.35**
1020
+ 0.37**
1021
+ 0.35**
1022
+ 0.28*
1023
+ 0.19
1024
+ FLIC score
1025
+ −0.46**
1026
+ −0.59**
1027
+ −0.50**
1028
+ −0.37**
1029
+ −0.47**
1030
+ −0.43**
1031
+ −0.32*
1032
+ −0.34*
1033
+ CT regimen
1034
+ 0.17
1035
+ 0.01
1036
+ 0.12
1037
+ 0.14
1038
+ 0.01
1039
+ 0.04
1040
+ 0.08
1041
+ 0.09
1042
+ No. of CT cycles
1043
+ 0.08
1044
+ −0.06
1045
+ −0.12
1046
+ 0.03
1047
+ −0.07
1048
+ 0.03
1049
+ 0.00
1050
+ 0.05
1051
+ Mid CT toxicity score
1052
+ 0.37**
1053
+ 0.47**
1054
+ 0.36**
1055
+ 0.42**
1056
+ 0.30*
1057
+ 0.30*
1058
+ 0.23
1059
+ 0.27*
1060
+ *P < 0.05, **P < 0.01.
1061
+ An Nau, anticipatory nausea; An Vom, anticipatory vomiting; BDI, Beck’s Depression Inventory; CT, chemotherapy; FLIC, Functional
1062
+ Living Index for Cancer; STAI, State Trait Anxiety Inventory.
1063
+ RAGHAVENDRA et al.
1064
+ 470
1065
+ © 2007 The Authors
1066
+ Journal compilation © 2007 Blackwell Publishing Ltd
1067
+ nausea frequency (t = 1.979, P = 0.053), nausea severity
1068
+ (t = −3.08, P = 0.003) and vomiting severity (t = −2.056, P =
1069
+ 0.044) in the yoga group as compared with controls
1070
+ (Table 3).
1071
+ Anticipatory nausea frequency and severity correlated
1072
+ significantly and positively with anxiety state, depression,
1073
+ chemotherapy-related toxicity and distressful symptoms,
1074
+ and inversely with quality of life. Anticipatory vomiting
1075
+ frequency correlated significantly and positively with
1076
+ anxiety state and distressful symptoms, and inversely
1077
+ with quality of life. Severity of anticipatory vomiting
1078
+ correlated significantly and positively with anxiety state,
1079
+ depression and chemotherapy-related toxicity, and in-
1080
+ versely with quality of life (Table 4).
1081
+ Approximately 35% of the subjects in the study
1082
+ received anxiolytic administration in both the groups.
1083
+ Administration of anxiolytic tended to be beneficial in
1084
+ reducing the severity of post-chemotherapy vomiting
1085
+ overall in both the groups (t = 4.04, P < 0.001), and indi-
1086
+ vidually in the intervention (t = 2.147, P = 0.04) and con-
1087
+ trol groups (t = 3.39, P = 0.002). Anxiolytics were also
1088
+ effective in reducing nausea severity (t = 2.01, P = 0.05)
1089
+ and anticipatory nausea frequency (t = 2.56, P = 0.016) in
1090
+ the control group alone (Table 5).
1091
+ When intervention effects were compared in the sample
1092
+ who did not use anxiolytics, the interventions were found
1093
+ to reduce significantly post-treatment related nausea
1094
+ frequency (t = 2.03, P = 0.05) and severity (t = 3.42, P =
1095
+ 0.002), and vomiting frequency (t = 2.16, P = 0.039) and
1096
+ severity (t = 2.29, P = 0.03). Yoga intervention was also
1097
+ effective in significantly reducing anticipatory nausea
1098
+ severity (t = 2.49, P = 0.02) and anticipatory vomiting
1099
+ severity (t = 2.77, P = 0.01) (Table 6).
1100
+ Secondary outcome measures (Table 7)
1101
+ There was a significant decrease in reactive anxiety states,
1102
+ depression, number of treatment-related distressful symp-
1103
+ toms, severity of symptoms and distress experienced, and
1104
+ improvement in quality of life during chemotherapy in
1105
+ the yoga group as compared with controls.
1106
+ Common toxicity criteria (Table 3)
1107
+ Common toxicity criteria guidelines were used to evalu-
1108
+ ate the chemotherapy-induced systemic and organ toxic-
1109
+ ity. Both systemic and organ toxicity were graded from 0
1110
+ to 4 (no toxicity to very severe toxicity) using clinical
1111
+ notes and laboratory data , and the total score was extrap-
1112
+ olated. Independent samples t-test showed the yoga group
1113
+ with significantly reduced toxicity scores as compared
1114
+ with controls (t = −4.1, P < 0.001).
1115
+ Table 5. Effects of anxiolytic administration on measures of Morrow Assessment of Nausea and Emesis in each group and in the overall study sample.
1116
+ Nausea
1117
+ intensity
1118
+ Nausea
1119
+ frequency
1120
+ Vomiting
1121
+ frequency
1122
+ Vomiting
1123
+ intensity
1124
+ An Nau
1125
+ frequency
1126
+ An Nau
1127
+ intensity
1128
+ An Vom
1129
+ frequency
1130
+ An Vom
1131
+ intensity
1132
+ Administration of anxiolytics
1133
+ Yoga group
1134
+ Yes (n = 10), mean ± SD
1135
+ 2.22 ± 1.2
1136
+ 3.3 ± 1.6
1137
+ 2.06 ± 1.4
1138
+ 1.28 ± 0.89
1139
+ 1.22 ± 1
1140
+ 0.61 ± 1.0
1141
+ 1.1 ± 1.08
1142
+ 0.22 ± 0.55
1143
+ No (n = 18), mean ± SD
1144
+ 2.4 ± 1.1
1145
+ 4.2 ± 1.5
1146
+ 2.6 ± 1.2
1147
+ 2.1 ± 1.1*
1148
+ 1.5 ± 0.97
1149
+ 0.6 ± 1.1
1150
+ 1.1 ± 0.32
1151
+ 0.44 ± 0.88
1152
+ Control group
1153
+ Yes (n = 14), mean ± SD
1154
+ 3.05 ± 1.1
1155
+ 4.35 ± 0.93
1156
+ 2.55 ± 1.32
1157
+ 1.60 ± 0.88
1158
+ 1.45 ± 1.1
1159
+ 1.28 ± 1.13
1160
+ 1.15 ± 0.59
1161
+ 0.56 ± 0.78
1162
+ No (n = 20), mean ± SD
1163
+ 3.79 ± 1.1*
1164
+ 4.71 ± 0.8
1165
+ 3.43 ± 1.34
1166
+ 3.0 ± 1.52**
1167
+ 2.5 ± 1.3*
1168
+ 2.14 ± 1.83
1169
+ 1.29 ± 0.91
1170
+ 1.31 ± 0.75
1171
+ Overall
1172
+ Yes (n = 24), mean ± SD
1173
+ 2.7 ± 1.9
1174
+ 3.87 ± 1.4
1175
+ 2.32 ± 1.3
1176
+ 1.45 ± 0.89
1177
+ 1.3 ± 1.0
1178
+ 0.94 ± 1.1
1179
+ 1.13 ± 0.84
1180
+ 0.39 ± 0.69
1181
+ No (n = 38), mean ± SD
1182
+ 3.21 ± 1.3
1183
+ 4.50 ± 1.1
1184
+ 3.1 ± 1.3
1185
+ 2.63 ± 1.4
1186
+ 2.08 ± 1.3
1187
+ 1.5 ± 1.7
1188
+ 1.21 ± 0.72
1189
+ 0.95 ± 1.5
1190
+ t-value
1191
+ 1.74
1192
+ 1.87
1193
+ 2.17
1194
+ 4.04
1195
+ 2.52
1196
+ 1.51
1197
+ 0.36
1198
+ 1.96
1199
+ d.f.
1200
+ 60
1201
+ 60
1202
+ 60
1203
+ 60
1204
+ 60
1205
+ 58
1206
+ 60
1207
+ 56
1208
+ P-value
1209
+ 0.087
1210
+ 0.067
1211
+ 0.034
1212
+ <0.001
1213
+ 0.014
1214
+ 0.134
1215
+ 0.714
1216
+ 0.055
1217
+ An Nau, anticipatory nausea; An Vom, anticipatory vomiting.
1218
+ *p < 0.05.
1219
+ **p < 0.01.
1220
+ Yoga for CINV
1221
+ © 2007 The Authors
1222
+ 471
1223
+ Journal compilation © 2007 Blackwell Publishing Ltd
1224
+ DISCUSSION
1225
+ The results of the study suggest that yoga intervention
1226
+ helped reduce post-chemotherapy-related nausea and
1227
+ anticipatory nausea and vomiting compared with support-
1228
+ ive therapy and coping preparation in stage II and III breast
1229
+ cancer subjects receiving adjuvant chemotherapy. There
1230
+ was a trend towards reduction in post-chemotherapy-
1231
+ related vomiting in the yoga group.
1232
+ Yoga intervention helped significantly to reduce the fre-
1233
+ quency and intensity of post-chemotherapy nausea by
1234
+ 18% as compared with the supportive therapy group. Our
1235
+ intervention was also helpful in significantly reducing the
1236
+ frequency and intensity of anticipatory nausea by 12%
1237
+ and 18%, and vomiting intensity by 9% as compared with
1238
+ controls. Even though yoga intervention helped reduce
1239
+ the frequency and intensity of post-chemotherapy vomit-
1240
+ ing by 13% and 10% and anticipatory vomiting frequency
1241
+ by 2% compared with controls, the effects were not sig-
1242
+ nificant. However, when the effects of intervention were
1243
+ compared in the yoga and control groups, which did not
1244
+ receive anxiolytic medications, yoga intervention de-
1245
+ creased nausea intensity by 39%, nausea frequency by
1246
+ 21.8%, vomiting frequency by 33.65%, vomiting intensity
1247
+ by 39.9%, anticipatory nausea intensity by 63.2%, and an-
1248
+ ticipatory vomiting intensity by 83%. These results indi-
1249
+ cate that addition of anxiolytics may have created a floor
1250
+ effect (Razavi et al. 1993), masking the actual effects of
1251
+ yoga intervention. Furthermore, these results also indi-
1252
+ cate that yoga may have had a significant anxiolytic effect
1253
+ in subjects who were not on any anxiolytic medication.
1254
+ Another reason why the intervention was not effective
1255
+ in reducing post-treatment vomiting could be that admin-
1256
+ istration of 5-HT3 receptor antagonist class of antiemetics
1257
+ may have significantly decreased the episodes of vomiting
1258
+ but increased the frequency and duration of nausea (Roscoe
1259
+ et al. 2000). Our results are similar to the studies reviewed
1260
+ by Burish and Tope (1992), in which supportive therapy and
1261
+ coping preparation interventions have been beneficial in
1262
+ reducing the conditioned side effects of chemotherapy.
1263
+ Our results are similar to other studies using behav-
1264
+ ioural interventions that have shown reductions in
1265
+ anticipatory and post-chemotherapy-related nausea and
1266
+ emesis, anxiety and levels of distress associated with che-
1267
+ motherapy (Redd et al. 2001; Mundy et al. 2003). Our
1268
+ results are also in congruence with other studies using
1269
+ relaxation that have shown decreases in the frequency and
1270
+ duration of chemotherapy-related nausea and emesis (Bur-
1271
+ ish & Tope 1992; Arakawa 1997; Molassiotis et al. 2002).
1272
+ However, the effect sizes seen with our intervention on
1273
+ nausea and vomiting variables was larger compared to
1274
+ above studies using relaxation. We could attribute these
1275
+ effects to two reasons. First, unlike earlier studies using
1276
+ relaxation intervention, where subjects were followed up
1277
+ over a single chemotherapy cycle, interventions in our
1278
+ study were given over the complete course of chemother-
1279
+ Table 6. Effects of intervention on measures of Morrow Assessment of Nausea and Emesis in subjects not on anxiolytic medication
1280
+ during chemotherapy
1281
+ Nausea
1282
+ intensity
1283
+ Nausea
1284
+ frequency
1285
+ Vomiting
1286
+ frequency
1287
+ Vomiting
1288
+ intensity
1289
+ An Nau
1290
+ frequency
1291
+ An Nau
1292
+ intensity
1293
+ An Vom
1294
+ frequency
1295
+ An Vom
1296
+ intensity
1297
+ Yoga group (n = 15),
1298
+ mean ± SD
1299
+ 2.07 ± 1.0
1300
+ 3.4 ± 1.6
1301
+ 2.07 ± 1.4
1302
+ 1.13 ± 0.8
1303
+ 1.27 ± 1
1304
+ 0.53 ± 0.92
1305
+ 1.13 ± 1.1
1306
+ 0.13 ± 0.35
1307
+ Control group (n = 17),
1308
+ mean ± SD
1309
+ 3.41 ± 1.2
1310
+ 4.35 ± 0.9
1311
+ 3.12 ± 1.3
1312
+ 1.88 ± 0.9
1313
+ 2.5 ± 1.3
1314
+ 2.14 ± 1.83
1315
+ 1.29 ± 0.91
1316
+ 1.31 ± 1.75
1317
+ t-value
1318
+ 1.74
1319
+ 1.87
1320
+ 2.17
1321
+ 4.04
1322
+ 2.52
1323
+ 1.51
1324
+ 0.36
1325
+ 1.96
1326
+ d.f.
1327
+ 60
1328
+ 60
1329
+ 60
1330
+ 60
1331
+ 60
1332
+ 58
1333
+ 60
1334
+ 56
1335
+ P-value
1336
+ 0.087
1337
+ 0.067
1338
+ 0.034
1339
+ <0.001
1340
+ 0.014
1341
+ 0.134
1342
+ 0.714
1343
+ 0.055
1344
+ An Nau, anticipatory nausea; An Vom, anticipatory vomiting.
1345
+ Table 7. Comparison of scores of STAI, BDI, symptom number, severity, distress and FLIC during chemotherapy in yoga and control
1346
+ groups
1347
+ Secondary outcome measure
1348
+ Yoga (n = 28)
1349
+ Mean ± SD
1350
+ Control (n = 34)
1351
+ Mean ± SD
1352
+ t-value
1353
+ d.f
1354
+ P-value
1355
+ STAI – anxiety state score
1356
+ 29.2 ± 3.8
1357
+ 37.5 ± 7.6
1358
+ −5.18
1359
+ 59
1360
+ <0.001
1361
+ Beck’s depression score
1362
+ 6.6 ± 4.6
1363
+ 14.2 ± 6.6
1364
+ −5.50
1365
+ 57
1366
+ Number of distressful symptoms
1367
+ 11.4 ± 4.5
1368
+ 14.7 ± 3.6
1369
+ −3.34
1370
+ 53
1371
+ 0.002
1372
+ Severity of symptoms
1373
+ 17.6 ± 9.3
1374
+ 27.3 ± 9.2
1375
+ −3.89
1376
+ 58
1377
+ <0.001
1378
+ Symptom distress
1379
+ 16.6 ± 10.1
1380
+ 29.9 ± 11.2
1381
+ −4.70
1382
+ 59
1383
+ <0.001
1384
+ FLIC – overall quality of life
1385
+ 142.1 ± 10.2
1386
+ 111.7 ± 25.5
1387
+ 6.48
1388
+ 59
1389
+ <0.001
1390
+ Total toxicity score
1391
+ 7.3 ± 2.7
1392
+ 11.1 ± 4.3
1393
+ −4.1
1394
+ 56
1395
+ <0.001
1396
+ BDI, Beck’s Depression Inventory; FLIC, Functional Living Index for Cancer; STAI, State Trait Anxiety Inventory.
1397
+ RAGHAVENDRA et al.
1398
+ 472
1399
+ © 2007 The Authors
1400
+ Journal compilation © 2007 Blackwell Publishing Ltd
1401
+ apy. Second, subjects in both the groups were given the
1402
+ intervention much before the commencement of chemo-
1403
+ therapy, during their surgery and radiotherapy. This long-
1404
+ term intervention may have contributed to increasing
1405
+ benefits resulting from our intervention against the earlier
1406
+ studies using relaxation.
1407
+ This long-term intervention may have also helped in
1408
+ improving quality of life and reducing anxiety, depression,
1409
+ distressful symptoms and treatment-related toxicity.
1410
+ Thus, maintenance of such interventions over a longer
1411
+ period could enhance the care provided to cancer patients
1412
+ and help them control the undesirable effects of
1413
+ chemotherapy.
1414
+ One of the major limitations of this study was that man-
1415
+ agement of delayed emesis was not according to current
1416
+ guidelines and consensus statements, as this study was
1417
+ carried out much before the publication of these guide-
1418
+ lines (Gralla et al. 1999). Thus, the results of this study
1419
+ may be applicable only to chemotherapy patients with a
1420
+ poor control of delayed nausea and emesis. Second, sub-
1421
+ jects in the control group were offered supportive coun-
1422
+ selling and coping preparation less frequently than their
1423
+ counterparts who received yoga intervention, and this dis-
1424
+ crepancy in the duration of interventions could account
1425
+ for the significant differences seen between the groups.
1426
+ However, it should be noted that most of these CAM
1427
+ interventions are time-intensive and involve more
1428
+ contact hours than these standard supportive therapy
1429
+ sessions. For practical purposes, this difference was
1430
+ acceptable, as we are using supportive therapy interven-
1431
+ tions only with an intention of negating the confounding
1432
+ variables, such as social support, attention, education and
1433
+ self-control, which are known to improve the psycholog-
1434
+ ical and social functioning of cancer patients (Roscoe et al.
1435
+ 2000). Since both the groups received the same supportive
1436
+ therapy and coping preparation programme, in addition to
1437
+ yoga intervention in the yoga group, it is possible to
1438
+ attribute the effects of the yoga programme to stress
1439
+ reduction rather than supportive care. However, because
1440
+ of the desire to incorporate support and education in the
1441
+ yoga programme, it is not clear whether a yoga programme
1442
+ without support and education would have resulted in the
1443
+ same benefits. Third, subjects were given yoga interven-
1444
+ tion much before the start of chemotherapy during sur-
1445
+ gery and radiotherapy, and pre-exposure to interventions
1446
+ before chemotherapy may have reduced the responses of
1447
+ patients to conditioning stimuli during chemotherapy.
1448
+ This may also be the reason why our intervention was bet-
1449
+ ter than coping preparation and counselling which had the
1450
+ same beneficial effects as progressive muscle relaxation
1451
+ training in earlier studies (Burish et al. 1991). Finally,
1452
+ because of the overlap with physical symptoms of cancer,
1453
+ the use of BDI and STAI in cancer populations has its lim-
1454
+ itations and results should be interpreted with caution.
1455
+ Overall, the beneficial effects observed in this study can
1456
+ be attributed to yoga practices that helped in stress reduc-
1457
+ tion, rather than to mere social support and education.
1458
+ This is consistent with other behaviourally orientated
1459
+ programmes, which have shown better results with stress
1460
+ reduction than with purely supportive interventions
1461
+ (Telch & Telch 1986; Vasterling et al. 1993). It is in this
1462
+ context that our study has been able to elucidate the
1463
+ effects of a yoga-based stress reduction programme.
1464
+ Several studies mentioned above have demonstrated the
1465
+ effectiveness of attention-diversion strategies for the
1466
+ reduction of stress and pain. It is likely that relaxation and
1467
+ deep somatic restfulness induced by yoga practices may
1468
+ reduce anxiety, physiological arousal and stress associated
1469
+ with chemotherapy and prevent the exacerbation of
1470
+ responses induced by post-chemotherapy nausea and vom-
1471
+ iting, thereby reducing the general feelings of distress. The
1472
+ yoga postures may have also helped reduce muscular con-
1473
+ tractions in the gastrointestinal tract (Taneja et al. 2004)
1474
+ that accompany post-chemotherapy nausea and vomiting,
1475
+ or may have decreased the sensitivity of chemoreceptor
1476
+ trigger zone to vomiting response (stimuli) (Borison &
1477
+ McCarthy 1983).
1478
+ This indicates that yoga probably shares some common
1479
+ techniques with other behavioural interventions that
1480
+ influence pathways from stress to somatic symptoms.
1481
+ Yoga is one such intervention, which is gaining popularity
1482
+ among the Indian masses, and oncology clinics could
1483
+ adopt these interventions by training nurses involved in
1484
+ cancer care. Approximately 56% of the cancer patients in
1485
+ a developing country like India take recourse to comple-
1486
+ mentary and alternative therapies with an intention to
1487
+ gain benefit and not because of dissatisfaction with con-
1488
+ ventional treatment (Gupta et al. 2002). The popular
1489
+ beliefs associated with these treatments have helped can-
1490
+ cer patients to adopt healthy self-care behaviours. Use of
1491
+ these interventions in a hospital setting could help com-
1492
+ plement the effects of conventional antiemetic treatments
1493
+ in managing chemotherapy-related nausea and emesis.
1494
+ These interventions can be particularly useful in the
1495
+ Indian context and in developing countries where subjec-
1496
+ tive concerns regarding treatment-related side effects are
1497
+ not given due their concern. Moreover, infrastructure for
1498
+ offering supportive care and cancer support groups rarely
1499
+ exists, and access to care is not affordable for the majority
1500
+ of the cancer population.
1501
+ In summary, our yoga-based intervention was more
1502
+ effective in reducing post-chemotherapy and anticipatory
1503
+ Yoga for CINV
1504
+ © 2007 The Authors
1505
+ 473
1506
+ Journal compilation © 2007 Blackwell Publishing Ltd
1507
+ nausea compared with supportive therapy and coping
1508
+ preparation. Yoga intervention served as a useful additive
1509
+ to antiemetic treatment in reducing post-chemotherapy
1510
+ and anticipatory vomiting. However, larger experimental
1511
+ studies under controlled conditions are required to vali-
1512
+ date our findings.
1513
+ ACKNOWLEDGEMENTS
1514
+ This research was supported by a grant from the Central
1515
+ Council for Research in Yoga and Naturopathy, Ministry
1516
+ of Health and Family Welfare, Government of India. We
1517
+ are thankful to Dr Jayashree and Mrs Anupama for impart-
1518
+ ing the yoga intervention.
1519
+ REFERENCES
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subfolder_0/Effects of integrated yoga on quality of life and interpersonal relationship of pregnant women.txt ADDED
@@ -0,0 +1,1107 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Effects of integrated yoga on quality of life and interpersonal
2
+ relationship of pregnant women
3
+ Abbas Rakhshani • Satyapriya Maharana •
4
+ Nagarathna Raghuram • Hongasandra R. Nagendra •
5
+ Padmalatha Venkatram
6
+ Accepted: 29 June 2010 / Published online: 15 July 2010
7
+  Springer Science+Business Media B.V. 2010
8
+ Abstract
9
+ Purpose
10
+ The objective of this study was to investigate the
11
+ effects of integrated yoga on the quality of life and inter-
12
+ personal relationships in normal pregnant women.
13
+ Methods
14
+ One hundred and two pregnant women between
15
+ 18 and 20 weeks of gestation who met the inclusion criteria
16
+ were recruited from the obstetric units in Bangalore and
17
+ were randomly assigned to two groups of yoga (n = 51)
18
+ and control (n = 51). Women with medical conditions that
19
+ could potentially lead to pregnancy complications and
20
+ those with abnormal fetal parameters were excluded. The
21
+ yoga group received integrated yoga while control group
22
+ received standard antenatal exercises, both for 1-h three
23
+ times a week from 20th to 36th week of gestation. Pre and
24
+ post assessments were done using WHOQOL-100 and
25
+ FIRO-B questionnaires.
26
+ Results
27
+ Of the six domains of WHOQOL-100, between
28
+ groups analysis showed significant improvements in the
29
+ yoga group compared to the control in the physical
30
+ (P = 0.001),
31
+ psychological
32
+ (P \ 0.001),
33
+ social
34
+ (P =
35
+ 0.003), and environmental domains (P = 0.001). In FIRO-B,
36
+ the yoga group showed significant improvements in
37
+ ‘Expressed Inclusion’ (P = 0.02) and ‘Wanted Control’
38
+ (P = 0.009) domains compared to the control group.
39
+ Conclusion
40
+ The integrated yoga is an efficacious means of
41
+ improving the quality of life of pregnant women and
42
+ enhancing certain aspects of their interpersonal relationships.
43
+ Keywords
44
+ Yoga  Pregnancy  World Health
45
+ Organization Quality of Life  WHOQOL-100 
46
+ Fundamental Interpersonal Relationships Orientation 
47
+ FIRO-B
48
+ Abbreviations
49
+ WHOQOL
50
+ World Health Organization Quality of Life
51
+ FIRO
52
+ Fundamental Interpersonal Relationships
53
+ Orientation
54
+ Introduction
55
+ World Health Organization defines health as ‘‘a state of
56
+ physical, mental, social and spiritual [1] well-being, and
57
+ not merely the absence of disease or infirmity’’ [2]. This
58
+ broad definition of well-being is reflected in an increasing
59
+ appreciation of quality of life issues and the interper-
60
+ sonal relationships of the subject with his/her environment
61
+ [3].
62
+ Chronic psychosocial stress has become prevalent in
63
+ modern society [4] and is associated with a substantial
64
+ reduction in the quality of life [5]. Maternal psychological
65
+ stress has been associated with reduced placental perfusion
66
+ [6] and endothelial dysfunction [7], which are known as the
67
+ main causes of many pregnancy complications, including
68
+ intrauterine growth restriction (IUGR), pregnancy-induced
69
+ hypertension (PIH), and preeclampsia [7]. In particular,
70
+ maternal stress is strongly linked to many hypertension-
71
+ related complications of pregnancy [8]. However, it is now
72
+ documented that PIH and related complications can be
73
+ reversed [9].
74
+ Stress can affect maternal immunity adversely [10],
75
+ contribute to reduced placental perfusion [11], and nega-
76
+ tively impact the pregnancy outcome [12]. In addition,
77
+ A. Rakhshani (&)  S. Maharana  N. Raghuram 
78
+ H. R. Nagendra  P. Venkatram
79
+ SVYASA University, Bangalore, India
80
+ e-mail: [email protected]
81
+ 123
82
+ Qual Life Res (2010) 19:1447–1455
83
+ DOI 10.1007/s11136-010-9709-2
84
+ pregnancy itself represents a time of significant physical,
85
+ emotional, and psychological stress for the mother [13],
86
+ which has been shown to take away from her overall
87
+ quality of life and alter her ability to cope with her
88
+ expected role [14]. In fact, social relationships have been
89
+ shown to have a direct impact on our physical health and
90
+ psychological well-being [15] and that these influences are
91
+ not just spurious findings attributable to our personalities
92
+ [16]. Therefore, it is important to take into consideration
93
+ the social and interpersonal relationships of women when
94
+ directing treatment during pregnancy.
95
+ It is now well documented that yoga and meditation help
96
+ in stress reduction [17–19]. Furthermore, yoga has been
97
+ shown to improve not only the quality of life of healthy
98
+ subjects [20] but also patients suffering from variety of
99
+ ailments, including pulmonary disorders [21], cardiovas-
100
+ cular dysfunctions [22], cancer [23], diabetes [24], rheu-
101
+ matoid arthritis [25], menopause [26], and schizophrenia
102
+ [27].
103
+ The purpose of this study was to assess the effect of
104
+ yoga in improving quality of life as well as the sources of
105
+ tension, incompatibility, and dissatisfaction in women
106
+ during their normal pregnancy that could potentially affect
107
+ their interpersonal relationships.
108
+ Materials and methods
109
+ Subjects
110
+ Two hundred and twenty normal pregnant women at
111
+ 18–20 weeks of gestation between 20 and 35 years of age
112
+ were interviewed at antenatal clinics in south of Bangalore,
113
+ India. One hundred and fifty of these women met the entry
114
+ criteria for the study and only 111 agreed to sign the
115
+ informed consent form. These 111 selected subjects were
116
+ randomly assigned to yoga and control groups (n = 56 and
117
+ n = 55, respectively) using a computerized random gen-
118
+ erator number. During the course of the study five subjects
119
+ dropped out of the yoga group and four dropped out
120
+ of control (mostly due to relocation), leaving 51 subjects
121
+ in each group for data analysis. Our power analysis
122
+ (alpha = 0.05, power = 0.8, effect size = 0.54) had yiel-
123
+ ded 44 subjects per group.
124
+ The recruitment criteria aimed at normal pregnancies that
125
+ were either primigravida or multigravida with at least one
126
+ living child. High-risk pregnancy conditions that would
127
+ heighten the stress adaptation responses during pregnancy
128
+ were avoided. These exclusion criteria incorporated: (a)
129
+ medical conditions that could potentially lead to pregnancy
130
+ complications (such as diabetes or hypertension), (b) mul-
131
+ tiple pregnancy, (c) IVF pregnancy, (d) previous history
132
+ of
133
+ IUGR,
134
+ preeclampsia,
135
+ or
136
+ other
137
+ severe
138
+ pregnancy
139
+ complications, (e) maternal structural abnormalities, (f)
140
+ multigravida, (g) fetal abnormality on ultrasound scanning,
141
+ and (h) previous exposure to yoga.
142
+ Signed informed consent was obtained from all subjects
143
+ before randomization and the project had received clear-
144
+ ance from the ethical committee of SVYASA University
145
+ prior to recruitment of the subjects.
146
+ Design
147
+ The study had adopted a prospective two-armed random-
148
+ ized parallel controlled design with supervised practices for
149
+ both groups from the time of recruitment until delivery.
150
+ Assessments were obtained at baseline (18–20 weeks
151
+ gestation) and at 36 weeks gestation. The yoga group
152
+ practiced specific set of integrated yoga while the control
153
+ group practiced standard antenatal exercises (both set of
154
+ practices are listed in Table 1). Subjects in both groups
155
+ received 1-h sessions from trained instructors 3 days per
156
+ week (yoga classes were held on Monday, Wednesday, and
157
+ Fridays while antenatal sessions were on Tuesday, Thurs-
158
+ day, and Saturday) for the first month. All instructors were
159
+ trained at SVYASA University in Bangalore, India.
160
+ Thereafter, they continued their respective practices at
161
+ home using a pre-recorded cassette until delivery. Addi-
162
+ tionally, every time the subjects of each group came to the
163
+ hospital for their regular antenatal check up, they received
164
+ a refresher class of 1-h duration. The frequency and dura-
165
+ tion of the daily practices of subjects at home were mon-
166
+ itored closely by research staff through an ‘exercise diary’
167
+ that was maintained by the subjects in each group. The
168
+ follow-ups were through phone and in person when sub-
169
+ jects visited the hospital. No incentives were given to the
170
+ subjects for attending the classes.
171
+ Due to the nature of the study, blinding was not a pos-
172
+ sibility. However, all efforts were made to mask the staff
173
+ whenever possible. The team who did the assessments was
174
+ not involved in administering the intervention. The statis-
175
+ tician who did the randomization and analysis was blind to
176
+ the source of the data. Care was taken to avoid interaction
177
+ and exchange of techniques between participants of the two
178
+ groups by staggering the timings and venue of the classes
179
+ for the two groups.
180
+ Interventions
181
+ Integrated approach of yoga
182
+ Detailed information about yoga and its mechanism of
183
+ action as a mind–body medicine from the yogic point of view
184
+ can be found in many books including one by Nagendra and
185
+ Nagarathna [28]. Briefly, integrated approach of yoga (IAY)
186
+ is a holistic approach to well-being at physical, emotional,
187
+ 1448
188
+ Qual Life Res (2010) 19:1447–1455
189
+ 123
190
+ mental, and spiritual levels. It is designed to reduce chronic
191
+ psychological stress that, from the yogic point of view, is the
192
+ root causes of psychosomatic ailments [28].
193
+ Practice modules
194
+ The practices of IAY used in this study were selected
195
+ carefully by the investigators for normal pregnancy. This
196
+ means that certain yogic practices that are not advisable for
197
+ pregnant women (such as postures that can put too much
198
+ pressure on the uterus) were omitted. The practices for the
199
+ control group involved simple stretches approved by the
200
+ Executive Council of the society of Obstetrician and
201
+ Gynecologists of Canada, and by the board of directors of
202
+ the Canadian society for exercise physiology. The control
203
+ exercises were followed by supine rest. Table 1 lists the
204
+ Table 1 Interventions for the yoga and control groups
205
+ Yoga group practices
206
+ 2nd
207
+ trimester
208
+ 3rd
209
+ trimester
210
+ Control group practices
211
+ 2nd
212
+ trimester
213
+ 3rd
214
+ trimester
215
+ Lecture topics
216
+ 15 min
217
+ 10 min
218
+ Lecture topics
219
+ 15 min
220
+ 10 min
221
+ Pregnancy is physiological, child birth, yogic
222
+ concepts of healthy life style, and yogic
223
+ management of stress including diet, daily
224
+ activities, thinking, feeling and behavior
225
+ Yes
226
+ Yes
227
+ Pregnancy is physiological, child birth, modern
228
+ scientific concepts of healthy life style, and
229
+ modern management of stress including diet,
230
+ daily activities, thinking, feeling and behavior.
231
+ Yes
232
+ Yes
233
+ Breathing exercises
234
+ 10 min
235
+ 5 min
236
+ Loosening exercises
237
+ 10 min
238
+ 5 min
239
+ Hasta a
240
+ ¯ya
241
+ ¯ma s
242
+ ´vasanam (Hands in and out
243
+ breathing)
244
+ Yes
245
+ Yes
246
+ Twisting
247
+ Yes
248
+ Yes
249
+ Hasta vista
250
+ ¯ra s
251
+ ´vasanam (Hands stretch
252
+ breathing)
253
+ Yes
254
+ Yes
255
+ Forward and backward bend
256
+ Yes
257
+ No
258
+ Gulpha vista
259
+ ¯ra s
260
+ ´vasanam (Ankle stretch
261
+ breathing)
262
+ Yes
263
+ No
264
+ Side bending
265
+ Yes
266
+ Yes
267
+ Vya
268
+ ¯ghra s
269
+ ´vasanam (Tiger breathing)
270
+ Yes
271
+ Yes
272
+ Calf-raise
273
+ Yes
274
+ Yes
275
+ Setu bandha s
276
+ ´vasanam (Bridge posture
277
+ breathing)
278
+ Yes
279
+ No
280
+ Hamstring stretch
281
+ Yes
282
+ Yes
283
+ Lat pulls-up and down
284
+ Yes
285
+ No
286
+ Calf extension
287
+ Yes
288
+ No
289
+ Hip abduction
290
+ No
291
+ Yes
292
+ Asanas
293
+ 15 min
294
+ 10 min
295
+ Stretch exercises
296
+ 15 min
297
+ 10 min
298
+ Tadasana (tree pose)
299
+ Yes
300
+ Yes
301
+ Thigh stretch
302
+ Yes
303
+ Yes
304
+ Ardhakati-chakrasana (Lateral Arc Pose)
305
+ Yes
306
+ Yes
307
+ Push-up and Down
308
+ Yes
309
+ Yes
310
+ Trikonasana (triangle pose)
311
+ Yes
312
+ Yes
313
+ Pulls downs
314
+ Yes
315
+ No
316
+ Vajrasana (The Ankle Posture)
317
+ Yes
318
+ Yes
319
+ Low-back lift
320
+ Yes
321
+ No
322
+ Vakrasana (spine twist pose)
323
+ Yes
324
+ No
325
+ Inner thigh stretch
326
+ Yes
327
+ Yes
328
+ Siddhasana (sage pose)
329
+ No
330
+ Yes
331
+ Calf stretch
332
+ Yes
333
+ Yes
334
+ BaddhaKonasana (Bound Ankle Pose)
335
+ No
336
+ Yes
337
+ Dips
338
+ Yes
339
+ No
340
+ UpavistaKonasana (sit with legs apart)
341
+ No
342
+ Yes
343
+ Squatting
344
+ No
345
+ Yes
346
+ Squatting (Garland pose)
347
+ No
348
+ Yes
349
+ Hip abduction
350
+ Yes
351
+ Yes
352
+ Viparita karani (half shoulder stand)
353
+ Yes
354
+ No
355
+ Shoulder-chest stretch
356
+ Yes
357
+ Yes
358
+ ardha-pavanamuktasana (folded leg lumbar
359
+ stretch)
360
+ Yes
361
+ Yes
362
+ Neck and upper back stretch
363
+ Yes
364
+ Yes
365
+ Seated rowing
366
+ Yes
367
+ Yes
368
+ Oblique curis
369
+ Yes
370
+ Yes
371
+ Kick backs
372
+ Yes
373
+ Yes
374
+ Pelvic floor exercise
375
+ Yes
376
+ Yes
377
+ Pelvic Tilt
378
+ Yes
379
+ Yes
380
+ Pranayama and meditation
381
+ 10 min
382
+ 20 min
383
+ Supine rest
384
+ 10 min
385
+ 20 min
386
+ Sectional breathing, nadishiddhi, Sheetali,
387
+ bharamari, Nadanusandhana, Om meditation
388
+ Yes
389
+ Yes
390
+ Slow walking
391
+ 10 min
392
+ 20 min
393
+ DRT (Deep relaxation technique)
394
+ 10 min
395
+ 15 min
396
+ Supine rest
397
+ 10 min
398
+ 15 min
399
+ Qual Life Res (2010) 19:1447–1455
400
+ 1449
401
+ 123
402
+ practices for each group in greater detail. All subjects had
403
+ sufficient understanding of English language and instruc-
404
+ tions for both groups were given in English. There was no
405
+ need to use any props, chairs, or wall support to practice
406
+ the yoga poses. However, women sat in Siddhasana instead
407
+ of Vajrasana in their third trimester.
408
+ Instruments
409
+ WHOQOL-100 instrument
410
+ World Health Organization Quality of Life assessment
411
+ instrument (WHOQOL-100) is a generic, client-completed
412
+ measure of health-related quality of life that was simulta-
413
+ neously developed in 15 sites worldwide [29]. It is focused
414
+ around the definition of quality of life advocated by the
415
+ World Health Organization which includes the culture
416
+ and context which influence an individual’s perception
417
+ of health [29]. It consists of six domains (physical
418
+ health, psychological health, level of independence, social
419
+ relationships,
420
+ environment,
421
+ spirituality/religion/personal
422
+ beliefs) and 24 facets, each consisting of four items, dis-
423
+ tributed across domains plus a general facet (overall quality
424
+ of life and general health) [30]. Items are scaled on five-
425
+ point Likert scale and scoring is available for domain,
426
+ facet, and overall—with higher scores indicating higher
427
+ quality of life [30]. The WHOQOL-100 instrument is
428
+ widely used to compare the QOL of different populations.
429
+ Its growing popularity is in part due to the substantial
430
+ evidence that the questionnaire is sensitive and responsive
431
+ to important changes in the physical and emotional
432
+ domains of QOL [31].
433
+ FIRO-B instrument
434
+ Fundamental Interpersonal Relations Orientation (FIRO) is
435
+ a theory of interpersonal relations, introduced by William
436
+ Schutz in 1958 [32]. Schutz in this theory formulated three
437
+ dimensions of interpersonal relations, which he believed
438
+ were necessary and sufficient to explain most human inter-
439
+ actions [32]. He named these dimensions as: Inclusion,
440
+ Control and Affection [32]. Within these spaces, the level of
441
+ interaction an individual wants can be measured in the areas
442
+ of socializing, leadership and responsibilities, and more
443
+ intimate personal relations [33]. FIRO-B scores are graded
444
+ from 0 to 9 in scales of expressed and wanted behavior,
445
+ which define how much a person expresses to others, and
446
+ how much he wants from others [33]. Therefore, the stan-
447
+ dard FIRO-B questionnaire consists of six different spheres:
448
+ Expressed Inclusion (EI), Wanted Inclusion (WI), Expres-
449
+ sed Control (EC), Wanted Control (WC), Expressed
450
+ Affection (EA), and Wanted Affection (WA). Historically,
451
+ FIRO-B is used in the corporate environment to determine
452
+ leadership style and to identify team building and personal
453
+ development requirements. However, to do so, the instru-
454
+ ment tries to identify the sources of tension, incompatibility,
455
+ and dissatisfaction. In the study, we wanted to know how
456
+ yoga can contribute to the improvement of these factors in
457
+ the stressful period of pregnancy.
458
+ Data collection and analysis
459
+ Statistical software SPSS version 16.0.1 was used for all
460
+ data analysis. Test of normality (Kolmogorov–Smirnov)
461
+ was performed on the data of each domain for both
462
+ instruments. When the data was found not to be normal
463
+ (P \ 0.05), the non-parametric Mann–Whitney test was
464
+ used for comparison between groups and Wilcoxon’s
465
+ signed rank’s test for within groups. We used paired t-test
466
+ for within groups and Independent Sample t-test for
467
+ between groups for analyzing the data that was normally
468
+ distributed. Chi-squared test and Independent Samples
469
+ t-tests were used for baseline comparisons of the two
470
+ groups.
471
+ Results
472
+ Table 2 shows the demographic data of the subjects in both
473
+ groups. All baseline maternal characteristics were matched
474
+ between the two groups and there were no statistically
475
+ significant differences between them except for profession.
476
+ WHOQOL-100 test
477
+ This study compared the mean test and retest scores for each
478
+ domain of WHOQOL-100 instrument. Table 3 shows the
479
+ results on all domains of WHOQOL-100 instrument.
480
+ There were significant differences between groups with
481
+ higher improvements in yoga than the control group in the
482
+ Physical (P \ 0.01, Mann–Whitney test, effect size =
483
+ 0.48), Psychological (P \ 0.01, Independent Sample t-test,
484
+ effect size = 0.65), Social Relationships (P \ 0.01, Inde-
485
+ pendent Sample t-test, effect size = 0.65), and the General
486
+ Health
487
+ (P \ 0.01
488
+ Independent
489
+ Sample
490
+ t-test,
491
+ effect
492
+ size = 0.65) domains.
493
+ FIRO-B test
494
+ We compared the mean pre-interventions and post-inter-
495
+ ventions scores for each domain of FIRO-B questionnaire.
496
+ The between groups statistical analysis showed signifi-
497
+ cance in ‘‘Expressed Inclusion’’ (P = 0.02, Independent
498
+ Sample t-test) and ‘‘Wanted Control’’ (P = 0.009, Mann–
499
+ Whitney test) domains. However, within group analysis
500
+ showed significant improvements in all domains for the
501
+ 1450
502
+ Qual Life Res (2010) 19:1447–1455
503
+ 123
504
+ yoga group (Expressed Inclusion: P = 0.038, Wanted
505
+ Inclusion:
506
+ P = 0.001,
507
+ Expressed
508
+ Control:
509
+ P = 0.013,
510
+ Wanted Control: P = 0.01, Expressed Affection: P =
511
+ 0.007, Wanted Affection: P = 0.001) while no significant
512
+ improvement in any domain for the control group. Table 4
513
+ outlines our results. Large effect sizes in each of the
514
+ domains of the yoga group are notable.
515
+ Discussion
516
+ This prospective two-armed randomized controlled study
517
+ of 102 normotensive pregnant women compared the qual-
518
+ ity of life and interpersonal relationships of normal preg-
519
+ nant women who received integrated yoga interventions
520
+ from the twentieth week of gestation until 36 weeks ges-
521
+ tation to those who received standard antenatal practices
522
+ during the same period. Our study has shown that inte-
523
+ grated yoga interventions can significantly improve the
524
+ quality of life of pregnant women in the physical, psy-
525
+ chological, social, and general health domains using
526
+ WHOQOL-100 instrument. In the Independence domain,
527
+ our results were just above the borderline (P = 0.065).
528
+ Overall, the effect sizes for the IAY interventions used
529
+ in the yoga group were significantly higher than those used
530
+ in the control group, except for the spiritual domain that the
531
+ control group scored higher (P: 0.27 control vs. 0.12 yoga).
532
+ Aside from the general health quality, the largest effect size
533
+ among the six domains of WHOQOL-100 in the yoga
534
+ group was of the psychological domain (0.65) followed by
535
+ social relationships (0.59), physical (0.48), and environ-
536
+ mental (0.48) domains. Our results are consistent with
537
+ previous studies that have used WHOQOL instrument in
538
+ evaluating the quality of life of patients with various ail-
539
+ ments using yoga interventions [34–36].
540
+ In the FIRO-B instrument, our within groups’ analysis
541
+ showed significant improvements in each domain (EI:
542
+ P = 0.038; WI: P \ 0.001; EC: P = 0.013; WC: P =
543
+ 0.01; EA: P = 0.007; WA: P = 0.001) for the yoga group
544
+ and no statistically significant improvements for the control
545
+ group. The between groups’ analysis showed statistically
546
+ significant improvements in the Expressed Inclusion and
547
+ Wanted Control. A quick glance of the pre-interventions
548
+ means for the subjects in both groups (listed in Table 4)
549
+ shows that the scores are all low to moderate across the
550
+ board. To understand the significance of this, we must
551
+ review Schutz’s own classifications of the scores. He
552
+ identified individuals based on their scores in each of the
553
+ FIRO-B domains into the following nine categories [32]:
554
+ I.
555
+ Inclusion types
556
+ a.
557
+ The under-social (low EI, low WI)
558
+ b.
559
+ The over-social (high EI, high WI)
560
+ c.
561
+ The social (moderate EI, moderate WI)
562
+ II.
563
+ Control types
564
+ a.
565
+ The under-controller or abdicrat (low EC, high
566
+ WC)
567
+ b.
568
+ The over-controller or autocrat (high EC, low
569
+ WC)
570
+ c.
571
+ The democrat (moderate EC, moderate WC)
572
+ III.
573
+ Affection types
574
+ a.
575
+ The under-personal (low EA, low WA)
576
+ b.
577
+ The over-personal (high EA, high WA)
578
+ c.
579
+ The personal (moderate EA moderate WA)
580
+ Using Schutz’s above classification, our subjects in this
581
+ study could be described as generally under-social, under-
582
+ control, and under-personal. The nature of our subjects
583
+ could have a direct impact on our results. In fact, Schutz
584
+ himself warned that many factors, including cultural
585
+ influences, could affect these scores. To our knowledge,
586
+ there has not been a large cohort study that can provide the
587
+ normative values for FIRO-B instrument among normal
588
+ pregnant Indian women. But if our data is any indication,
589
+ Table 2 Demographic data on the subjects
590
+ Variables
591
+ Yoga (n = 51)
592
+ Control (n = 51)
593
+ P-values
594
+ Age
595
+ 26.23 ± 2.98
596
+ 25.47 ± 2.87
597
+ 0.50*
598
+ Height (cms)
599
+ 63.58 ± 1.96
600
+ 62.98 ± 2.04
601
+ 0.13*
602
+ Weight (kg)
603
+ Pre
604
+ 63.45 ± 10.06
605
+ 62.90 ± 8.82
606
+ 0.77*
607
+ Post
608
+ 72.30 ± 10.37
609
+ 71.65 ± 9.05
610
+ 0.74*
611
+ BMI
612
+ Pre
613
+ 25.07 ± 3.45
614
+ 25.45 ± 3.85
615
+ 0.60*
616
+ Post
617
+ 28.55 ± 3.53
618
+ 28.89 ± 3.76
619
+ 0.64*
620
+ BP (Sys)
621
+ Pre
622
+ 114.53 ± 14.62
623
+ 115.88 ± 7.87
624
+ 0.57*
625
+ Post
626
+ 116.60 ± 10.18
627
+ 110.16 ± 0.04
628
+ 0.40*
629
+ BP (Dia)
630
+ Pre
631
+ 73.57 ± 5.54
632
+ 73.22 ± 6.36
633
+ 0.77*
634
+ Post
635
+ 74.68 ± 5.31
636
+ 75.94 ± 6.37
637
+ 0.28*
638
+ Gravida
639
+ G1
640
+ 45 (88.24%)
641
+ 43 (84.31%)
642
+ 0.77^
643
+ G2
644
+ 6 (11.76%)
645
+ 8 (15.69%)
646
+ Profession
647
+ W
648
+ 33 (64.71%)
649
+ 21 (38.18%)
650
+ 0.03^
651
+ HW
652
+ 18 (35.29%)
653
+ 30 (58.82%)
654
+ BP blood pressure (sys-systolic and dia-diastolic), BMI body mass
655
+ index, G1 prime, G2 Gravida 2, HW house wife, W working
656
+ P-values were calculated using: ^Chi-Square; *Independent Samples
657
+ t-tests
658
+ There were no significant differences between groups on any of
659
+ maternal characteristics except in the profession
660
+ Qual Life Res (2010) 19:1447–1455
661
+ 1451
662
+ 123
663
+ the values would be expected to be lower than those of
664
+ similar population in the western countries.
665
+ As mentioned above, we found statistical significance in
666
+ the Expressed Inclusion and Wanted Control domains and
667
+ near significance in the Wanted Affection domain in the
668
+ yoga group when compared to the control. In other words,
669
+ compared to non-yoga group, the integrated yoga interven-
670
+ tions helped the subjects in developing a sense of belonging,
671
+ wanting more influence on their environment, and desiring
672
+ more warmth and closeness. One might wonder if these
673
+ could be considered improvements to the subjects’ inter-
674
+ personal relationships. For example, if a subject wants more
675
+ influence on her environment but cannot get it, would not
676
+ that add to her frustrations? Of course, it could if she totally
677
+ fails in gaining any control. However, the chances are that
678
+ she will gain a certain degree of control on her environment
679
+ and that would be an improvement.
680
+ We also used paired sample test to compare the means
681
+ within groups. The yoga interventions showed statistically
682
+ significant improvements in all domains: EI (P = 0.038),
683
+ WI (P \ 0.001), EC (P = 0.01), WC (P = 0.013), EA
684
+ (P = 0.007),
685
+ and
686
+ WA
687
+ (P = 0.001). In
688
+ contrast,
689
+ the
690
+ improvements of the control interventions were not statis-
691
+ tically significant in any of the FIRO-B spheres.
692
+ Finally, we obtained bivariate Pearson correlations
693
+ between the domains of WHOQOL-100 and FIRO-B
694
+ instruments. The correlations were low and statistically
695
+ insignificant. However, this does not mean that there is no
696
+ relationship between the two instruments. A more plausible
697
+ explanation would be that our study was not large enough to
698
+ find such correlations. After all, it would be logical to think
699
+ that individuals feeling less control over their environment or
700
+ those who perceive less affection from their environment
701
+ could be more prone to have a lower quality of life than
702
+ Table 3 Results of the
703
+ WHOQOL-100 test after
704
+ intervention in both groups
705
+ Statistically significant P-values
706
+ are shown in bold
707
+ a Independent Sample t-test
708
+ b Mann–Whitney test
709
+ c Paired samples test
710
+ Domain
711
+ Groups
712
+ Between groups
713
+ P-values
714
+ Mean ± standard deviation [95% confidence interval]
715
+ Yoga
716
+ Control
717
+ Physical (n = 51)
718
+ Pre
719
+ 14.55 ± 2.4 [13.88–15.22]
720
+ 14.27 ± 2.32 [13.62–14.92]
721
+ 0.001b
722
+ Post
723
+ 15.79 ± 2.77 [15–16.57]
724
+ 14.12 ± 2.14 [13.51–14.72]
725
+ Effect size
726
+ 0.48
727
+ 0.07
728
+ Psychological (n = 51)
729
+ Pre
730
+ 14.6 ± 2.42 [13.92–15.28]
731
+ 14.5 ± 1.83 [13.98–15.01]
732
+ 0.001a
733
+ Post
734
+ 16.08 ± 2.12 [15–16.57]
735
+ 14.7 ± 1.63 [14.24–15.17]
736
+ Effect size
737
+ 0.65
738
+ 0.12
739
+ Independence (n = 51)
740
+ Pre
741
+ 15.44 ± 2.31 [14.79–16.08]
742
+ 14.94 ± 2.14 [14.34–15.54]
743
+ 0.065a
744
+ Post
745
+ 15.91 ± 2.2 [15.29–16.53]
746
+ 15.01 ± 2.1 [15.01 ± 2.1]
747
+ Effect size
748
+ 0.21
749
+ 0.03
750
+ Social relationships (n = 51)
751
+ Pre
752
+ 15.58 ± 2.46 [14.89–16.27]
753
+ 15.11 ± 2.76 [14.34–15.89]
754
+ 0.003a
755
+ Post
756
+ 16.88 ± 1.91 [16.34–17.42]
757
+ 15.67 ± 2.09 [15.08–16.26]
758
+ Effect size
759
+ 0.59
760
+ 0.23
761
+ Environment (n = 51)
762
+ Pre
763
+ 15.32 ± 1.86 [14.8–15.85]
764
+ 14.93 ± 2.49 [14.23–15.63]
765
+ 0.001b
766
+ Post
767
+ 16.25 ± 2 [15.69–16.82]
768
+ 15 ± 1.69 [14.52–15.47]
769
+ Effect size
770
+ 0.48
771
+ 0.03
772
+ Spiritual (n = 51)
773
+ Pre
774
+ 15.73 ± 2.48 [15.03–16.42]
775
+ 14.71 ± 2.44 [14.02–15.39]
776
+ 0.23b
777
+ Post
778
+ 16.02 ± 2.42 [15.34–16.70]
779
+ 15.41 ± 2.67 [14.66–16.16]
780
+ Effect size
781
+ 0.12
782
+ 0.27
783
+ General health quality (n = 51)
784
+ Pre
785
+ 15.76 ± 2.84 [14.97–16.56]
786
+ 14.98 ± 1.94 [14.43–15.53]
787
+ 0.001b
788
+ Post
789
+ 17.08 ± 2.31 [16.43–17.73]
790
+ 15.35 ± 2.51 [14.65–16.06]
791
+ Effect size
792
+ 0.51
793
+ 0.17
794
+ 1452
795
+ Qual Life Res (2010) 19:1447–1455
796
+ 123
797
+ otherwise. But this has to be proven by a larger multi-center
798
+ study.
799
+ Our data demonstrates that QOL of pregnant women can
800
+ be substantially improved after 16 weeks of integrated
801
+ yoga practices. These results reaffirm that on most
802
+ dimensions, changes in the scores of WHOQOL-100 are
803
+ responsive to behavioral, emotional, and physical change
804
+ over time. Our results are in-line with other studies that
805
+ have used yoga to improve quality of life of patients with
806
+ other ailments using WHOQOL instrument [35, 36]. Even
807
+ in healthy non-pregnant subjects, yoga has shown to
808
+ improve the quality of life [27]. Oken et al. used the SF-36
809
+ instrument to assess health-related quality-of-life of heal-
810
+ thy seniors using yoga interventions [27]. Their results
811
+ demonstrated a significant yoga assignment group effect on
812
+ vitality/energy
813
+ and
814
+ fatigue
815
+ (P = 0.006),
816
+ role-physical
817
+ (P = 0.001), bodily pain (P = 0.006), social functioning
818
+ (P = 0.015), and the physical composite scale (P = 0.005)
819
+ [27]. While it is not possible to compare the different
820
+ components of SF-36 and WHOQOL-100 instruments
821
+ directly, it is meaningful to observe the closeness of the
822
+ results in the pregnant and non-pregnant population.
823
+ Strength of this study
824
+ This study has several prominent features: (1) both study
825
+ and control groups received supervised training, (2) the
826
+ groups were matched at baseline for maternal characteris-
827
+ tics, (3) the sample size was sufficiently large to reduce the
828
+ possibility of type 1 and type 2 errors. We used the data
829
+ from 51 subjects in each group for our data analysis.
830
+ Qualified instructors for both yoga and control interven-
831
+ tions were used throughout the 16 weeks study. Further-
832
+ more, this is the first study that we are aware of that has
833
+ focused on improving and assessing the quality of life of
834
+ women during pregnancy using yoga. The WHOQOL-100
835
+ and FIRO-B instruments are widely used and their reli-
836
+ ability has been well-documented globally and within dif-
837
+ ferent socioeconomic populations. We were not able to find
838
+ the exact reliability and validity of these two instruments
839
+ for the Indian population; however, the internal reliability
840
+ of WHOQOL (as measured by Cronbach alpha) has been
841
+ shown to range from 0.65 to 0.93 globally.
842
+ We believe the results obtained in this study can be used
843
+ effectively with future projects as the foundation for
844
+ Table 4 Results from the FIRO-B test
845
+ Domain
846
+ Measurements in
847
+ time and effect sizes
848
+ Groups
849
+ Pre-post
850
+ P-values
851
+ Mean ± standard deviation [95% confidence interval]
852
+ Yoga
853
+ Control
854
+ Expressed Inclusion (EI)
855
+ Pre
856
+ 5.24 ± 2.17 [4.64–5.87]
857
+ 5.18 ± 2.06 [4.6–5.75]
858
+ 0.02a
859
+ Post
860
+ 5.84 ± 2.09 [5.24–6.43]
861
+ 4.88 ± 2.07 [4.3–5.46]
862
+ Effect size
863
+ 0.29
864
+ 0.15
865
+ Wanted Inclusion (WI)
866
+ Pre
867
+ 2.47 ± 2.46 [1.78–3.16]
868
+ 2.25 ± 2.82 [1.46–3.05]
869
+ 0.07b
870
+ Post
871
+ 1.29 ± 1.91 [0.76–1.83]
872
+ 2.16 ± 2.56 [1.44–2.88]
873
+ Effect size
874
+ 0.54
875
+ 0.03
876
+ Expressed Control (EC)
877
+ Pre
878
+ 2.61 ± 1.98 [2.05–3.16]
879
+ 3.16 ± 2.77 [2.38–3.94]
880
+ 0.3b
881
+ Post
882
+ 3.43 ± 2.06 [2.85–4.01]
883
+ 3.12 ± 2.71 [2.36–3.88]
884
+ Effect size
885
+ 0.41
886
+ 0.02
887
+ Wanted Control (WC)
888
+ Pre
889
+ 3.37 ± 2.17 [2.76–3.98]
890
+ 3.94 ± 2.56 [3.22–4.66]
891
+ 0.009b
892
+ Post
893
+ 2.41 ± 2.39 [1.74–3.08]
894
+ 3.69 ± 2.6 [2.95–4.42]
895
+ Effect size
896
+ 0.42
897
+ 0.1
898
+ Expressed Affection (EA)
899
+ Pre
900
+ 2.67 ± 2.31 [2.02–3.32]
901
+ 3.06 ± 2.03 [2.49–3.63]
902
+ 0.29b
903
+ Post
904
+ 3.61 ± 2.26 [2.97–4.24]
905
+ 3.10 ± 1.81 [2.59–3.61]
906
+ Effect size
907
+ 0.41
908
+ 0.02
909
+ Wanted Affection (WA)
910
+ Pre
911
+ 3.1 ± 2.3 [2.45–3.74]
912
+ 2.84 ± 2.1 [2.25–3.43]
913
+ 0.057b
914
+ Post
915
+ 2.12 ± 1.98 [1.56–2.67]
916
+ 2.76 ± 1.98 [2.21–3.32]
917
+ Effect size
918
+ 0.46
919
+ 0.04
920
+ Statistically significant P-values are shown in bold
921
+ a Independent Sample t-test
922
+ b Mann–Whitney test
923
+ c Paired samples test
924
+ Qual Life Res (2010) 19:1447–1455
925
+ 1453
926
+ 123
927
+ improving the quality of life of women at such a special
928
+ and crucial period of their lives.
929
+ Limitations
930
+ This study excluded high-risk pregnancies. Among these
931
+ risk factors were women with hypertension and diabetes,
932
+ which are quite prevalent in India. That could raise the
933
+ question that whether the results of this study would apply
934
+ to the general population. A larger sample size could have
935
+ produced a different result, particularly in the FIRO-B data.
936
+ Suggestions for future direction
937
+ Future
938
+ larger
939
+ multi-center
940
+ studies
941
+ with
942
+ interventions
943
+ beginning at earlier gestational age (or even prior to
944
+ pregnancy) are needed to establish the exact role that
945
+ integrated yoga practices can play in improving the inter-
946
+ personal relationships of pregnant women. Large cross-
947
+ cultural cohort studies using FIRO-B and WHOQOL-100
948
+ instruments would offer normative data for these instru-
949
+ ments. Finally, it would be interesting to see if similar
950
+ results could be obtained from a study targeting high-risk
951
+ pregnancy population.
952
+ Applications of this study
953
+ The stressful lifestyle of modern women superimposed on
954
+ the challenges that pregnancy imposes on the mothers can
955
+ be too much to cope with. Many women turn to medica-
956
+ tions for help, which can compromise the health of their
957
+ pregnancy. Yoga is non-invasive, economical, and easy to
958
+ learn solution to improve the quality of life of pregnant
959
+ women, improve their abilities to perform their social roles,
960
+ and potentially prevent adverse obstetrics outcome. Preg-
961
+ nancy is a very special time in a woman’s life. Yoga can
962
+ give her the opportunity and the tools to enjoy this
963
+ miraculous period to the fullest.
964
+ Conclusion
965
+ This prospective randomized controlled trial was able to
966
+ show that integrated yoga practices can be used effectively
967
+ to improve the quality of life of pregnant women who are
968
+ distressed by the overwhelming physiological, psycholog-
969
+ ical, and emotional changes of pregnancy. We were also
970
+ able to show that yoga interventions as well as other simple
971
+ exercises could have a certain level of impact on the
972
+ interpersonal relationships of the pregnant women.
973
+ Acknowledgments
974
+ We acknowledge with deep gratitude the efforts
975
+ made by the staff members of Maiya Hospital and SVYASA Uni-
976
+ versity who facilitated this study. We particularly appreciate Dr. Ravi
977
+ Kulkarni’s guidance during the data analysis and Mrs. Sushama
978
+ Kirtikar’s assistance in proof reading the article. This project was
979
+ institutionally funded by the SVYASA University of yogic sciences
980
+ based in Bangalore, India.
981
+ References
982
+ 1. Larson, J. S. (2006). The World Health Organization’s definition
983
+ of health: Social versus spiritual health. Social Indicators
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+ Research, 38, 181–192.
985
+ 2. World Health Organization. (1948). Preamble to the constitution
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+ of the World Health Organization. Geneva: WHO.
987
+ 3. Symon, A. (2003). A review of mothers’ prenatal and postnatal
988
+ quality of life. Health Qual Life Outcomes, 1, 38.
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+ 4. Tamashiro, K. L., et al. (2007). Dynamic body weight and body
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+ composition changes in response to subordination stress. Physi-
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+ ology & Behavior, 91, 440–448.
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+ 5. Zahran, H. S., Kobau, R., Moriarty, D. G., Zack, M. M., Holt, J.,
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+ & Donehoo, R. (2005). Health-related quality of life surveil-
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+ 6. Gheorghe, C. P., Goyal, R., Mittal, A., & Longo, L. D. (2010).
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+ Gene expression in the placenta: Maternal stress and epigenetic
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+ 7. Cindrova-Davies, T. (2009). Gabor than award lecture 2008: Pre-
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+ 8. Higgins, J. R., Walshe, J. J., Conroy, R. M., & Darling, M. R.
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+ (2002). The relation between maternal work, ambulatory blood
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+ and Community Health, 56, 389–393.
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+ 9. Marcoux, S., Brisson, J., & Fabia, J. (1989). The effect of leisure
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+ 10. Coussons-Read, M. E., Okun, M. L., & Simms, B. S. (2003). The
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+ psychoneuroimmunology of pregnancy. Journal of Reproductive
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+ and Infant Psychology, 21, 103–112.
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+ 11. Weissgerber, T. L., Wolfe, L. A., & Davies, G. A. (2004). The
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+ Medicine and Science in Sports and Exercise, 36, 2024–2031.
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+ 12. Armour, B., Pitts, M.M. & Walker, M.B. (2007) Maternal job
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+ Working Paper Series, 09–29.
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+ 13. Da Costa, D., Larouche, J., Dritsa, M., & Brender, W. (1999).
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+ Variations in stress levels over the course of pregnancy: Factors
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+ associated with elevated hassles state anxiety and pregnancy—
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+ specific stress. Journal of Psychosomatic Research, 47, 609–621.
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+ 14. Gjerdingen, D. K., Froberg, D. G., & Fontaine, P. (1991). The
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+ effects of social support on women’s health during pregnancy,
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+ labor and delivery and the postpartum period. Family Medicine,
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+ 23, 370–375.
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+ 15. House, J. S., Landis, K. R., & Umberson, D. (1988). Social
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+ relationships and health. Science, 241, 540–545.
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+ 16. Cohen, S. (2004). Social relationships and health. American
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+ Psychologist, 59, 676–684.
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+ 17. Parshad, O. (2004). Role of yoga in stress management. West
1033
+ Indian Medical Journal, 53, 191–194.
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+ 18. Michalsen, A., Grossman, P., Acil, A., Langhorst, J., Ludtke, R.,
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+ Esch, T., et al. (2005). Rapid stress reduction and anxiolysis among
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+ distressed women as a consequence of a three-month intensive
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+ yoga program. Medical Science Monitor, 11, 555–561.
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+ 1454
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+ 19. Berger, B. G., & Owen, D. R. (1988). Stress reduction and mood
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+ enhancement in four exercise modes: Swimming, body condi-
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+ tioning, hatha yoga and fencing. Research Quarterly for Exercise
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+ and Sport, 59(2), 148–159.
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+ 20. Oken, B. S., et al. (2006). Randomized, controlled six-month trial
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+ of yoga in healthy seniors: Effects on cognition and quality of
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+ life. Altern Ther Health Med, 12, 40–47.
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+ 21. Donesky-Cuenco, D., Nguyen, H. Q., Paul, S., & Carrieri-Kohl-
1049
+ man, V. (2009). Yoga therapy decreases dyspnea-related distress
1050
+ and improves functional performance in people with chronic
1051
+ obstructive pulmonary disease: A pilot study. J Altern Comple-
1052
+ ment Med, 15, 225–234.
1053
+ 22. Pullen, P. R., et al. (2008). Effects of yoga on inflammation and
1054
+ exercise capacity in patients with chronic heart failure. J Card
1055
+ Fail, 14, 407–413.
1056
+ 23. Moadel, A. B., et al. (2007). Randomized controlled trial of yoga
1057
+ among a multiethnic sample of breast cancer patients: Effects on
1058
+ quality of life. Journal of Clinical Oncology, 25, 4387–4395.
1059
+ 24. Skoro-Kondza, L., Tai, S. S., Gadelrab, R., Drincevic, D., &
1060
+ Greenhalgh, T. (2009). Community based yoga classes for type 2
1061
+ diabetes: An exploratory randomised controlled trial. BMC
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+ Health Serv Res, 9, 33.
1063
+ 25. Badsha, H., Chhabra, V., Leibman, C., Mofti, A., & Kong, K. O.
1064
+ (2009). The benefits of yoga for rheumatoid arthritis: Results of a
1065
+ preliminary, structured 8-week program. Rheumatology Interna-
1066
+ tional, 29(12), 1417–1421.
1067
+ 26. Mastrangelo, M. A., Galantino, M. L., & House, L. (2007).
1068
+ Effects of yoga on quality of life and flexibility in menopausal
1069
+ women: A case series. Explore (NY), 3, 42–45.
1070
+ 27. Duraiswamy, G., Thirthalli, J., Nagendra, H. R., & Gangadhar, B.
1071
+ N. (2007). Yoga therapy as an add-on treatment in the management
1072
+ of patients with schizophrenia—A randomized controlled trial.
1073
+ Acta Psychiatrica Scandinavica, 116, 226–232.
1074
+ 28. Nagendra, H. R., & Nagarathna, R. (1993). Therapeutic appli-
1075
+ cations of an integrated approach of yoga therapy. Health
1076
+ Administrator, 4, 52–55.
1077
+ 29. WHOQOL Group. (1995). Field trial WHOQOL-100. February
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+ 1995: Facet definitions and questions. WHO: Geneva (MNH/
1079
+ PSF/95.1.B).
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+ 30. De Vire, J., & Van Heck, G. L. (1997). The World Health
1081
+ Organization Quality of Life assessment instrument (WHOQOL-
1082
+ 100): Validation study with the Dutch version. European Journal
1083
+ of Psychological Assessment;, 13(3), 164–178.
1084
+ 31. Bonomi, A. E., Patrick, D. L., Bushnell, D. M., & Martin, M.
1085
+ (2000). Validation of the United States’ version of the World
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+ Health Organization Quality of Life (WHOQOL) instrument.
1087
+ Journal of Clinical Epidemiology, 53, 1–12.
1088
+ 32. Schutz, W. C. (1958). FIRO: A three dimensional theory of
1089
+ interpersonal behavior. New York, NY: Holt, Rinehart & Winston.
1090
+ 33. Ryan, L. R. (1977). Clinical interpretation of the FIRO-B. Palo
1091
+ Alto, CA: Consulting Psychologists.
1092
+ 34. Lundgren, T., Dahl, J., Yardi, N., & Melin, L. (2008). Acceptance
1093
+ and commitment therapy and yoga for drug-refractory epilepsy: A
1094
+ randomized controlled trial. Epilepsy & Behavior, 13, 102–108.
1095
+ 35. Lundgren, T., Dahl, J., Yardi, N., & Melin, L. (2008). Acceptance
1096
+ and commitment therapy and yoga for drug-refractory epilepsy:
1097
+ A randomized
1098
+ controlled
1099
+ trial. Epilepsy & Behavior, 13,
1100
+ 102–108.
1101
+ 36. Duraiswamy, G., Thirthalli, J., Nagendra, H. R., & Gangadhar, B.
1102
+ N. (2007). Yoga therapy as an add-on treatment in the manage-
1103
+ ment of patients with schizophrenia—A randomized controlled
1104
+ trial. Acta Psychiatrica Scandinavica, 116, 226–232.
1105
+ Qual Life Res (2010) 19:1447–1455
1106
+ 1455
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+ 123
subfolder_0/Effects of yoga program on quality of life and affect the early breast cancer.txt ADDED
@@ -0,0 +1,898 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ This article appeared in a journal published by Elsevier. The attached
2
+ copy is furnished to the author for internal non-commercial research
3
+ and education use, including for instruction at the authors institution
4
+ and sharing with colleagues.
5
+ Other uses, including reproduction and distribution, or selling or
6
+ licensing copies, or posting to personal, institutional or third party
7
+ websites are prohibited.
8
+ In most cases authors are permitted to post their version of the
9
+ article (e.g. in Word or Tex form) to their personal website or
10
+ institutional repository. Authors requiring further information
11
+ regarding Elsevier’s archiving and manuscript policies are
12
+ encouraged to visit:
13
+ http://www.elsevier.com/copyright
14
+ Author's personal copy
15
+ Complementary Therapies in Medicine (2009) 17, 274—280
16
+ available at www.sciencedirect.com
17
+ journal homepage: www.elsevierhealth.com/journals/ctim
18
+ Effects of yoga program on quality of life and affect
19
+ in early breast cancer patients undergoing adjuvant
20
+ radiotherapy: A randomized controlled trial
21
+ H.S. Vadiraja a, M. Raghavendra Rao b, Raghuram Nagarathna a,∗,
22
+ H.R. Nagendra a, M. Rekha a, N. Vanitha a, K.S. Gopinath b,
23
+ B.S. Srinath b, M.S. Vishweshwara c, Y.S. Madhavi c, B.S. Ajaikumar c,
24
+ S. Ramesh Bilimagga b, Nalini Rao b
25
+ a Department of Yoga Research, Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore, India
26
+ b Departments of Complementary and Alternative Medicine, Surgical Oncology and Radiation Oncology, Bangalore Institute of
27
+ Oncology, Bangalore, India
28
+ c Department of Radiation Oncology, Bharath Hospital Institute of Oncology, Mysore, India
29
+ Available online 28 October 2009
30
+ KEYWORDS
31
+ Yoga;
32
+ Breast cancer;
33
+ Meditation;
34
+ Quality of life;
35
+ Affect
36
+ Summary
37
+ Objectives: This study compares the effects of an integrated yoga program with brief supportive
38
+ therapy in breast cancer outpatients undergoing adjuvant radiotherapy at a cancer centre.
39
+ Methods: Eighty-eight stage II and III breast cancer outpatients were randomly assigned to
40
+ receive yoga (n = 44) or brief supportive therapy (n = 44) prior to their radiotherapy treatment.
41
+ Intervention consisted of yoga sessions lasting 60 min daily while the control group was imparted
42
+ supportive therapy once in 10 days. Assessments included European Organization for Research
43
+ in the Treatment of Cancer-Quality of Life (EORTCQoL C30) functional scales and Positive and
44
+ Negative Affect Schedule (PANAS). Assessments were done at baseline and after 6 weeks of
45
+ radiotherapy treatment.
46
+ Results: An intention to treat GLM repeated measures ANOVA showed significant difference
47
+ across groups over time for positive affect, negative affect and emotional function and social
48
+ function. There was significant improvement in positive affect (ES = 0.59, p = 0.007, 95%CI 1.25
49
+ to 7.8), emotional function (ES = 0.71, p = 0.001, 95%CI 6.45 to 25.33) and cognitive function
50
+ (ES = 0.48, p = 0.03, 95%CI 1.2 to 18.5), and decrease in negative affect (ES = 0.84, p < 0.001,
51
+ 95%CI −13.4 to −4.4) in the yoga group as compared to controls. There was a significant positive
52
+ correlation between positive affect with role function, social function and global quality of life.
53
+ There was a significant negative correlation between negative affect with physical function,
54
+ role function, emotional function and social function.
55
+  Sources of support: Central Council for Research in Yoga and Naturopathy, Ministry of Health and Family Welfare, Govt. of India.
56
+ ∗Corresponding author at: Division of Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, No-19, Eknath Bhavan,
57
+ Gavipuram Circle, K.G. Nagar, Bangalore 560019, Karnataka, India.
58
+ Tel.: +91 080 26507585; fax: +91 080 26608645.
59
+ E-mail address: [email protected] (R. Nagarathna).
60
+ 0965-2299/$ — see front matter © 2009 Elsevier Ltd. All rights reserved.
61
+ doi:10.1016/j.ctim.2009.06.004
62
+ Author's personal copy
63
+ Effects of yoga program
64
+ 275
65
+ Conclusion: The results suggest a possible role for yoga to improve quality of life and affect in
66
+ breast cancer outpatients.
67
+ © 2009 Elsevier Ltd. All rights reserved.
68
+ Introduction
69
+ Quality of life is an important concern and outcome of
70
+ cancer treatment. Several studies have documented that
71
+ both diagnosis and treatment of breast cancer have an
72
+ impact on quality of life.1,2 Further, there is evidence to
73
+ suggest that decrements in quality of life are related to
74
+ treatment related distress and psychological well being.2,3
75
+ Various dimensions of quality of life such as physical,
76
+ emotional, social, functional and spiritual well being are
77
+ affected in both newly diagnosed and long-term survivors
78
+ of breast cancer.2,4—6 However, growing evidence suggests
79
+ that psychosocial and psycho-educational interventions are
80
+ beneficial adjunctive treatments for cancer patients.7—11
81
+ Patients who have used active behavioral coping meth-
82
+ ods have reported positive affective states, decrease in
83
+ anxiety and depression, higher levels of self-esteem and
84
+ fewer physical symptoms while those with avoidance cop-
85
+ ing showed greater depression, anxiety and lower quality
86
+ of life.12 Similarly mind—body approaches such as prayer,
87
+ meditation, affirmation, imagery and movement therapies
88
+ have shown improvements in overall quality of life in cancer
89
+ patients.13—15
90
+ Yoga as a mind—body intervention is being practiced
91
+ increasingly in both Indian and western populations. It is
92
+ an ancient Indian science that has been used for thera-
93
+ peutic benefits in numerous health care concerns where
94
+ stress is believed to play a role.16 Beneficial effects have
95
+ been seen on a variety of outcomes, including sleep quality,
96
+ mood, stress, cancer-related distress, cancer-related symp-
97
+ toms, and overall quality of life, as well as functional and
98
+ physiological measures. These effects were similar across a
99
+ number of different therapeutic approaches that employed
100
+ postures, meditation breathing practices or a combination
101
+ of all these.17 The results from these studies are bolstered by
102
+ several randomized studies using yoga interventions in both
103
+ healthy and chronically ill populations.18—20 Results from
104
+ recent randomized controlled studies are mixed with one
105
+ study showing improvement in various quality of life domains
106
+ in breast cancer population at different stages of cancer
107
+ treatment21 and the other showing no improvement in qual-
108
+ ity of life domains.22 In both these studies adherence to
109
+ intervention and contact time for yoga intervention was low
110
+ compared to our earlier study that has shown decrements in
111
+ anxiety states23; reduction in chemotherapy induced nau-
112
+ sea and emesis24 and improved immune outcomes.25 In the
113
+ former adherence seemed to be affected by radiotherapy
114
+ treatment and distress and in the latter the intervention
115
+ was based on a different form of yoga intervention known
116
+ as Tibetan yoga.
117
+ Overall effects following yoga or similar interventions
118
+ have been attributed to an improvement in positive affect
119
+ and decrease in negative affect.26—28 Patients on radiother-
120
+ apy experience distressing side effects such as fatigue, skin
121
+ changes, pulmonary symptoms during radiotherapy and anx-
122
+ iety and depression before, during, and after radiotherapy.29
123
+ Reducing treatment related distress and improving quality
124
+ of life is known to improve adjustment later30 and manage
125
+ related morbidity that accumulates over time.31 Moreover
126
+ earlier study has shown radiotherapy to predict poorer
127
+ adherence to yoga intervention.21
128
+ We hypothesize that yoga intervention would help
129
+ improve quality of life, improve positive affect and decrease
130
+ negative affect in stage II and III breast cancer patients
131
+ undergoing adjuvant radiotherapy.
132
+ In this study, we compared the effects of a 6-week
133
+ ‘‘Integrated yoga program’’ with ‘‘Brief supportive ther-
134
+ apy’’ as a control intervention in early operable breast
135
+ cancer patients undergoing adjuvant radiotherapy.
136
+ Methods
137
+ Subjects
138
+ This randomized control trial recruited 85 recently diag-
139
+ nosed women with stage II and III breast cancer from two
140
+ different urban cancer centres. All subjects had undergone
141
+ primary treatment as surgery and were receiving adjuvant
142
+ radiotherapy. Subjects in this study were recruited over a 2-
143
+ year period from January 2004 to June 2006. Patients were
144
+ eligible to participate in this study if they met the following
145
+ selection criteria at the study start: (i) women with recently
146
+ diagnosed operable breast cancer, (ii) age between 30 and
147
+ 70 years, (iii) Zubrod’s performance status 0—2 (ambulatory
148
+ >50% of time), (iv) high school education and, (v) consent-
149
+ ing to participate in the study. Subjects were excluded, (i) if
150
+ they had any concurrent medical condition that was likely to
151
+ interfere with the treatment, (ii) major psychiatric, neuro-
152
+ logical illness or autoimmune disorders, and, (iii) any known
153
+ metastases. Each study participant was prescribed adjuvant
154
+ radiotherapy with a cumulative dose of 50.4 Gy with frac-
155
+ tionations spread over 6 weeks. The details of the study were
156
+ explained to the participants and their informed consent was
157
+ obtained in writing.
158
+ Randomization
159
+ Of the 103 eligible participants 88 (85.4%) consented to
160
+ participate and were randomized to receive yoga (n = 44)
161
+ or supportive therapy (n = 44) initially before intervention
162
+ (prior to radiotherapy) using computer generated ran-
163
+ dom numbers. Randomization was performed using opaque
164
+ envelopes with group assignments. Personnel who had no
165
+ part in the trial performed randomization. The envelopes
166
+ were opened sequentially in the order of assignment dur-
167
+ ing recruitment, with the names and registration numbers
168
+ of the participants written on the covers. The order of
169
+ Author's personal copy
170
+ 276
171
+ H.S. Vadiraja et al.
172
+ randomization was verified with the hospital date of admis-
173
+ sion records for radiation therapy at study intervals to make
174
+ sure that field personnel had not altered the sequence of
175
+ randomization to suit the allocation of consenting partici-
176
+ pants into two study arms.
177
+ Sample size
178
+ Earlier study with Mindfulness Based Stress Reduction Pro-
179
+ gram (MBSR) had shown a modest effect size (ES = 0.38) on
180
+ EORTC QLC30 global quality of life measure.32 We used G
181
+ power to calculate the sample size with ˛ = 0.05 and ˇ = 0.2
182
+ and above effect size of 0.38 for repeated measures ANOVA
183
+ between factor effects. The sample size thus required was
184
+ n = 44 in each group.
185
+ Among the 88 participants 75 (yoga n = 42; control n = 33)
186
+ completed their prescribed radiation therapy of 6 weeks
187
+ and follow-up assessment. There were 13 dropouts in the
188
+ study (see trial profile, Fig. 1). The reasons for dropouts
189
+ were migration to other hospitals (n = 4), use of other com-
190
+ plementary therapies (e.g. homeopathy or ayurveda) (n = 2),
191
+ refusal to continue the study (n = 2), time constraints (n = 4)
192
+ and other concurrent illnesses such as infections delaying
193
+ radiotherapy and intervention (n = 1).
194
+ Measures
195
+ During the initial visit, demographic information, including
196
+ age, marital status, education, occupation, obstetric and
197
+ gynecological history, medical history and intake of med-
198
+ ications, was obtained, and clinical data were abstracted
199
+ on the history of breast cancer. The following self-report
200
+ questionnaires were distributed to the subjects during the
201
+ study.
202
+ Figure 1
203
+ Trial profile.
204
+ Positive and Negative Affect Schedule (PANAS)
205
+ Positive affect and negative affect was assessed using the
206
+ PANAS scale.33 PANAS contains two subscales, each consist-
207
+ ing of 10 items: positive affect (PA) and negative affect (NA).
208
+ PA reflects the extent to which a person feels enthusiastic,
209
+ active, and alert. A high PA score reflects a state of high
210
+ energy, full concentration, and pleasurable engagement. In
211
+ contrast, NA is a general dimension of subjective distress
212
+ with a variety of aversive mood states, and a high NA score
213
+ indicates more distress. Patients were instructed to indicate
214
+ how they had been feeling during the last 2 weeks. The reli-
215
+ ability of this descriptive scale has been reported to range
216
+ from 0.86 to 0.90 for PA and from 0.84 to 0.87 for NA.33
217
+ European Organization for Research and Treatment
218
+ of Cancer-Quality of life C30
219
+ Health related quality of life was assessed using the Euro-
220
+ pean Organization for the Research and Treatment of
221
+ Cancer-Quality of Life (EORTCQoL C30 questionnaire ver-
222
+ sion 1).34 This 30-item questionnaire provides a measure
223
+ on the dimensions of global health status, physical, role,
224
+ emotional, cognitive and social functioning (with high scores
225
+ representing good quality of life) and cancer-related symp-
226
+ tomatology. The reliability of this descriptive scale during
227
+ the study has been reported to range from 0.52 to 0.89
228
+ for functional and global quality of life scales. Assessments
229
+ were carried out before and after radiotherapy treatment.
230
+ However, we report results for only functional quality of life
231
+ subscales in this study.
232
+ Interventions
233
+ The intervention group received integrated yoga program
234
+ and the control group received brief supportive therapy both
235
+ imparted individually. This integrated yoga program has a
236
+ combination of a set of asanas (postures done with aware-
237
+ ness) breathing exercises, pranayama (voluntarily regulated
238
+ nostril breathing), meditation and yogic relaxation that are
239
+ based on principles of stimulation and relaxation taken from
240
+ ancient Indian texts called Upanishads. Contrary to the west
241
+ where yoga is considered to be a form of exercise and various
242
+ components such as asanas, meditation and breathing exer-
243
+ cises are being used separately, in the east these practices
244
+ are interspersed with a view to developing greater relax-
245
+ ation and internal awareness.35 Subjects develop insight in
246
+ recognizing inherent tensions and stress responses and learn
247
+ ways to relax them. This would be particularly useful in
248
+ cancer patients who perceive cancer as a threat. These
249
+ practices were based on principles of attention diversion,
250
+ mindful awareness and relaxation to cope with day-to-day
251
+ stressful experiences. Participants were asked to attend a
252
+ minimum of at least three in-person sessions/week for 6
253
+ weeks during their adjuvant radiotherapy treatment in the
254
+ hospital with self-practice as homework on the remaining
255
+ days. Each of these sessions lasted 1 h and was administered
256
+ by a trained yoga therapist either before or after radiother-
257
+ apy. These sessions started with a few easy yoga postures,
258
+ breathing exercises and pranayama (voluntarily regulated
259
+ nostril breathing), and yogic relaxation. After this prepara-
260
+ Author's personal copy
261
+ Effects of yoga program
262
+ 277
263
+ tory practice for about 20 min, the subjects were guided
264
+ through any one of the meditation practices for the next
265
+ 30 min, which included focusing awareness on sounds and
266
+ chants from Vedic texts,36 or breath awareness and impulses
267
+ of touch emanating from palms and fingers while practic-
268
+ ing yogic mudras, or a dynamic form of meditation that
269
+ involved practicing with eyes closed of four yoga postures
270
+ interspersed with relaxation while supine, thus achieving a
271
+ combination of both ‘stimulating’ and ‘calming’ practice.37
272
+ The instructions were recorded on an audio tape so that
273
+ the patients could practice the same at home. The control
274
+ intervention consisted of brief supportive therapy with edu-
275
+ cation as a component that is routinely offered to patients
276
+ as a part of their care in this centre. We chose to have
277
+ this as a control intervention mainly to control for the non-
278
+ specific effects of the yoga program that may be associated
279
+ with factors such as attention, support and a sense of con-
280
+ trol as described in our earlier study.23 Subjects and their
281
+ caretakers underwent counseling by a trained social worker
282
+ (once in 10 days, 15 min sessions) during their hospital vis-
283
+ its for adjuvant radiotherapy. The control group received
284
+ 3—4 such counseling sessions during a 6-week period, where
285
+ as the intervention group received anywhere between 18
286
+ and 24 yoga sessions. Supportive counseling was a part of
287
+ routine care offered in hospitals. While the goals of yoga
288
+ intervention were stress reduction and appraisal changes,
289
+ the goals of supportive therapy were education, reinforcing
290
+ social support and coping preparation.
291
+ Data analysis
292
+ Data were analyzed using Statistical Package for Social
293
+ Sciences version 10.0. Descriptive statistics were used
294
+ to
295
+ summarize
296
+ the
297
+ data.
298
+ A
299
+ GLM
300
+ repeated
301
+ measures
302
+ ANOVA was done with the within-subjects factor being
303
+ time/assessments at two levels and between-subjects fac-
304
+ tor being groups at two levels (yoga vs. supportive therapy).
305
+ Both group by time interaction effects, between-subjects
306
+ and within-subjects effect were assessed. Post hoc tests
307
+ were done using Holms—Bonferroni correction for changes
308
+ at different time points between groups. Intention to treat
309
+ analysis was also done on the initially randomized sample
310
+ (n = 88) with baseline measure (T1) and post-measure (post-
311
+ RT
312
+ , T2) for all participants. Missing value analysis was done
313
+ using SPSS 16 by regression using the corresponding baseline
314
+ Table 1
315
+ Demographic and medical characteristics of the initially randomized sample.
316
+ All subjects
317
+ Yoga group
318
+ Control group
319
+ n = 88
320
+ %
321
+ n = 44
322
+ %
323
+ n = 44
324
+ %
325
+ Religion
326
+ Hindu
327
+ 73
328
+ 83
329
+ 36
330
+ 81.8
331
+ 37
332
+ 84.1
333
+ Muslim
334
+ 9
335
+ 10.2
336
+ 6
337
+ 13.7
338
+ 3
339
+ 6.9
340
+ Christian
341
+ 6
342
+ 6.8
343
+ 2
344
+ 4.5
345
+ 4
346
+ 9
347
+ Stage of breast cancer
348
+ I
349
+ 5
350
+ 5.7
351
+ 2
352
+ 4.5
353
+ 3
354
+ 6.8
355
+ II
356
+ 18
357
+ 20.4
358
+ 11
359
+ 25.0
360
+ 7
361
+ 15.9
362
+ III
363
+ 65
364
+ 73.9
365
+ 31
366
+ 70.5
367
+ 34
368
+ 77.3
369
+ Grade of breast cancer
370
+ I
371
+ 1
372
+ 1.1
373
+ 1
374
+ 2.3
375
+ 0
376
+ 0
377
+ II
378
+ 33
379
+ 37.5
380
+ 21
381
+ 47.7
382
+ 10
383
+ 22.7
384
+ III
385
+ 54
386
+ 61.4
387
+ 22
388
+ 50
389
+ 34
390
+ 77.3
391
+ Menopausal status
392
+ Pre
393
+ 48
394
+ 54.5
395
+ 26
396
+ 59.1
397
+ 23
398
+ 52.3
399
+ Post
400
+ 40
401
+ 45.5
402
+ 18
403
+ 40.9
404
+ 21
405
+ 47.7
406
+ Histopathology type
407
+ IDC
408
+ 72
409
+ 81.8
410
+ 37
411
+ 84.1
412
+ 35
413
+ 39.7
414
+ ILC
415
+ 7
416
+ 7.9
417
+ 2
418
+ 4.5
419
+ 5
420
+ 11.4
421
+ IPC
422
+ 3
423
+ 3.4
424
+ 2
425
+ 4.5
426
+ 1
427
+ 2.2
428
+ DCI
429
+ 2
430
+ 2.2
431
+ 2
432
+ 4.5
433
+ 0
434
+ 0
435
+ CC
436
+ 2
437
+ 2.2
438
+ 1
439
+ 2.3
440
+ 1
441
+ 2.2
442
+ PC
443
+ 2
444
+ 2.2
445
+ 0
446
+ 0
447
+ 2
448
+ 4.5
449
+ Regimen
450
+ After ChemoTherapy
451
+ 68
452
+ 77.3
453
+ 32
454
+ 72.7
455
+ 37
456
+ 84
457
+ After surgery
458
+ 20
459
+ 22.7
460
+ 12
461
+ 27.3
462
+ 7
463
+ 15.9
464
+ Marital status
465
+ Single
466
+ 2
467
+ 2.2
468
+ 1
469
+ 2.3
470
+ 1
471
+ 2.2
472
+ Married
473
+ 86
474
+ 97.8
475
+ 43
476
+ 97.7
477
+ 43
478
+ 97.8
479
+ IDC- Infiltrating Ductal Carcinoma, IPC- Infiltrating Papillary Carcinoma, ILC- Infiltrating Lobular Carcinoma, CC- Comedo Carcinoma, PC-
480
+ Papillary Carcinoma.
481
+ Author's personal copy
482
+ 278
483
+ H.S. Vadiraja et al.
484
+ Table 2
485
+ Comparison of scores for affect and functional scales of EORTCQoL C30 scores using GLM repeated measures ANOVA
486
+ between yoga and control groups.
487
+ Outcome variables
488
+ Yoga (n = 47)
489
+ Control (n = 44)
490
+ Effect size, Cohen’s f
491
+ Pre-mean (SD)
492
+ Post-mean (SD)
493
+ Pre-mean (SD)
494
+ Post-mean (SD)
495
+ PANAS-positive
496
+ 24.05 (7.28)
497
+ 27.85(7.11)**
498
+ 21.81 (7.37)
499
+ 23.33(8.3)
500
+ 0.59
501
+ PANAS-negative
502
+ 22.15 (10.6)
503
+ 12.91 (10.39)**
504
+ 25.22 (8.82)
505
+ 21.85 (10.86)
506
+ 0.84
507
+ Physical function
508
+ 73.2 (23.2)
509
+ 73.26 (25.33)
510
+ 62.72 (30.98)
511
+ 68.96 (30.12)
512
+ 0.16
513
+ Role function
514
+ 72.72 (34.86)
515
+ 79.88 (34.41)
516
+ 71.59 (36.40)
517
+ 72.85 (39.94)
518
+ 0.19
519
+ Emotional function
520
+ 56.45 (19.77)
521
+ 75.12 (21.16)**
522
+ 51.58 (17.44)
523
+ 59.23 (23.32)
524
+ 0.71
525
+ Cognitive function
526
+ 85.29 (18.0)
527
+ 90.57 (15.88)*
528
+ 82.67 (21.12)
529
+ 80.77 (24.10)
530
+ 0.48
531
+ Social function
532
+ 52.82 (26.55)
533
+ 54.96 (23.98)
534
+ 52.41 (24.43)
535
+ 49.93 (24.23)
536
+ 0.21
537
+ * p-Values < 0.05, for post hoc tests comparing groups at pre and post-radiotherapy using Holms—Bonferroni correction.
538
+ ** p-Values < 0.01, for post hoc tests comparing groups at pre and post-radiotherapy using Holms—Bonferroni correction.
539
+ value as predictors. Pearson correlation analyses were used
540
+ to study the bivariate relationships between quality of life
541
+ domains and affect.
542
+ Results
543
+ 75 Participants (yoga n = 42; control n = 33) completed the
544
+ prescribed radiotherapy regimen. All participants were
545
+ ambulatory and had a Zubrod’s performance status score
546
+ of 0—2. All patients had mastectomy as primary treatment,
547
+ 16 subjects received radiotherapy following mastectomy
548
+ and 59 subjects received radiotherapy following mastec-
549
+ tomy and three cycles of chemotherapy. The mean age of
550
+ the study population in yoga group was (46.7 ± 9.3 years)
551
+ and control group was (48.5 ± 10.2 years). Majority of sub-
552
+ jects belonged to middle class (94.2%) and remaining 5.8%
553
+ belonged to upper middle class. 9% of the population had
554
+ some previous exposure to yoga practices though none of
555
+ them seemed to practice it in the last few years. Par-
556
+ ticipants in both groups were comparable with respect to
557
+ socio-demographic and medical characteristics (Table 1). All
558
+ subjects in the intervention group tolerated the intervention
559
+ with out any adverse events.
560
+ Outcome measures
561
+ A repeated measures analysis of variance was done using
562
+ post hoc Holms—Bonferroni correction on positive affect
563
+ scores. Intention to treat analysis on the initially randomized
564
+ sample showed significant improvement in PA (Mean dif-
565
+ ference ± SE, p-value, 95%CI) (4.52 ± 1.7, p = 0.007, 1.25 to
566
+ 7.8), decrease in NA (−8.95 ± 2.3, p < 0.001, −13.4 to −4.4),
567
+ improvement in emotional function (15.88 ± 4.75, p = 0.001,
568
+ 6.45 to 25.33) and cognitive function (9.8 ± 4.35, p = 0.03,
569
+ 1.2 to 18.5) in yoga group as compared to controls following
570
+ intervention. There was a significant improvement in posi-
571
+ tive affect (−3.81 ± 1.1, p < 0.001, 1.75 to 5.89), decrease
572
+ in negative affect (9.25 ± 1.45, p < 0.001, 6.4 to 12.1),
573
+ improvement in emotional (−18.63 ± 2.8, p < 0.001, −24.3
574
+ to −12.9) and cognitive function (5.27 ± 2.69, p = 0.05,
575
+ −10.63 to −0.007) in yoga group following intervention
576
+ (T1—T2). There was also a significant decrease in negative
577
+ affect (3.37 ± 1.5, p = 0.02, 0.49 to 6.24), improvement in
578
+ physical function (−6.23 ± 2.9, p = 0.03, −11.9 to −0.49)
579
+ and emotional function (−7.66 ± 2.88, p = 0.009, −13.4 to
580
+ −1.9), in control group following intervention.
581
+ There was no significant change in social function and role
582
+ function following intervention in both the groups (Table 2).
583
+ Bivariate relationships
584
+ Bivariate relationships were determined between the out-
585
+ come measures. There was a significant positive correlation
586
+ between PA with physical function (p = 0.002), emotional
587
+ function (p < 0.001), cognitive function (p = 0.01), social
588
+ function (p = 0.007) and global quality of life (p < 0.001).
589
+ There was a significant negative correlation between
590
+ NA with emotional function (p < 0.01), physical function
591
+ (p = 0.004), cognitive function (p = 0.001), global quality of
592
+ life (p = 0.001) and social function (p = 0.008) (Table 3).
593
+ Adherence to intervention
594
+ Adherence to intervention was good with 29.7% attending
595
+ 10—20 supervised sessions, 56.7% attending 20—25 super-
596
+ vised sessions and 13.7% attending >25 supervised sessions
597
+ over a 6-week period. Level of adherence did not seem to
598
+ affect quality of life or affect scores (results not shown).
599
+ Table 3
600
+ Pearson correlation (r-values) between affect
601
+ (PANAS) and functional subscales on EORTCQoL C30.
602
+ Functional subscales
603
+ on EORTCQoL C30
604
+ PANAS-P
605
+ , r
606
+ PANAS-N, r
607
+ Physical function
608
+ 0.32**
609
+ −0.31**
610
+ Role function
611
+ 0.26*
612
+ −0.16
613
+ Cognitive function
614
+ 0.27***
615
+ −0.35**
616
+ Emotional function
617
+ 0.4***
618
+ −0.64***
619
+ Social function
620
+ 0.29**
621
+ −0.28**
622
+ GQOL
623
+ 0.50***
624
+ −0.36**
625
+ p-Values for Pearson correlation coefficients.
626
+ * p < 0.05.
627
+ ** p < 0.01.
628
+ *** p < 0.001.
629
+ Author's personal copy
630
+ Effects of yoga program
631
+ 279
632
+ Discussion
633
+ We compared the effects of a 6-week integrated yoga pro-
634
+ gram with supportive therapy in stage II and III breast cancer
635
+ patients undergoing adjuvant radiotherapy. There was a
636
+ significant difference across groups over time for positive
637
+ affect, negative affect, and emotional function. There was
638
+ significant improvement in positive affect, emotional func-
639
+ tion and cognitive function, and decrease in negative affect
640
+ in the yoga group as compared to controls.
641
+ Though intervention showed small to large effect size for
642
+ these outcome measures, the effect size was highest for
643
+ decrease in negative affect and lowest for physical function
644
+ scores on quality of life subscale. This is in contrast to earlier
645
+ study (Moadel et al.) that has shown improvements in qual-
646
+ ity of life, emotional, social and spiritual well being even
647
+ with poor adherence to yoga intervention. This could be
648
+ due to the fact that their study21 lacked a control interven-
649
+ tion and differed from ours with respect to scales used for
650
+ measuring QoL (Functional Assessment of Cancer Treatment-
651
+ Breast), ethnicity of study population and heterogeneity in
652
+ conventional cancer treatments. In their study radiother-
653
+ apy predicted poor adherence to treatment and outcome
654
+ measures. However, adherence to intervention was better in
655
+ our study with 56.7% attending 20—25 supervised yoga ses-
656
+ sions and 13.7% attending >25 supervised yoga sessions over
657
+ a 6-week period. This was primarily due to the fact that all
658
+ patients were undergoing adjuvant radiotherapy and were
659
+ visiting the hospital 5 days a week for six consecutive weeks
660
+ and this could have contributed to improved adherence. Our
661
+ results are also in contrast to earlier study using MBSR inter-
662
+ vention that has shown some improvement in functional
663
+ scales that were not significant following intervention. In
664
+ this study too adherence to intervention, duration and het-
665
+ erogeneity in cancer population could have confounded the
666
+ actual effects of intervention.32 However, adherence did not
667
+ seem to influence the outcome measures possibly due to
668
+ the fact that an improved adherence created an ‘‘overall
669
+ floor effect’’ thereby not influencing the outcome mea-
670
+ sures.
671
+ Several studies have shown that both psychological and
672
+ treatment related distress affect quality of life concerns
673
+ in cancer patients.38—41 Cancer patients have to constantly
674
+ make lifestyle changes to adjust and cope with these treat-
675
+ ment related distress and seek supportive care.42 Yoga
676
+ and exercise as a lifestyle and stress reduction interven-
677
+ tion has shown to decrease negative affect and improve
678
+ positive affect.26—28 This change in affect could have con-
679
+ tributed to improvement in quality of life concerns in these
680
+ patients. This is further corroborated by our results with
681
+ decrease in negative affect being related to improvement
682
+ in physical function, emotional function and social func-
683
+ tion and improvement in positive affect being related to
684
+ improvement in role function. Possible threat perceptions
685
+ and intrusive thoughts could motivate cancer patients to
686
+ pursue health care behaviors that offer spiritual solace.43
687
+ It is here that yoga as a psycho-spiritual intervention could
688
+ offer much needed support. However, in our study we were
689
+ not able to assess this spiritual component in quality of life,
690
+ nevertheless it could be one of the possible mechanisms
691
+ by which yoga could have influenced other quality of life
692
+ domains.
693
+ Using patients with high school education could have
694
+ affected the generalizability of the study findings. Though
695
+ the intervention was imparted as individual sessions, group
696
+ sessions could have been more feasible and far more acces-
697
+ sible. Sessions in a group setting could have instilled a sense
698
+ of community where patients could model successful coping
699
+ and gain self-esteem and motivation in their ability to help
700
+ others in a group contributing to improvement in outcome
701
+ measures.44,7 This could have confounded the effects of our
702
+ intervention and hence we chose to have individual sessions
703
+ in this study. However, considering the adherence neither
704
+ access nor feasibility was a problem. None of the subjects
705
+ who underwent intervention had any adverse effects of
706
+ intervention suggesting that these interventions were safe
707
+ and feasible.
708
+ The contrast in results from earlier studies could be due
709
+ to lack of concordance between EORTCQoL C30 and FACT
710
+ scales on several domains of quality of life.45 Though this
711
+ could be a limitation, our results still offer support for
712
+ improving quality of life concerns in a homogenous group of
713
+ breast cancer patients similar to our earlier observations on
714
+ reductions in anxiety23 and distressful symptoms.24 However,
715
+ larger randomized controlled studies using more structured
716
+ behavioral approaches and multiple assessment tools are
717
+ needed to further validate our findings.
718
+ Acknowledgements
719
+ We are thankful to Ms. Jayalakshmi for imparting the yoga
720
+ intervention. We are thankful to Dr Ravi Kulkarni for his
721
+ advice and help with statistical analyses.
722
+ References
723
+ 1. Ganz P
724
+ , Coscarelli A, Fred C, Kahn B, Polinsky ML, Petersen L.
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+ Breast cancer survivors: psychosocial concerns and quality of
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+ 22. Cohen L, Chandwani KD, Perkins G, Thornton B, Arun B, Raghu-
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+ ram NV, et al. Randomized trial of yoga in women with breast
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+ Journal of Clinical Oncology 2008;26(May (Suppl.)).
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+ 23. Rao MR, Raghuram N, Nagendra HR, Gopinath KS, Srinath BS,
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+ Diwakar RB, et al. Anxiolytic effects of a yoga program in
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+ 24. Raghavendra RM, Nagarathna R, Nagendra HR, Gopinath
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+ KS, Srinath BS, Ravi BD, et al. Effects of an integrated
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+ 462—74.
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+ 25. Rao RM, Telles S, Nagendra HR, Nagarathna R, Gopinath K,
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+ Srinath S, et al. Effects of yoga on natural killer cell counts
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+ in early breast cancer patients undergoing conventional treat-
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+ ment. Med Sci Monit 2008;14:LE10.
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+ 26. Mutrie N, Campbell AM, Whyte F
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+ 27. Danhauer SC, Mihalko SL, Russell GB, Campbell CR, Felder L,
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+ 29. Chaturvedi SK, Chandra P
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+ 30. Cordova MJ, Andrykowski MA, Kenady DE, McGrath PC, Sloan
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+ 31. Overgaard M, Hansen PS, Overgaard J. Postoperative radiother-
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+ Engl J Med 1997;337(14):949—55.
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+ 32. Carlson LE, Speca M, Patel DK, Goodey E. Mindfulness-based
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+ 33. Watson D, Clark LA, Tellegen A. Development and validation
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+ lore: Dept of Psychiatry, NIMHANS; 1998.
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subfolder_0/Efficacy of yoga based life style modification program on medication score and lipid profile in type 2 diabetes.txt ADDED
@@ -0,0 +1,1100 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ORIGINAL ARTICLE
2
+ Efficacy of yoga based life style modification program
3
+ on medication score and lipid profile in type 2
4
+ diabetes—a randomized control study
5
+ R. Nagarathna & M. R. Usharani & A. Raghavendra Rao & R. Chaku &
6
+ R. Kulkarni & H. R. Nagendra
7
+ Received: 13 April 2011 /Accepted: 15 May 2012 /Published online: 1 August 2012
8
+ # Research Society for Study of Diabetes in India 2012
9
+ Abstract Several studies have documented the beneficial
10
+ short term effects of yoga in type 2 diabetics. In this pro-
11
+ spective two-armed interventional randomized control study,
12
+ 277 type 2 diabetics of both genders aged above 28 years
13
+ who satisfied the study criteria were recruited from 5 zones
14
+ in and around Bengaluru, India. They were allocated to a
15
+ yoga-based life style modification program or exercise-based
16
+ life style modification program. Integrated yoga special tech-
17
+ nique for diabetes included yogasanas, pranayama, medita-
18
+ tion and lectures on yogic life style. Control intervention
19
+ included physical exercises and life style education. Medi-
20
+ cation score, blood glucose, HbA1c and lipid profile were
21
+ assessed at baseline and after 9 months. Intention to treat
22
+ analysis showed better reduction (P<0.05, Mann-Whitney
23
+ test) in the dose of oral hypoglycemic medication required
24
+ (Yoga - 12.8 %) (Yoga-12.3 %) and increase in HDL (Yoga-
25
+ 7 %) in Yoga as compared to the control group; FBG
26
+ reduced (7.2 %, P00.016) only in the Yoga group. There
27
+ was significant reduction within groups (P<0.01) in PPBG
28
+ (Yoga-14.6 %, Control-9 %), HbA1c (Yoga-14.1 %,
29
+ Control-0.5 %), Triglycerides (Yoga-15.4 %, Control-
30
+ 16.3 %), VLDL (Yoga-21.5 %, Control-5.2 %) and total
31
+ cholesterol (Yoga-11.3 %, Control-8.6 %). Thus, Yoga based
32
+ life style modification program is similar to exercise-based
33
+ life style modification in reducing blood glucose, HbA1c,
34
+ triglycerides, total cholesterol and VLDL. Yoga is better than
35
+ exercise in decreasing oral hypoglycemic medication re-
36
+ quirement and LDL; and increasing HDL in type 2 diabetics.
37
+ Keywords Yoga . Exercise . Hypoglycemic agent . HDL .
38
+ Blood glucose
39
+ Introduction
40
+ Diabetes mellitus is a major global health problem affecting
41
+ 150 million people worldwide. In India, the prevalence of
42
+ type 2 diabetes (T2DM) and premature coronary artery
43
+ disease is rapidly escalating in all socioeconomic groups
44
+ parallel with the obesity epidemic [1].
45
+ R. Nagarathna (*)
46
+ Division of Yoga and Life Sciences, Swami Vivekananda
47
+ Yoga Anusandhana Samsthana, (SVYASA) University,
48
+ Eknath Bhavan, 19, Gavipuram circle, Kempegowda Nagar,
49
+ Bengaluru 560019, India
50
+ e-mail: [email protected]
51
+ R. Nagarathna
52
+ e-mail: [email protected]
53
+ M. R. Usharani: A. R. Rao: R. Chaku: R. Kulkarni:
54
+ H. R. Nagendra
55
+ SVYASA University,
56
+ Eknath Bhavan, 19, Gavipuram circle, Kempegowda Nagar,
57
+ Bengaluru 560019, India
58
+ M. R. Usharani
59
+ e-mail: [email protected]
60
+ A. R. Rao
61
+ e-mail: [email protected]
62
+ R. Chaku
63
+ e-mail: [email protected]
64
+ R. Kulkarni
65
+ e-mail: [email protected]
66
+ H. R. Nagendra
67
+ e-mail: [email protected]
68
+ R. Chaku
69
+ WHO project, Morarji Desai National Institute of Yoga,
70
+ New Delhi, India
71
+ Present Address:
72
+ A. R. Rao
73
+ HOD, Department of Complementary and Alternative Medicine,
74
+ Bangalore Insititute of Oncology,
75
+ Bengaluru 560027, India
76
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
77
+ DOI 10.1007/s13410-012-0078-y
78
+ The primary reasons for this rapid global epidemiological
79
+ transition include aging of the population [2], genetic factors
80
+ [3], changing life style with altered dietary patterns with
81
+ decreased physical activity [4], and psychosocial stresses
82
+ [5]. The associated lipoprotein abnormalities such as elevated
83
+ concentrations of triglycerides and LDL, with decreased
84
+ HDL, and the oxidative stress play an important role in the
85
+ occurrence of early atherosclerosis in diabetics. Hence, the
86
+ primary role of life style modification programs that include
87
+ exercise, diet and stress reduction has been widely accepted
88
+ to reduce the incidence of type 2 diabetes [6, 7, 8]. There are
89
+ reports that the physician’s advice in a diabetic clinic is
90
+ usually ineffective [8]. Studies have also shown that people
91
+ have considerable interest in lifestyle interventions than a
92
+ pharmaceutical trial [9]. Incidence of type 2 diabetes has
93
+ reduced by 40 to 60 % over 3 to 4 years in high risk
94
+ population in USA after modest weight loss through diet
95
+ and physical activity [7].
96
+ Alternative methods of exercise, stress reduction [10],
97
+ and relaxation techniques [11] including cognitive behav-
98
+ iour therapy [12] have been shown to improve the mood
99
+ with better glycemic control and prevention of complica-
100
+ tions of the metabolic syndrome. Psychological stresses
101
+ resulting in depression contributes to poor compliance and
102
+ outcome of therapeutic measures [6] and its treatment has
103
+ shown better glycemic control and improved quality of life
104
+ [13]. Yoga has been explored scientifically since the 1970’s
105
+ as a widely available resource for life style-related problems
106
+ such as hypertension [14], bronchial asthma [15], diabetes
107
+ [16] and coronary artery disease [17]. A critical review of all
108
+ published literature from 1970 to 2006 on the effects of
109
+ yoga based programs on the risk profiles in adults with
110
+ T2DM showed that yoga reduces the risk profiles and may
111
+ help in prevention and management of its cardiovascular
112
+ complications [18]. These beneficial effects of yoga seem to
113
+ be due to the relaxation response [16] that has the potential
114
+ to reduce the heightened stress responses through techni-
115
+ ques that promote mastery over the modifications of mind
116
+ [19].
117
+ Studies in India have also shown the beneficial effects of
118
+ yoga in diabetics. Damodaran et al observed decrease in
119
+ blood pressure, drug scores, sympathetic activity (VMA
120
+ catecholamine and MDA), oxidant stress (vitamin C cholin-
121
+ esterase) and improvements in risk factors such as blood
122
+ glucose, cholesterol and triglycerides with better subjective
123
+ well being and quality of life in a non randomized study
124
+ on outpatients for 3 months [20]. Singh et al showed
125
+ significant decrease in fasting and post prandial blood
126
+ glucose levels and glycosylated hemoglobin with stable
127
+ autonomic functions after forty days of yogic exercises in
128
+ Type 2 Diabetics [21].
129
+ More recently, Hegde et al (2011) in south India in a
130
+ stratified control trial studied diabetics with and without
131
+ complications (peripheral neuropathy or microvascular or
132
+ macrovascular) and observed significant reduction in BMI,
133
+ improved glycemic control, and oxidative stress within
134
+ 3 months when yoga was added to standard care [22]. Yoga
135
+ improved the ‘heart friendly’ status of lipid profile in peri
136
+ and post-menopausal patients receiving standard medical
137
+ treatment for type 2 DM with decrease in low density
138
+ lipoprotein as well as fasting and postprandial blood glucose
139
+ levels within six weeks [23]. A review by the American
140
+ diabetes association on yoga and other mind body interven-
141
+ tion concluded that clinical trials on patients with diabetes
142
+ have shown improvement in measures of quality of life and
143
+ stress but consistent long-term improvements in glycemic
144
+ control or HbA1C have not been documented [24].
145
+ There are not many long-term follow up studies which
146
+ have directly compared the effects of exercise with yoga on
147
+ medication requirement and lipid profile. Hence, the present
148
+ study was planned with an objective to compare the efficacy
149
+ of a Yoga based Life Style modification Program (YLSP)
150
+ with conventional Exercise based Life Style modification
151
+ Program (ELSP) in type 2 diabetics, with the hypothesis that
152
+ YLSP will be better than ELSP, in achieving better control
153
+ of diabetes with favourable changes in medication require-
154
+ ment and lipid profile.
155
+ Subjects and methods
156
+ Design
157
+ The study Registered Trial number - CTRI/2008/091/
158
+ 000293 was a prospective randomized two arm parallel
159
+ control study with active intervention for the control group.
160
+ The research protocol was approved by the Ethics Committee
161
+ of SVYASA University. Signed informed consent was
162
+ obtained from all participants before recruitment.
163
+ Subjects
164
+ The participants were selected from five different zones
165
+ (east, west, north, south and central) in and around Bengaluru
166
+ city, India, between 2003–2007. Inclusion criteria were, (a)
167
+ type 2 diabetics of both sexes above 25 years, (b) fasting
168
+ venous blood glucose level >120 mg% at the time of diag-
169
+ nosis (checked from their records), (c) T2DM of more than
170
+ one year, (d) those stabilized on a stable dosage of oral
171
+ hypoglycemic agents or insulin for at least three weeks
172
+ and (e) no prior exposure to yoga practice. Those with major
173
+ complications of T2DM such as chronic infections (tubercu-
174
+ losis, HIV), coronary artery disease, severe hypertension,
175
+ nephropathy, proliferative retinopathy and/or cerebrovascular
176
+ disease were excluded. Those with peripheral neuropathy,
177
+ mild urinary or cutaneous fungal infections, mild to moderate
178
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
179
+ 123
180
+ hypertension and obesity were not excluded. The sample size
181
+ was calculated by Cohen’s formula [25] with alpha of 0.05,
182
+ powered at 0.80 for an effect size of 0.34 based on our earlier
183
+ interventional study [16]. All participants who satisfied the
184
+ selection criteria and signed the informed consent were
185
+ assigned a numbered envelope containing a computer gener-
186
+ ated random number (using www.randomizer.org). To conceal
187
+ bias during randomization, the statistician at the university
188
+ centre, who was not involved in administering the interven-
189
+ tion, allocated them to yoga or control groups. Different
190
+ random number tables were used for five different venues.
191
+ Masking
192
+ As this was an interventional study blinding was not possible.
193
+ The laboratory staff and the statistician were blind to the
194
+ source of the data. Care was taken to prevent crossover of
195
+ participants or interaction between the two groups.
196
+ Methods
197
+ Within one week after recruitment all baseline data were
198
+ documented. Those who needed any change in the dosage of
199
+ oral hypoglycemic medication or insulin were made to wait
200
+ for 3 weeks for a second assessment before starting the
201
+ intervention. Both groups were trained by certified thera-
202
+ pists through daily (one hour/day - 5 days /week) classes, for
203
+ 12 weeks followed by weekly follow up classes for 2 h for
204
+ 9 months. During the follow up period they were asked to
205
+ continue the practices for 1 h daily at home using a pre-
206
+ recorded instruction audio tape. All participants were pro-
207
+ vided with a diary to tick the type and duration of their daily
208
+ recommended practice, monthly fasting and post-prandial
209
+ blood glucose levels, body weight, visits to family physician
210
+ for any health problem, episodes of hypoglycemia, and any
211
+ change in their diet, medication or daily practice of yoga or
212
+ exercise. The medical officer and the dietitian were avail-
213
+ able at the venue once a month to check their progress and
214
+ advise suitable changes. All outcome measures for the study
215
+ were checked at the end of 9 months.
216
+ Intervention
217
+ The modules of intervention for the two groups were care-
218
+ fully developed by a team consisting of two senior yoga
219
+ experts of the university, a psychiatrist and a diabetologist.
220
+ Table 1 shows the details of the intervention for the two
221
+ groups. The interventions for both modules were aimed at
222
+ achieving, (a) conventional diabetes education, (b) stress man-
223
+ agement, and (c) empowerment for adherence to long term life
224
+ style change. The specific yoga module for YLSP was the
225
+ same as that used in our earlier study on yoga in diabetes [16].
226
+ This ‘Integrated Approach of Yoga for Diabetes (IAYD)’ is
227
+ based on the knowledge culled out from yoga scriptures
228
+ (Patanjali yoga sutras, Bhagvadgita and Mandukya karika).
229
+ The practices included (i) physical practices such as cleans-
230
+ ing techniques (kriyas), loosening practices (shithilikarana
231
+ vyayama), sun salutation (suryanamaskara) and yoga pos-
232
+ tures (asanas) to provide mild intensity physical exercise
233
+ effect. (ii) Pranayama and meditation (dharana and dhyana)
234
+ for calmness of mind, (iii) devotional sessions (Bhakti
235
+ yoga) for better emotional stability and (iv) lectures and
236
+ yogic counseling for notional correction through self
237
+ analysis (Jnana yoga) [16, 26]. The kriyas (Neti, Dhouti
238
+ and Shankaprakshalana) were done once a week. The ELSP
239
+ module consisted of (i) standard physical training (PT) exer-
240
+ cises and walking designed to achieve a comparable intensity
241
+ of physical exertion, (ii) non-yogic breathing exercises used in
242
+ physiotherapy and (iii) supine rest. Both groups had access to
243
+ reading material on conventional diabetes education.
244
+ Measurements
245
+ Baseline measurements before recruitment included demo-
246
+ graphic data and investigations to satisfy the selection crite-
247
+ ria. They were (i) fasting blood glucose, (ii) resting blood
248
+ pressure using a sphygmomanometer, (iii) electrocardio-
249
+ gram using a portable ECG recorder (one channel recorder,
250
+ version 6108 T, BPL, India), (iv) fundoscopy by a certified
251
+ ophthalmologist and (v) serum urea and creatinine [27] to
252
+ look for nephropathy.
253
+ Outcome measures
254
+ A semi-structured interview for medical history, and demo-
255
+ graphic data were recorded by the medical officer after
256
+ recruitment.
257
+ 1.
258
+ Medication score: The oral medication scores (standard
259
+ quantity of the drug per tablet as indicated in CIMS
260
+ India [28] expressed as number of tablets per day) were
261
+ calculated separately for each category i.e. Oral Hypo-
262
+ glycemic Agents (OHA), Lipid Lowering Drugs (LLD)
263
+ and Antihypertensive drugs (AHT). Total medication
264
+ score indicates the total number of tablets of all drugs
265
+ consumed in a day. The insulin score was calculated by
266
+ using a scoring system ranging from 0–3 (00nil, 1e15
267
+ units, 2016–30 units, 3>30 units), for the total number
268
+ of units of insulin injected in 24 h.
269
+ 2.
270
+ Biochemical measures included blood glucose, HbA1c
271
+ and lipid profile. Blood samples were drawn from an ante-
272
+ cubital vein in the fasting state (Fasting Blood Glucose—
273
+ FBG) between 8 am and 9 am, and 2 h after breakfast
274
+ (Post-Prandial Blood Glucose—PPBG) between 10 am
275
+ and 11 am. The participants were instructed to abstain
276
+ from morning yoga or PT exercises on the day of blood
277
+ 124
278
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
279
+ Table 1 Practices used for the
280
+ intervention in both groups
281
+ YLSP Yoga based Life Style
282
+ change Program, ELSP Exercise
283
+ based Life Style change Program
284
+ Practices for Yoga (YLSP) group
285
+ Practices for control (ELSP) group
286
+ Breathing Exercises
287
+ Exercises in standing position
288
+ Shasha Shwasa (Rabbit Breathing)
289
+ Forward backward bending
290
+ Vyaghra Shwasa(Tiger Breathing )
291
+ Side bending
292
+ Navasana Shwasa (Boat Breathing)
293
+ Jogging
294
+ Shithilikarana Vyayama (yogic loosening)
295
+ Sit-up
296
+ Padahatasana Ardha Cakrasana Chalana
297
+ (Forward Backward Bending)
298
+ Twisting
299
+ Cross leg lifting
300
+ Trikonasana Chalana (Side Bending)
301
+ Alternative toe touching
302
+ Kati Parivartana Chalana (Twisting)
303
+ Hip rotation
304
+ Dhanurasana Chalana (Swinging in Bow)
305
+ Knee rotation
306
+ Pavanamuktasana Kriya (wind releasing)
307
+ forward drill
308
+ Surya Namaskara (Sun Salutation)
309
+ Backward drill
310
+ Shavaansa (Quick Relaxation Technique—QRT)
311
+ Sideward drill
312
+ Asanas (Yoga postures)
313
+ Neck movements
314
+ Parivritta Trikonasana (Twisted triangle)
315
+ Shoulder rotation
316
+ Vakrasana or Ardha Matsyendrasana
317
+ (Spinal Twist or Sage Matsyendra posture)
318
+ Full arm rotation
319
+ Ustrasana (Camel)
320
+ Free walking
321
+ Hamsasana or Mayurasana (Swan or Peacock)
322
+ Exercises in sitting position
323
+ Bhujangasana (Cobra)
324
+ Knee cap tightening
325
+ Dhanurasana (Bow)
326
+ Swimming
327
+ Sarvangasana (Whole Body Inverted posture)
328
+ Supine relaxation
329
+ Matsyasana (Fish)
330
+ Half butterfly exercise
331
+ Deep Relaxation Technique (DRT)
332
+ Chakki chalana (waist twisting))
333
+ Bandhas (locks) and Kriyas (cleansing)
334
+ Ankle bend exercise
335
+ Jala Neti (nasal wash with water)
336
+ Toe Bend exercise
337
+ Sutra Neti (nasal wash with catheter)
338
+ Crow walking
339
+ Vaman Dhouti (yogic vomiting)
340
+ Knee rotation
341
+ Shankha Prakshalana(yogic bowel cleansing)
342
+ Exercises in prone position
343
+ Uddiyana Bandha (diaphragm lock)
344
+ Prone bow swing
345
+ Agnisara Kriya( abdominal flap)
346
+ Prone Alternate
347
+ Kapalabhati (Blasting breath)
348
+ head and leg swing
349
+ Pranayama (yogic breathing)
350
+ Boating
351
+ Vibhagiya Pranayama (Sectional Breathing)
352
+ Rolling
353
+ ujjayi (glottis breathing)
354
+ Alternate Arm swing
355
+ Nadi Suddhi (alternate nostril)
356
+ Hip stretch
357
+ Sitali or Sitkari (cooling breath)
358
+ Exercises in Supine position.
359
+ Bhramari (Bee Breathing)
360
+ Cycling
361
+ Meditation (Dharana and Dhaya)
362
+ Straight leg rising
363
+ Nadanusandhana (sound resonance Merger)
364
+ Side leg rising
365
+ Om Meditation (meditation on Om syllable)
366
+ Knee exercise
367
+ Lectures—topics covered
368
+ Dorsal Stretch
369
+ Diabetes: burden, causes, management
370
+ Rolling and rocking
371
+ Yogic concepts of healthy life style
372
+ Supine rest
373
+ including thinking, feeling and behaviour,
374
+ Lectures—topics covered
375
+ Yogic management of stress,
376
+ Diabetes: burden, cause, management causes, management.
377
+ Diabetes and yoga Diet,
378
+ Modern scientific concepts of healthy life style including
379
+ thinking, feeling and behaviour
380
+ How to stop smoking, the yogic way
381
+ Modern concepts of management of stress and how to stop
382
+ smoking
383
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
384
+ 125
385
+ collection. The sera were separated within an hour of
386
+ collection. A certified technician carried out all the tests
387
+ at the SVYASA university laboratory. Heparinised blood
388
+ was used to analyze HbA1c by using affinity assay meth-
389
+ od on a Nycocord reader [29]. The concentration of
390
+ glucose was determined by using glucose-oxidase method
391
+ [30] and serum total cholesterol, triglyceride and HDL by
392
+ enzymatic methods [31]. High density lipoprotein was
393
+ measured after precipitating VLDL and LDL cholesterol
394
+ in the presence of magnesium ions. The VLDL and LDL
395
+ fractions were calculated by the Friedwald’s formula [32].
396
+ Statistical analysis
397
+ Data were analyzed using SPSS version 16. The baseline data
398
+ were not normally distributed (Shapiro Wilk’s test P<0.05).
399
+ Mann Whitney test was used for pre values for checking the
400
+ baseline matching. As there was an attrition rate of about 38 %
401
+ by the 9th month, we carried out ‘intention to treat analysis’
402
+ considering both pre and post data as predictors [33–35] based
403
+ on the concept of ‘Expectation Maximisation’. Wilcoxon’s
404
+ signed ranks test was used to compare the pre-post changes
405
+ and Mann-Whitney ‘U’ test to compare groups.
406
+ Results
407
+ Figure 1 shows the trial profile. Out of 520 screened, 277
408
+ (87 females) participants (141 in YLSP and 136 in ELSP),
409
+ were randomized into two groups; 264 completed the initial
410
+ 12 weeks of training and 173 (88 in yoga and 85 in control
411
+ group) completed the study. The reasons for drop outs are
412
+ given in Fig. 1. Table 2 shows the demographic features.
413
+ There was no baseline matching between groups in mean
414
+ duration of diabetes before recruitment (6.19±5.49 years
415
+ in YLSP and 4.75±4.18 years in ELSP). The baseline
416
+ measurements used to rule out nephropathy before recruit-
417
+ ment was matched for creatinine concentration and blood
418
+ urea nitrogen in both groups.
419
+ Medication score (Table 3)
420
+ Oral hypoglycemic drug requirement reduced in 30 partic-
421
+ ipants in YLSP and 14 in ELSP with significant reduction of
422
+ mean scores in YLSP (12.8 %, P<0.001) and non-signifi-
423
+ cant reduction (3.7 %) in ELSP. There was significant dif-
424
+ ference between groups at P00.05 (Mann Whitney). The
425
+ total medication that included all categories of drugs re-
426
+ duced by 10.9 % in YLSP (P00.004) with no significant
427
+ difference in ELSP or between groups. It reduced in 35
428
+ patients in YLSP and 19 patients in ELSP. Amongst those
429
+ who were taking insulin (16 in YLSP and 10 in ELSP) at the
430
+ time of recruitment, five in YLSP group and one in ELSP
431
+ had discontinued (no significant statistical change).
432
+ Lipid profile (Table 4)
433
+ HDL increased by 7 % in YLSP (P00.002) with significant
434
+ difference between groups (P00.007). LDL reduced signif-
435
+ icantly in YLSP by 12.3 % (P<0.001), with difference
436
+ between groups at P00.003. Triglycerides, total cholesterol
437
+ and VLDL reduced significantly in both groups with non
438
+ significant differences between groups and better effect
439
+ sizes in yoga group.
440
+ Changes in blood glucose (Table 4)
441
+ There was a significant reduction in FBG by 7.2 % in
442
+ YLSP (P00.016) at 9th month. PPBG reduced significant-
443
+ ly in both the groups, 14.6 % in YLSP (P<0.001) and
444
+ 8.9 % in ELSP (P00.019) groups, with non-significant
445
+ difference between groups. The concentration of HbA1c
446
+ reduced in both groups, 14.1 % in YLSP (P<0.001) and
447
+ 0.5 % in ELSP (P00.002) with no significant difference
448
+ between groups.
449
+ Subgroup analysis based on duration of illness:
450
+ A subgroup analysis was done between groups with a
451
+ median cut off of 5 years for duration of illness. The
452
+ trends observed between groups when duration of
453
+ illness was <5 years or >5 years was similar to trends
454
+ seen when groups were compared without cut offs for
455
+ duration of illnesses as reported above. Hence, this has
456
+ not been reported separately in tables.
457
+ Discussion
458
+ This was a prospective randomized control study that com-
459
+ pared YLSP with ELSP on 277 participants with type 2
460
+ diabetes selected from 5 zones in and around Bengaluru.
461
+ After 9 months of intervention there was significant differ-
462
+ ence between groups (P<0.01) in HDL, LDL and medica-
463
+ tion requirement with higher effect sizes in YLSP group.
464
+ There was reduction in PPBG and HbA1c, triglycerides,
465
+ total cholesterol and VLDL in both groups with better effect
466
+ sizes in yoga group (non-significant differences between
467
+ groups) whereas FBG reduced significantly only in the yoga
468
+ group. A review by Innes KE et al [18] of 25 yoga studies
469
+ on type 2 diabetics (of which 4 were RCTs), concluded that
470
+ yoga practice was associated with reduction of 6.1–34.4 %
471
+ 126
472
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
473
+ in blood glucose and 10.5–27.3 % in HbA1c. A recent three
474
+ armed RCT showed a 30 % reduction in FBG with no
475
+ changes in HbA1c or medication scores after 6 months of
476
+ yoga [36]. Our study adds evidence to the efficacy of yoga
477
+ in a south Indian diabetic population. This is the first study
478
+ that has documented significantly better reduction in oral
479
+ hypoglycemic agents (12.8 %) in YLSP than ELSP.
480
+ Significant reduction in serum total cholesterol, triglycer-
481
+ ides and LDL concentrations in type 2 diabetics after yoga
482
+ exercises [37] and Sudarshan Kriya Yoga (SKY) [38] have
483
+ Table 2 Demographic data
484
+ YLSP Yoga based Life Style
485
+ change Program, ELSP Exercise
486
+ based Life Style change
487
+ Programs
488
+ Variables
489
+ YLSP group (141)
490
+ ELSP group (136)
491
+ 1
492
+ Gender
493
+ Males
494
+ 91
495
+ 99
496
+ Females
497
+ 50
498
+ 37
499
+ 2
500
+ Age
501
+ Range
502
+ 30–78 years
503
+ 30–74 years
504
+ Mean±SD
505
+ 53.46±8.86
506
+ 51.38±8.39
507
+ 3
508
+ Education
509
+ School
510
+ 78
511
+ 73
512
+ Undergraduates
513
+ 36
514
+ 38
515
+ Graduates
516
+ 27
517
+ 22
518
+ Post Graduates
519
+
520
+ 3
521
+ 4
522
+ Socio-Economic Status
523
+ Upper class
524
+ 1
525
+ 0
526
+ Middle class
527
+ 140
528
+ 136
529
+ 5
530
+ Duration of DM
531
+ Mean±SD
532
+ 6.19±5.49
533
+ 4.75±4.18
534
+ 1–5
535
+ 92
536
+ 96
537
+ 5.1–10
538
+ 25
539
+ 29
540
+ 10–20
541
+ 20
542
+ 9
543
+ 20–30
544
+ 2
545
+ 1
546
+ 30–40
547
+ 2
548
+ 1
549
+ 6
550
+ Family History of DM2
551
+ 63
552
+ 45
553
+ 7
554
+ Tobacco chewing
555
+ 19
556
+ 9
557
+ 8
558
+ Alcohol Consumption
559
+ 13
560
+ 12
561
+ Control group -136
562
+ Yoga group - 141
563
+ SCREENED - 520
564
+ Recruited & Randomized - 277
565
+ Not interested - 63
566
+ Did not fulfill the selection criteria - 78
567
+ Interested but could not commit for the
568
+ study - 102
569
+ 9 months - 88
570
+ (62.4%)
571
+ Drop outs - 53
572
+ Time constraints - 13
573
+ Minor Illnesses - 6
574
+ Personal reasons - 15
575
+ Secondary complications - 3
576
+ Shifted to other systems - 6
577
+ Change of address - 10
578
+ 4 weeks -135
579
+ (96%)
580
+ Drop outs - 51
581
+ Time constraints - 12
582
+ Minor Illnesses - 4
583
+ Personal reasons-10
584
+ Secondary complications - 8
585
+ Shifted to yoga - 5
586
+ Shifted to other systems - 5
587
+ Change of address - 7
588
+ Death - 1
589
+ 4 weeks -129
590
+ (95%)
591
+ 3 months -112
592
+ 3 months -105
593
+ 6 months - 97
594
+ 6 months - 91
595
+ 9 months - 85
596
+ (62.5%)
597
+ Fig. 1 Trial profile
598
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
599
+ 127
600
+ Table 3 Results- Changes in
601
+ medication scores after 9 months
602
+ of intervention in both groups
603
+ OHA Oral Hypoglycemic
604
+ Agents, LLD Lipid Lowering
605
+ Drugs, Anti HT Antihyperten-
606
+ sive drugs, ES Effect Size, NS
607
+ Not Significant
608
+ Variable
609
+ Group
610
+ Pre-intervention
611
+ Post-intervention
612
+ % Change
613
+ Within groups
614
+ Between groups
615
+ Mean±SD
616
+ Mean±SD
617
+ P
618
+ ES
619
+ P
620
+ ES
621
+ Total
622
+ YLSP (N0141)
623
+ 3.38±2.19
624
+ 3.01±1.88
625
+ 10.94
626
+ 0.004
627
+ 0.29
628
+ NS
629
+
630
+ ELSP (N0136)
631
+ 3.24±1.95
632
+ 3.15±1.74
633
+ 2.77
634
+ 0.37
635
+ 0.09
636
+ OHA
637
+ YLSP
638
+ 2.27±1.29
639
+ 1.98±1.27
640
+ 12.77
641
+ <0.001
642
+ 0.37
643
+ 0.05
644
+ 0.25
645
+ ELSP
646
+ 2.41±1.52
647
+ 2.32±1.42
648
+ 3.65
649
+ 0.22
650
+ 0.11
651
+ NS
652
+
653
+ LLD
654
+ YLSP
655
+ 0.76±0.44
656
+ 0.88±0.48
657
+ 15.79
658
+ NS
659
+
660
+ NS
661
+
662
+ ELSP
663
+ 0.77±0.43
664
+ 0.92±0.28
665
+ 19.48
666
+ NS
667
+ Anti HT
668
+ YLSP
669
+ 1.10±0.52
670
+ 1.08±0.47
671
+ 1.81
672
+ NS
673
+
674
+ NS
675
+
676
+ ELSP
677
+ 0.98±0.68
678
+ 1.02±0.51
679
+ 4.08
680
+ NS
681
+ Table 4 Changes in glycemic control and lipids in both groups after 9 months of intervention
682
+ Variables
683
+ YLSP (N0141)
684
+ ELSP (N0136)
685
+ Between Groups
686
+ Mean±SD
687
+ 95% CI
688
+ pre-post
689
+ Mean±SD
690
+ 95% CI
691
+ pre-post
692
+ ES
693
+ P Post YLSP vs
694
+ Post ELSP
695
+ LB
696
+ %
697
+ P
698
+ LB
699
+ %
700
+ P
701
+ UB
702
+ ES
703
+ UB
704
+ ES
705
+ FBG
706
+ Pre
707
+ 133.72±44.52
708
+ 126.65
709
+ 7.2%
710
+ 0.016
711
+ 130.31±39.58
712
+ 123.21
713
+ 3.9 %
714
+ NS
715
+ 0.03
716
+ 0.53
717
+ 140.78
718
+ 137.40
719
+ Post
720
+ 124.08±32.46
721
+ 118.93
722
+ 0.22
723
+ 125.20±32.65
724
+ 119.34
725
+ 0.12
726
+ 129.23
727
+ 131.05
728
+ PPBG
729
+ Pre
730
+ 184.02±72.53
731
+ 172.51
732
+ 14.6%
733
+ <0.001
734
+ 171.90±65.25
735
+ 160.21
736
+ 8.9%
737
+ 0.019
738
+ 0.01
739
+ 0.72
740
+ 195.53
741
+ 183.60
742
+ Post
743
+ 157.19±55.22
744
+ 148.43
745
+ 0.36
746
+ 156.48±55.01
747
+ 146.62
748
+ 0.21
749
+ 165.95
750
+ 166.34
751
+ HbA1c
752
+ Pre
753
+ 8.54±1.68
754
+ 8.27
755
+ 14.1%
756
+ <0.001
757
+ 8.07±1.42
758
+ 7.81
759
+ 0.5%
760
+ 0.002
761
+ 0.19
762
+ 0.11
763
+ 8.80
764
+ 8.32
765
+ Post
766
+ 7.33±3.00
767
+ 6.86
768
+ 0.38
769
+ 8.03±4.26
770
+ 7.27
771
+ 0.01
772
+ 7.81
773
+ 8.80
774
+ HDL
775
+ Pre
776
+ 44.75±13.82
777
+ 42.56
778
+ 7%
779
+ 0.002
780
+ 45.11±13.43
781
+ 42.70
782
+ 2.1%
783
+ NS
784
+ 0.32
785
+ 0.007
786
+ 46.95
787
+ 47.52
788
+ Post
789
+ 47.88±11.80
790
+ 46.01
791
+ 0.20
792
+ 44.16±11.51
793
+ 42.10
794
+ 0.06
795
+ 49.75
796
+ 46.22
797
+ LDL
798
+ Pre
799
+ 91.16±33.10
800
+ 85.90
801
+ 12.3%
802
+ 0.001
803
+ 92.59±35.26
804
+ 86.27
805
+ 0.9%
806
+ NS
807
+ 0.38
808
+ 0.003
809
+ 96.41
810
+ 98.91
811
+ Post
812
+ 79.89±30.20
813
+ 75.10
814
+ 0.28
815
+ 91.72±31.93
816
+ 86.00
817
+ 0.02
818
+ 84.68
819
+ 97.45
820
+ Trigly
821
+ Pre
822
+ 174.10±81.22
823
+ 161.22
824
+ 15.4%
825
+ <0.001
826
+ 180.86±102.59
827
+ 162.47
828
+ 16.3%
829
+ 0.018
830
+ 0.08
831
+ 0.64
832
+ 186.99
833
+ 199.25
834
+ Post
835
+ 147.28±49.14
836
+ 139.49
837
+ 0.31
838
+ 151.38±51.66
839
+ 142.12
840
+ 0.28
841
+ 155.08
842
+ 160.64
843
+ T.Cho
844
+ Pre
845
+ 182.86±39.55
846
+ 176.58
847
+ 11.3%
848
+ <0.001
849
+ 182.09±41.31
850
+ 174.69
851
+ 8.6%
852
+ <0.001
853
+ 0.11
854
+ 0.38
855
+ 189.13
856
+ 189.50
857
+ Post
858
+ 162.20±36.74
859
+ 156.37
860
+ 0.47
861
+ 166.34±37.94
862
+ 159.54
863
+ 0.32
864
+ 168.03
865
+ 173.14
866
+ VLDL
867
+ Pre
868
+ 44.30±23.26
869
+ 40.61
870
+ 21.5%
871
+ <0.001
872
+ 42.33±17.71
873
+ 39.16
874
+ 5.2%
875
+ 0.009
876
+ 0.23
877
+ 0.18
878
+ 47.99
879
+ 45.50
880
+ Post
881
+ 34.76±12.12
882
+ 32.84
883
+ 0.38
884
+ 40.13±31.14
885
+ 34.55
886
+ 0.06
887
+ 36.69
888
+ 45.71
889
+ YLSP Yoga based Life Style change Program, ELSP Exercise based Life Style change Program, ES Effect Size, FBG Fasting Blood Glucose, PPBG
890
+ Post Prandial Blood Glucose, HbA1c Glycosylated Hemoglobin, HDL High Density Lipoprotein, LDL Low Density Lipoprotein, Trigly
891
+ Triglycerides, T.chol Total Cholesterol, VLDL Very Low Density Lipoprotein
892
+ 128
893
+ Int J Diabetes Dev Ctries (July–September 2012) 32(3):122–130
894
+ been observed. The yoga exercise study [37] showed an
895
+ increase in HDL whereas this was not achieved after SKY.
896
+ Significant improvement in HDL and LDL profiles in YLSP
897
+ group in the present study with an increase in HDL (7 %) in
898
+ the yoga group is noteworthy.
899
+ Several studies have proven the efficacy of different
900
+ types of exercises in increasing HDL and decreasing LDL
901
+ [6, 10–12, 39]. It appears that moderate intensity exercises
902
+ (and not vigorous intensity exercises) are effective in reduc-
903
+ ing VLDL complex of triglycerides, whereas sustained in-
904
+ crease in HDL may occur only after vigorous exercises such
905
+ as jogging [39]. This may explain the non-significant
906
+ changes in HDL and LDL in our ELSP group. This also
907
+ seems to indicate that the increase in HDL found in the
908
+ YLSP group may involve pathways other than its exercise
909
+ component. Activation of hypothalamic pituitary axis
910
+ (HPA) axis and sympatho-adrenal system is known to in-
911
+ hibit glucose uptake by peripheral tissues by inhibiting
912
+ insulin release, inducing insulin resistance and increasing
913
+ hepatic glucose production [40]. Better sympathovagal bal-
914
+ ance [16, 41] better insulin receptor sensitivity [42, 43] and
915
+ reduced oxidative stress [44] may have contributed to the
916
+ beneficial effects of the integrated yoga practices.
917
+ Major strengths of this study includes, the longitudinal
918
+ prospective randomized multi-venue control design with
919
+ good sample size selected from five zones of a metropolitan
920
+ city in south India, active intervention for the control group,
921
+ follow up duration of nine months and the results showing
922
+ significant reduction in oral hypoglycemic medication better
923
+ than control group. Limitations of this study were: (a) the
924
+ data of body weight, BMI and calorie intake before and after
925
+ the intervention could not be reported because different
926
+ instruments were used in different venues. These parameters
927
+ were documented in the diaries and used for advice during
928
+ the monthly medical monitoring; (b) the compliance for the
929
+ initial classes of 12 weeks was good with 95 % attendance
930
+ with an attrition rate of 38 % by 9th month. This attrition rate
931
+ is similar to that reported in clinical trials involving diabetics
932
+ for self monitoring and management of diabetes (2.3 % –
933
+ 50 %) [33]. This attrition rate could be attributed to longer
934
+ duration of intervention. The yoga based lifestyle program
935
+ was safe and did not cause any injuries to participants. All
936
+ facets of the yoga program were equally adhered to by the
937
+ participants.
938
+ In conclusion, YLSP is better than ELSP in reducing the
939
+ requirement of oral hypoglycemic agents, increasing HDL
940
+ and decreasing LDL and YLSP is similar to ELSP in reduc-
941
+ ing blood glucose, HbA1c, triglycerides, VLDL and total
942
+ cholesterol levels. Our study suggests that yoga, a non-
943
+ expensive technique that has become popular around the
944
+ globe with good acceptability and generalizability, may be
945
+ incorporated in all primary and secondary prevention pro-
946
+ grams for type 2 diabetics in clinical practice.
947
+ Future research should be three armed randomised con-
948
+ trol designs to control for other confounding variables such
949
+ as diet, weight and monitoring of VO2 max to match the
950
+ intensity of exercises between groups and inclusion of other
951
+ measures to understand the underlying mechanisms.
952
+ Acknowledgments
953
+ The study was funded by the Department of
954
+ Ayurveda, Yoga, Unani, Siddha and Homoeopathy (AYUSH), Ministry
955
+ of Health and family welfare, New Delhi, India under the ‘Extra Mural
956
+ Research’ scheme. The AYUSH technical expert committee had
957
+ reviewed the study design. We thank Dr Srikanta SS, Dr Vadiraja
958
+ HS, Dr Shruddha K, Dr Bogavi L, Dr Mallikarjuna, Dr Srividya, Dr
959
+ Pradhan B, Omkar G, the management, doctors and the paramedical
960
+ staff of TVS company, and BEML company the management of Satya
961
+ Sai trust, Diwakar hospital.
962
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963
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