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EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL TRIAL

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EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL TRIAL
Balaji Rajasekaran1, Ananda Balayogi Bhavanani2, Meena Ramanathan3
1 Assistant Professor, Centre for Yogic sciences, Aarupadai Veedu Medical Colleges, Vinayaka Missions Research Foundation, Pondicherry
2 & 3 Director and Deputy Director, Centre for Yoga Therapy, Education and Research, Sri Balaji Vidyapeeth, Pondicherry.
E-mail of presenter: balaji.rajasekaran@avmc.edu.in
Abstract:
Context: Recent studies provide ample evidence of the benefits of yoga in various chronic disorders. Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia and Sandler coined the term “Diabetic Lung" for the abnormal pulmonary function detected in diabetic patients due underlying pulmonary dysfunction. Yoga therapy may help in achieving better pulmonary function along with enhanced glycaemic control and overall health benefits.
Aim: To study the effect of adjuvant yoga therapy in diabetic lung through spirometry.
Settings and Design: Randomized control trial done as interdisciplinary collaborative work between Yoga Therapy, Pulmonary Medicine and Endocrinology departments of MGMC & RI, Sri Balaji Vidyapeeth Puducherry.
Materials and Methods: 72 patients of diabetic lung as confirmed by spirometry (<70% of expected) were randomized and divided equally into control group who received only standard medical treatment and yoga group who received yoga training thrice weekly for 4 months along with that. Yoga therapy protocol included yogic counseling, preparatory practices, Asanas or static postures, Pranayama or breathing techniques and relaxation techniques. Hathenas of the Gitananda Yoga tradition were the main practices used. Spirometry was done at the end of the study period. Data was analyzed by Student’s paired and unpaired ’t’ test as it passed normality.
Results: There was a statistically significant (p < 0.05) reduction in weight, BMI along with a significant (p < 0.01) improvement in pulmonary function (FEV1, FVC) in yoga group as compared to control group where parameters worsened over study period.
Conclusion: It is concluded from the present RCT that yoga has a definite role as an adjuvant therapy as it enhances standard medical care and hence is even more significant in routine clinical management of diabetes, improving physical condition and pulmonary function.
Key words: diabetic lung, PFT, hathenas, yoga therapy

Published in: Health & Medicine
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EFFECTIVENESS OF ADJUVANT YOGA THERAPY IN DIABETIC LUNG: A RANDOMIZED CONTROL TRIAL

  1. 1. Effectiveness of Adjuvant Yoga Therapy in Diabetic Lung: A Randomised Control Trial Dr. R. BALAJI, MBBS, MD (A.M ), FCD, M.Phil ( YT ) Assistant Professor- Center for Yogic Sciences, AVMC&H Consultant: Mother Care Foundation Yoga Therapist- Yoganjali Natyalayam
  2. 2. Introduction • Recent studies provide evidence for Yoga as therapy in chronic disorders such as DM. • Microvascular complications of DM include nephropathy, neuropathy & retinopathy. • Sandler reported abnormal pulmonary function in DM due to pulmonary dysfunction referred to as “Diabetic Lung". • D/t non-enzymatic glycosylation induced alteration of lung connective tissue, reduced diffusion & lung capacities. • Yoga therapy may help in achieving better pulmonary function along with enhanced glycaemic control & overall health benefits.
  3. 3. Materials and Methods: • Collaborative work bet CYTER & depts of Pul Medicine & Endocrinology of MGMC&RI, SBV • Study design: Randomized control trial • Approval from competent authority: By IRC (MGMCRI/IRC/2017/0177), and IHEC (2017/05/76), SBV and registered with Clinical Trial Registry-India (CTRI) 2017/11/010479). • Patient’s recruitment Consecutive patients of Diabetic Lung satisfying inclusion criteria, referred from Endocrinology and Pulmonary Medicine OPD till sample size was reached.
  4. 4. • Inclusion Criteria 1. Diabetic patients with lung function less than 70% of predicted values by spirometry, in the absence of other co-morbidities of lung. 2. Willing to participate in Yoga therapy along with informed consent. 3. Able to perform techniques in the protocol. • Exclusion criteria 1. Any active infections of lungs especially pulmonary tuberculosis. 2. Evidence of complications of diabetes & lungs
  5. 5. • Sampling Procedure and Randomization 1. Subjects allocated randomly [Zelen’s design (blocks of 4)] using statistics & sample size app. 2. 100 DL* patients assessed, 72 satisfied inclusion criteria, randomized to YT* or Control group. • Study Groups 1. Two groups: Group A (YT) & Group B (Control). 2. Group A received YT at CYTER thrice weekly for 4 months along with standard medical management & subjects motivated to do Yoga techniques at home. 3. Group B received only standard medical management. • Diabetic Lung • Yoga Therapy*
  6. 6. Recruitment of 72 DM patients with Diabetic Lung as confirmed by spirometry (served as baseline PFT) Randomization of subjects 4 month study period Post - study evaluation of spirometry parameters Group A (3x weekly adjunct YT with standard medical Rx) Group B (controls on standard medical Rx alone)
  7. 7. • Medical management Patients in both groups received regular medications viz. OHA drugs (sulphonylureas/ biguanides/ glitazones) or insulin for glycaemic control • Study Intervention Group A Yoga Therapy schedule at CYTER with medical management & advice on diet. Group B Medical management, advice on diet • Yoga therapy: YT given at CYTER by qualified therapists including yogic counseling (5-10 min briefing about basis & benefits of Yoga & relevance of yogic lifestyle), Hathenas, Pranayamas (breathing techniques) & relaxation (Table 1) .
  8. 8. Various Yoga practices and their duration Yoga Practices Duration Frequency per week Duration Hathenas 30 minutes 3 days 4 months Chandranadi Pranayama 5 minutes 3 days 4 months Brahma Mudra 5 minutes 3 days 4 months Bhramari Pranayama 5 minutes 3 days 4 months Shavasana 15 minutes 3 days 4 months
  9. 9. • Hathenas are specially designed forcing techniques used to produce a specific effect on the human body • These techniques enables reflexogenic feedback through various nerves in body corresponding to parts of the lungs to be expanded, reconditioned or rejuvenated.
  10. 10. Statistical Analysis Statistical analysis done using GraphPad InStat version 3.06. Student’s paired t test used for intra group comparisons as data passed normality testing. Students unpaired t test used for inter group comparison as data passed normality testing. Significant p value <0.05. Results There was a statistically significant reduction in weight, BMI along with an improved pulmonary function in yoga group as compared to control group where parameters worsened over study period.
  11. 11. Comparison of forced expiratory volume in first second (FEV1), forced vital capacity (FVC) and their ratio (FEV1 /FVC) in Yoga and Control groups before and after 4 months of study period. Values are given as mean ± SD. *p<0.05,**p<0.01,***p<0.001 by Student’s paired T test for intra group comparisons and actual p values given for intergroup comparison by Student’s unpaired T test. Yoga (n=34) Control (n=35) p value Pre Post Pre Post Pre Post FEV1 ( l ) 1.79 ± 0.57 2.34 ± 0.79 *** 1.77 ± 0.53 1.82 ± 0.54 0.8888 0.0028 FVC ( l ) 2.43 ± 1.18 2.95 ± 1.25 ** 2.15 ± 0.63 2.30 ± 0.78 * 0.2512 0.0160 FEV1/ FVC % 76.02 ± 12.02 78.8 ± 17.45 77.50 ± 8.94 75.99 ± 9.37 * 0.5609 0.4064
  12. 12. Values are given as mean ± SD. *p<0.05,**p<0.01,***p<0.001 by Student’s paired T test for intra group comparisons. #p<0.05,##p<0.01,###p<0.001 by Student’s unpaired T test for intergroup comparisons. Changes in FEV1, FVC, FEV1/FVC in Yoga and Control Group before and after 4 months of study period.
  13. 13. Effect of Yoga therapy on pulmonary function:  • Scientific basis for using Yoga as an adjunct therapy in respiratory  disorders  is  shown  by  significant  improvements  in  lung  function,  quality  of  life  indices  and  bronchial  provocation  responses  along  with decreased need for medicinal usage. • Studies on PFT in Diabetic Lung patients showed decline in all the  lung parameters. • In the present study Yoga therapy showed significant improvements  in FEV1 and FVC.  • Inter group comparison of delta and delta % showed statistically significant difference in FEV1 and FVC between groups with Yoga group showing significantly greater improvements. • Improvement of lung function in Yoga group may be attributed to  regular practice of Hathenas aimed at increasing lung expansion as  well as conscious breath work improving elasticity and compliance. • Yoga may have improved pulmonary functions by mechanisms such  as  obesity  reduction,  increased  oxygenation,  opening  of  airspaces  and recruitment of alveoli. 20,21,23
  14. 14. •Our results along with earlier studies reported similar  changes  in  healthy  volunteers  and  patients  of  different conditions. •Earlier  studies  also  suggested  that  Yoga  increases  respiratory  stamina,  relaxes  chest  muscles,  expands  lungs, raises energy levels, and calms body and mind. •Well-performed  slow  Yogic  breathing  has  been  reported  to  maintain  better  blood  oxygenation  without  increasing  minute  ventilation  while  reducing  sympathetic activation.
  15. 15. Conclusions: • The  results  of  this  RCT  provide  preliminary  evidence  that  the  addition  of  Yoga  as  an  adjuvant  therapy  to  standard medical care can provide additional benefit in  terms  of  improving  glycaemic  control,  pulmonary  function. • As many of the parameters worsened in control group over the study period, the addition of Yoga as an adjuvant therapy may be said to even be enhancing standard medical care and  hence  is  even  more  significant  in  the  routine  clinical  management  of  diabetes. • Yoga  as  a  therapy  is  also  cost effective, relatively simple and carries minimal risk and hence should be  advocated  as  an  adjunct,  complementary  therapy  in 
  16. 16. Strength of the study • Study design and novelty: The study is first of its kind to assess global impact of yoga-based intervention in Diabetic Lung patients . • To the best of our knowledge, there is no study in literature which showed the effect of adjuvant yoga Therapy in Diabetic Lung. • Methods: Internationally accepted latest guidelines used for measuring the study parameters. • Intervention: Using Hathenas - The Forcing Techniques, as one of the main intervention is one of uniqueness of this study. • Yoga therapy was provided as an add-on intervention to the standard medical care provided by our hospital, and not as an alternative therapy. • Sessions supervised by qualified yoga therapists and practices were individualized according to each patients. • Recruits of both groups were motivated for diet modification.
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  18. 18. THANK YOU

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