Ambalam M Chandrasekaran1, Sanjay Kinra2, Vamadevan S Ajay3, Kaushik Chattopadhyay4, Kalpana Singh1, Kavita Singh3, Pradeep A Praveen5, Divya Soni1, Raji Devarajan1, Dimple Kondal3, Subhash C Manchanda6, Alun D Hughes7, Nishi Chaturvedi7, Ian Roberts2, Stuart Pocock2, Shah Ebrahim2, Kolli S Reddy3, Nikhil Tandon8, Dorairaj Prabhakaran9. 1. Centre for Chronic Disease Control, New Delhi, India. 2. London School of Hygiene and Tropical Medicine, London, UK. 3. Centre for Chronic Disease Control, New Delhi, India; Public Health Foundation of India, Gurgaon, India. 4. London School of Hygiene and Tropical Medicine, London, UK; The University of Nottingham, Nottingham, UK. 5. Centre for Chronic Disease Control, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India. 6. Sir Ganga Ram Hospital, New Delhi, India. 7. University College London, London, UK; Imperial College London, London, UK. 8. All India Institute of Medical Sciences, New Delhi, India. 9. Centre for Chronic Disease Control, New Delhi, India; London School of Hygiene and Tropical Medicine, London, UK; Public Health Foundation of India, Gurgaon, India; Rollins School of Public Health, Emory University, Atlanta, GA, USA. Electronic address: dprabhakaran@ccdcindia.org.
Abstract
BACKGROUND:Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. METHODS: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18-80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. CONCLUSION: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings.
RCT Entities:
BACKGROUND: Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. METHODS: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18-80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. CONCLUSION: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings.
Authors: Grace Dibben; James Faulkner; Neil Oldridge; Karen Rees; David R Thompson; Ann-Dorthe Zwisler; Rod S Taylor Journal: Cochrane Database Syst Rev Date: 2021-11-06
Authors: Kaushik Chattopadhyay; Ambalam M Chandrasekaran; Pradeep A Praveen; Subhash C Manchanda; Kushal Madan; Vamadevan S Ajay; Kavita Singh; Therese Tillin; Alun D Hughes; Nishi Chaturvedi; Shah Ebrahim; Stuart Pocock; K Srinath Reddy; Nikhil Tandon; Dorairaj Prabhakaran; Sanjay Kinra Journal: Evid Based Complement Alternat Med Date: 2019-05-02 Impact factor: 2.629