Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: study rationale and design of a multi-centre randomized controlled trial

Chandrasekaran, Ambalam M.; Kinra, Sanjay; Ajay, Vamadevan S.; Chattopadhyay, Kaushik; Singh, Kalpana; Singh, Kavita; Praveen, Pradeep A.; Soni, Divya; Devarajan, Raji; Kondal, Dimple; Manchanda, Subhash C.; Hughes, Alun D.; Chaturvedi, Nishi; Roberts, Ian; Pocock, Stuart; Ebrahim, Shah; Reddy, Kolli S.; Tandon, Nikhil; Prabhakaran, Dorairaj; Yoga-CaRe Trial Team

Abstract

© 2019 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.

Citation

Chandrasekaran, A. M., Kinra, S., Ajay, V. S., Chattopadhyay, K., Singh, K., Singh, K., Praveen, P. A., Soni, D., Devarajan, R., Kondal, D., Manchanda, S. C., Hughes, A. D., Chaturvedi, N., Roberts, I., Pocock, S., Ebrahim, S., Reddy, K. S., Tandon, N., Prabhakaran, D., & Yoga-CaRe Trial Team. (2019). Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: study rationale and design of a multi-centre randomized controlled trial. International Journal of Cardiology, 280, 14-18. https://doi.org/10.1016/j.ijcard.2019.01.012

• Journal Article Type: Article
• Acceptance Date: Jan 2, 2019
• Online Publication Date: Jan 7, 2019
• Publication Date: Apr 1, 2019
• Deposit Date: Jan 21, 2019
• Publicly Available Date: Jan 8, 2020
• Journal: International Journal of Cardiology
• Print ISSN: 0167-5273
• Electronic ISSN: 1874-1754
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 280
• Pages: 14-18
• DOI: https://doi.org/10.1016/j.ijcard.2019.01.012
• Keywords: Cardiology and Cardiovascular Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/1484611
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S016752731834539X
• Additional Information: This article is maintained by: Elsevier; Article Title: Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: Study rationale and design of a multi-center randomized controlled trial; Journal Title: International Journal of Cardiology; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.ijcard.2019.01.012; Content Type: article; Copyright: © 2019 Published by Elsevier B.V.
• Contract Date: Jan 21, 2019