Development and evaluation of a yoga-based cardiac rehabilitation programme (Yoga-CaRe) for secondary prevention of myocardial infarction

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

Cardiac rehabilitation (CR) programmes aim to reduce the risk of death or illness following a heart attack; in order to help the patient regain their health and ability to participate in normal day-to-day activities. CR programmes attempt to do this by improving the physical fitness of the patient, reducing stress levels and encouraging long-term lifestyle changes (such as quitting smoking, reducing alcohol consumption and eating a healthy diet). There is strong scientific evidence from developed countries, such as the UK, to show that CR programmes are effective in doing this.

In developed countries, CR programmes are usually delivered as a combination of exercise and educational sessions, run by large multi-disciplinary teams including nurses, occupational therapists, doctors, psychologists, pharmacists, dieticians and counsellors. However, in developing countries such as India this is often regarded as an unaffordable luxury; as a result CR programmes are virtually non-existent.

The practice of yoga, a traditional Indian mind-body discipline has similar short term objectives to a CR programme (improved physical fitness, stress reduction and lifestyle change) and a similar method of delivery (combined exercise-education sessions). However, instead of a large multi-disciplinary team only one individual is needed: the yoga teacher. A yoga-based CR programme is therefore likely to be more cost-effective to deliver on a large-scale in the Indian setting. It is also likely to be more culturally appropriate. We suggest that the development of a yoga-based CR programme will have greater acceptability both in India and also amongst particular groups in the UK (such as Asian Indian ethnic groups, women and the elderly) who currently have a low rate of uptake of traditional CR programmes.

This project will combine two complementary studies: (i) a large randomised controlled trial in India to evaluate the effectiveness of a specially designed yoga-based CR programme compared to standard care; (ii) a smaller in-depth study of the underlying physiological mechanisms, carried out in the UK using high-tech exercise laboratory facilities. We will also investigate the cost effectiveness of the yoga-based CR package compared to current standard care; such information will be of great use to policymakers in scaling up the intervention if found to be effective.
The large trial in India will randomise 4000 heart attack patients from 16 hospitals in India to receive either a specially designed yoga-based CR package or to receive standard care. Patients will be followed up for one year and we will compare the number of deaths, health-related quality of life and subsequent heart attacks and strokes in the two groups. In the UK patients already get CR. We will randomise 80 patients to get yoga classes in addition to their standard CR, or to just to receive standard care and carry out detailed physiological and metabolic tests, this component will allow us to understand how yoga may have beneficial effects on heart health.

If found to work, the new CR programme will on implementation lead to considerable savings in lives, quality of life and economic productivity in both countries. A second outcome of this research programme will be a markedly improved scientific knowledge base on the processes underlying the health benefits of yoga, about which little is currently known.

Technical Summary

Cardiac rehabilitation (CR) programmes aim to restore functioning and reduce the risk of adverse vascular outcomes in cardiac patients by improving their physical fitness, reducing stress, and bringing about lifestyle change. CR programmes have been shown to be highly effective, but they are virtually non-existent in developing countries such as India, because the large, multidisciplinary teams required for CR programmes are considered unaffordable. Yoga practice leads to similar outcomes as a CR programme (improved physical fitness, stress reduction and lifestyle change), but entails considerably fewer resources (single yoga teacher). In the UK, yoga may appeal to certain disadvantaged groups (e.g. ethnic minorities, women and the elderly) that currently have low CR uptake.

We will summarise existing knowledge on yoga's cardiovascular health effects from scientific literature and yogic texts, and apply that knowledge to a model of CR to develop a yoga-based CR programme (Yoga-CaRe). Then, we will evaluate the effectiveness and cost-effectiveness of Yoga-CaRe in a large clinical trial in India, randomising 4,000 patients with acute myocardial infarction (AMI) to receive Yoga-CARE or enhanced standard care, and follow them for quality of life and cardiac morbidity and mortality over one year. In the UK we will perform a mechanistic study which will provide complementary information to the clinical trial in India; 80 patients with AMI will be randomised to receive yoga classes in addition to CR (routinely offered in the UK), and assessed for the acute (after first yoga class) and chronic (after 3 months) effects of yoga on neuro-endocrine pathways, cardiovascular risk factors and sub-clinical outcomes. Providing a sound scientific mechanism for observed clinical effects is vital for traditional therapies to gain wider acceptance. The expected outcomes of this research include a scalable intervention and greater collaboration between India and UK researchers.

Planned Impact

The direct beneficiaries of this research include patients with cardiovascular disease, health managers and policy makers, and those working in the area of traditional therapies. Patients with cardiovascular disease in India who do not currently get cardiac rehabilitation because it is not available will benefit from its availability. Cardiac rehabilitation is available to patients in the UK, but many do not participate in it, particularly those from ethnic minorities, women and the elderly; this may be because the available formats of CR do not suit everyone's preferences, for cultural and other reasons. These patients with cardiovascular disease in India and UK will benefit by lower rates of recurrence in cardiac illness and improvements in their quality of life. Earlier return to work and re-engagement with society will also benefit the society more widely, both socially and through greater economic productivity.

Policy makers in India and managers of the small hospitals in India will benefit from the availability of a low-cost solution to provision of cardiac rehabilitation, since more expensive models of cardiac rehabilitation currently in use in developed countries are unaffordable for them. The UK policy makers and health trusts would also be interested in cardiac rehabilitation options that may appeal to certain groups that currently have low rates of participation in CR. The savings of costs from subsequent hospitalisations and medical treatment of these patients will be of considerable interest to policy makers and health managers in India and the UK.

Currently traditional therapies are viewed with suspicion by the wider scientific community; as a result there is limited integration of these therapies within mainstream clinical practice. This is a great loss to both those working in traditional therapies and also to the mainstream medical practice since they do not currently avail of the potentially complementary benefits of these approaches. Scientific evidence of the beneficial effect of yoga on cardiovascular health and its potential pathways could lead to greater acceptance of yoga by the scientific and wider communities reduce scepticism where it exists and bring together greater integration. Traditional therapies are often more holistic, and can lead to healthier societies and reduce medical expenditure which becomes increasingly important as societies get older. Those working in yoga and traditional therapies will potentially get a boost due to greater interest in their services.

This project involves collaboration between India and UK researchers which should also improve scientific links between these two countries. There is also a strong capacity building component of this proposal since the staff working on these projects will learn from complementary research skills and experience.

Publications

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Chattopadhyay K (2019) Development of a Yoga-Based Cardiac Rehabilitation (Yoga-CaRe) Programme for Secondary Prevention of Myocardial Infarction. in Evidence-based complementary and alternative medicine : eCAM

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PRABHAKARAN D (2020) A Randomized Trial of Yoga-based Cardiac Rehabilitation after Acute Myocardial Infarction in Journal of the American College of Cardiology

 
Description Yoga programme for type-2 diabetes prevention (YOGA-DP) among high-risk people in India: intervention development and feasibility study
Amount £127,089 (GBP)
Funding ID MR/R018278/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 05/2018 
End 04/2020
 
Title Yoga-CaRe Programme 
Description The main components of the intervention are- yoga practice and diet/lifestle advice. A systematic process was followed to develop the intervention, based on the MRC guideline for developing and evaluating complex interventions. This process included steps like literature review and consultation with various experts and patients. The outputs from this intervention development process are- 1) A booklet for patients 2) A digital video disc (DVD) for patients 3) A manual for yoga instructors All are available in English and in multiple Indian languages. This intervention is currently undergoing evaluation (randomised controlled trial) in India. The project is jointly funded by the MRC and ICMR. 
Type Therapeutic Intervention - Complementary
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2014
Development Status Under active development/distribution
Clinical Trial? Yes
UKCRN/ISCTN Identifier CTRI/2012/02/002408
Impact The development process brought together both modern science experts and yoga experts, which helped to integrate two systems (modern and traditional). Secondly, the development process helped to improve scientific links and mutual capacity building between India and UK researchers. 
URL http://www.isrctn.com/ISRCTN12924088
 
Title Web-based CRF and randomisation software 
Description This is a web-based case report form (CRF) and randomisation software, which is being used in this randomised controlled trial. 
Type Of Technology Software 
Year Produced 2014 
Impact This is a web-based case report form (CRF) and randomisation software, which is being used in this randomised controlled trial. 
URL http://125.22.91.149:5050/MemberLogin.aspx#b
 
Description Yoga-based intervention study for the BBC program "Trust me I'm a Doctor" 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact On the back of this MRC-funded Yoga trial, Sanjay Kinra was invited to design and conduct a small pre-post intervention study on the impact of yoga on blood pressure in healthy volunteers, for the BBC TV show "Trust Me, I'm a Doctor". Study and filming were conducted in 2019, and show was aired on 12th February 2020 on BBC 2 to audiences nationwide and internationally.
Year(s) Of Engagement Activity 2019,2020
URL https://www.bbc.co.uk/programmes/m000f952