Yoga-Based Cardiac Rehabilitation After Acute Myocardial Infarction: A Randomized Trial.

BACKGROUND: Given the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly). OBJECTIVES: This study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial. METHODS: The trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks. RESULTS: MACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes). CONCLUSIONS: Yoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408).

Development of a Yoga-Based Cardiac Rehabilitation (Yoga-CaRe) Programme for Secondary Prevention of Myocardial Infarction.

Cardiac rehabilitation (CR) after myocardial infarction is highly effective. It is unavailable in public hospitals in India due to limited resources. Our objective was to develop a scalable model of CR for India based on yoga, which could also appeal to some groups with low uptake of CR (e.g., ethnic minorities, women, and older people) globally. The intervention was developed using a structured process. A literature review and consultations with yoga experts, CR experts, and postmyocardial infarction patients were conducted to systematically identify and shortlist appropriate yoga exercises and postures, breathing exercises, meditation and relaxation practices, and lifestyle changes, which were incorporated into a conventional CR framework. The draft intervention was further refined based on the feedback from an internal stakeholder group and an external panel of international experts, before being piloted with yoga instructors and patients with myocardial infarction. A four-phase yoga-based CR (Yoga-CaRe) programme was developed for delivery by a single yoga instructor with basic training. The programme consists of a total of 13 instructor-led sessions (2 individual and 11 group) over a 3-month period. Group sessions include guided practice of yoga exercises and postures, breathing exercises, and meditation and relaxation practices, and support for the lifestyle change and coping through a moderated discussion. Patients are encouraged to self-practice daily at home and continue long-term with the help of a booklet and digital video disc (DVD). Family members/carers are encouraged to join throughout. In conclusion, a novel yoga-based CR programme has been developed, which promises to provide a scalable CR solution for India and an alternative choice for CR globally. It is currently being evaluated in a large multicentre randomised controlled trial across India.

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.

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.

m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial.

BACKGROUND: The proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India. Thus, there is a need to improve blood pressure management among patients with uncontrolled hypertension through innovative strategies directed at health system strengthening. METHODS: We designed an intervention consisting of two important components - an electronic decision support system (EDSS) used by a trained nurse care coordinator (NCC). Based on preliminary data, we hypothesized that this intervention will be able to reduce mean systolic blood pressure by 6.5 mmHg among those with uncontrolled blood pressure in the intervention arm compared to the standard treatment arm (paper-based hypertension treatment guidelines). The study will adopt a cluster randomized trial design with the community health center (CHC) as the unit of randomization. The trial will be conducted in Visakhapatnam district (southern India). A total of 1876 participants aged ≥30 years with high blood pressure - systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg will be enrolled from 12 CHCs. The intervention consists of trained NCCs equipped with an evidence-based hypertension treatment algorithm in the form of the EDSS with regular SMSs to patients with hypertension to promote hypertension treatment and blood pressure control for 12 months. The primary outcome will be difference in the mean change of SBP, from baseline to 12 months, between the intervention and the standard treatment arm. The secondary outcomes are the difference in mean change of DBP; difference in the proportion of patients with controlled blood pressure (< 140/90 mmHg); difference in mean change of fasting blood sugar, HbA1C, eGFR, and albumin to creatinine ratio; difference in the proportion of patients visiting the CHC regularly (number of actual visits to the CHC/number of visits suggested by the EDSS > 80%); difference in proportion of patients compliant to anti-hypertensive medication/s; cost-effectiveness of intervention versus enhanced care. All the outcomes will be assessed at 12 months. DISCUSSION: The study is expected to provide evidence on the effectiveness of NCC-led, EDSS-based hypertension management in India and can likely offer an exemplar for improving cardiovascular disease (CVD) management in India within the resource-constrained public healthcare system. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03164317 ). Registered retrospectively on 23 May 2017 (first patient enrolled on 6 April 2017) because the authors did not receive a response to their original registration submission (5 January 2017) to the Clinical Trial Registry - India (CTRI).

Technology for Diagnosis, Treatment, and Prevention of Cardiometabolic Disease in India.

Cardiometabolic diseases (CMD) are a major cause of mortality, morbidity and disability worldwide. Among Indians, CMD onset is at a much younger age and is prevalent in all sections of the society. Prevention, control and management of CMD and its risk factors is a major public health challenge, and alternative approaches need to be explored and integrated into public health programs. Advancements in the fields of computers, electronics, telecommunication and medicine have resulted in the rapid development of health-related technology. In this paper we provide an overview of the major technological advances in diagnosis, treatment and prevention within the field of CMD in the last few decades. This non-exhaustive review focuses on the most promising technologies that the authors feel might be of relevance in the Indian context. Some of the techniques detailed include advances in imaging and mobile phone technology, surgical techniques, electronic health records, Nano medicine, telemedicine and decision support systems.