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).

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.

Objectives: Patients with acute myocardial infarction (AMI) demonstrates poor health-related quality of life (HRQoL) scores in comparison to the general population. Although hypertension is associated with quality of life, little is known about the synergistic effect of blood pressure on HRQoL following AMI in patients. To examine the association of blood pressure with HRQoL among AMI patients at the time of discharge. Methods: Data were obtained from 3522 patients with AMI, aged 18–80 years, admitted to 22 cardiac care centers across India, recruited in the Yoga-CaRe, a multicenter randomized controlled trial. Baseline data including socio-demographics, medical history, clinical features, behavioral characteristics and health-related quality of life (HRQoL) were collected. HRQoL was assessed using EuroQol-5 dimension (EQ-5D) questionnaire. Linear regression model was fitted to adjust for the other covariates. Results: The mean age of AMI patients was 53.5 ± 10.9 years. Systolic blood pressure and pulse pressure were inversely associated with HRQoL. However, presence of hypertension was not associated with HRQoL. Findings remained significant after adjusting for age, gender, education status, number of vessels involved, physical activity, waist circumference, ever used alcohol, consumption of fruits and green leafy vegetables (Table 1). Conclusion: Health-related quality of life was significantly associated with pulse pressure and systolic blood pressure, however, no association was found with hypertension.

Objectives: Previous studies have shown that hypertension is a risk factor of mortality and morbid events following acute myocardial infarction. In addition, patients with hypertension may have other risk factors for acute myocardial infarction such as diabetes mellitus, tobacco use, physical inactivity. This study aimed to explore the distribution of cardiovascular (CV) risk factors among patients of acute myocardial infarction with and without hypertension. Methods: Participants were acute myocardial infarction patients (n = 3522) admitted to 22 tertiary care hospitals with hypertension (n = 1014) and without hypertension (n = 2508), aged 18–80 years, recruited for the Yoga-CaRe, a multicenter randomized controlled trial. Data on socio-demographics, clinical and behavioral characteristics of those with and without hypertension were compared and analyzed using multivariable logistic regression model. Results: The prevalence of hypertension among male and female AMI patients were 25.9% and 47.0% respectively. The mean age (years) for hypertensive patients was 57.1 ± 9.7 and for non-hypertensive patients was 51.8 ± 11.0. Patients with hypertension had higher odds of having diabetes, overweight, central obesity and being physically inactive (Table 1). No differences were found in ever tobacco use between hypertensive and non-hypertensive groups. Conclusion: Hypertensive acute myocardial infarction patients had higher odds of behavioral and physiological cardiovascular risk factors. Cardiac rehabilitation may be tailored to address these differentials.

Diabetes mellitus (DM) is a known independent predictor of mortality following acute myocardial infarction (AMI). In addition, patients with DM may have other risk factors for AMI such as hypertension (HTN), tobacco use, physical inactivity. This study aimed to explore the distribution of cardiovascular (CV) risk factors among patients of AMI with and without DM. Yoga-CaRe, a multicenter randomized controlled trial, included patients of AMI (first or consequent AMI) with DM (n=856) and without DM (n=2330), aged 18-80 years from 24 cardiac centers across India. The baseline socio-demographics, clinical and behavioral characteristics of those with and without DM were analyzed using multivariable logistic/linear regression models, sequentially adjusted for age, gender, education and physical inactivity. Patients of AMI with DM were older as compared to those without DM (mean age 56.4± 9.4 vs. 51.9 ± 11.2). Patients with DM had higher odds of having hypertension, being physically inactive and had lower odds of self-reported ever tobacco use. Patients with DM had higher mean waist circumference, systolic and diastolic blood pressure (Table). No differences were found in body mass index between diabetes and nondiabetes groups.The observed differential distribution of CV risk factors in AMI patients with DM calls for a tailored rehabilitation plan. Cardiovascular risk factors among AMI patients with diabetes vs. without diabetesVariableDiabetes (n=856)Without diabetes (n=2330)Adjusted OR/Regression coefficient* [95% CI]Ever tobacco use (%)34.2%49.2%0.73 [0.60-0.88]Physical inactivity (%)57.8%49.2%1.38 [1.18-1.62]Body Mass Index ≥25Kg/m2 (%)57.6%50.8%1.13 [0.95-1.34]Waist circumference (cm) (mean)99.3±20.792.3±17.94.7 [3.1-6.3]*Systolic blood pressure (mmHg) (mean)123.4±17.2118.8±16.13.6 [2.3-4.9]*Diastolic blood pressure (mmHg) (mean)76.7±10.774.9±10.31.9 [1.02-2.7] *Hypertension (%)53.1%18.6%3.8 [2.9-5.1] Disclosure D. Soni: None. C.M. Ambalam: None. V.S. Ajay: None. K. Singh: None. K. Singh: None. P.A. Praveen: None. A. Roy: None. S.C. Manchanda: None. B. Mohan: None. P.C. Negi: None. P. Bhat: None. K.S. Sadananda: None. P.M. R.: None. P. Sarma: None. S. Natarajan: None. C. Narasimhan: None. N. Desai: None. S. Patil: None. D.S. Chadha: None. S. Chandra: None. S. Kinra: None. D. Prabhakaran: None.

Objectives: The association between clinical profile such as electrocardiographic changes and angiographic changes without and with comorbid hypertension among acute myocardial infarction (AMI) patients is not explored in Indian population. To examine the clinical profile among AMI patients with and without hypertension. Methods: Data of 3522 AMI patients, recruited across 22 hospitals in India in the Yoga-CaRe trial, a multicenter randomized controlled trial, were included in the analysis. Baseline data on socio-demographics, clinical profile - electrocardiographic changes and angiography, and medical history were compared and analyzed using multivariate logistic regression. Results: Mean age of participants was 53.5 ± 10.9 years (males proportion - 86%). The overall prevalence of hypertension was 28.8% and the mean duration of hypertension was 6.5 ± 5.8 years. Patients with comorbid hypertension as compared to without hypertension at admission had higher odds of having atrial fibrillation (25.7% vs 21.6%, adjusted OR - 1.25 [1.05, 1.50], and lower odds of having ST depression (12.7% vs 16.4%, adjusted - OR 0.71 [0.57, 0.89]) after adjusting for age, gender and diabetes mellitus. More hypertensive patients underwent angiography during hospitalization for AMI (93.8% vs74.3%). Among those who underwent angiography, although insignificant, hypertensive subjects had higher odds of having multivessel disease (51.8% vs 39.8%, adjusted – OR 1.16 [0.97, 1.39]) after adjusting for age, gender, history of diabetes mellitus and coronary artery disease. No differences were observed in the location of infarct or other electrocardiographic changes. Conclusion: Hypertension was associated only with electrocardiographic changes such as atrial fibrillation and ST depression whereas it was not associated with angiographic changes.