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.

Incidence and risk factors of asymptomatic first-dose hypotension with angiotensin-converting enzyme inhibitors in chronic heart failure due to systolic dysfunction.

BACKGROUND: In practice, chronic heart failure is often not treated with angiotensin-converting enzyme inhibitors. One reason is the fear of first-dose hypotension. In the majority of patients, this condition is asymptomatic and the consequences are unexpected. Presently, little is known of its epidemiology. METHODS AND RESULTS: This was a prospective, 48-hour observational study of 160 patients with chronic heart failure due to systolic dysfunction, previously untreated with angiotensin-converting enzyme inhibitors, randomly drawn from the clinical practice of selected cardiologists across India. The primary outcome was a change in the mean arterial pressure during the first 24-hours after the first dose of an angiotensin-converting enzyme inhibitor. In 131/160 patients (81.9%) with no hypotensive symptoms, the incidence of first-dose hypotension (maximum 24-hour fall in mean arterial pressure greater than 10% from baseline) was 56/131 (42.7%). Pre-treatment diastolic pressure had a negative, independent association with 24-hour change in mean arterial pressure, accounting for 29% (R2=0.29, p<0.01) of its variability, and its predictive value was greater with pro-drug angiotensin-converting enzyme inhibitors. The incidence of first-dose hypotension increased from 1 patient (4.8%) at a pre-treatment diastolic pressure of 50-70 mmHg to 35 patients (42.7%) at 71-90 mmHg, p<0.01. CONCLUSIONS: The incidence of first-dose hypotension with angiotensin-converting enzyme inhibitors in outpatients with chronic heart failure due to systolic dysfunction is high. Pre-treatment diastolic pressure is an independent risk factor, and its predictive value increases with pro-drug angiotensin-converting enzyme inhibitors. This could help physicians to anticipate asymptomatic first-dose hypotension and increase the utilization of these agents in heart failure.

Chlamydia pneumoniae infection and nonspecific aortoarteritis: search for a link with a nonatherosclerotic inflammatory arterial disease.

BACKGROUND: The association between Chlamydia pneumoniae infection and atherosclerosis has gained recognition. However, the nature of this association is controversial. The infective link may not be specific for atherosclerosis and may also exist in other nonatherosclerotic arterial diseases. We investigated patients with nonspecific aortoarteritis for serological evidence of prior Chlamydia pneumoniae infection. METHODS AND RESULTS: Fifty patients each of nonspecific aortoarteritis and coronary artery disease with angiographic evidence of significant (>70%) coronary artery lesions were tested for the presence of IgG antibodies against Chlamydia pneumoniae by micro-immunofluorescence assay and compared with 50 age- and sex-matched normal healthy controls. The number of patients with nonspecific aortoarteritis who tested positive for Chlamydia pneumoniae antibodies (IgG) was not significantly different from controls (8 v. 7, p=ns). The mean titer amongst positive subjects in the two groups was also similar (1:40+/-40 v. 1:50+/-25; p=ns). Patients with coronary artery disease were significantly older than patients with nonspecific aortoarteritis and controls (53.2+/-5.8 v. 21.2+/-9.9 years and 24.5+/-5.2 years, p<0.01 for both) and showed a higher seroprevalence of prior Chlamydia pneumoniae infection (18 v. 8 and 7, p < 0.05 for both). The mean IgG titers of patients with coronary artery disease who tested positive were also significantly higher than the other two groups (1:98+/-34 v. 1:40+/-40, p<0.001 and 1:98+/-34 v. 1:50+/-25, p<0.01, respectively). CONCLUSIONS: In patients with nonspecific aortoarteritis, the seroprevalence of prior Chlamydia pneumnoniae infection is not more than that in healthy individuals of the same age group, but is significantly lesser than that in patients with coronary artery disease. Thus Chlamydia pneumoniae infection may not be associated with all forms of chronic inflammatory arterial lesions.