Yoga-CaRe

Clinical Trial Details

Effectiveness of a Yoga-Based Cardiac Rehabilitation (yoga-care) Program: A Multi-Centre Randomised Controlled Trial of 4,014 Patients With Acute Myocardial Infarction From India

The purpose of this trial is to evaluate the effect and cost-effectiveness of a low-cost yoga-based cardiac rehabilitation program in a post-MI population in India.

Results

Compared to standard care, the Yoga-CaRe program did not significantly reduce cardiovascular events, but did improve QOL.

Purpose: evaluation of a yoga-based cardiac rehabilitation program in India for effectiveness and cost-effectiveness.

Trial Design: randomized 1:1, controlled trial; 3959 AMI patients from 24 cardiac centers in India; Yoga-CaRe program (13 supervised in-hospital sessions) vs. enhanced standard care (3 educational sessions). Trial: 50 months.12 week follow-up.

Primary Endpoints: composite of a) First cardiac event (composite of death, nonfatal myocardial infarctions and stroke) and emergency cardiac admissions, and b) QOL at 12 weeks.

Results: compared to standard care, the yoga-based cardiac rehabilitation program did not improve cardiovascular outcomes during this study, but QOL improvements were noted.

BRIDGE CV Prevention Data
 Yoga-caReEnhanced
standard care
 
Composite
cardiac events
6.7%7.3%HR=0.91;
p=0.33
Death4.0%3.9%HR=1.02;
p=0.99
MI, non-fatal0.7%0.8%HR=0.88;
p=0.73
Stroke, non-fatal0.2%0.2%HR=1.34;
p=0.43
Emergency
admissions
2.4%3.0%HR=0.82;
p=0.26
Quality of life10.7%9.2%p=0.002

Yoga-CaRe Commentary

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Eric Peterson, MD, chair of the program committee for Scientific Sessions 2018, comments on the results of the Yoga-CaRe trial.

Principal Investigators on Yoga-CaRe

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Dorairaj Prabhakaran, MD, DM, MSc and Sanjay Kinra, MD, PhD, principal investigators, summarize the results of the Yoga-CaRe trial, which was presented during Scientific Sessions 2018 in Chicago.

Detailed Results

Primary: Yoga-based cardiac rehabilitation compared to enhanced standard care

  1. Composite of major cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction or stroke, and emergency cardiovascular hospitalization)
    Enhanced Standard care: 7.3%
    Yoga Care: 6.7%
    HR=0.91; p=0.33

    Yoga Care vs enhanced standard care
    Death: 4.0% vs 3.9%, HR=1.02, p=0.99
    Non-fatal MI: 0.7% vs 0.8%; HR=0.88; p=0.73
    Non-fatal stroke: 0.2% vs 0.2%; HR= 1.34; p=0.43
    Emergency CV hospitalizations: 2.4% vs 3.0%; HR=0.82; p=0.26
     
  2. Quality of life (measured by mean change from baseline to 12 weeks in Euro-QoL 5D)
    Yoga Care 10.7; Enhanced standard care: 9.2; p=0.002

Secondary:

  1. Return to pre-infarct daily activities – questionnaire: p<0.001
  2. Smoking cessation and medication adherence data – self reported: p=0.11
  3. Prescribed medications compliance: p=0.52

Trial Design — multi-center, controlled, randomized trial. Patients are from 22 centers across India. 12-week follow-up. Following an Acute MI, patients were randomized 1:1 to either:

  • Enhanced standard care (control group, 3 educational sessions)
  • Session 1: a leaflet provided in the hospital before discharge
  • Sessions 2, 3: standard educational advice in a group session at weeks 5 and 12
  • Yoga-CaRe Intervention group: 13 sessions of Yoga-CaRe (instructor supervised) in the hospital over 3 months + self-supervised sessions at home (audio-video material)

Trial Population — 4,014 patients aged 30-80 years with acute myocardial infarction

Primary Endpoints: at 12 weeks

  • composite of major cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction or stroke, and emergency cardiovascular hospitalization)
  • quality of life (measured by Euro-QoL 5D)

Secondary Endpoints

  • Return to pre-infarct daily activities – questionnaire
  • Smoking cessation and medication adherence data – self reported
  • site-specific cancers and total cancer mortality
  • Cost-effectiveness measured by Euro-QoL

Sponsor— Indian Council of Medical Research; secondary sponsor: Medical Research Council

References

Keywords
Acute myocardial infarction, rehabilitation, cardiac rehabilitation, secondary prevention, quality of care, Yoga

Related clinical topics
Quality, stroke, myocardial infarction, secondary prevention, physical activity

Key Words
AHA Scientific Sessions, AHA2018, vitamin D3, omega-3 fatty acids, fish oil, cardiovascular disease, cancer, primary prevention, ergocalciferols, cholecalciferol

Related Clinical Topics
nutrition, metabolism, stroke, cardiovascular disease, cancer, prevention