About this trial
The clinical study compares the benefits of yoga based rehabilitation programme versus an educational package during recovery of patients with heart failure. Cardiac rehabilitation programmes help patients with cardiac illness to return as quickly as possible to full and productive life and to reduce the chances of further cardiac illness or death. We want to know whether our package of yoga classes can provide effective cardiac rehabilitation and how that compares with a package of educational classes. Both packages are especially designed by us to improve heart health
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients above 18years
Physician diagnosed heart failure patients with reduced ejection fraction based on ESC guidelines
Patients should be NYHA class II/III
Willing and able to attend the complete hospital-based CR programme on their own
Disqualifiers
Comorbid disease or behavioral or other limitations that interfere with performing Yoga training or prevent the completion of 1 y of exercise training
Elective Cardiovascular procedure or hospitalization planned in the coming 3 months
Currently pregnant or intend to become pregnant in the next year
Heart failure secondary to significant correctable/reversible cause like primary valvular disease/ correctable congential heat disease
Trial design
Parallel
Treatments tested in this trial
Yoga-CaRe HF
BehavioralA cardiac rehabilitation programme comprising of health education and yogic practices.
Health Education
BehavioralHealth education on "Healthy Living with Heart Failure"
Treatment groups
Trial outcomes
Primary outcomes
Major Adverse Cardiovascular event
Time to first cardiovascular event
Heart Failure Specific Quality of life
Change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score from baseline. The MLHFQ consists of 21 items, each scored from 0 (no impact) to 5 (very much impacted), with a total score ranging from 0 to 105. Lower scores indicate better health-related quality of life
Secondary outcomes
Six minute walk test
Six-minute walk distance (6MWD), measured as the total distance in metres walked by the participant during a standardized six-minute walk test. A greater distance indicates better functional exercise capacity.
Generic Quality of life
European Quality of Life (EQ-5D-5L) Questionnaire evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels. The outcome will be expressed as the EQ-5D-5L utility index score, with higher scores indicating better health-related quality of life.
Self-rated health (EQ-5D-5L)
EQ-VAS score, ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better perceived health status.
Tobacco cessation
Smoking cessation will be assessed based on self-reported tobacco use status. Current smokers at baseline who report no tobacco use at follow-up will be classified as having achieved tobacco cessation.
Sponsors and contacts
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Centre for Chronic Disease Control, India
Lead sponsor
Indian Council of Medical Research
Collaborator
Central Council for Research in Yoga & Naturopathy
Collaborator
All India Institute of Medical Sciences
Collaborator
All India Institute of Medical Sciences, Bathinda
Collaborator
All India Institute of Medical Sciences, Rishikesh
Collaborator
All India Institute of Medical Sciences, Jodhpur
Collaborator
Dayanand Medical College and Hospital
Collaborator
KLES Prabhakar Kore Hospital Belagavi
Collaborator
JSS Medical College Hospital
Collaborator
SDM College of Medical Sciences & Hospital
Collaborator
North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences
Collaborator
Sri Ramachandra Institute of Higher Education and Research
Collaborator
Madras Medical College
Collaborator
Acharya Vinoba Bhave Rural Hospital
Collaborator
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Collaborator