Yoga Based Cardiac Rehabilitation in Heart Failure Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre for Chronic Disease Control, India

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Yoga-CaRe HF

    Behavioral

    A cardiac rehabilitation programme comprising of health education and yogic practices.

  • Health Education

    Behavioral

    Health education on "Healthy Living with Heart Failure"

Treatment groups

3,500 Participants
are divided into 2 treatment groups
Group A: Yoga-CaRe groupExperimental treatment 2 interventions
Group B: Enhanced standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular event

Time to first cardiovascular event

Time frame
Median follow-up of 1 year
2

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

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months
4

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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