Yoga Based Cardiac Rehabilitation in Heart Failure Failure (Yoga-CaRe HF)

September 7, 2026 updated by: Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India

Effectiveness of Yoga Based Cardiac Rehabilitation (Yoga-CaRe) in Heart Failure: A Randomized Controlled Clinical 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Bangalore, India
        • Recruiting
        • Sri Jayadeva Institute of Cardiovascular Sciences and Research
        • Contact:
      • Bathinda, India
        • Recruiting
        • All India Institute of Medical Sciences, Bathinda
        • Contact:
      • Belagavi, India
        • Suspended
        • KLES Dr. Prabhakar Kore Charitable Hospital
      • Delhi, India
      • Delhi, India
      • Mysore, India
        • Recruiting
        • Sri Jayadeva Institute of Cardiovascular Sciences and Research
        • Contact:
      • Wardha, India
        • Suspended
        • Acharya Vinobha Bhave Rural Hospital
    • Karnataka
      • Dharwad, Karnataka, India, 580009
        • Recruiting
        • SDM College of Medical Sciences & Hospital
        • Contact:
          • Kiran Aithal, MD General Medicine
      • Mysore, Karnataka, India, 570004
        • Recruiting
        • JSS Hospital
        • Contact:
          • Sunil Kumar S, DM Cardiology
    • Meghālaya
      • Shillong, Meghālaya, India, 793018
        • Recruiting
        • North Eastern Indira Gandhi Regional Institute of Medical Sciences
        • Contact:
          • Amit Malviya, DM Cardiology
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Active, not recruiting
        • All India Institute of Medical Sciences
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Recruiting
        • Dayanand Medical College and Hospital
        • Contact:
          • Bishav Mohan, DM Cardiology
    • Rajasthan
      • Jodhpur, Rajasthan, India, 342005
        • Suspended
        • All India Institute of Medical Sciences
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600003
        • Recruiting
        • Madras Medical College
        • Contact:
          • G Justin Paul, DM Cardiology
      • Chennai, Tamil Nadu, India, 600116
        • Recruiting
        • Sri Ramchandra Institute of Higher Education and Research
        • Contact:
          • Nagendra Boopathy, DM Cardiology
    • Uttarakand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Performance of exercise training/yoga at regular intervals (more than once per week) at a moderate-to-vigorous intensity at any time in the previous 6 week
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga-CaRe group
Yoga based cardiac rehabilitation programme delivered as 20 sessions spread over three months and long term care and follow-up.
Behavioral: Yoga-CaRe HF
A cardiac rehabilitation programme comprising of health education and yogic practices.
Behavioral: Health Education
Health education on "Healthy Living with Heart Failure"
Active Comparator: Enhanced standard care
Enhanced standard care comprising of health education delivered in 3 sessions spread over three months.
Behavioral: Health Education
Health education on "Healthy Living with Heart Failure"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular event
Time Frame: Median follow-up of 1 year
Time to first cardiovascular event
Median follow-up of 1 year
Heart Failure Specific Quality of life
Time Frame: 3 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walk test
Time Frame: 3 months
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.
3 months
Generic Quality of life
Time Frame: 3 months
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.
3 months
Self-rated health (EQ-5D-5L)
Time Frame: 3 months
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.
3 months
Tobacco cessation
Time Frame: 3 months
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.
3 months
Self-reported Frailty
Time Frame: 3 months
Frailty assessed by Fried Frailty Phenotype tool
3 months
Caregiver's depression - Patient Health Questionnaire-9
Time Frame: 3 months
PHQ-9 total score, ranging from 0 to 27, with each of the nine items scored from 0 to 3. Higher scores indicate greater severity of depressive symptoms.
3 months
Caregiver's Quality of Life - EQ-5D-5L
Time Frame: at 3 months
Quality of life will be assessed using the EQ-5D-5L questionnaire, which 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 and visual analogue scale (EQ-VAS), with higher scores indicating better health-related quality of life.
at 3 months
Costs of care
Time Frame: Median follow-up of 1 year
Cost effectiveness as assessed by a piloted tool
Median follow-up of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Chronic Disease Control, India

Collaborators

Indian Council of Medical Research
Dayanand Medical College and Hospital
All India Institute of Medical Sciences, Rishikesh
Madras Medical College
Sri Jayadeva Institute of Cardiovascular Sciences and Research
SDM College of Medical Sciences & Hospital
North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences
All India Institute of Medical Sciences, Jodhpur
All India Institute of Medical Sciences, Bathinda
All India Institute of Medical Sciences
JSS Medical College Hospital
Sri Ramachandra Institute of Higher Education and Research
Central Council for Research in Yoga & Naturopathy
KLES Prabhakar Kore Hospital Belagavi
Acharya Vinoba Bhave Rural Hospital

Investigators

  • Principal Investigator: Dorairaj Prabhakaran, MD DM (Cardiology), Centre for Chronic Disease Control, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDC-2023-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are preparing a IPD sharing plan

IPD Sharing Time Frame

12 months after completion of study follow-up

IPD Sharing Access Criteria

Bonafide researchers will be provided access to data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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