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NCT Number: NCT07817589

Yoga Based Cardiac Rehabilitation in Heart Failure Failure

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

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure NYHA Class II Heart Failure NYHA Class III

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SDM College of Medical Sciences & Hospital, Dharwad, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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"

Primary outcomes

  1. Major Adverse Cardiovascular event

    Time frame: Median follow-up of 1 year

    Time to first cardiovascular event

  2. 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

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. Self-reported Frailty

    Time frame: 3 months

    Frailty assessed by Fried Frailty Phenotype tool

  6. 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.

  7. 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.

  8. Costs of care

    Time frame: Median follow-up of 1 year

    Cost effectiveness as assessed by a piloted tool

Study contacts

Contact information is provided by the study sponsor or research team.

Ambalam M Chandrasekaran, BNYS MPH

CONTACT

[email protected]

+91 11 41618456 ext. 4804

Dorairaj Prabhakaran, MD DM

CONTACT

[email protected]

+91 11 41618456

Sponsors and collaborators

Lead sponsor

Centre for Chronic Disease Control, India

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Yoga-CaRe HF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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