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RecruitingNCT07817589Yoga-CaRe HFUpdated Sep 14, 2026

Yoga Based Cardiac Rehabilitation in Heart Failure Failure

An interventional study of Yoga-CaRe HF and Health Education in Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II and Heart Failure NYHA Class III, sponsored by Centre for Chronic Disease Control, India. Recruiting at 16 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Centre for Chronic Disease Control, India · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3,500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction
  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III

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Keywords

  • Heart failure
  • Yoga
  • Yoga-CaRe
  • cardiac rehabilitation
  • rehabilitation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
3,500 participants (estimated)

Study arms

  • 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 · Behavioral: Health Education

  • Active comparator
    Enhanced standard care

    Enhanced standard care comprising of health education delivered in 3 sessions spread over three months.

    Behavioral: Health Education

Interventions

  • BehavioralYoga-CaRe HF

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

  • BehavioralHealth Education

    Health education on "Healthy Living with Heart Failure"

05

What researchers measure

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

  5. Self-reported Frailty

    Frailty assessed by Fried Frailty Phenotype tool

    Time frame: 3 months

  6. Caregiver's depression - Patient Health Questionnaire-9

    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.

    Time frame: 3 months

  7. Caregiver's Quality of Life - EQ-5D-5L

    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.

    Time frame: at 3 months

  8. Costs of care

    Cost effectiveness as assessed by a piloted tool

    Time frame: Median follow-up of 1 year

06

Study locations

12 of 16 sites recruiting
  • SDM College of Medical Sciences & Hospital
    Dharwad, Karnataka 580009, India
    • Kiran Aithal, MD General Medicine · Contact
    Recruiting
  • JSS Hospital
    Mysore, Karnataka 570004, India
    • Sunil Kumar S, DM Cardiology · Contact
    Recruiting
  • North Eastern Indira Gandhi Regional Institute of Medical Sciences
    Shillong, Meghālaya 793018, India
    • Amit Malviya, DM Cardiology · Contact
    Recruiting
  • All India Institute of Medical Sciences
    New Delhi, National Capital Territory of Delhi 110029, India
    Active, not recruiting
  • Dayanand Medical College and Hospital
    Ludhiana, Punjab 141001, India
    • Bishav Mohan, DM Cardiology · Contact
    Recruiting
  • All India Institute of Medical Sciences
    Jodhpur, Rajasthan 342005, India
    Suspended
  • Madras Medical College
    Chennai, Tamil Nadu 600003, India
    • G Justin Paul, DM Cardiology · Contact
    Recruiting
  • Sri Ramchandra Institute of Higher Education and Research
    Chennai, Tamil Nadu 600116, India
    • Nagendra Boopathy, DM Cardiology · Contact
    Recruiting
  • All India Institute of Medical Sciences, Rishikesh
    Rishikesh, Uttarakand, India
    Recruiting
  • Sri Jayadeva Institute of Cardiovascular Sciences and Research
    Bangalore, India
    Recruiting
  • All India Institute of Medical Sciences, Bathinda
    Bathinda, India
    Recruiting
  • KLES Dr. Prabhakar Kore Charitable Hospital
    Belagavi, India
    Suspended
  • Safdarjung Hospital
    Delhi, India
    Recruiting
  • Sir Ganga Ram Hospital
    Delhi, India
    Recruiting
  • Sri Jayadeva Institute of Cardiovascular Sciences and Research
    Mysore, India
    Recruiting
  • Acharya Vinobha Bhave Rural Hospital
    Wardha, India
    Suspended
07

References and documents

Individual participant data

Plan to share: Yes — We are preparing a IPD sharing plan

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07817589
Lead sponsor
Centre for Chronic Disease Control, India
Collaborators
Indian Council of Medical Research, Central Council for Research in Yoga & Naturopathy, All India Institute of Medical Sciences, All India Institute of Medical Sciences, Bathinda, All India Institute of Medical Sciences, Rishikesh, All India Institute of Medical Sciences, Jodhpur, Dayanand Medical College and Hospital, KLES Prabhakar Kore Hospital Belagavi, JSS Medical College Hospital, SDM College of Medical Sciences & Hospital, North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences, Sri Ramachandra Institute of Higher Education and Research, Madras Medical College, Acharya Vinoba Bhave Rural Hospital, Sri Jayadeva Institute of Cardiovascular Sciences and Research
Responsible party
Dr. Dorairaj Prabhakaran (Director, Centre for Chronic Disease Control, India) — Principal investigator
First posted
Sep 14, 2026
Start date
Apr 24, 2023
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Sep 14, 2026

Study contacts

Dorairaj Prabhakaran, MD DM
Contact
dprabhakaran@ccdcindia.org
+91 11 41618456
Ambalam M Chandrasekaran, BNYS MPH
Contact
Chandrasekaran@ccdcindia.org
+91 11 41618456 ext. 4804
Dorairaj Prabhakaran, MD DM (Cardiology)
principal investigator · Centre for Chronic Disease Control, New Delhi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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