Heart Failure With Reduced Ejection FractionYoga-CaRe HFNCT07817589
Yoga Based Cardiac Rehabilitation in Heart Failure Failure
A study testing Yoga-CaRe HF and Health Education in people with Heart Failure With Reduced Ejection Fraction and Heart Failure NYHA Class II, run by Centre for Chronic Disease Control, India at 16 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- Yoga-CaRe HF and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 16 sitesIndia
- Study dates
- 24 Apr 2023to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
India16 sites, 12 recruiting
- Recruiting
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore
Prabhavathi, prabhavathi_in@yahoo.com
- Recruiting
All India Institute of Medical Sciences, Bathinda
Bathinda
Bhupinder Singh, docbhupi@gmail.com
- Suspended
KLES Dr. Prabhakar Kore Charitable Hospital
Belagavi
- Recruiting
Madras Medical College
Chennai, Tamil Nadu, 600003
G Justin Paul, DM Cardiology
- Recruiting
Sri Ramchandra Institute of Higher Education and Research
Chennai, Tamil Nadu, 600116
Nagendra Boopathy, DM Cardiology
- Recruiting
Safdarjung Hospital
Delhi
Anunay Gupta, dranunaygupta@gmail.com
- Recruiting
Sir Ganga Ram Hospital
Delhi
Subhash Chand Manchanda, doctormanchanda@yahoo.com
- Recruiting
SDM College of Medical Sciences & Hospital
Dharwad, Karnataka, 580009
Kiran Aithal, MD General Medicine
- Suspended
All India Institute of Medical Sciences
Jodhpur, Rajasthan, 342005
- Recruiting
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
Bishav Mohan, DM Cardiology
- Recruiting
JSS Hospital
Mysore, Karnataka, 570004
Sunil Kumar S, DM Cardiology
- Recruiting
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Mysore
Sadanand K S, sadanand_dm@rediffmail.com
- Active, not recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
- Recruiting
All India Institute of Medical Sciences, Rishikesh
Rishikesh, Uttarakand
Bhanu Duggal, bhanu.cardio@aiimsrishikesh.edu.in
- Recruiting
North Eastern Indira Gandhi Regional Institute of Medical Sciences
Shillong, Meghālaya, 793018
Amit Malviya, DM Cardiology
- Suspended
Acharya Vinobha Bhave Rural Hospital
Wardha
About this study
Official title: 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
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- Being tested
- Yoga-CaRe HF, Health Education
- Keywords
- Heart failure, Yoga, Yoga-CaRe, cardiac rehabilitation, rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-CaRe HFBehavioural
A cardiac rehabilitation programme comprising of health education and yogic practices.
Health EducationBehavioural
Health education on "Healthy Living with Heart Failure"
| Study group | Role | What they receive |
|---|---|---|
| Yoga-CaRe group | Experimental | Yoga based cardiac rehabilitation programme delivered as 20 sessions spread over three months and long term care and follow-up. Receives: Behavioral: Yoga-CaRe HF; Behavioral: Health Education |
| Enhanced standard care | Active comparator | Enhanced standard care comprising of health education delivered in 3 sessions spread over three months. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular event
Time to first cardiovascular event
Measured: Median follow-up of 1 year
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
Measured: 3 months
Secondary outcomes (8)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Self-reported Frailty
Frailty assessed by Fried Frailty Phenotype tool
Measured: 3 months
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.
Measured: 3 months
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.
Measured: at 3 months
Costs of care
Cost effectiveness as assessed by a piloted tool
Measured: Median follow-up of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start24 Apr 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Chronic Disease Control, India
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India
- Investigators
- Dorairaj Prabhakaran, MD DM (Cardiology), Principal investigator, Centre for Chronic Disease Control, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817589
- Sponsor's protocol ID
- CCDC-2023-0001
- Acronym
- Yoga-CaRe HF
- Status last verified
- Oct 2025
- First submitted
- 20 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are preparing a IPD sharing plan