NCT07817589

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2023Nov 2026

Study Start

First participant enrolled

April 24, 2023

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

September 14, 2026

Status Verified

October 1, 2025

Enrollment Period

3.6 years

First QC Date

July 20, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Heart failureYogaYoga-CaRecardiac rehabilitationrehabilitation

Outcome Measures

Primary Outcomes (2)

  • Major Adverse Cardiovascular event

    Time to first cardiovascular event

    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

    3 months

Secondary Outcomes (8)

  • Six minute walk test

    3 months

  • Generic Quality of life

    3 months

  • Self-rated health (EQ-5D-5L)

    3 months

  • Tobacco cessation

    3 months

  • Self-reported Frailty

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Yoga-CaRe group

EXPERIMENTAL

Yoga based cardiac rehabilitation programme delivered as 20 sessions spread over three months and long term care and follow-up.

Behavioral: Yoga-CaRe HFBehavioral: Health Education

Enhanced standard care

ACTIVE COMPARATOR

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

Behavioral: Health Education

Interventions

Yoga-CaRe HFBEHAVIORAL

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

Yoga-CaRe group

Health education on "Healthy Living with Heart Failure"

Enhanced standard careYoga-CaRe group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

SDM College of Medical Sciences & Hospital

Dharwad, Karnataka, 580009, India

RECRUITING

JSS Hospital

Mysore, Karnataka, 570004, India

RECRUITING

North Eastern Indira Gandhi Regional Institute of Medical Sciences

Shillong, Meghālaya, 793018, India

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

RECRUITING

All India Institute of Medical Sciences

Jodhpur, Rajasthan, 342005, India

SUSPENDED

Madras Medical College

Chennai, Tamil Nadu, 600003, India

RECRUITING

Sri Ramchandra Institute of Higher Education and Research

Chennai, Tamil Nadu, 600116, India

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dorairaj Prabhakaran, MD DM (Cardiology)

    Centre for Chronic Disease Control, New Delhi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorairaj Prabhakaran, MD DM

CONTACT

Ambalam M Chandrasekaran, BNYS MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 20, 2026

First Posted

September 14, 2026

Study Start

April 24, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

September 14, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

We are preparing a IPD sharing plan

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 months after completion of study follow-up
Access Criteria
Bonafide researchers will be provided access to data

Locations