Yoga Based Cardiac Rehabilitation in Heart Failure Failure

Centre for Chronic Disease Control, India3,500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,500

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

SDM College of Medical Sciences & Hospital

Dharwad, Karnataka, India

RECRUITING

JSS Hospital

Mysore, Karnataka, India

RECRUITING

North Eastern Indira Gandhi Regional Institute of Medical Sciences

Shillong, Meghālaya, India

RECRUITING

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

ACTIVE_NOT_RECRUITING

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

RECRUITING

All India Institute of Medical Sciences

Jodhpur, Rajasthan, India

SUSPENDED

Madras Medical College

Chennai, Tamil Nadu, India

RECRUITING

Sri Ramchandra Institute of Higher Education and Research

Chennai, Tamil Nadu, India

RECRUITING

All India Institute of Medical Sciences, Rishikesh

Rishikesh, Uttarakand, India

RECRUITING

Sri Jayadeva Institute of Cardiovascular Sciences and Research

Bangalore, India

RECRUITING

...and 6 more locations

Outcomes

Primary Outcomes

Major Adverse Cardiovascular event

Time to first cardiovascular event

Time frame: 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

Time frame: 3 months

Secondary Outcomes

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

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

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

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

Self-reported Frailty

Frailty assessed by Fried Frailty Phenotype tool

Time frame: 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.

Time frame: 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.

Time frame: at 3 months

Costs of care

Cost effectiveness as assessed by a piloted tool

Time frame: Median follow-up of 1 year

Yoga Based Cardiac Rehabilitation in Heart Failure Failure

Overview

Conditions

Interventions

Eligibility

Locations (16)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts