Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Heart failure, Yoga, Yoga-CaRe, cardiac rehabilitation, rehabilitation
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
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"
Sponsors
Centre for Chronic Disease Control, India
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular event | Median follow-up of 1 year | Time to first cardiovascular event |
| Heart Failure Specific Quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test | 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. |
| Generic Quality of life | 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. |
| Self-rated health (EQ-5D-5L) | 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. |
| Tobacco cessation | 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. |
| Self-reported Frailty | 3 months | Frailty assessed by Fried Frailty Phenotype tool |
| Caregiver's depression - Patient Health Questionnaire-9 | 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. |
| Caregiver's Quality of Life - EQ-5D-5L | 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. |
| Costs of care | Median follow-up of 1 year | Cost effectiveness as assessed by a piloted tool |
Countries
India
Contacts
CONTACTDorairaj Prabhakaran, MD DM
CONTACTAmbalam M Chandrasekaran, BNYS MPH
PRINCIPAL_INVESTIGATORDorairaj Prabhakaran, MD DM (Cardiology)
Centre for Chronic Disease Control, New Delhi
Outcome results
None listed