Yoga Based Cardiac Rehabilitation in Heart Failure Failure (Yoga-CaRe HF)
7. september 2026 opdateret af: Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India
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
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
3500
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dorairaj Prabhakaran, MD DM
- Telefonnummer: +91 11 41618456
- E-mail: dprabhakaran@ccdcindia.org
Undersøgelse Kontakt Backup
- Navn: Ambalam M Chandrasekaran, BNYS MPH
- Telefonnummer: 4804 +91 11 41618456
- E-mail: Chandrasekaran@ccdcindia.org
Studiesteder
-
-
-
Bangalore, Indien
- Rekruttering
- Sri Jayadeva Institute of Cardiovascular Sciences and Research
-
Kontakt:
- Prabhavathi
- E-mail: prabhavathi_in@yahoo.com
-
Bathinda, Indien
- Rekruttering
- All India Institute of Medical Sciences, Bathinda
-
Kontakt:
- Bhupinder Singh
- E-mail: docbhupi@gmail.com
-
Belagavi, Indien
- Suspenderet
- KLES Dr. Prabhakar Kore Charitable Hospital
-
Delhi, Indien
- Rekruttering
- Safdarjung Hospital
-
Kontakt:
- Anunay Gupta
- E-mail: dranunaygupta@gmail.com
-
Delhi, Indien
- Rekruttering
- Sir Ganga Ram Hospital
-
Kontakt:
- Subhash Chand Manchanda
- E-mail: doctormanchanda@yahoo.com
-
Mysore, Indien
- Rekruttering
- Sri Jayadeva Institute of Cardiovascular Sciences and Research
-
Kontakt:
- Sadanand K S
- E-mail: sadanand_dm@rediffmail.com
-
Wardha, Indien
- Suspenderet
- Acharya Vinobha Bhave Rural Hospital
-
-
Karnataka
-
Dharwad, Karnataka, Indien, 580009
- Rekruttering
- SDM College of Medical Sciences & Hospital
-
Kontakt:
- Kiran Aithal, MD General Medicine
-
Mysore, Karnataka, Indien, 570004
- Rekruttering
- JSS Hospital
-
Kontakt:
- Sunil Kumar S, DM Cardiology
-
-
Meghālaya
-
Shillong, Meghālaya, Indien, 793018
- Rekruttering
- North Eastern Indira Gandhi Regional Institute of Medical Sciences
-
Kontakt:
- Amit Malviya, DM Cardiology
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Indien, 110029
- Aktiv, ikke rekrutterende
- All India Institute of Medical Sciences
-
-
Punjab
-
Ludhiana, Punjab, Indien, 141001
- Rekruttering
- Dayanand Medical College and Hospital
-
Kontakt:
- Bishav Mohan, DM Cardiology
-
-
Rajasthan
-
Jodhpur, Rajasthan, Indien, 342005
- Suspenderet
- All India Institute of Medical Sciences
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, Indien, 600003
- Rekruttering
- Madras Medical College
-
Kontakt:
- G Justin Paul, DM Cardiology
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Chennai, Tamil Nadu, Indien, 600116
- Rekruttering
- Sri Ramchandra Institute of Higher Education and Research
-
Kontakt:
- Nagendra Boopathy, DM Cardiology
-
-
Uttarakand
-
Rishikesh, Uttarakand, Indien
- Rekruttering
- All India Institute of Medical Sciences, Rishikesh
-
Kontakt:
- Bhanu Duggal
- E-mail: bhanu.cardio@aiimsrishikesh.edu.in
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Yoga-CaRe group
Yoga based cardiac rehabilitation programme delivered as 20 sessions spread over three months and long term care and follow-up.
|
A cardiac rehabilitation programme comprising of health education and yogic practices.
Health education on "Healthy Living with Heart Failure"
|
|
Aktiv komparator: Enhanced standard care
Enhanced standard care comprising of health education delivered in 3 sessions spread over three months.
|
Health education on "Healthy Living with Heart Failure"
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Adverse Cardiovascular event
Tidsramme: Median follow-up of 1 year
|
Time to first cardiovascular event
|
Median follow-up of 1 year
|
|
Heart Failure Specific Quality of life
Tidsramme: 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
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Six minute walk test
Tidsramme: 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.
|
3 months
|
|
Generic Quality of life
Tidsramme: 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.
|
3 months
|
|
Self-rated health (EQ-5D-5L)
Tidsramme: 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.
|
3 months
|
|
Tobacco cessation
Tidsramme: 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.
|
3 months
|
|
Self-reported Frailty
Tidsramme: 3 months
|
Frailty assessed by Fried Frailty Phenotype tool
|
3 months
|
|
Caregiver's depression - Patient Health Questionnaire-9
Tidsramme: 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.
|
3 months
|
|
Caregiver's Quality of Life - EQ-5D-5L
Tidsramme: 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.
|
at 3 months
|
|
Costs of care
Tidsramme: Median follow-up of 1 year
|
Cost effectiveness as assessed by a piloted tool
|
Median follow-up of 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dorairaj Prabhakaran, MD DM (Cardiology), Centre for Chronic Disease Control, New Delhi
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. april 2023
Primær færdiggørelse (Anslået)
30. november 2026
Studieafslutning (Anslået)
30. november 2026
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
7. september 2026
Først opslået (Faktiske)
14. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2026
Sidst verificeret
1. oktober 2025
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCDC-2023-0001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
We are preparing a IPD sharing plan
IPD-delingstidsramme
12 months after completion of study follow-up
IPD-delingsadgangskriterier
Bonafide researchers will be provided access to data
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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