Yoga Based Cardiac Rehabilitation in Heart Failure Failure (Yoga-CaRe HF)
7. september 2026 oppdatert av: 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
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
3500
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Dorairaj Prabhakaran, MD DM
- Telefonnummer: +91 11 41618456
- E-post: dprabhakaran@ccdcindia.org
Studer Kontakt Backup
- Navn: Ambalam M Chandrasekaran, BNYS MPH
- Telefonnummer: 4804 +91 11 41618456
- E-post: Chandrasekaran@ccdcindia.org
Studiesteder
-
-
-
Bangalore, India
- Rekruttering
- Sri Jayadeva Institute of Cardiovascular Sciences and Research
-
Ta kontakt med:
- Prabhavathi
- E-post: prabhavathi_in@yahoo.com
-
Bathinda, India
- Rekruttering
- All India Institute of Medical Sciences, Bathinda
-
Ta kontakt med:
- Bhupinder Singh
- E-post: docbhupi@gmail.com
-
Belagavi, India
- Suspendert
- KLES Dr. Prabhakar Kore Charitable Hospital
-
Delhi, India
- Rekruttering
- Safdarjung Hospital
-
Ta kontakt med:
- Anunay Gupta
- E-post: dranunaygupta@gmail.com
-
Delhi, India
- Rekruttering
- Sir Ganga Ram Hospital
-
Ta kontakt med:
- Subhash Chand Manchanda
- E-post: doctormanchanda@yahoo.com
-
Mysore, India
- Rekruttering
- Sri Jayadeva Institute of Cardiovascular Sciences and Research
-
Ta kontakt med:
- Sadanand K S
- E-post: sadanand_dm@rediffmail.com
-
Wardha, India
- Suspendert
- Acharya Vinobha Bhave Rural Hospital
-
-
Karnataka
-
Dharwad, Karnataka, India, 580009
- Rekruttering
- SDM College of Medical Sciences & Hospital
-
Ta kontakt med:
- Kiran Aithal, MD General Medicine
-
Mysore, Karnataka, India, 570004
- Rekruttering
- JSS Hospital
-
Ta kontakt med:
- Sunil Kumar S, DM Cardiology
-
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Meghālaya
-
Shillong, Meghālaya, India, 793018
- Rekruttering
- North Eastern Indira Gandhi Regional Institute of Medical Sciences
-
Ta kontakt med:
- Amit Malviya, DM Cardiology
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, India, 110029
- Aktiv, ikke rekrutterende
- All India Institute of Medical Sciences
-
-
Punjab
-
Ludhiana, Punjab, India, 141001
- Rekruttering
- Dayanand Medical College and Hospital
-
Ta kontakt med:
- Bishav Mohan, DM Cardiology
-
-
Rajasthan
-
Jodhpur, Rajasthan, India, 342005
- Suspendert
- All India Institute of Medical Sciences
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India, 600003
- Rekruttering
- Madras Medical College
-
Ta kontakt med:
- G Justin Paul, DM Cardiology
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Chennai, Tamil Nadu, India, 600116
- Rekruttering
- Sri Ramchandra Institute of Higher Education and Research
-
Ta kontakt med:
- Nagendra Boopathy, DM Cardiology
-
-
Uttarakand
-
Rishikesh, Uttarakand, India
- Rekruttering
- All India Institute of Medical Sciences, Rishikesh
-
Ta kontakt med:
- Bhanu Duggal
- E-post: bhanu.cardio@aiimsrishikesh.edu.in
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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"
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dorairaj Prabhakaran, MD DM (Cardiology), Centre for Chronic Disease Control, New Delhi
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. april 2023
Primær fullføring (Antatt)
30. november 2026
Studiet fullført (Antatt)
30. november 2026
Datoer for studieregistrering
Først innsendt
20. juli 2026
Først innsendt som oppfylte QC-kriteriene
7. september 2026
Først lagt ut (Faktiske)
14. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. september 2026
Sist bekreftet
1. oktober 2025
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CCDC-2023-0001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
We are preparing a IPD sharing plan
IPD-delingstidsramme
12 months after completion of study follow-up
Tilgangskriterier for IPD-deling
Bonafide researchers will be provided access to data
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .