Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients (YOG-IC)

January 13, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design :

Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two parallel groups

  • Arm control workshops around social activities
  • Yoga arm (Y): Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.

Population concerned :

Patients with stabilized chronic heart failure (last episode of acute heart failure dating back more than a month) followed at the Pitié Salpêtrière cardiology institut

The study may be offered to any stabilized heart failure patient followed in the study centre. Visit V1 (D0): Information, Inclusion and randomization Visit V2 (M3): final visit. Between V1 and V2: weekly workshop sessions around storytelling (arm C) or Hatha yoga (Arm Y).

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient ≥18 years old
  • Chronic heart failure patient defined by: Most recent LVEF ≤50% (regardless of measurement method)
  • Stabilized (last episode of acute heart failure dating back more than a month) in NYHA stage I to III dyspnoea, ambulatory, discharged from hospital for > 1 month
  • Drug treatment optimized according to the judgment of the investigator
  • Ability to participate in activities as proposed (remote or face-to-face)
  • Patient affiliated with a social security scheme
  • Written consent to participate

Exclusion Criteria:

  • Patients who have practiced yoga regularly (> once a month) in the six months prior to selection.
  • Current pregnancy / lactation
  • Etiology of heart failure: hypertrophic cardiomyopathy, restrictive heart disease or severe curable valve disease
  • Severe renal impairment GFR<25ml/min/1.73 m2 or on dialysis.
  • Persons subject to legal protection measures (guardianship, curatorship)
  • Person not "receptive" to the practice of yoga
  • Participation in intervention research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga classes
Participation in YOGA classes performed by Mme Laura BOGANI from The Blue Fish LAB Association. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months.
Other: Yoga arm
Participation in YOGA classes performed by Mme Laura BOGANI from The Blue Fish LAB Association. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.
Active Comparator: Workshops around social activities
Participate in workshops around social activities. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months.
Other: storytelling activities
Participate in workshops around storytelling led by the association of storytellers l'Age D'or. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months. An attendance sheet will be completed at each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 quality of life
Time Frame: at day 0 and maximum at 5 month
The SF-36 quality of life self-questionnaire is one of the most widely used questionnaires to assess the quality of life of patients. Its result is between 0 and 100. It includes a physical summary score and a psychological summary score.
at day 0 and maximum at 5 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score Hospital Anxiety and Depression Scale (HAD)
Time Frame: at day 0 and maximum at 5 month
Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome
at day 0 and maximum at 5 month
Weight (kg)
Time Frame: at day 0 and maximum at 5 month
Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
at day 0 and maximum at 5 month
Waist circumference (cm)
Time Frame: at day 0 and maximum at 5 month
Measurement of the waist circumference during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
at day 0 and maximum at 5 month
Heart rate (Bpm)
Time Frame: at day 0 and maximum at 5 month
Measurement of the heart rate during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
at day 0 and maximum at 5 month
Blood pressure (mmHg)
Time Frame: at day 0 and maximum at 5 month
Measurement of blood pressure during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
at day 0 and maximum at 5 month
NYHA assessment
Time Frame: at day 0 and maximum at 5 month
Definition of the stage of heart failure by the NHYA classification at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
at day 0 and maximum at 5 month
Concentration of Nt-pro BNP Biomarker
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Analysis of Nt-pro BNP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center
3 months before inclusion and maximum 7 months after inclusion
Concentration of CRP Biomarkers
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Analysis of CRP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center
3 months before inclusion and maximum 7 months after inclusion
Concentration IL6 Biomarkers
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Analysis of IL6 biomarkers during the inclusion visit (1st visit) and the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center
3 months before inclusion and maximum 7 months after inclusion
Distance during 6-minute walk test
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
distance traveled by the patient in 6 minutes
3 months before inclusion and maximum 7 months after inclusion
Peak VO2
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Peak VO2 measurement on two different dates to analyze the results of walk tests carried out according to the center's current practice
3 months before inclusion and maximum 7 months after inclusion
VO2 charge level
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
VO2 charge level on two different dates to analyze the results of walk tests carried out according to the center's current practice
3 months before inclusion and maximum 7 months after inclusion
VE/VCO2
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Measurement of the VE/VCO2 ratio on two different dates to analyze the results of the walk tests carried out according to the current practice of the center
3 months before inclusion and maximum 7 months after inclusion
First ventilatory threshold
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Measurement of the first ventilatory threshold on two different dates to analyze the results of the walking tests carried out according to the current practice of the center
3 months before inclusion and maximum 7 months after inclusion
First ventilatory load level
Time Frame: 3 months before inclusion and maximum 7 months after inclusion
Measurement of the first ventilatory level of load on two different dates to analyze the results of the walking tests carried out according to the current practice of the center
3 months before inclusion and maximum 7 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Lise LEGRAND, Dr, Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
  • Study Director: Gilles MONTALESCOT, Pr, Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

March 26, 2027

Study Completion (Estimated)

April 26, 2027

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Heart Failure

Clinical Trials on storytelling activities

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe