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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Chronic Heart Failure

Treatments: Other: Yoga arm; Other: storytelling activities

Study type: Interventional

Funder types: Other

Identifiers

NCT06019169

APHP230227

Details and patient eligibility

About

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.

Full 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).

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Workshops around social activities

Active Comparator group

Description:

Participate in workshops around social activities. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months.

Treatment:

Other: storytelling activities

Yoga classes

Experimental group

Description:

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.

Treatment:

Other: Yoga arm