Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yoga arm

    Other intervention

    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.

  • storytelling activities

    Other intervention

    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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Workshops around social activitiesActive comparator 1 intervention
Group B: Yoga classesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SF-36 quality of life

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.

Time frame
at day 0 and maximum at 5 month

Secondary outcomes

1

Score Hospital Anxiety and Depression Scale (HAD)

Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome

Time frame
at day 0 and maximum at 5 month
2

Weight (kg)

Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.

Time frame
at day 0 and maximum at 5 month
3

Waist circumference (cm)

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.

Time frame
at day 0 and maximum at 5 month
4

Heart rate (Bpm)

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.

Time frame
at day 0 and maximum at 5 month

Other outcomes

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