Clinical trial NCT06019169: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients
Official title: Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
Yoga
randomized
SF36
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Study design :

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

* Arm control workshops around storytelling
* 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).

Eligibility criteria: 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

Primary outcomes:
measure: SF-36 quality of life
timeFrame: at day 0 and maximum at 5 month
Secondary outcomes:
measure: Score Hospital Anxiety and Depression Scale (HAD)
timeFrame: at day 0 and maximum at 5 month
measure: Weight (kg)
timeFrame: at day 0 and maximum at 5 month
measure: Waist circumference (cm)
timeFrame: at day 0 and maximum at 5 month
measure: Heart rate (Bpm)
timeFrame: at day 0 and maximum at 5 month
measure: Blood pressure (mmHg)
timeFrame: at day 0 and maximum at 5 month
measure: NYHA assessment
timeFrame: at day 0 and maximum at 5 month
measure: Concentration of Nt-pro BNP Biomarker
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: Concentration of CRP Biomarkers
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: Concentration IL6 Biomarkers
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: Distance during 6-minute walk test
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: Peak VO2
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: VO2 charge level
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: VE/VCO2
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: First ventilatory threshold
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
measure: First ventilatory load level
timeFrame: 3 months before inclusion and maximum 7 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
Study officials:
affiliation: Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
name: Lise LEGRAND, Dr
role: STUDY_CHAIR
affiliation: Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
name: Gilles MONTALESCOT, Pr
role: STUDY_DIRECTOR
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