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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06019169

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Other: Yoga arm Other: storytelling activities	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2023

Anticipated Primary Completion Date :

Jan 30, 2024

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Workshops around storytelling 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.	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.
Experimental: Yoga classes Participation in YOGA classes. 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. 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.

Arm

Intervention/Treatment

Active Comparator: Workshops around storytelling

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.

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.

Experimental: Yoga classes

Participation in YOGA classes. 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. 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.

Outcome Measures

Primary Outcome Measures

SF-36 quality of life [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.

Secondary Outcome Measures

Score Hospital Anxiety and Depression Scale (HAD) [at day 0 and maximum at 5 month]
Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome
Weight (kg) [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.
Waist circumference (cm) [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.
Heart rate (Bpm) [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.
Blood pressure (mmHg) [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.
NYHA assessment [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.
Concentration of Nt-pro BNP Biomarker [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
Concentration of CRP Biomarkers [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
Concentration IL6 Biomarkers [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
Distance during 6-minute walk test [3 months before inclusion and maximum 7 months after inclusion]
distance traveled by the patient in 6 minutes
Peak VO2 [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
VO2 charge level [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
VE/VCO2 [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
First ventilatory threshold [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
First ventilatory load level [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC	Paris		France	75013

Sponsors and Collaborators

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)