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

Study Overview
=================
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).

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

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Other: Yoga arm
* Other: storytelling activities


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Workshops around storytelling<br>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<br>* 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.<br>|
| Experimental: Yoga classes<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at day 0 and maximum at 5 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score Hospital Anxiety and Depression Scale (HAD) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | distance traveled by the patient in 6 minutes | 3 months before inclusion and maximum 7 months after inclusion | 
| Peak VO2 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Heart Failure, Yoga, randomized, SF36