Chronic Heart Failure
Conditions
Keywords
Chronic Heart Failure, Yoga, randomized, SF36
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 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).
Interventions
OTHERYoga arm
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.
OTHERstorytelling 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactLise LEGRAND, Dr
Backup ContactNicolas VIGNOLLES
Outcome results
None listed