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| Name | Class |
|---|---|
| Gulf Estuarine Research Society (GERS) | OTHER |
| Bourgogne Association of Cardiology | UNKNOWN |
| Ile-de-France Association of Cardiology | UNKNOWN |
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The purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.
In chronic heart failure, low exercise capacity is due, in part, to peripheral muscles abnormalities. Exercise training performed during cardiac rehabilitation improves exercise tolerance measured by cardiopulmonary exercise test. Low frequency electromyostimulation (EMS) was proposed as an alternative to exercise training (ET) in this population.
However, the effectiveness of the combination (EMS +ET) compared with ET alone is not proved. The main objective is to compare exercise capacity judged by peak VO2 after treatment by ET alone versus EMS+ET. The secondary end points are results on sub maximal parameters, muscular resistance, quality of life and effectiveness regarding clinical sub-groups.
This study is a controlled, randomized, multicentric (14 centres) designed to include 90 patients by group in two years period. Inclusion criteria are: CHF patients , NYHA class II to IIIb, with LVEF < 40% referred to complete a cardiac rehabilitation program.
All the patients benefit from a comprehensive cardiac rehabilitation program including educational program, therapeutical optimisation and exercise training for 20 sessions, 3 to 5 days a week. The group of patients randomized for additional EMS has 20 sessions of 1 hour electrical quadricipital myostimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation and EMS Group | Experimental | Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation. |
|
| Rehabilitation Group only | No Intervention | Patient Heart Failure who follows physical training |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low electrical myostimulation | Device | The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak VO2 | The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program. | at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on muscular strength | Measure of weight that the patient can lift 3 times but not four with quadriceps. | at inclusion then after 4 to 7 weeks of cardiac rehabilitation |
| Changes on sub maximal parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Christine Iliou, MD | Hôpital Corentin Celton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de réadaptation spécialisé Saint Luc | Abreschviller | 57560 | France | |||
| Polyclinique Bordeaux Nord Aquitaine |
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Measure of ventilatory threshold and walk test of 6 min.
| at inclusion then after 4 to 7 weeks of cardiac rehabilitation |
| Modifications of quality of life | Minnesota questionnaire completed by the patient | at inclusion then after 4 to 7 weeks of cardiac rehabilitation |
| Bordeaux |
| 33077 |
| France |
| Centre Hospitalier de la Côte Fleurie | Cricquebœuf | 14113 | France |
| Clinique SSR "Les Rosiers" | Dijon | 21002 | France |
| Hôpital Bocage Central | Dijon | 21079 | France |
| Hôpital Corentin Celton | Issy-les-Moulineaux | 92133 | France |
| Hôpital de Joigny | Joigny | 89306 | France |
| Clinique de la Mitterie | Lomme | 59160 | France |
| Centre Hospitalier Loire Vendée Ocean | Machecoul | 44270 | France |
| Hôpital de jour de soins de suite et de réadaptation Léopold Bellan | Paris | 75010 | France |
| Clinique Saint-Yves | Rennes | 35044 | France |
| Hôpital Intercommunal Sud Léman Valserine | Saint-Julien-en-Genevois | 74164 | France |
| Centre de réadaptation cardiaque Leopold Bellan | Tracy-le-Mont | 60170 | France |
| Les Grands Prés | Villeneuve-Saint-Denis | 77174 | France |