Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure (CREMS-HF)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure|
- Peak VO2 [ Time Frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program.
- Changes on muscular strength [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]Measure of weight that the patient can lift 3 times but not four with quadriceps.
- Changes on sub maximal parameters [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]Measure of ventilatory threshold and walk test of 6 min.
- Modifications of quality of life [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]Minnesota questionnaire completed by the patient
|Study Start Date:||October 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Rehabilitation and EMS Group
Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.
Device: Low electrical myostimulation
The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
No Intervention: Rehabilitation Group only
Patient Heart Failure who follows physical training
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408875
|Centre de réadaptation spécialisé Saint Luc|
|Abreschviller, France, 57560|
|Polyclinique Bordeaux Nord Aquitaine|
|Bordeaux, France, 33077|
|Centre Hospitalier de la Côte Fleurie|
|Cricqueboeuf, France, 14113|
|Hôpital Bocage Central|
|Dijon, France, 21079|
|Clinique SSR "Les Rosiers"|
|Dijon, France, 21002|
|Hôpital Corentin Celton|
|Issy-les-Moulineaux, France, 92133|
|Hôpital de Joigny|
|Joigny, France, 89306|
|Clinique de la Mitterie|
|Lomme, France, 59160|
|Centre Hospitalier Loire Vendée Ocean|
|Machecoul, France, 44270|
|Hôpital de jour de soins de suite et de réadaptation Léopold Bellan|
|Paris, France, 75010|
|Rennes, France, 35044|
|Hôpital Intercommunal Sud Léman Valserine|
|Saint Julien en Genevois, France, 74164|
|Centre de réadaptation cardiaque Leopold Bellan|
|Tracy-le-Mont, France, 60170|
|Les Grands Prés|
|Villeneuve-Saint-Denis, France, 77174|
|Principal Investigator:||Marie Christine Iliou, MD||Hôpital Corentin Celton|