Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure (CREMS-HF)
|ClinicalTrials.gov Identifier: NCT01408875|
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : March 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Device: Low electrical myostimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
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
- Peak VO2 [ Time Frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation ]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 ]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 ]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 ]Minnesota questionnaire completed by the patient
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Clinique SSR "Les Rosiers"|
|Dijon, France, 21002|
|Hôpital Bocage Central|
|Dijon, France, 21079|
|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|