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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
94
The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
Centre de réadaptation spécialisé Saint Luc
Abreschviller, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre Hospitalier de la Côte Fleurie
Cricquebœuf, France
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.
Time frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation
Changes on muscular strength
Measure of weight that the patient can lift 3 times but not four with quadriceps.
Time frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Changes on sub maximal parameters
Measure of ventilatory threshold and walk test of 6 min.
Time frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Modifications of quality of life
Minnesota questionnaire completed by the patient
Time frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
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