Chronic Heart Failure Clinical Trial
Official title:
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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