Chronic Heart Failure Clinical Trial
Official title:
Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.
Advanced Chronic Heart Failure (ACHF) is a severe and frequent disease inducing a strong
limitation of exercise capacity and a poor quality of life. Hospitalisation for cardiac
decompensation is frequent and could alter their incapacities because of muscular
deconditionning. Tradionnal aerobic rehabilitation exercises fighting against this
deconditionning are not relevant in these patients because of dyspnea.
In litterature, Functionnal Electrostimulation (FES) has been tested in stable Chronic Heart
Failure (NYHA I to III), far from decompensation. Several authors showed the same
improvements than those obtained with conventionnal rehabilitation on aerobic capacities
(peak VO2, 6 minutes walking test) and quality of life.
The originality of this study is to test FES soon after acute heart decompensation in ACHF
patients. This type of rehabilitation could represent in the future an alternative to
conventionnal rehabilitation until the patients could be able to do aerobic exercise.
60 patients will be randomised between two groups, the firsth receiving FES (treatment
group), the second receiving skin electrostimulation in the same place without muscular
contraction (Sham group). Patient and evaluator do not know what type of stimulation they
have. These treatments spread over six weeks, five days per seven. They are began in
rehabilitation unit then continued at home.
The principal criteria of judgement of FES efficacy is peak VO2 after the protocol.
Secondary criteria are distance to the six minutes walking test, muscular strengh of
quadriceps, the muscle mass measured by Dual energy X-ray absorptiometry (DEXA), inflamatory
dosage (TNF alpha, IL-1, IL-6, CRP), rest value of Muscle sympathetic nerve activity, score
to Minnesota questionnaire and fuctionnal independance.
The attempted results are an significative improvement of aerobic capacity(peak VO2 and six
minutes walking test) and the others secondary criteria in FES group compared with Sham
group.
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