Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Functionnal ElectroStimulation (FES); SHAM
Intervention type(s): Other; Other
Intervention description(s): Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks; SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Advanced Chronic Heart Failure, physical therapy, Exercise