An interventional study of Functionnal ElectroStimulation (FES) and SHAM in Chronic Heart Failure, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 46 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
Other: Functionnal ElectroStimulation (FES)
Other: SHAM
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
VO2 peak
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
Muscle nerve sympathetic activity (MSNA)
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
Six minutes walking test
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
DEXA
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
maximal quadriceps strengh
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 1
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 6
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
TNF alpha
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
CRP
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
BNP
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
score of minessota test
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
score of Functional independency measure
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse