Clinical trial NCT01548508: Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
Official title: Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Advanced Chronic Heart Failure, physical therapy, Exercise
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Foundation for the Future, Paris, France
First posted: 2012-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Advanced Chronic Heart Failure (NYHA III to IV)
* Cardiac Ejection Fraction \< 40 %
* peak VO2 \< 16 ml/kg/min,
* optimal drug treatment of CHF,
* hospitalised for acute decompensation but not in intensive care

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease with FEV \< 50%,
* History of stroke with walking disability, dementia.

Primary outcomes:
measure: VO2 peak
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary outcomes:
measure: Muscle nerve sympathetic activity (MSNA)
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: Six minutes walking test
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: DEXA
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: maximal quadriceps strengh
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: interleukin 1
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: interleukin 6
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: TNF alpha
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: CRP
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: BNP
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: score of minessota test
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
measure: score of Functional independency measure
timeFrame: change between baseline and 60 days after the Functional Electromyo Stimulation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Universty Hospital Toulouse Cardiology
Study officials:
affiliation: University Hospital, Toulouse
name: Michel GALINIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labrunee M, Despas F, Marque P, Guiraud T, Galinier M, Senard JM, Pathak A. Acute electromyostimulation decreases muscle sympathetic nerve activity in patients with advanced chronic heart failure (EMSICA Study). PLoS One. 2013 Nov 12;8(11):e79438. doi: 10.1371/journal.pone.0079438. eCollection 2013.