Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation (EMSICA)

Toulouse University Hospital

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Other: SHAM; Other: Functionnal ElectroStimulation (FES)

Study type: Interventional

Funder types: Other

Identifiers

NCT01548508

0730502

2008-A00330-55 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

46 participants in 2 patient groups

Functionnal ElectroStimulation (FES)

Experimental group

Treatment:

Other: Functionnal ElectroStimulation (FES)

SHAM

Sham Comparator group

Treatment:

Other: SHAM