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

NCT ID: NCT01548508

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Functionnal ElectroStimulation (FES)

Group Type: EXPERIMENTAL

Functionnal ElectroStimulation (FES)

Intervention Type: OTHER

Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks

SHAM

Group Type: SHAM_COMPARATOR

SHAM

Intervention Type: OTHER

SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks

Interventions

Functionnal ElectroStimulation (FES)

Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks

Intervention Type: OTHER

SHAM

SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for the Future, Paris, France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel GALINIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Universty Hospital Toulouse Cardiology

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 24265770 (View on PubMed)

Other Identifiers

2008-A00330-55

Identifier Type: OTHER

Identifier Source: secondary_id

0730502

Identifier Type: -

Identifier Source: org_study_id