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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: Functionnal ElectroStimulation (FES); Other: SHAM

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Universty Hospital Toulouse Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functionnal ElectroStimulation (FES)	Other: Functionnal ElectroStimulation (FES); Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks
Sham Comparator: SHAM	Other: SHAM; SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VO2 peak	change between baseline and 60 days after the Functional Electromyo Stimulation

Secondary Outcome Measures

Outcome Measure	Time Frame
Muscle nerve sympathetic activity (MSNA)	change between baseline and 60 days after the Functional Electromyo Stimulation
Six minutes walking test	change between baseline and 60 days after the Functional Electromyo Stimulation
DEXA	change between baseline and 60 days after the Functional Electromyo Stimulation
maximal quadriceps strengh	change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 1	change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 6	change between baseline and 60 days after the Functional Electromyo Stimulation
TNF alpha	change between baseline and 60 days after the Functional Electromyo Stimulation
CRP	change between baseline and 60 days after the Functional Electromyo Stimulation
BNP	change between baseline and 60 days after the Functional Electromyo Stimulation
score of minessota test	change between baseline and 60 days after the Functional Electromyo Stimulation
score of Functional independency measure	change between baseline and 60 days after the Functional Electromyo Stimulation

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Foundation for the Future, Paris, France
• Investigators: Principal Investigator: Michel GALINIER, MD, PhD, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Advanced Chronic Heart Failure, physical therapy, Exercise
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0730502; 2008-A00330-55 (Other Identifier: Afssaps)