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

Chronic Heart Failure Clinical Trial

— EMSICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548508
• Other study ID #: 0730502
• Secondary ID: 2008-A00330-55
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: May 10, 2017
• Start date: July 2008
• Est. completion date: June 2014

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Functionnal ElectroStimulation (FES)
Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks
• SHAM
SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks

Locations

Country	Name	City	State
France	Universty Hospital Toulouse Cardiology	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Foundation for the Future, Paris, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Labrunée 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 peak		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	Muscle nerve sympathetic activity (MSNA)		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	Six minutes walking test		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	DEXA		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	maximal quadriceps strengh		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	interleukin 1		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	interleukin 6		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	TNF alpha		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	CRP		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	BNP		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	score of minessota test		change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary	score of Functional independency measure		change between baseline and 60 days after the Functional Electromyo Stimulation