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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Toulouse
Sponsor:
Collaborator:
Foundation for the Future, Paris, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01548508
First received: February 23, 2012
Last updated: January 28, 2013
Last verified: January 2013

February 23, 2012
January 28, 2013
July 2008
June 2013   (final data collection date for primary outcome measure)
VO2 peak [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
VO2 peak [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01548508 on ClinicalTrials.gov Archive Site
  • Muscle nerve sympathetic activity (MSNA) [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • Six minutes walking test [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • DEXA [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • maximal quadriceps strengh [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • interleukin 1 [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • interleukin 6 [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • TNF alpha [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • score of minessota test [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • score of Functional independency measure [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]
  • Muscle nerve sympathetic activity (MSNA) [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • Six minutes walking test [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • DEXA [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • maximal quadriceps strengh [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • interleukin 1 [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • interleukin 6 [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • TNF alpha [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • score of minessota test [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
  • score of Functional independency measure [ Time Frame: change before and after the Functional Electromyo Stimulation at 60 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
  • Other: Functionnal ElectroStimulation (FES)
    Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks
  • Other: SHAM
    SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks
  • Experimental: Functionnal ElectroStimulation (FES)
    Intervention: Other: Functionnal ElectroStimulation (FES)
  • Sham Comparator: SHAM
    Intervention: Other: SHAM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact: Michel GALINIER, MD , PhD 05 61 32 26 61 ext 33 galinier.m@chu-toulouse.fr
Contact: Marc LABRUNEE, MD 05 61 32 28 01 ext 33 marclabrunee@gmail.com
France
 
NCT01548508
0730502, 2008-A00330-55
Yes
University Hospital, Toulouse
University Hospital, Toulouse
Foundation for the Future, Paris, France
Principal Investigator: Michel GALINIER, MD, PhD University Hospital, Toulouse
University Hospital, Toulouse
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP