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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Chronic Heart Failure
 Other: Functionnal ElectroStimulation (FES)
Other: SHAM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • VO2 peak [ Time Frame: change between baseline and 60 days after the Functional Electromyo Stimulation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548508

Contacts
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

Locations
France
Universty Hospital Toulouse Cardiology Recruiting
Toulouse, France, 31059
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    
Principal Investigator: Michel GALINIER, MD, PhD            
Sub-Investigator: Atul PATAK, MD, PhD            
Sub-Investigator: Marc LABRUNEE, MD            
Sponsors and Collaborators
University Hospital, Toulouse
Foundation for the Future, Paris, France
Investigators
Principal Investigator: Michel GALINIER, MD, PhD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01548508     History of Changes
Other Study ID Numbers: 0730502, 2008-A00330-55
Study First Received: February 23, 2012
Last Updated: January 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Advanced Chronic Heart Failure, physical therapy, Exercise

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013