Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure (CREMS-HF)

This study has been completed.
Sponsor:
Collaborators:
GERS
Bourgogne Association of Cardiology
Ile-de-France Association of Cardiology
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01408875
First received: August 2, 2011
Last updated: January 13, 2014
Last verified: January 2014

August 2, 2011
January 13, 2014
October 2011
December 2013   (final data collection date for primary outcome measure)
Peak VO2 [ Time Frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]
The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program.
Same as current
Complete list of historical versions of study NCT01408875 on ClinicalTrials.gov Archive Site
  • Changes on muscular strength [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]
    Measure of weight that the patient can lift 3 times but not four with quadriceps.
  • Changes on sub maximal parameters [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]
    Measure of ventilatory threshold and walk test of 6 min.
  • Modifications of quality of life [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]
    Minnesota questionnaire completed by the patient
Same as current
Not Provided
Not Provided
 
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

The purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.

In chronic heart failure, low exercise capacity is due, in part, to peripheral muscles abnormalities. Exercise training performed during cardiac rehabilitation improves exercise tolerance measured by cardiopulmonary exercise test. Low frequency electromyostimulation (EMS) was proposed as an alternative to exercise training (ET) in this population.

However, the effectiveness of the combination (EMS +ET) compared with ET alone is not proved. The main objective is to compare exercise capacity judged by peak VO2 after treatment by ET alone versus EMS+ET. The secondary end points are results on sub maximal parameters, muscular resistance, quality of life and effectiveness regarding clinical sub-groups.

This study is a controlled, randomized, multicentric (14 centres) designed to include 90 patients by group in two years period. Inclusion criteria are: CHF patients , NYHA class II to IIIb, with LVEF < 40% referred to complete a cardiac rehabilitation program.

All the patients benefit from a comprehensive cardiac rehabilitation program including educational program, therapeutical optimisation and exercise training for 20 sessions, 3 to 5 days a week. The group of patients randomized for additional EMS has 20 sessions of 1 hour electrical quadricipital myostimulation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Heart Failure
Device: Low electrical myostimulation
The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
  • Experimental: Rehabilitation and EMS Group
    Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.
    Intervention: Device: Low electrical myostimulation
  • No Intervention: Rehabilitation Group only
    Patient Heart Failure who follows physical training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age from 18 to 75 yo
  • stable Chronic Heart Failure (CHF) under "optimal" treatment since at least 1 week
  • NYHA functional class II to IIIb
  • left ventricular ejection fraction < 40%
  • cardiopulmonary exercise test feasible
  • whatever etiology of heart failure
  • age of heart failure ≥ 3 months.
  • have signed the consent document to participate in the study

Exclusion Criteria:

  • previous treatment by functional electrical myo stimulation
  • recent acute heart failure or inotropic intravenous agents used (< 10 days)
  • recent coronary angioplasty (< 10 days)
  • cardiac surgery < 1 month
  • valvular disease requiring surgical treatment
  • uncontrolled hypertension (≥ systolic 180 and/or diastolic 110 mmHg)
  • severe respiratory insufficiency (VEMS < 1000 ml)
  • pregnancy
  • Automatic implantable defibrillator
  • pace-makers : cardiac stimulation dependence or not known
  • incapacity to achieve 6 min walk test and/or exercise testing
  • absolute contra-indication to exercise test and/or exercise training
  • myocarditis or pericarditis
  • uncontrolled ventricular arrhythmias
  • Obesity (BMI ≥ 35)
  • known and documented peripheral myopathy
  • participation to another study protocol
  • patient incapable of giving consent
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01408875
2007-03
Yes
French Cardiology Society
French Cardiology Society
  • GERS
  • Bourgogne Association of Cardiology
  • Ile-de-France Association of Cardiology
Principal Investigator: Marie Christine Iliou, MD Hôpital Corentin Celton
French Cardiology Society
January 2014

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