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
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Device: Low electrical myostimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 94
Study Start Date: October 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation and EMS Group
Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.
Device: Low electrical myostimulation
The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
No Intervention: Rehabilitation Group only
Patient Heart Failure who follows physical training

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408875

Locations
France
Centre de réadaptation spécialisé Saint Luc
Abreschviller, France, 57560
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
Centre Hospitalier de la Côte Fleurie
Cricqueboeuf, France, 14113
Clinique SSR "Les Rosiers"
Dijon, France, 21002
Hôpital Bocage Central
Dijon, France, 21079
Hôpital Corentin Celton
Issy-les-Moulineaux, France, 92133
Hôpital de Joigny
Joigny, France, 89306
Clinique de la Mitterie
Lomme, France, 59160
Centre Hospitalier Loire Vendée Ocean
Machecoul, France, 44270
Hôpital de jour de soins de suite et de réadaptation Léopold Bellan
Paris, France, 75010
Clinique Saint-Yves
Rennes, France, 35044
Hôpital Intercommunal Sud Léman Valserine
Saint Julien en Genevois, France, 74164
Centre de réadaptation cardiaque Leopold Bellan
Tracy-le-Mont, France, 60170
Les Grands Prés
Villeneuve-Saint-Denis, France, 77174
Sponsors and Collaborators
French Cardiology Society
GERS
Bourgogne Association of Cardiology
Ile-de-France Association of Cardiology
Investigators
Principal Investigator: Marie Christine Iliou, MD Hôpital Corentin Celton
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01408875     History of Changes
Other Study ID Numbers: 2007-03
Study First Received: August 2, 2011
Last Updated: January 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French Cardiology Society:
Chronic Heart Failure
Cardiac rehabilitation
Exercise training
Peak VO2
Electrical myostimulation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014