NCT01408875

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

August 2, 2011

Last Update Submit

March 6, 2015

Conditions

Chronic Heart Failure

Keywords

Chronic Heart FailureCardiac rehabilitationExercise trainingPeak VO2Electrical myostimulation

Outcome Measures

Primary Outcomes (1)

  • Peak VO2

    The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program.

    at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation

Secondary Outcomes (3)

  • Changes on muscular strength

    at inclusion then after 4 to 7 weeks of cardiac rehabilitation

  • Changes on sub maximal parameters

    at inclusion then after 4 to 7 weeks of cardiac rehabilitation

  • Modifications of quality of life

    at inclusion then after 4 to 7 weeks of cardiac rehabilitation

Study Arms (2)

Rehabilitation and EMS Group

EXPERIMENTAL

Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.

Device: Low electrical myostimulation

Rehabilitation Group only

NO INTERVENTION

Patient Heart Failure who follows physical training

Interventions

Low electrical myostimulationDEVICE

The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.

Rehabilitation and EMS Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Centre de réadaptation spécialisé Saint Luc

Abreschviller, 57560, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

Centre Hospitalier de la Côte Fleurie

Cricquebœuf, 14113, France

Location

Clinique SSR "Les Rosiers"

Dijon, 21002, France

Location

Hôpital Bocage Central

Dijon, 21079, France

Location

Hôpital Corentin Celton

Issy-les-Moulineaux, 92133, France

Location

Hôpital de Joigny

Joigny, 89306, France

Location

Clinique de la Mitterie

Lomme, 59160, France

Location

Centre Hospitalier Loire Vendée Ocean

Machecoul, 44270, France

Location

Hôpital de jour de soins de suite et de réadaptation Léopold Bellan

Paris, 75010, France

Location

Clinique Saint-Yves

Rennes, 35044, France

Location

Hôpital Intercommunal Sud Léman Valserine

Saint-Julien-en-Genevois, 74164, France

Location

Centre de réadaptation cardiaque Leopold Bellan

Tracy-le-Mont, 60170, France

Location

Les Grands Prés

Villeneuve-Saint-Denis, 77174, France

Location

Study Officials

  • Marie Christine Iliou, MD

    Hôpital Corentin Celton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

FR(14)