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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low electrical myostimulation
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Cardiac rehabilitation, Exercise training, Peak VO2, Electrical myostimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de réadaptation spécialisé Saint Luc
  • Polyclinique Bordeaux Nord Aquitaine
  • Centre Hospitalier de la Côte Fleurie
  • Clinique SSR "Les Rosiers"
  • Hôpital Bocage Central
  • Hôpital Corentin Celton
  • Hôpital de Joigny
  • Clinique de la Mitterie
  • Centre Hospitalier Loire Vendée Ocean
  • Hôpital de jour de soins de suite et de réadaptation Léopold Bellan
  • Clinique Saint-Yves
  • Hôpital Intercommunal Sud Léman Valserine
  • Centre de réadaptation cardiaque Leopold Bellan
  • Les Grands Prés

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rehabilitation and EMS Group

Rehabilitation Group only

Arm Description

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

Patient Heart Failure who follows physical training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes on muscular strength
Measure of weight that the patient can lift 3 times but not four with quadriceps.
Changes on sub maximal parameters
Measure of ventilatory threshold and walk test of 6 min.
Modifications of quality of life
Minnesota questionnaire completed by the patient

Full Information

First Posted
August 2, 2011
Last Updated
March 6, 2015
Sponsor
French Cardiology Society
Collaborators
Gulf Estuarine Research Society (GERS), Bourgogne Association of Cardiology, Ile-de-France Association of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT01408875
Brief Title
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Acronym
CREMS-HF
Official Title
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
Gulf Estuarine Research Society (GERS), Bourgogne Association of Cardiology, Ile-de-France Association of Cardiology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, Cardiac rehabilitation, Exercise training, Peak VO2, Electrical myostimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation and EMS Group
Arm Type
Experimental
Arm Description
Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.
Arm Title
Rehabilitation Group only
Arm Type
No Intervention
Arm Description
Patient Heart Failure who follows physical training
Intervention Type
Device
Intervention Name(s)
Low electrical myostimulation
Intervention Description
The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
Primary Outcome Measure Information:
Title
Peak VO2
Description
The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program.
Time Frame
at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation
Secondary Outcome Measure Information:
Title
Changes on muscular strength
Description
Measure of weight that the patient can lift 3 times but not four with quadriceps.
Time Frame
at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Title
Changes on sub maximal parameters
Description
Measure of ventilatory threshold and walk test of 6 min.
Time Frame
at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Title
Modifications of quality of life
Description
Minnesota questionnaire completed by the patient
Time Frame
at inclusion then after 4 to 7 weeks of cardiac rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Christine Iliou, MD
Organizational Affiliation
Hôpital Corentin Celton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de réadaptation spécialisé Saint Luc
City
Abreschviller
ZIP/Postal Code
57560
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Centre Hospitalier de la Côte Fleurie
City
Cricqueboeuf
ZIP/Postal Code
14113
Country
France
Facility Name
Clinique SSR "Les Rosiers"
City
Dijon
ZIP/Postal Code
21002
Country
France
Facility Name
Hôpital Bocage Central
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Corentin Celton
City
Issy-les-Moulineaux
ZIP/Postal Code
92133
Country
France
Facility Name
Hôpital de Joigny
City
Joigny
ZIP/Postal Code
89306
Country
France
Facility Name
Clinique de la Mitterie
City
Lomme
ZIP/Postal Code
59160
Country
France
Facility Name
Centre Hospitalier Loire Vendée Ocean
City
Machecoul
ZIP/Postal Code
44270
Country
France
Facility Name
Hôpital de jour de soins de suite et de réadaptation Léopold Bellan
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Clinique Saint-Yves
City
Rennes
ZIP/Postal Code
35044
Country
France
Facility Name
Hôpital Intercommunal Sud Léman Valserine
City
Saint Julien en Genevois
ZIP/Postal Code
74164
Country
France
Facility Name
Centre de réadaptation cardiaque Leopold Bellan
City
Tracy-le-Mont
ZIP/Postal Code
60170
Country
France
Facility Name
Les Grands Prés
City
Villeneuve-Saint-Denis
ZIP/Postal Code
77174
Country
France

12. IPD Sharing Statement

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Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

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