Chronic Heart FailureCREMS-HFNCT01408875
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
A study testing Low electrical myostimulation in people with Chronic Heart Failure, run by French Cardiology Society at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Low electrical myostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 14 sitesFrance
- Study dates
- Oct 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Centre de réadaptation spécialisé Saint Luc
Abreschviller, 57560
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077
Centre Hospitalier de la Côte Fleurie
Cricquebœuf, 14113
Clinique SSR "Les Rosiers"
Dijon, 21002
Hôpital Bocage Central
Dijon, 21079
Hôpital Corentin Celton
Issy-les-Moulineaux, 92133
Hôpital de Joigny
Joigny, 89306
Clinique de la Mitterie
Lomme, 59160
Centre Hospitalier Loire Vendée Ocean
Machecoul, 44270
Hôpital de jour de soins de suite et de réadaptation Léopold Bellan
Paris, 75010
Clinique Saint-Yves
Rennes, 35044
Hôpital Intercommunal Sud Léman Valserine
Saint-Julien-en-Genevois, 74164
Centre de réadaptation cardiaque Leopold Bellan
Tracy-le-Mont, 60170
Les Grands Prés
Villeneuve-Saint-Denis, 77174
About this study
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.
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- Low electrical myostimulation
- Keywords
- Chronic Heart Failure, Cardiac rehabilitation, Exercise training, Peak VO2, Electrical myostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low electrical myostimulationDevice
The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation and EMS Group | Experimental | Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation. Receives: Device: Low electrical myostimulation |
| Rehabilitation Group only | No intervention | Patient Heart Failure who follows physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation
Secondary outcomes (3)
Changes on muscular strength
Measure of weight that the patient can lift 3 times but not four with quadriceps.
Measured: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Changes on sub maximal parameters
Measure of ventilatory threshold and walk test of 6 min.
Measured: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Modifications of quality of life
Minnesota questionnaire completed by the patient
Measured: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Gulf Estuarine Research Society (GERS), Bourgogne Association of Cardiology, Ile-de-France Association of Cardiology
- Responsible party
- Sponsor
- Investigators
- Marie Christine Iliou, MD, Principal investigator, Hôpital Corentin Celton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408875
- Sponsor's protocol ID
- 2007-03
- Acronym
- CREMS-HF
- Status last verified
- Mar 2015
- First submitted
- 2 Aug 2011
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01408875
- Acronym / sponsor ID
- CREMS-HF / 2007-03
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, Cardiac rehabilitation, Exercise training, Peak VO2, Electrical myostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Gulf Estuarine Research Society (GERS), Bourgogne Association of Cardiology, Ile-de-France Association of Cardiology
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation and EMS Group | Experimental | Device: Low electrical myostimulationPatient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation. |
| Rehabilitation Group only | No intervention | –Patient Heart Failure who follows physical training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low electrical myostimulationThe group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation. | Device | Rehabilitation and EMS Group |
Primary outcome
Peak VO2
Time frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation
The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program.
3 secondary outcomes
Changes on muscular strength
Time frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Changes on sub maximal parameters
Time frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Modifications of quality of life
Time frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Christine Iliou, MD principal investigator
Hôpital Corentin Celton
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low electrical myostimulation in people with Chronic Heart Failure, run by French Cardiology Society at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.