Chronic Heart FailureEMSICANCT01548508
Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
A study testing Functionnal ElectroStimulation (FES) in people with Chronic Heart Failure, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Functionnal ElectroStimulation (FES)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Jun 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Advanced Chronic Heart Failure (NYHA III to IV)
- Cardiac Ejection Fraction < 40 %
- peak VO2 < 16 ml/kg/min,
- optimal drug treatment of CHF,
- hospitalised for acute decompensation but not in intensive care
Who cannot join
- Chronic Obstructive Pulmonary Disease with FEV < 50%,
- History of stroke with walking disability, dementia.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.
Read the detailed description
Advanced Chronic Heart Failure (ACHF) is a severe and frequent disease inducing a strong limitation of exercise capacity and a poor quality of life. Hospitalisation for cardiac decompensation is frequent and could alter their incapacities because of muscular deconditionning. Tradionnal aerobic rehabilitation exercises fighting against this deconditionning are not relevant in these patients because of dyspnea.
In litterature, Functionnal Electrostimulation (FES) has been tested in stable Chronic Heart Failure (NYHA I to III), far from decompensation. Several authors showed the same improvements than those obtained with conventionnal rehabilitation on aerobic capacities (peak VO2, 6 minutes walking test) and quality of life.
The originality of this study is to test FES soon after acute heart decompensation in ACHF patients. This type of rehabilitation could represent in the future an alternative to conventionnal rehabilitation until the patients could be able to do aerobic exercise.
60 patients will be randomised between two groups, the firsth receiving FES (treatment group), the second receiving skin electrostimulation in the same place without muscular contraction (Sham group). Patient and evaluator do not know what type of stimulation they have. These treatments spread over six weeks, five days per seven. They are began in rehabilitation unit then continued at home.
The principal criteria of judgement of FES efficacy is peak VO2 after the protocol. Secondary criteria are distance to the six minutes walking test, muscular strengh of quadriceps, the muscle mass measured by Dual energy X-ray absorptiometry (DEXA), inflamatory dosage (TNF alpha, IL-1, IL-6, CRP), rest value of Muscle sympathetic nerve activity, score to Minnesota questionnaire and fuctionnal independance.
The attempted results are an significative improvement of aerobic capacity(peak VO2 and six minutes walking test) and the others secondary criteria in FES group compared with Sham group.
- Conditions
- Chronic Heart Failure
- Being tested
- Functionnal ElectroStimulation (FES), SHAM
- Keywords
- Advanced Chronic Heart Failure, physical therapy, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functionnal ElectroStimulation (FES)Other
Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks
SHAMOther
SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Functionnal ElectroStimulation (FES) | Experimental | Not described Receives: Other: Functionnal ElectroStimulation (FES) |
| SHAM | Sham comparator | Not described Receives: Other: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary outcomes (11)
Muscle nerve sympathetic activity (MSNA)
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
Six minutes walking test
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
DEXA
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
maximal quadriceps strengh
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 1
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 6
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
TNF alpha
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
CRP
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
BNP
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
score of minessota test
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
score of Functional independency measure
Measured: change between baseline and 60 days after the Functional Electromyo Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJul 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for the Future, Paris, France
- Responsible party
- Sponsor
- Investigators
- Michel GALINIER, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548508
- Sponsor's protocol ID
- 0730502
- Other IDs
- 2008-A00330-55
- Acronym
- EMSICA
- Status last verified
- May 2017
- First submitted
- 23 Feb 2012
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Labrunee M, Despas F, Marque P, Guiraud T, Galinier M, Senard JM, Pathak A. Acute electromyostimulation decreases muscle sympathetic nerve activity in patients with advanced chronic heart failure (EMSICA Study). PLoS One. 2013 Nov 12;8(11):e79438. doi: 10.1371/journal.pone.0079438. eCollection 2013.
PubMed 24265770
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
- ClinicalTrials.gov ID
- NCT01548508
- Acronym / sponsor ID
- EMSICA / 0730502
- Conditions
- Chronic Heart Failure
- Keywords
- Advanced Chronic Heart Failure, physical therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Foundation for the Future, Paris, France
- Study start
- Jul 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Mar 2012 (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 the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.
Detailed description
Advanced Chronic Heart Failure (ACHF) is a severe and frequent disease inducing a strong limitation of exercise capacity and a poor quality of life. Hospitalisation for cardiac decompensation is frequent and could alter their incapacities because of muscular deconditionning. Tradionnal aerobic rehabilitation exercises fighting against this deconditionning are not relevant in these patients because of dyspnea.
In litterature, Functionnal Electrostimulation (FES) has been tested in stable Chronic Heart Failure (NYHA I to III), far from decompensation. Several authors showed the same improvements than those obtained with conventionnal rehabilitation on aerobic capacities (peak VO2, 6 minutes walking test) and quality of life.
The originality of this study is to test FES soon after acute heart decompensation in ACHF patients. This type of rehabilitation could represent in the future an alternative to conventionnal rehabilitation until the patients could be able to do aerobic exercise.
60 patients will be randomised between two groups, the firsth receiving FES (treatment group), the second receiving skin electrostimulation in the same place without muscular contraction (Sham group). Patient and evaluator do not know what type of stimulation they have. These treatments spread over six weeks, five days per seven. They are began in rehabilitation unit then continued at home.
The principal criteria of judgement of FES efficacy is peak VO2 after the protocol. Secondary criteria are distance to the six minutes walking test, muscular strengh of quadriceps, the muscle mass measured by Dual energy X-ray absorptiometry (DEXA), inflamatory dosage (TNF alpha, IL-1, IL-6, CRP), rest value of Muscle sympathetic nerve activity, score to Minnesota questionnaire and fuctionnal independance.
The attempted results are an significative improvement of aerobic capacity(peak VO2 and six minutes walking test) and the others secondary criteria in FES group compared with Sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functionnal ElectroStimulation (FES) | Experimental | Other: Functionnal ElectroStimulation (FES) |
| SHAM | Sham comparator | Other: SHAM |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced Chronic Heart Failure (NYHA III to IV)
- Cardiac Ejection Fraction < 40 %
- peak VO2 < 16 ml/kg/min,
- optimal drug treatment of CHF,
- hospitalised for acute decompensation but not in intensive care
Key exclusion criteria (2 listed)
- Chronic Obstructive Pulmonary Disease with FEV < 50%,
- History of stroke with walking disability, dementia.
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 |
|---|---|---|
| Functionnal ElectroStimulation (FES)Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks | Other | Functionnal ElectroStimulation (FES) |
| SHAMSHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks | Other | SHAM |
Primary outcome
VO2 peak
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
11 secondary outcomes
Muscle nerve sympathetic activity (MSNA)
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
Six minutes walking test
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
DEXA
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
maximal quadriceps strengh
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 1
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 6
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
TNF alpha
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
CRP
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
BNP
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
score of minessota test
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
score of Functional independency measure
Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation
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 11 May 2017.
- Results publication: PubMed 24265770Labrunee M, Despas F, Marque P, Guiraud T, Galinier M, Senard JM, Pathak A. Acute electromyostimulation decreases muscle sympathetic nerve activity in patients with advanced chronic heart failure (EMSICA Study). PLoS One. 2013 Nov 12;8(11):e79438. doi: 10.1371/journal.pone.0079438. eCollection 2013.
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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.
Michel GALINIER, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functionnal ElectroStimulation (FES) in people with Chronic Heart Failure, run by University Hospital, Toulouse at 1 site 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 5 inclusion and 2 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
VO2 peak (time frame: change between baseline and 60 days after the Functional Electromyo Stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01548508, which also lists 1 linked publication.
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 11 May 2017.