Chronic Obstructive Pulmonary DiseaseExaEMS2005NCT01167283
Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Electrostimulation in people with Chronic Obstructive Pulmonary Disease, run by Institut National de la Santé Et de la Recherche Médicale, France.
Trial summary
This study was designed to test the following hypothesis: To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Apr 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients during or after exacerbation
Who cannot join
- Comorbidities that could limit exercise training
- Obesity (body mass index [BMI] > 30 kg/m²)
- Neuromuscular disease
- Pacemaker implantation
About this study
Official title: Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease
This study was designed to test the following hypothesis:
To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.
Read the detailed description
Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress. Classical training does not improve these features.
Objectives: To investigate whether electrostimulation program following exacerbation can modify muscle structure and function in COPD patients.
Method: We propose to conduct a controlled and randomized clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 15 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes in muscle structure, muscle oxidative stress and their relationship with quadriceps force and exercise tolerance.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Electrostimulation, Sham stimulation
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrostimulationDevice
Also called NMES
Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
Sham stimulationDevice
Also called Sham
Sham stimulation: 1 h; 5 times/week
| Study group | Role | What they receive |
|---|---|---|
| Electrostimulation | Active comparator | Neuromuscular electrical stimulation Receives: Device: Electrostimulation |
| Sham stimulation | Sham comparator | Sham stimulation Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiber-type distribution
Typology was evaluated by immunohistochemistry
Measured: 6 to 8 weeks
Secondary outcomes (1)
Change in the strength of the quadriceps over the 6-week electrostimulation program
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier Régional Universitaire Montpellier
- Investigators
- Olivier OJ Jonquet, PU-PH, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167283
- Sponsor's protocol ID
- APARD
- Acronym
- ExaEMS2005
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01167283
- Acronym / sponsor ID
- ExaEMS2005 / APARD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Centre Hospitalier Régional Universitaire Montpellier
- Study start
- Jul 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Jul 2010 (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.
This study was designed to test the following hypothesis:
To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.
Detailed description
Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress. Classical training does not improve these features.
Objectives: To investigate whether electrostimulation program following exacerbation can modify muscle structure and function in COPD patients.
Method: We propose to conduct a controlled and randomized clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 15 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes in muscle structure, muscle oxidative stress and their relationship with quadriceps force and exercise tolerance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrostimulation | Active comparator | Device: ElectrostimulationNeuromuscular electrical stimulation |
| Sham stimulation | Sham comparator | Device: Sham stimulationSham stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients during or after exacerbation
Key exclusion criteria (4 listed)
- Comorbidities that could limit exercise training
- Obesity (body mass index [BMI] > 30 kg/m²)
- Neuromuscular disease
- Pacemaker implantation
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 |
|---|---|---|
| ElectrostimulationAlso: NMESElectrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week | Device | Electrostimulation |
| Sham stimulationAlso: ShamSham stimulation: 1 h; 5 times/week | Device | Sham stimulation |
Primary outcome
Fiber-type distribution
Time frame: 6 to 8 weeks
Typology was evaluated by immunohistochemistry
1 secondary outcome
Change in the strength of the quadriceps over the 6-week electrostimulation program
Time frame: 6 to 8 weeks
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 6 Aug 2010.
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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.
Olivier OJ Jonquet, PU-PH principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Questions about this trial
What is this clinical trial studying?
A study testing Electrostimulation in people with Chronic Obstructive Pulmonary Disease, run by Institut National de la Santé Et de la Recherche Médicale, 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 1 inclusion and 4 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 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Fiber-type distribution (time frame: 6 to 8 weeks). 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 6 Aug 2010.