Chronic Obstructive Pulmonary Disease Overlap SyndromeCOMBIELECNCT04684966
Combined Neuromuscular Electrical Stimulation for Quadriceps and Triceps During Pulmonary Rehabilitation in COPD
A study testing Neuromuscular Electrical Stimulation in people with Chronic Obstructive Pulmonary Disease Overlap Syndrome and Asthma, run by University Hospital, Brest at 1 site in France.
Trial summary
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Overlap Syndrome, Asthma
- What is being tested?
- Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2021to 23 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with COPD stages 2 to 4 (A to D) admitted to the Pulmonary Rehabilitation Department of the "Centre Hospitalier des Pays de Morlaix" or the "CHRU of Brest".
- Patient aged 18 years or older.
- Patient able to consent and having signed a consent form.
Who cannot join
- Patient with a history of pneumonectomy, lobectomy dated less than 6 months old
- Patient with an inability to complete a respiratory rehabilitation program in its entirety
- Patient under guardianship or curatorship
- Person equipped with electronic devices such as pacemakers and intracardiac defibrillators.
- Skin lesions and infectious foci on the area where the electrodes.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.
Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.
Read more
Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.
A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.
- Being tested
- Neuromuscular Electrical Stimulation, Sham Neuromuscular Electrical Stimulation
- Keywords
- Pulmonary Rehabilitation, Neuromuscular Electrical Stimulation, COPD, Muscular Strengthening
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationDevice
Standart pulmonary rehabilitation with combined quadriceps and triceps surae ESNM using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (EG group).
Sham Neuromuscular Electrical StimulationDevice
Standart pulmonary rehabilitation with combined sham NMES of the quadriceps and triceps surae performed using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (CG group)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (EG) | Experimental | Randomized intervention in the NMES (GE) group:
Patients in the NMES group will receive, in addition to conventional rehabilitation, combined quadriceps femoris and triceps surae NMES.
Detail of the NMES :
* Stimulation is performed in a semi-seated position, biphasic current, 8 channels in total (possibility of 16 electrodes).
* One device per lower limb of each patient is necessary: 4 electrodes are placed on the quadriceps and 4 electrodes on the triceps, on each lower limb.
* Stimulation frequency: 50hz.
* Pulse duration: 400 μs.
* Contraction time: 6 seconds.
* Rest time: 6 seconds.
* The intensity must generate a visible muscular contraction and must be well supported. by the patient.
* The voluntary contraction accompanies the electrical stimulation.
* Surface electrode 50 × 50 mm. Receives: Device: Neuromuscular Electrical Stimulation |
| Control group (CG) | Sham comparator | Patients in the control group (GC) will receive, in addition to the classical rehabilitation, the combined sham NMES of the quadriceps femoris and triceps surae.
Detail of the NMES :
* It is carried out 5 times a week for 4 weeks, supervised by a physiotherapist.
* The device used will be the same as in the EG group.
* Stimulation is performed in a semi-seated position, biphasic current, 8 channels in total (16 electrodes can be used).
* One device per lower limb of each patient is required: 4 electrodes are placed on the quadriceps and 4 electrodes on the triceps, on each lower limb.
* Stimulation frequency: 5hz.
* Pulse duration: 100 μs.
* Contraction time: 6 seconds.
* Rest time: 6 seconds.
* The intensity must generate a visible muscle contraction and must be well supported by the patient.
* The voluntary contraction accompanies the electrical stimulation.
* Surface electrode 50 × 50 mm. Receives: Device: Sham Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance change
Assessment of the walking distance (in meters) covered during the 6-minute walking test before and after rehabilitation (between D0 and D28± 4 days). The main endpoint is the change (in meters) between Day 0 and Day 28.
Measured: Day 0 and Day 28
Secondary outcomes (20)
Maximal isometric voluntary quadriceps strengh
Maximal isometric voluntary quadriceps strengh assessment (in newton) with handheld dynamometer
Measured: Day 0 and Day 28
Maximal isometric voluntary endurance change
Maximal isometric voluntary endurance assessment with handheld dynamometer
Measured: Day 0 and Day 28
Maximal isometric voluntary triceps surae strengh change
Maximal isometric voluntary triceps surae strengh assessment (in newton) with dynamometer type MICROFET 2 before and after rehabilitation.
Measured: Day 0 and Day 28
Exercise capacity change with the 1 min sit to stand test
Exercise capacity assessment during the 1 min sit to stand test before and after rehabilitation.
Measured: Day 0 and Day 28
Exercise capacity change with the 6 min step test
Exercise capacity assessment during the 6 min step test before and after rehabilitation.
Measured: Day 0 and Day 28
Exercise capacity change with the incremental shuttle test
Exercise capacity assessment during the incremental shuttle test before and after rehabilitation.
Measured: Day 0 and Day 28
Exercise capacity change with the endurance shuttle walk test
Exercise capacity assessment during the endurance shuttle walk test before and after rehabilitation.
before and after rehabilitation.
Measured: Day 0 and Day 28
Dyspnea change during the 6-minute walking test
Dyspnea assessment at the end of the 6-minute walking test, with the Borg scale, before and after rehabilitation
Measured: Day 0 and Day 28
Dyspnea change during the 6-minute walking test
Dyspnea assessment at the end of the 6-minute walking test, with the Multidimensional dyspnea profile questionnaire, before and after rehabilitation
Measured: Day 0 and Day 28
Isotime dyspnea change with the endurance shuttle walk test
Isotime dyspnea assessment during the endurance shuttle walk test, using Borg scale after rehabilitation.
Measured: Day 28
Dyspnea change with the mMRC (modified Medical Research Council) scale
Assessment of dyspnea with the mMRC scale (min : 0 ; max : 4), before and after rehabilitation.
Measured: Day 0 and Day 28
Dyspnea change with the LCADL (London Chest Activity of Daily Living) questionnaire
Assessment of dyspnea with the LCADL questionnaire (better score : 0; worse score: 5), before and after rehabilitation.
Measured: Day 0 and Day 28
Dyspnea change with the Dyspnea-12 questionnaire
Assessment of dyspnea with the Dyspnea-12 questionnaire, before and after rehabilitation.
Measured: Day 0 and Day 28
Quality of life change with the St George's Respiratory Questionnaire
Quality of life assessment with the St George's Respiratory Questionnaire, before and after rehabilitation.
Measured: Day 0 and Day 28
Quality of life change with the CAT (COPD Assessment Test) Questionnaire
Quality of life assessment with COPD Assessment Test (better : 0; worse : 5), before and after rehabilitation.
Measured: Day 0 and Day 28
Fear of fall change with the FES (Falls Efficacy Scale) questionnaire
Fear of fall (FES-I Questionnaire) assessment (better : 1; worse : 4), before and after rehabilitation.
Measured: Day 0 and Day 28
Anxiety disorder change
Anxiety disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.
Measured: Day 0 and Day 28
Depressive disorder change
Depressive disorder assessment (HAD questionnaire) (better : 0; worse : 3) before and after rehabilitation.
Measured: Day 0 and Day 28
Non fat mass index change
Assessment of the non fat mass index with impedancemetry , before and after rehabilitation.
Measured: Day 0 and Day 28
Self esteem change
Self esteem assessment with PSI-6 (Physical Self Inventory) questionnaire (worse :0 ; better :10)
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start8 Apr 2021
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease Overlap SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684966
- Sponsor's protocol ID
- 29BRC20.0249
- Acronym
- COMBIELEC
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2020
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04684966
- Acronym / sponsor ID
- COMBIELEC / 29BRC20.0249
- Keywords
- Pulmonary Rehabilitation, Neuromuscular Electrical Stimulation, COPD, Muscular Strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 28 Dec 2020 (actual)
- 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.
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.
Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.
Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.
A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (EG) | Experimental | Device: Neuromuscular Electrical StimulationRandomized intervention in the NMES (GE) group: Patients in the NMES group will receive, in addition to conventional rehabilitation, combined quadriceps femoris and triceps surae NMES. Detail of the NMES : * Stimulation is performed in a semi-seated position, biphasic current, 8 channels in total (possibility of 16 electrodes). * One device per lower limb of each patient is necessary: 4 electrodes are placed on the quadriceps and 4 electrodes on the triceps, on each lower limb. * Stimulation frequency: 50hz. * Pulse duration: 400 μs. * Contraction time: 6 seconds. * Rest time: 6 seconds. * The intensity must generate a visible muscular contraction and must be well supported. by the patient. * The voluntary contraction accompanies the electrical stimulation. * Surface electrode 50 × 50 mm. |
| Control group (CG) | Sham comparator | Device: Sham Neuromuscular Electrical StimulationPatients in the control group (GC) will receive, in addition to the classical rehabilitation, the combined sham NMES of the quadriceps femoris and triceps surae. Detail of the NMES : * It is carried out 5 times a week for 4 weeks, supervised by a physiotherapist. * The device used will be the same as in the EG group. * Stimulation is performed in a semi-seated position, biphasic current, 8 channels in total (16 electrodes can be used). * One device per lower limb of each patient is required: 4 electrodes are placed on the quadriceps and 4 electrodes on the triceps, on each lower limb. * Stimulation frequency: 5hz. * Pulse duration: 100 μs. * Contraction time: 6 seconds. * Rest time: 6 seconds. * The intensity must generate a visible muscle contraction and must be well supported by the patient. * The voluntary contraction accompanies the electrical stimulation. * Surface electrode 50 × 50 mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with COPD stages 2 to 4 (A to D) admitted to the Pulmonary Rehabilitation Department of the "Centre Hospitalier des Pays de Morlaix" or the "CHRU of Brest".
- Patient aged 18 years or older.
- Patient able to consent and having signed a consent form.
Key exclusion criteria (6 listed)
- Patient with a history of pneumonectomy, lobectomy dated less than 6 months old
- Patient with an inability to complete a respiratory rehabilitation program in its entirety
- Patient under guardianship or curatorship
- Person equipped with electronic devices such as pacemakers and intracardiac defibrillators.
- Skin lesions and infectious foci on the area where the electrodes.
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 |
|---|---|---|
| Neuromuscular Electrical StimulationStandart pulmonary rehabilitation with combined quadriceps and triceps surae ESNM using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (EG group). | Device | Experimental group (EG) |
| Sham Neuromuscular Electrical StimulationStandart pulmonary rehabilitation with combined sham NMES of the quadriceps and triceps surae performed using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (CG group) | Device | Control group (CG) |
Primary outcome
Walking distance change
Time frame: Day 0 and Day 28
Assessment of the walking distance (in meters) covered during the 6-minute walking test before and after rehabilitation (between D0 and D28± 4 days). The main endpoint is the change (in meters) between Day 0 and Day 28.
20 secondary outcomes
Maximal isometric voluntary quadriceps strengh
Time frame: Day 0 and Day 28
Maximal isometric voluntary endurance change
Time frame: Day 0 and Day 28
Maximal isometric voluntary triceps surae strengh change
Time frame: Day 0 and Day 28
Exercise capacity change with the 1 min sit to stand test
Time frame: Day 0 and Day 28
Exercise capacity change with the 6 min step test
Time frame: Day 0 and Day 28
Exercise capacity change with the incremental shuttle test
Time frame: Day 0 and Day 28
Exercise capacity change with the endurance shuttle walk test
Time frame: Day 0 and Day 28
Dyspnea change during the 6-minute walking test
Time frame: Day 0 and Day 28
Dyspnea change during the 6-minute walking test
Time frame: Day 0 and Day 28
Isotime dyspnea change with the endurance shuttle walk test
Time frame: Day 28
Dyspnea change with the mMRC (modified Medical Research Council) scale
Time frame: Day 0 and Day 28
Dyspnea change with the LCADL (London Chest Activity of Daily Living) questionnaire
Time frame: Day 0 and Day 28
Dyspnea change with the Dyspnea-12 questionnaire
Time frame: Day 0 and Day 28
Quality of life change with the St George's Respiratory Questionnaire
Time frame: Day 0 and Day 28
Quality of life change with the CAT (COPD Assessment Test) Questionnaire
Time frame: Day 0 and Day 28
Fear of fall change with the FES (Falls Efficacy Scale) questionnaire
Time frame: Day 0 and Day 28
Anxiety disorder change
Time frame: Day 0 and Day 28
Depressive disorder change
Time frame: Day 0 and Day 28
Non fat mass index change
Time frame: Day 0 and Day 28
Self esteem change
Time frame: Day 0 and Day 28
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 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation in people with Chronic Obstructive Pulmonary Disease Overlap Syndrome and Asthma, run by University Hospital, Brest 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 3 inclusion and 6 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 5 Feb 2025. 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?
Walking distance change (time frame: Day 0 and Day 28). 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 5 Feb 2025.