COPDESNMNCT02656667
Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
A study testing neuromuscular electrical stimulation, cycle ergometer training and Conventional pulmonary rehabilitation in people with COPD, run by University Hospital, Brest at 2 sites in France.
Trial summary
The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- neuromuscular electrical stimulation, cycle ergometer training and Conventional pulmonary rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jun 2016to 21 Mar 2019
- 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
- Patients with COPD stage 3 or 4, with BODE index ≥ 5
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;
Who cannot join
- FEV ≥ 50%
- Pneumonectomy, Lobectomy less than 6 months
- Contraindications to muscle electrostimulation quadriceps
- Absence of written consent
- Inability to follow the respiratory rehabilitation program in its entirety
- People equipped with electronic devices such as pacemakers and intracardiac defibrillators
- Skin lesions and infectious foci on the electrode placement area.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre des maladies respiratoires et allergiques - Les Acacias
Briançon, France, 05107
CH de Morlaix
Morlaix, France, 29672
About this study
The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .
Read the detailed description
It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program.
The program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5.
The commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary.
The primary criterion is the one minute sit to stand test.
- Conditions
- COPD
- Being tested
- neuromuscular electrical stimulation, cycle ergometer training, Conventional pulmonary rehabilitation
- Keywords
- COPD pulmonary rehabilitation, neuromuscular electrical stimulation, sit to stand test COPD, quadriceps strengthening
- 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.
neuromuscular electrical stimulationDevice
quadriceps strenghthening with neuromuscular electrical stimulation (medical device)
cycle ergometer trainingDevice
quadriceps strenghthening with cycle ergometer training
Conventional pulmonary rehabilitationOther
excercise training on treadmill
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular electrical stimulation | Experimental | conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening Receives: Device: neuromuscular electrical stimulation; Other: Conventional pulmonary rehabilitation |
| cycle ergometer training | Experimental | conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer Receives: Device: cycle ergometer training; Other: Conventional pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capacity of the lower limb muscles
Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "
Measured: 21 - 4 days / +7 days
Secondary outcomes (8)
Maximal isometric voluntary quadriceps strength assessment
Quadriceps strength assessment with handheld dynamometer
Measured: 21 - 4 days / +7 days
isometric voluntary quadriceps endurance assessment
Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer
Measured: 21 - 4 days / +7 days
assessment of exercise capacity
Six minute walking test for assessing exercise capacity
Measured: 21 - 4 days / +7 days
Quality of Life Assessment
COPD assessment test for assessing quality of life
Measured: 21 - 4 days / +7 days
Dyspnea Assessment with Borg scale
Measure of dyspnea with Borg scale at the end of the six minute walking test
Measured: 21 - 4 days / +7 days
Dyspnea Assessment with MRC Scale
Measure of dyspnea with Medical Research Council Dyspnea Scale
Measured: 21 - 4 days / +7 days
Dyspnea Assessment with Dyspnea 12 questionnary
Measure of dyspnea with Dyspnea 12 questionnary
Measured: 21 - 4 days / +7 days
Inspiratory capacity (in litres) by spirometry
Measure of inspiratory capacity (in litres) by spirometry
Measured: 21 - 4 days / +7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start8 Jun 2016
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
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 COPDStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Couturaud, MD, PhD, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656667
- Sponsor's protocol ID
- ESNM (RB 15.058)
- Acronym
- ESNM
- Status last verified
- Apr 2019
- First submitted
- 6 Jan 2016
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Peran L, Beaumont M, Le Ber C, Le Mevel P, Berriet AC, Nowak E, Consigny M, Couturaud F. Effect of neuromuscular electrical stimulation on exercise capacity in patients with severe chronic obstructive pulmonary disease: A randomised controlled trial. Clin Rehabil. 2022 Aug;36(8):1072-1082. doi: 10.1177/02692155221091802. Epub 2022 Apr 11.
PubMed 35404157
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
- ClinicalTrials.gov ID
- NCT02656667
- Acronym / sponsor ID
- ESNM / ESNM (RB 15.058)
- Conditions
- COPD
- Keywords
- COPD pulmonary rehabilitation, neuromuscular electrical stimulation, sit to stand test COPD, quadriceps strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 15 Jan 2016 (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 aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .
Detailed description
It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program.
The program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5.
The commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary.
The primary criterion is the one minute sit to stand test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuromuscular electrical stimulation | Experimental | Device: neuromuscular electrical stimulation, Other: Conventional pulmonary rehabilitationconventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening |
| cycle ergometer training | Experimental | Device: cycle ergometer training, Other: Conventional pulmonary rehabilitationconventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with COPD stage 3 or 4, with BODE index ≥ 5
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;
Key exclusion criteria (7 listed)
- FEV ≥ 50%
- Pneumonectomy, Lobectomy less than 6 months
- Contraindications to muscle electrostimulation quadriceps
- Absence of written consent
- Inability to follow the respiratory rehabilitation program in its entirety
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 stimulationquadriceps strenghthening with neuromuscular electrical stimulation (medical device) | Device | neuromuscular electrical stimulation |
| cycle ergometer trainingquadriceps strenghthening with cycle ergometer training | Device | cycle ergometer training |
| Conventional pulmonary rehabilitationexcercise training on treadmill | Other | cycle ergometer training, neuromuscular electrical stimulation |
Primary outcome
functional capacity of the lower limb muscles
Time frame: 21 - 4 days / +7 days
Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "
8 secondary outcomes
Maximal isometric voluntary quadriceps strength assessment
Time frame: 21 - 4 days / +7 days
isometric voluntary quadriceps endurance assessment
Time frame: 21 - 4 days / +7 days
assessment of exercise capacity
Time frame: 21 - 4 days / +7 days
Quality of Life Assessment
Time frame: 21 - 4 days / +7 days
Dyspnea Assessment with Borg scale
Time frame: 21 - 4 days / +7 days
Dyspnea Assessment with MRC Scale
Time frame: 21 - 4 days / +7 days
Dyspnea Assessment with Dyspnea 12 questionnary
Time frame: 21 - 4 days / +7 days
Inspiratory capacity (in litres) by spirometry
Time frame: 21 - 4 days / +7 days
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 3 Dec 2025.
- Results publication: PubMed 35404157Peran L, Beaumont M, Le Ber C, Le Mevel P, Berriet AC, Nowak E, Consigny M, Couturaud F. Effect of neuromuscular electrical stimulation on exercise capacity in patients with severe chronic obstructive pulmonary disease: A randomised controlled trial. Clin Rehabil. 2022 Aug;36(8):1072-1082. doi: 10.1177/02692155221091802. Epub 2022 Apr 11.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Francis Couturaud, MD, PhD principal investigator
University Hospital, Brest
2 sites 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, cycle ergometer training and Conventional pulmonary rehabilitation in people with COPD, run by University Hospital, Brest at 2 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 2 inclusion and 7 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
functional capacity of the lower limb muscles (time frame: 21 - 4 days / +7 days). 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 NCT02656667, 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 3 Dec 2025.