Chronic Obstructive Pulmonary DiseaseEMI IINCT02074813
Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD
A study testing Inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Brest at 2 sites in France.
Trial summary
Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2014to Oct 2016
- 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
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course;
Who cannot join
- FEV ≥ 50%
- Pneumonectomy, Lobectomy less than 6 months
- Patient with risk of spontaneous pneumothorax or rib fracture
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre des maladies respiratoires et allergiques - Les Acacias
Briançon, France, 05107
Brest University Hospital
Morlaix, France, 29672
About this study
Official title: Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial
Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inspiratory muscle training
- Keywords
- Inspiratory muscle training, COPD, dyspnea, Multidimensional Dyspnea Profile questionnaire (MDP)., pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Inspiratory muscle training
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | conventional pulmonary rehabilitation |
| Inspiratory muscle training | Experimental | Inspiratory muscle training associated with a conventional pulmonary rehabilitation Receives: Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea measure
Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.
Measured: 21 - 4 days / +7 jours
Secondary outcomes (3)
PI max variation
Measure of PI max variation with MicroRPM
Measured: 21 - 4 days / +7 days
CI variation
Measure of CI variation with spirobank II
Measured: 21 - 4 days / +7 days
Dyspnea measure
Meausre of dyspnea with London Chest of Activity Daily Living (LCADL)
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 posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 150 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
- NCT02074813
- Sponsor's protocol ID
- EMI II (RB 13.124)
- Acronym
- EMI II
- Status last verified
- Oct 2016
- First submitted
- 27 Feb 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Beaumont M, Couasnon C, Peran L, Berriet AC, Ber CL, Pichon R. Determination of the minimal important difference for inspiratory muscle strength in people with severe and very severe COPD. Clin Rehabil. 2023 Nov;37(11):1521-1532. doi: 10.1177/02692155231174124. Epub 2023 May 15.
PubMed 37186772Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
PubMed 29371379
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02074813
- Acronym / sponsor ID
- EMI II / EMI II (RB 13.124)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Inspiratory muscle training, COPD, dyspnea, Multidimensional Dyspnea Profile questionnaire (MDP)., pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Feb 2014 (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.
Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –conventional pulmonary rehabilitation |
| Inspiratory muscle training | Experimental | Other: Inspiratory muscle trainingInspiratory muscle training associated with a conventional pulmonary rehabilitation |
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
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course;
Key exclusion criteria (3 listed)
- FEV ≥ 50%
- Pneumonectomy, Lobectomy less than 6 months
- Patient with risk of spontaneous pneumothorax or rib fracture
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 |
|---|---|---|
| Inspiratory muscle trainingInspiratory muscle training | Other | Inspiratory muscle training |
Primary outcome
Dyspnea measure
Time frame: 21 - 4 days / +7 jours
Measure of dyspnea with the Multidimensional Dyspnea Profile (MDP) questionnaire.
3 secondary outcomes
PI max variation
Time frame: 21 - 4 days / +7 days
CI variation
Time frame: 21 - 4 days / +7 days
Dyspnea measure
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 25 Oct 2016.
- Derived from this study: PubMed 37186772Beaumont M, Couasnon C, Peran L, Berriet AC, Ber CL, Pichon R. Determination of the minimal important difference for inspiratory muscle strength in people with severe and very severe COPD. Clin Rehabil. 2023 Nov;37(11):1521-1532. doi: 10.1177/02692155231174124. Epub 2023 May 15.
- Derived from this study: PubMed 29371379Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease, 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 3 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 25 Oct 2016. 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?
Dyspnea measure (time frame: 21 - 4 days / +7 jours). 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 NCT02074813, which also lists 2 linked publications.
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 25 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.