Chronic Obstructive Pulmonary DiseaseIMTNCT01545011
Effects of Inspiratory Muscle Training on Dyspnea in Subjects With Chronic Obstructive Pulmonary Disease
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
The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal… 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
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2011to Sep 2012
- 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
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course
Who cannot join
- Pneumonectomy, Lobectomy less than 6 months
- Cardio-pulmonary anomaly
- Max inspiratory pressure < 60 cm H2O
Trial locations and contacts
2 sites in 1 country.
France2 sites
Brest University Hospital
Brest, Brittany Region, 29200
Hospital of Morlaix
Morlaix, Brittany Region, 29600
About this study
Official title: Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial
The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).
Read the detailed description
Dyspnea is the main complaint of patients with COPD. Dyspnea is explained largely by the distension, objectified by measuring inspiratory capacity (IC), which places the diaphragm at a disadvantage to be effective, which raises the sensation of dyspnea.
Currently, inspiratory muscles training is recommended by the French-language Society of Pneumology, in case of an objective reduction of the strength of these muscles (corresponding to maximum inspiratory pressure <60 cm H20).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inspiratory muscle training
- Keywords
- Inspiratory muscle training, COPD, Conventional respiratory rehabilitation, Dyspnea scale
- 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.
Inspiratory muscle trainingOther
Inspiratory muscle training
| Study group | Role | What they receive |
|---|---|---|
| standard | No intervention | conventional respiratory rehabilitation |
| IMT | Experimental | Inspiratory muscle training and conventional respiratory 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 changes in Mutidimentionnal Dyspnea Profile result questionnaire
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionSep 2012
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 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545011
- Sponsor's protocol ID
- RB 11.083 (EMI)
- Acronym
- IMT
- Status last verified
- Sep 2012
- First submitted
- 29 Feb 2012
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Beaumont M, Mialon P, Le Ber-Moy C, Lochon C, Peran L, Pichon R, Gut-Gobert C, Leroyer C, Morelot-Panzini C, Couturaud F. Inspiratory muscle training during pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomized trial. Chron Respir Dis. 2015 Nov;12(4):305-12. doi: 10.1177/1479972315594625. Epub 2015 Jul 13.
PubMed 26170421
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
- Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01545011
- Acronym / sponsor ID
- IMT / RB 11.083 (EMI)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Inspiratory muscle training, COPD, Conventional respiratory rehabilitation, Dyspnea scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 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 this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).
Detailed description
Dyspnea is the main complaint of patients with COPD. Dyspnea is explained largely by the distension, objectified by measuring inspiratory capacity (IC), which places the diaphragm at a disadvantage to be effective, which raises the sensation of dyspnea.
Currently, inspiratory muscles training is recommended by the French-language Society of Pneumology, in case of an objective reduction of the strength of these muscles (corresponding to maximum inspiratory pressure <60 cm H20).
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 respiratory rehabilitation |
| IMT | Experimental | Other: Inspiratory muscle trainingInspiratory muscle training and conventional respiratory 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)
- Patient with COPD
- Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course
Key exclusion criteria (3 listed)
- Pneumonectomy, Lobectomy less than 6 months
- Cardio-pulmonary anomaly
- Max inspiratory pressure < 60 cm H2O
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 | IMT |
Primary outcome
Dyspnea measure
Time frame: 21 days
Measure of changes in Mutidimentionnal Dyspnea Profile result questionnaire
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 26170421Beaumont M, Mialon P, Le Ber-Moy C, Lochon C, Peran L, Pichon R, Gut-Gobert C, Leroyer C, Morelot-Panzini C, Couturaud F. Inspiratory muscle training during pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomized trial. Chron Respir Dis. 2015 Nov;12(4):305-12. doi: 10.1177/1479972315594625. Epub 2015 Jul 13.
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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 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?
Dyspnea measure (time frame: 21 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 NCT01545011, 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.