Chronic Obstructive Pulmonary DiseaseNCT04120142
Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients
A study testing Pulmonary rehabilitation+IMT and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial summary
Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress. The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation+IMT and Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2019to 1 Dec 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Were COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consert
Who cannot join
- Were previous pneumonectomy or lobectomy in the past 6 months
- spontaneous risk of pneumothorax or rib fracture
- Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
- The absence of written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in Chronic Obstructive (COPD)
Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress.
The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. The investigators aimed to demonstrate that, in patients with obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement of dyspnoea and exercise tolerance.
Read the detailed description
The purpose of this study is to evaluate the effect of the inspiratory muscle training (with incremental load every two weeks in two months) performed during pulmonary rehabilitation on dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory questionnaire (SGRQ) in COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation+IMT, Pulmonary rehabilitation
- Keywords
- COPD, IMT, 6MWT, Dyspoea, SGRQ
- 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.
Pulmonary rehabilitation+IMTOther
The experimental group receives inspiratory muscle training and aerobic exercise.
Pulmonary rehabilitationOther
The Active Comparator group received only aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| IMT goup | Experimental | Inspiratory muscle training + aerobic exercice Receives: Other: Pulmonary rehabilitation+IMT |
| Control group | Active comparator | aerobic exercice Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnoea
The dyspnoea were measured before and after the 6 minutes walk test
Measured: Baseline, After 2 months
Inspiratory muscle strength
The inspiratory muscle strength were measured by maximal inspiratory pressure test
Measured: Baseline, After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Feb 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilel Tounsi, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120142
- Sponsor's protocol ID
- COPD-DYS
- Status last verified
- Jan 2020
- First submitted
- 30 Sep 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
PubMed 25858974Beaumont 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 29371379Ambrosino N. Inspiratory muscle training in stable COPD patients: enough is enough? Eur Respir J. 2018 Jan 25;51(1):1702285. doi: 10.1183/13993003.02285-2017. Print 2018 Jan. No abstract available.
PubMed 29371389
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in Chronic Obstructive (COPD)
- ClinicalTrials.gov ID
- NCT04120142
- Acronym / sponsor ID
- COPD-DYS
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, IMT, 6MWT, Dyspoea, SGRQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 9 Oct 2019 (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.
Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress.
The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. The investigators aimed to demonstrate that, in patients with obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement of dyspnoea and exercise tolerance.
Detailed description
The purpose of this study is to evaluate the effect of the inspiratory muscle training (with incremental load every two weeks in two months) performed during pulmonary rehabilitation on dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory questionnaire (SGRQ) in COPD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT goup | Experimental | Other: Pulmonary rehabilitation+IMTInspiratory muscle training + aerobic exercice |
| Control group | Active comparator | Other: Pulmonary rehabilitationaerobic exercice |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Were COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consert
Key exclusion criteria (4 listed)
- Were previous pneumonectomy or lobectomy in the past 6 months
- spontaneous risk of pneumothorax or rib fracture
- Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
- The absence of written informed consent.
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 |
|---|---|---|
| Pulmonary rehabilitation+IMTThe experimental group receives inspiratory muscle training and aerobic exercise. | Other | IMT goup |
| Pulmonary rehabilitationThe Active Comparator group received only aerobic exercise. | Other | Control group |
Primary outcome
Dyspnoea
Time frame: Baseline, After 2 months
The dyspnoea were measured before and after the 6 minutes walk test
Inspiratory muscle strength
Time frame: Baseline, After 2 months
The inspiratory muscle strength were measured by maximal inspiratory pressure test
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 2020.
- Background: PubMed 25858974Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
- Background: 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.
- Background: PubMed 29371389Ambrosino N. Inspiratory muscle training in stable COPD patients: enough is enough? Eur Respir J. 2018 Jan 25;51(1):1702285. doi: 10.1183/13993003.02285-2017. Print 2018 Jan. No abstract available.
- Individual participant dataSharing planned: No
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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 Pulmonary rehabilitation+IMT and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
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 4 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 5 Feb 2020. 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 Tunisia. 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?
Dyspnoea (time frame: Baseline, After 2 months). The study lists 2 primary outcomes in all. 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 NCT04120142, which also lists 3 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 5 Feb 2020.