COPDREHABGENRENCT04297514
Effects of Respiratory Rehabilitation by Gender in COPD Patients
An observational study of COPD and Pulmonary Rehabilitation, run by University Hospital, Brest at 1 site in France.
Trial summary
Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence . Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Pulmonary Rehabilitation
- How many people
- 504 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Feb 2023
- Phase
- Observational
- 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
Study population: COPD patients undergoing a pulmonary rehabilitation program
Who may be able to join
- Patient > 18 years old
- No opposition filed
- Patient with COPD
- Completed participation in respiratory rehabilitation program
Who cannot join
- Refusal of participation
- Patient under tutorship or curatorship
- No final assessment
- Patients with sex changes in marital status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pulmonary Rehabilitation According to Gender, in COPD Patients
Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence .
Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. The impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.
- Conditions
- COPD, Pulmonary Rehabilitation
- Keywords
- COPD, pulmonary rehabilitation, Dyspnea, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
DYSPNEA-12
Dyspnea-12 allows to evaluate sensori and emotional dyspnea
Measured: Change from baseline Dyspnea-12 score at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2020
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Beaumont, PhD, Principal investigator, CH des pays de Morlaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297514
- Sponsor's protocol ID
- REHABGENRE (29BRC20.0030)
- Acronym
- REHABGENRE
- Status last verified
- Aug 2022
- First submitted
- 27 Feb 2020
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation According to Gender, in COPD Patients
- ClinicalTrials.gov ID
- NCT04297514
- Acronym / sponsor ID
- REHABGENRE / REHABGENRE (29BRC20.0030)
- Conditions
- COPD, Pulmonary Rehabilitation
- Keywords
- COPD, pulmonary rehabilitation, Dyspnea, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 5 Mar 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.
Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence .
Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. The impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients undergoing a pulmonary rehabilitation program
Key inclusion criteria (4 listed)
- Patient > 18 years old
- No opposition filed
- Patient with COPD
- Completed participation in respiratory rehabilitation program
Key exclusion criteria (4 listed)
- Refusal of participation
- Patient under tutorship or curatorship
- No final assessment
- Patients with sex changes in marital status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DYSPNEA-12
Time frame: Change from baseline Dyspnea-12 score at 4 weeks
Dyspnea-12 allows to evaluate sensori and emotional dyspnea
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 9 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Marc Beaumont, PhD principal investigator
CH des pays de Morlaix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Pulmonary Rehabilitation, 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 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 9 Aug 2024. 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. 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-12 (time frame: Change from baseline Dyspnea-12 score at 4 weeks). 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 9 Aug 2024.