COPDPREDICTNCT05492149
Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?
An observational study of COPD and COPD Exacerbation, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD Exacerbation, Pulmonary Rehabilitation
- What is being tested?
- Performance follow-up
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Dec 2024
- 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 who referred to a pulmonary rehabilitation program
Who may be able to join
- Adult patients
- COPD patients
Who cannot join
- Patients who not performed not at least 5 sessions of the pulmonary rehabilitation program
- Occurence of an adverse event that prevents further rehabilitation
- Exacerbation in the previous month
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier du Havre
Montivilliers, Groupe Hospitalier Du Havre, 76290
About this study
The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.
- Conditions
- COPD, COPD Exacerbation, Pulmonary Rehabilitation
- Being tested
- Performance follow-up
- 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.
Performance follow-upOther
Diary performance during rehabilitation will be collected and a CAT questionnaire will be completed by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation group | Patients referred for a pulmonary rehabilitation program will be follow up. Receives: Other: Performance follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the decrease of performance during pulmonary rehabilitation session and the occurrence of pulmonary exacerbation.
The change in performance rehabilitation of patients between the last session will be screen when a patients will be admitted to hospital for a COPD exacerbation.
Measured: From admission to the program or first documented session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
Secondary outcomes (1)
Correlation between the decrease of performance during pulmonary rehabilitation session and the COPD Assessment Test (CAT) questionnaire score.
The change in performance rehabilitation of patients between the last session will be screen and compared to a COPD Assessment Test (CAT) questionnaire score.
Measured: Through study completion, at every pulmonary rehabilitation session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
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.
- 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492149
- Sponsor's protocol ID
- 2022-A00210-43
- Acronym
- PREDICT
- Status last verified
- Jan 2026
- First submitted
- 26 Jul 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: by contact the correspondent author
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?
- ClinicalTrials.gov ID
- NCT05492149
- Acronym / sponsor ID
- PREDICT / 2022-A00210-43
- Conditions
- COPD, COPD Exacerbation, Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Aug 2022 (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.
The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation group | – | Other: Performance follow-upPatients referred for a pulmonary rehabilitation program will be follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients who referred to a pulmonary rehabilitation program
Key inclusion criteria (2 listed)
- Adult patients
- COPD patients
Key exclusion criteria (3 listed)
- Patients who not performed not at least 5 sessions of the pulmonary rehabilitation program
- Occurence of an adverse event that prevents further rehabilitation
- Exacerbation in the previous month
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 |
|---|---|---|
| Performance follow-upDiary performance during rehabilitation will be collected and a CAT questionnaire will be completed by the patient. | Other | Pulmonary rehabilitation group |
Primary outcome
Correlation between the decrease of performance during pulmonary rehabilitation session and the occurrence of pulmonary exacerbation.
Time frame: From admission to the program or first documented session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
The change in performance rehabilitation of patients between the last session will be screen when a patients will be admitted to hospital for a COPD exacerbation.
1 secondary outcome
Correlation between the decrease of performance during pulmonary rehabilitation session and the COPD Assessment Test (CAT) questionnaire score.
Time frame: Through study completion, at every pulmonary rehabilitation session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
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 21 Jan 2026.
- Individual participant dataSharing planned: Undecided. by contact the correspondent author
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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?
An observational study of COPD and COPD Exacerbation, run by Groupe Hospitalier du Havre 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 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 21 Jan 2026. 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?
Correlation between the decrease of performance during pulmonary rehabilitation session and the occurrence of pulmonary exacerbation. (time frame: From admission to the program or first documented session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 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 21 Jan 2026.