COPDREHABTPNCT07202793
Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
An observational study of COPD and Pulmonary Hypertension, run by Poitiers University Hospital at 1 site in France.
Trial summary
Observational study summary The goal of this observational study is to determine whether an outpatient pulmonary rehabilitation (PR) program-already known to be effective and safe for chronic obstructive pulmonary disease (COPD)-is equally effective and well-tolerated when COPD is complicated by pulmonary hypertension… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Pulmonary Hypertension
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Oct 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: The source population consists of adults (18 years and older) with spirometry-confirmed chronic obstructive pulmonary disease who attended at least three consecutive weeks of supervised outpatient pulmonary rehabilitation at the University Hospital of Poitiers (France) between January 2013 and December 2023. Every individual had a six-minute walk test recorded both immediately before the programme and during its final week, plus a transthoracic echocardiogram performed within one year before or after programme start to grade the probability of pulmonary hypertension. Most candidates were current or former smokers with moderate-to-severe airflow limitation and common cardiometabolic or sleep-related comorbidities. Patients are classified into two analytic cohorts-COPD with pulmonary hypertension and COPD without pulmonary hypertension-according to their echocardiographic findings.
Who may be able to join
- Age 18 years or older
- Spirometry-confirmed chronic obstructive pulmonary disease with a post-bronchodilator FEV1 / FVC ratio below 0 .70
- Completion of at least three consecutive weeks of outpatient pulmonary rehabilitation between January 2013 and December 2023 at the University - Hospital of Poitiers centre
- Six-minute walk test performed within seven days before programme start and repeated during the final week
- Transthoracic echocardiogram carried out within one year before or one year after programme start, used to grade pulmonary hypertension
Who cannot join
- Pulmonary rehabilitation shorter than three weeks or missing six-minute walk test or echocardiogram data
- Chronic lung disease other than chronic obstructive pulmonary disease or previous lung transplantation
- -,Hospital admission for an acute chronic obstructive pulmonary disease exacerbation in the four weeks preceding rehabilitation
- Unstable cardiovascular disease that contraindicates exercise training
- Active cancer with an expected survival under one year
- Pregnancy at the time of rehabilitation
- Documented refusal to allow medical data to be used for research
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Poitiers, University of Poitiers, France
Poitiers, Vienne, 86000
About this study
Observational study summary The goal of this observational study is to determine whether an outpatient pulmonary rehabilitation (PR) program-already known to be effective and safe for chronic obstructive pulmonary disease (COPD)-is equally effective and well-tolerated when COPD is complicated by pulmonary hypertension (PH).
Main question In adults with COPD + PH, does outpatient PR improve six-minute walk distance (6MWD) and remain safe, to the same extent as in adults with COPD without PH?
Read more
How the study is conducted
Researchers retrospectively analyse medical records from the University Hospital of Poitiers covering a ten-year period. Eligible participants are adults with COPD who completed at least three weeks of supervised PR and underwent echocardiography to assess PH probability. Two cohorts are compared:
COPD + PH (intermediate or high echocardiographic suspicion) COPD without PH (no echocardiographic suspicion) Key data collected Change in 6MWD between the start and end of PR (primary endpoint) Proportion of participants achieving a clinically meaningful improvement in 6MWD Occurrence of severe exacerbations (hospital- or emergency-treated events) during the year after PR All-cause mortality within one year Adverse events or program interruptions indicating PR tolerance
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- Rehabilitation, Pulmonary Disease, Chronic Obstructive, Pulmonary hypertension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease with pulmonary hypertension | Adults (≥18 years) who have spirometry-confirmed COPD and an intermediate or high echocardiographic probability of pulmonary hypertension, determined according to ESC/ERS criteria 1 year before or after rehabilitation ; completed ≥ 3 consecutive weeks of outpatient pulmonary rehabilitation (PR) at the University Hospital of Poitiers affiliated centre between 2013 and 2023 ; performed a baseline and post-programme six-minute walk test (6MWT) under ATS guidelines. | |
| Chronic obstructive pulmonary disease without pulmonary hypertension | Adults (≥18 years) who have spirometry-confirmed COPD and no echocardiographic suspicion of pulmonary hypertension or low probability, determined according to ESC/ERS criteria 1 year before or after rehabilitation ; completed ≥ 3 consecutive weeks of outpatient pulmonary rehabilitation (PR) at the University Hospital of Poitiers affiliated centre between 2013 and 2023 ; performed a baseline and post-programme six-minute walk test (6MWT) under ATS guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six-minute walk distance (6MWD)
Absolute difference (metres) between the 6-minute walk test performed at the start of the pulmonary-rehabilitation (PR) programme and the test repeated at the final session, following ATS/ACCP standards
Measured: Up to 3 weeks
Secondary outcomes (4)
Participants achieving the minimum clinically important difference (MCID) in 6MWD
Number and proportion of participants whose 6MWD rises by ≥ 30.5 m between baseline and the end of PR, the accepted MCID for this test
Measured: Up to 3 weeks
Severe COPD exacerbations
Count of exacerbations requiring an emergency-department visit or hospital admission in the 12 months following completion of PR
Measured: Between 0 and 12 months after PR
All-cause mortality
Death from any cause, confirmed through the French national death registry
Measured: Between 0 and 12 months after PR
Tolerance of PR
Number of adverse events occurring during the PR course or Number of programme interruptions due to acute causes (e.g., infection, exacerbation)
Measured: Day 1 and up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Sep 2021
- Primary completion1 Dec 2023
- Study completion1 Oct 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.
- More trials run by Poitiers University HospitalThe 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation center, moulin vert
- Responsible party
- Sponsor
- Investigators
- Etienne Marie EMJ Jutant, MD PhD, Study chair, CHU de Poitiers, University of Poitiers, FranceChristian CG GIFFA, MD, Principal investigator, CHU de Poitiers, University of Poitiers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202793
- Sponsor's protocol ID
- REHABTP
- Acronym
- REHABTP
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared because this is a retrospective single-center study based on medical records, and no explicit consent for data sharing was obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07202793
- Acronym / sponsor ID
- REHABTP / REHABTP
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- Rehabilitation, Pulmonary Disease, Chronic Obstructive, Pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Rehabilitation center, moulin vert
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 2 Oct 2025 (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.
Observational study summary The goal of this observational study is to determine whether an outpatient pulmonary rehabilitation (PR) program-already known to be effective and safe for chronic obstructive pulmonary disease (COPD)-is equally effective and well-tolerated when COPD is complicated by pulmonary hypertension (PH).
Main question In adults with COPD + PH, does outpatient PR improve six-minute walk distance (6MWD) and remain safe, to the same extent as in adults with COPD without PH?
How the study is conducted
Researchers retrospectively analyse medical records from the University Hospital of Poitiers covering a ten-year period. Eligible participants are adults with COPD who completed at least three weeks of supervised PR and underwent echocardiography to assess PH probability. Two cohorts are compared:
COPD + PH (intermediate or high echocardiographic suspicion) COPD without PH (no echocardiographic suspicion) Key data collected Change in 6MWD between the start and end of PR (primary endpoint) Proportion of participants achieving a clinically meaningful improvement in 6MWD Occurrence of severe exacerbations (hospital- or emergency-treated events) during the year after PR All-cause mortality within one year Adverse events or program interruptions indicating PR tolerance
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease with pulmonary hypertension | – | –Adults (≥18 years) who have spirometry-confirmed COPD and an intermediate or high echocardiographic probability of pulmonary hypertension, determined according to ESC/ERS criteria 1 year before or after rehabilitation ; completed ≥ 3 consecutive weeks of outpatient pulmonary rehabilitation (PR) at the University Hospital of Poitiers affiliated centre between 2013 and 2023 ; performed a baseline and post-programme six-minute walk test (6MWT) under ATS guidelines. |
| Chronic obstructive pulmonary disease without pulmonary hypertension | – | –Adults (≥18 years) who have spirometry-confirmed COPD and no echocardiographic suspicion of pulmonary hypertension or low probability, determined according to ESC/ERS criteria 1 year before or after rehabilitation ; completed ≥ 3 consecutive weeks of outpatient pulmonary rehabilitation (PR) at the University Hospital of Poitiers affiliated centre between 2013 and 2023 ; performed a baseline and post-programme six-minute walk test (6MWT) under ATS guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population consists of adults (18 years and older) with spirometry-confirmed chronic obstructive pulmonary disease who attended at least three consecutive weeks of supervised outpatient pulmonary rehabilitation at the University Hospital of Poitiers (France) between January 2013 and December 2023. Every individual had a six-minute walk test recorded both immediately before the programme and during its final week, plus a transthoracic echocardiogram performed within one year before or after programme start to grade the probability of pulmonary hypertension. Most candidates were current or former smokers with moderate-to-severe airflow limitation and common cardiometabolic or sleep-related comorbidities. Patients are classified into two analytic cohorts-COPD with pulmonary hypertension and COPD without pulmonary hypertension-according to their echocardiographic findings.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Spirometry-confirmed chronic obstructive pulmonary disease with a post-bronchodilator FEV1 / FVC ratio below 0 .70
- Completion of at least three consecutive weeks of outpatient pulmonary rehabilitation between January 2013 and December 2023 at the University - Hospital of Poitiers centre
- Six-minute walk test performed within seven days before programme start and repeated during the final week
- Transthoracic echocardiogram carried out within one year before or one year after programme start, used to grade pulmonary hypertension
Key exclusion criteria (7 listed)
- Pulmonary rehabilitation shorter than three weeks or missing six-minute walk test or echocardiogram data
- Chronic lung disease other than chronic obstructive pulmonary disease or previous lung transplantation
- -,Hospital admission for an acute chronic obstructive pulmonary disease exacerbation in the four weeks preceding rehabilitation
- Unstable cardiovascular disease that contraindicates exercise training
- Active cancer with an expected survival under one year
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
Change in six-minute walk distance (6MWD)
Time frame: Up to 3 weeks
Absolute difference (metres) between the 6-minute walk test performed at the start of the pulmonary-rehabilitation (PR) programme and the test repeated at the final session, following ATS/ACCP standards
4 secondary outcomes
Participants achieving the minimum clinically important difference (MCID) in 6MWD
Time frame: Up to 3 weeks
Severe COPD exacerbations
Time frame: Between 0 and 12 months after PR
All-cause mortality
Time frame: Between 0 and 12 months after PR
Tolerance of PR
Time frame: Day 1 and up to 3 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 2 Oct 2025.
- Individual participant dataSharing planned: No. The individual participant data will not be shared because this is a retrospective single-center study based on medical records, and no explicit consent for data sharing was obtained from participants.
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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.
Etienne Marie EMJ Jutant, MD PhD study chair
CHU de Poitiers, University of Poitiers, France
Christian CG GIFFA, MD principal investigator
CHU de Poitiers, University of Poitiers, France
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 Hypertension, run by Poitiers University Hospital 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 5 inclusion and 7 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 2 Oct 2025. 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?
Change in six-minute walk distance (6MWD) (time frame: Up to 3 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 2 Oct 2025.