Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07202793
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Descriptive baseline data and course characteristics', 'timeFrame': 'Baseline', 'description': 'Age, sex, BMI, smoking status, comorbidities; PR duration, reasons for any interruption; minimal SpO₂ recorded during each 6MWT; lung-function and echocardiographic variables'}], 'primaryOutcomes': [{'measure': 'Change in six-minute walk distance (6MWD)', 'timeFrame': 'Up to 3 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Participants achieving the minimum clinically important difference (MCID) in 6MWD', 'timeFrame': 'Up to 3 weeks', 'description': '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'}, {'measure': 'Severe COPD exacerbations', 'timeFrame': 'Between 0 and 12 months after PR', 'description': 'Count of exacerbations requiring an emergency-department visit or hospital admission in the 12 months following completion of PR'}, {'measure': 'All-cause mortality', 'timeFrame': 'Between 0 and 12 months after PR', 'description': 'Death from any cause, confirmed through the French national death registry'}, {'measure': 'Tolerance of PR', 'timeFrame': 'Day 1 and up to 3 weeks', 'description': 'Number of adverse events occurring during the PR course or Number of programme interruptions due to acute causes (e.g., infection, exacerbation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Pulmonary Disease', 'Chronic Obstructive', 'Pulmonary hypertension'], 'conditions': ['COPD', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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).\n\nMain 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?\n\nHow the study is conducted\n\nResearchers 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:\n\nCOPD + 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Spirometry-confirmed chronic obstructive pulmonary disease with a post-bronchodilator FEV1 / FVC ratio below 0 .70\n* Completion of at least three consecutive weeks of outpatient pulmonary rehabilitation between January 2013 and December 2023 at the University - Hospital of Poitiers centre\n* Six-minute walk test performed within seven days before programme start and repeated during the final week\n* Transthoracic echocardiogram carried out within one year before or one year after programme start, used to grade pulmonary hypertension\n\nExclusion Criteria:\n\n* Pulmonary rehabilitation shorter than three weeks or missing six-minute walk test or echocardiogram data\n* Chronic lung disease other than chronic obstructive pulmonary disease or previous lung transplantation\n\n -,Hospital admission for an acute chronic obstructive pulmonary disease exacerbation in the four weeks preceding rehabilitation\n* Unstable cardiovascular disease that contraindicates exercise training\n* Active cancer with an expected survival under one year\n* Pregnancy at the time of rehabilitation\n* Documented refusal to allow medical data to be used for research'}, 'identificationModule': {'nctId': 'NCT07202793', 'acronym': 'REHABTP', 'briefTitle': 'Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'REHABTP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic obstructive pulmonary disease with pulmonary hypertension', 'description': '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\n\n; performed a baseline and post-programme six-minute walk test (6MWT) under ATS guidelines.'}, {'label': 'Chronic obstructive pulmonary disease without pulmonary hypertension', 'description': '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\n\n; performed a baseline and post-programme six-minute walk test (6MWT) under ATS guidelines.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'state': 'Vienne', 'country': 'France', 'facility': 'CHU de Poitiers, University of Poitiers, France', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Etienne Marie EMJ Jutant, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de Poitiers, University of Poitiers, France'}, {'name': 'Christian CG GIFFA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Poitiers, University of Poitiers, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rehabilitation center, moulin vert', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}