Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

Completed

• Conditions: COPD; Pulmonary Hypertension

• Registration Number: NCT07202793
• Lead Sponsor: Poitiers University Hospital

Brief 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 (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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-10-01
• Study First Submitted: 2025-08-04
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in six-minute walk distance (6MWD)	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

Secondary Outcome Measures

Name	Time	Method
Participants achieving the minimum clinically important difference (MCID) in 6MWD	Up to 3 weeks	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
Severe COPD exacerbations	Between 0 and 12 months after PR	Count of exacerbations requiring an emergency-department visit or hospital admission in the 12 months following completion of PR
All-cause mortality	Between 0 and 12 months after PR	Death from any cause, confirmed through the French national death registry
Tolerance of PR	Day 1 and up to 3 weeks	Number of adverse events occurring during the PR course or Number of programme interruptions due to acute causes (e.g., infection, exacerbation)

Trial Locations

Locations (1)

CHU de Poitiers, University of Poitiers, France; 🇫🇷 Poitiers, Vienne, France