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

NCT07202793 | Completed

• 1 other identifier: REHABTP
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; Pulmonary Hypertension

Keywords

Rehabilitation; Pulmonary Disease; Chronic Obstructive; Pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 3 weeks

Secondary Outcomes (4)

• Participants achieving the minimum clinically important difference (MCID) in 6MWD

  Up to 3 weeks

• Severe COPD exacerbations

  Between 0 and 12 months after PR

• All-cause mortality

  Between 0 and 12 months after PR

• Tolerance of PR

  Day 1 and up to 3 weeks

Other Outcomes (1)

• Descriptive baseline data and course characteristics

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Rehabilitation center, moulin vert: collaborator

Study Sites (1)

CHU de Poitiers, University of Poitiers, France

Poitiers, Vienne, 86000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Etienne Marie EMJ Jutant, MD PhD

  CHU de Poitiers, University of Poitiers, France

  STUDY CHAIR

• Christian CG GIFFA, MD

  CHU de Poitiers, University of Poitiers, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: October 2, 2025
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: October 1, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)