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

NCT ID: NCT07202793

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rehabilitation center, moulin vert

UNKNOWN

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne Marie EMJ Jutant, MD PhD

Role: STUDY_CHAIR

CHU de Poitiers, University of Poitiers, France

Christian CG GIFFA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Poitiers, University of Poitiers, France

Locations

CHU de Poitiers, University of Poitiers, France

Poitiers, Vienne, France

Countries

France

Other Identifiers

REHABTP

Identifier Type: -

Identifier Source: org_study_id