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

N/ACompletedNCT07202793

Poitiers University Hospital59 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

COPD Pulmonary Hypertension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Up to 3 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: Between 0 and 12 months after PR

All-cause mortality

Death from any cause, confirmed through the French national death registry

Time frame: 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)

Time frame: Day 1 and up to 3 weeks