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Completed

NCT Number: NCT07202793

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Poitiers, University of Poitiers, France

Poitiers, Vienne, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in six-minute walk distance (6MWD)

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Severe COPD exacerbations

    Time frame: 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

  3. All-cause mortality

    Time frame: Between 0 and 12 months after PR

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

  4. Tolerance of PR

    Time frame: 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)

Other outcomes

  1. Descriptive baseline data and course characteristics

    Time frame: Baseline

    Age, sex, BMI, smoking status, comorbidities; PR duration, reasons for any interruption; minimal SpO₂ recorded during each 6MWT; lung-function and echocardiographic variables

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • Rehabilitation center, moulin vert

Registry information

Acronym: REHABTP

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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