NCT05492149

Brief Summary

The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

July 26, 2022

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between the decrease of performance during pulmonary rehabilitation session and the occurrence of pulmonary exacerbation.

    The change in performance rehabilitation of patients between the last session will be screen when a patients will be admitted to hospital for a COPD exacerbation.

    From admission to the program or first documented session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.

Secondary Outcomes (1)

  • Correlation between the decrease of performance during pulmonary rehabilitation session and the COPD Assessment Test (CAT) questionnaire score.

    Through study completion, at every pulmonary rehabilitation session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.

Study Arms (1)

Pulmonary rehabilitation group

Patients referred for a pulmonary rehabilitation program will be follow up.

Other: Performance follow-up

Interventions

Diary performance during rehabilitation will be collected and a CAT questionnaire will be completed by the patient.

Pulmonary rehabilitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients who referred to a pulmonary rehabilitation program

You may qualify if:

  • Adult patients
  • COPD patients

You may not qualify if:

  • Patients who not performed not at least 5 sessions of the pulmonary rehabilitation program
  • Occurence of an adverse event that prevents further rehabilitation
  • Exacerbation in the previous month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier du Havre

Montivilliers, Groupe Hospitalier Du Havre, 76290, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 8, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations