NCT05850299

Brief Summary

In pulmonary rehabilitation, the 6-Minute Walk Test (6MWT) is essential to assess the effects of the program on patients' health. Current guidelines don't recommend to perform two 6MWT at the end of pulmonary rehabilitation. However, a more recent study shows that two 6MWT should be performed at the end of the program to accurately and reliably assess patients' capacities. The aim of this study is to compare the results of two tests performed at the end of the program by COPD patients to find out whether there is a benefit of performing two 6MWT at the end of pulmonary rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 19, 2025

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

April 28, 2023

Last Update Submit

September 16, 2025

Conditions

Keywords

pulmonary rehabilitationexercise capacity

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk distance (6MWD)

    Comparison of the 6MWD between the first and the second 6-Minute walk test (6MWT) performed at the end of pulmonary rehabilitation program.

    Two hours

Eligibility Criteria

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

COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix (CHPM).

You may qualify if:

  • Patient with stage 2 to 4 (A to D) COPD
  • Admitted to pulmonary rehabilitation unit of CH des Pays de Morlaix (CHPM)
  • To follow a pulmonary rehabilitation program (4 weeks)
  • Patient aged 18 or over
  • Patient able to formulate his non-opposition to participate in the study

You may not qualify if:

  • Contraindication to perform the 6-Minute Walk Test
  • Patient under legal protection
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29609, 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 Officials

  • Marc BEAUMONT, PhD

    Centre Hospitalier des Pays de Morlaix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 9, 2023

Study Start

March 24, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

September 19, 2025

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations