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2-TM6: Interest of Performing Two 6-minute Walk Tests at the End of a Pulmonary Rehabilitation Program, in COPD Patients.

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT05850299
Collaborator
(none)
176
Enrollment
1
Location
12.3
Anticipated Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    176 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Interest of Performing Two 6-minute Walk Tests at the End of a Pulmonary Rehabilitation Program, in COPD Patients.
    Actual Study Start Date :
    Mar 24, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 6 minute walk distance (6MWD) [Two hours]

      Comparison of the 6MWD between the first and the second 6MWT performed at the end of pulmonary rehabilitation program.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Contraindication to perform the 6-Minute Walk Test

    • Patient under legal protection

    • Refusal of participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Principal Investigator: Marc BEAUMONT, PhD, CH des pays de Morlaix

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05850299
    Other Study ID Numbers:
    • 29BRC23.0034 - 2-TM6
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    pulmonary rehabilitation
    exercise capacity

    Study Results

    No Results Posted as of May 9, 2023