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

April 28, 2023 updated by: University Hospital, Brest

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk distance (6MWD)
Time Frame: Two hours
Comparison of the 6MWD between the first and the second 6MWT performed at the end of pulmonary rehabilitation program.
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29BRC23.0034 - 2-TM6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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