Effects of Respiratory Rehabilitation by Gender in COPD Patients (REHABGENRE)

Effects of Pulmonary Rehabilitation According to Gender, in COPD Patients

Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence .

Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. The impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.

Study Overview

• Status: Completed
• Conditions: Pulmonary Rehabilitation; COPD

• Study Type: Observational
• Enrollment (Actual): 504

Contacts and Locations

Study Locations

• France
  • Morlaix, France, 29672
    • CH des Pays de Morlaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

COPD patients undergoing a pulmonary rehabilitation program

Description

Inclusion Criteria:

• Patient > 18 years old
• No opposition filed
• Patient with COPD
• Completed participation in respiratory rehabilitation program

Exclusion Criteria:

• Refusal of participation
• Patient under tutorship or curatorship
• No final assessment
• Patients with sex changes in marital status

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DYSPNEA-12	Dyspnea-12 allows to evaluate sensori and emotional dyspnea	Change from baseline Dyspnea-12 score at 4 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Marc BEAUMONT, PhD, CH des Pays de Morlaix

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; COPD; pulmonary rehabilitation; Dyspnea
• Other Study ID Numbers: REHABGENRE (29BRC20.0030)

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 6 Months and ending five years following the publication
• 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