NCT04297514

Completed

Effects of Respiratory Rehabilitation by Gender in COPD Pati...

University Hospital, Brest Source

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Other study identifiers

Sponsor study identifier

REHABGENRE (29BRC20.0030)

Study Type

observational

Actual enrollment (reported)

504

Locations

1 country

Sites

1

Timeline

Study Start

July 1, 2020

Actual (reported)

Primary Completion

July 1, 2020

Actual (reported)

Study Completion

February 1, 2023

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 504 participants
Study completion date: February 1, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 27, 2020
Actual (reported)
First Posted
March 5, 2020
Actual (reported)
Study Start
July 1, 2020
Actual (reported)
Primary Completion
July 1, 2020
Actual (reported)
Study Completion
February 1, 2023
Actual (reported)

Last Updated: August 9, 2024
Status Verified: August 2022
Last Update Submitted: August 8, 2024

Conditions

COPD Pulmonary Rehabilitation

Keywords

COPDpulmonary rehabilitationDyspneaquality of life

Outcome Measures

Primary Outcomes (1)

DYSPNEA-12
Dyspnea-12 allows to evaluate sensori and emotional dyspnea
Change from baseline Dyspnea-12 score at 4 weeks

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

COPD patients undergoing a pulmonary rehabilitation program

You may qualify if:

Patient \> 18 years old

Sponsors & Collaborators

University Hospital, Brest
Otherlead

Study Sites (1)

CH des pays de Morlaix

Morlaix, 29672, France

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

Marc Beaumont, PhD
CH des pays de Morlaix
PRINCIPAL INVESTIGATOR

Enrollment

504 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 5, 2020

Study Start

July 1, 2020

Actual (reported)

NCT00925171

Maintenance Schedules Following Pulmonary Rehabilitation

Phase 2Unknown

NCT04473313

Educational Follow-up in COPD Patients After Pulmonary Rehabilitation.

Completed

NCT04004689

6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease

Unknown

NCT04172155

Pulmonary Rehabilitation and Self-esteem in Patients With COPD

Completed

NCT03793452

Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients

Completed

NCT03295474

Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.

Completed

No opposition filed

Patient with COPD

Completed participation in respiratory rehabilitation program

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

July 1, 2020

Actual (reported)

Study Completion

February 1, 2023

Actual (reported)

Last Updated

August 9, 2024

Record last verified: 2022-08

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL
Time Frame: Data will be available beginning 6 Months and ending five years following the publication
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.

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04297514
Data provider: ClinicalTrials.gov
Source updated: 2024-08-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:16 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations