3 Minutes Chair Rise Test (3CRT) in Patients With COPD

Not Applicable

Completed

• Conditions: Evaluations; Rehabilitation; COPD
• Interventions: Diagnostic Test: Chair Rise Tests and short questionnaire

• Registration Number: NCT03286660
• Lead Sponsor: University Hospital, Lille

Brief Summary

Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.

In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-08
• Primary Completion: 2017-07-24
• Study Completion: 2017-07-24
• Status Verified: 2017-09
• Study First Submitted: 2017-09-09
• Study First Submitted QC: 2017-09-13
• Last Update Submitted: 2017-09-13
• Study First Posted: 2017-09-18
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• Patient with COPD Gold II to IV
• Patient admitted for a rehabilitation program in real life
• Person affiliated to the Social Security or beneficiary of such a scheme
• Informed and written consent by patient or legal representative

Exclusion Criteria

• Patient limited by reduced locomotor activity or joint pain that compromises their participation in a rehabilitation program
• Patients with a performance less than 250 meters during 6MWT
• Non-stable cardiac disease
• Any other lung disease than COPD
• Person subject to a legal protection measure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
COPD patients	Chair Rise Tests and short questionnaire	All convenient COPD patients admitted in real life for a rehabilitation program were included. Exercises consist on a Chair Rise Tests and short questionnaire were added to the usual tools for the evaluation.

Primary Outcome Measures

Name	Time	Method
Change of number of rise during 3 minutes Chair Rise Test (3CRT)	At Baseline, at 2 and 8 weeks.	The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline

Secondary Outcome Measures

Name	Time	Method
The change of Total score for the DIsability RElated to COPD Tool (DIRECT)	At Baseline and at 8 weeks.	Total Score
Change in endurance time at constant power on cyclo ergometer,	At Baseline, at 2 and 8 weeks.	The change of endurance time from baseline
Change of number of rise during 1 minute Chair Rise Test (1CRT)	At Baseline, at 2 and 8 weeks.	The change of total number of rise during a 1 minutes Chair Rise Test (3CRT) from baseline
Change of Time to perform 5 sit to stand	At Baseline, at 2 and 8 weeks.	The change of Time to perform 5 sit to stand from baseline
Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)	At Baseline, at 2 and 8 weeks.	End SpO2 - End Heart Rate
Change of Voluntary Quadriceps force output	At Baseline, at 2 and 8 weeks.	Change of Voluntary quadriceps force measurements (Mean of 3 maximal measurements) from baseline

Trial Locations

Locations (2)

Centre Hospitalier Universitaire; 🇫🇷 Grenoble, France

Hôpital Calmette, CHRU; 🇫🇷 Lille, France