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

COPD Clinical Trial

— 3CRT  

Official title:

Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286660
• Other study ID #: 2013_58
• Secondary ID: 2014-A00856-41
• Status: Completed
• Phase: N/A
• First received: September 9, 2017
• Last updated: September 13, 2017
• Start date: December 8, 2014
• Est. completion date: July 24, 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 24, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Evaluations
• Rehabilitation

Intervention

Diagnostic Test:
• Chair Rise Tests and short questionnaire
Exercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency. This test is combined with a questionnaire to collect quantitative and qualitative information: dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise Saturation at rest, and at the end of the exercise the number of total a chair rise

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Grenoble
France	Hôpital Calmette, CHRU	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Boehringer Ingelheim, HYLAB, Physiopathologie de l'exercice

Country where clinical trial is conducted

France, 

Outcome

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