Clinical trial NCT03286660: 3 Minutes Chair Rise Test (3CRT) in Patients With COPD
Official title: Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluations
Rehabilitation
COPD
Keywords: Exercise tests
COPD
Rehabilitation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: HYLAB, Physiopathologie de l'exercice
First posted: 2017-09-18
Enrollment: 127
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of number of rise during 3 minutes Chair Rise Test (3CRT)
timeFrame: At Baseline, at 2 and 8 weeks.
Secondary outcomes:
measure: Change of number of rise during 1 minute Chair Rise Test (1CRT)
timeFrame: At Baseline, at 2 and 8 weeks.
measure: Change of Time to perform 5 sit to stand
timeFrame: At Baseline, at 2 and 8 weeks.
measure: The change of Total score for the DIsability RElated to COPD Tool (DIRECT)
timeFrame: At Baseline and at 8 weeks.
measure: Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)
timeFrame: At Baseline, at 2 and 8 weeks.
measure: Change in endurance time at constant power on cyclo ergometer,
timeFrame: At Baseline, at 2 and 8 weeks.
measure: Change of Voluntary Quadriceps force output
timeFrame: At Baseline, at 2 and 8 weeks.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire
city: Lille
country: France
facility: Hôpital Calmette, CHRU
Study officials:
affiliation: University Grenoble Alps
name: Bernard AGUILANIU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.