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CompletedNCT032866603CRTUpdated Sep 18, 2017

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

An interventional study of Chair Rise Tests and short questionnaire in Evaluations, Rehabilitation and COPD, sponsored by University Hospital, Lille. Completed at 2 sites in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
127
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Evaluations
  • Rehabilitation
  • COPD

Keywords

  • Exercise tests
  • COPD
  • Rehabilitation
03

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Other
    COPD patients

    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.

    Diagnostic Test: Chair Rise Tests and short questionnaire

Interventions

  • Diagnostic testChair 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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: At Baseline, at 2 and 8 weeks.

Secondary outcomes

  1. 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

    Time frame: At Baseline, at 2 and 8 weeks.

  2. Change of Time to perform 5 sit to stand

    The change of Time to perform 5 sit to stand from baseline

    Time frame: At Baseline, at 2 and 8 weeks.

  3. The change of Total score for the DIsability RElated to COPD Tool (DIRECT)

    Total Score

    Time frame: At Baseline and at 8 weeks.

  4. Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)

    End SpO2 - End Heart Rate

    Time frame: At Baseline, at 2 and 8 weeks.

  5. Change in endurance time at constant power on cyclo ergometer,

    The change of endurance time from baseline

    Time frame: At Baseline, at 2 and 8 weeks.

  6. Change of Voluntary Quadriceps force output

    Change of Voluntary quadriceps force measurements (Mean of 3 maximal measurements) from baseline

    Time frame: At Baseline, at 2 and 8 weeks.

06

Study locations

2 sites
  • Centre Hospitalier Universitaire
    Grenoble, France
  • Hôpital Calmette, CHRU
    Lille, France
07

References and documents

Publications

  • 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. PubMed 30774324 ↗
08

Registry details

Key details

Study ID
NCT03286660
Lead sponsor
University Hospital, Lille
Collaborators
Boehringer Ingelheim, HYLAB, Physiopathologie de l'exercice
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Dec 8, 2014
Primary completion
Jul 24, 2017
Completion
Jul 24, 2017
Last update
Sep 18, 2017

Study contacts

Bernard AGUILANIU, MD,PhD
principal investigator · University Grenoble Alps

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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