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

September 13, 2017 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Centre Hospitalier Universitaire
      • Lille, France
        • Hôpital Calmette, CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of number of rise during 3 minutes Chair Rise Test (3CRT)
Time Frame: At Baseline, at 2 and 8 weeks.
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Boehringer Ingelheim
HYLAB, Physiopathologie de l'exercice

Investigators

  • Principal Investigator: Bernard AGUILANIU, MD,PhD, University Grenoble Alps

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 8, 2014

Primary Completion (ACTUAL)

July 24, 2017

Study Completion (ACTUAL)

July 24, 2017

Study Registration Dates

First Submitted

September 9, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (ACTUAL)

September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013_58
  • 2014-A00856-41 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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