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Completed

NCT Number: NCT03286660

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

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Key information

Conditions

Evaluations COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Rehabilitation Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chair Rise Tests and short questionnaire

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: At Baseline and at 8 weeks.

    Total Score

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Boehringer Ingelheim
  • HYLAB, Physiopathologie de l'exercice

Registry information

Official study title

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

Acronym: 3CRT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2017
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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