<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286660</url>
  </required_header>
  <id_info>
    <org_study_id>2013_58</org_study_id>
    <secondary_id>2014-A00856-41</secondary_id>
    <nct_id>NCT03286660</nct_id>
  </id_info>
  <brief_title>3 Minutes Chair Rise Test (3CRT) in Patients With COPD</brief_title>
  <acronym>3CRT</acronym>
  <official_title>Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>HYLAB, Physiopathologie de l'exercice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation&#xD;
      program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside&#xD;
      specialized centers.&#xD;
&#xD;
      In order to monitor the eventual decline of patients in the course of their RHB management,&#xD;
      Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The&#xD;
      goal of this prospective, multicenter, real-life study is to compare the change in several&#xD;
      functional function tests and questionnaires of quality of life and dyspnea related to daily&#xD;
      activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related&#xD;
      to COPS Tool) were specified.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2014</start_date>
  <completion_date type="Actual">July 24, 2017</completion_date>
  <primary_completion_date type="Actual">July 24, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of number of rise during 3 minutes Chair Rise Test (3CRT)</measure>
    <time_frame>At Baseline, at 2 and 8 weeks.</time_frame>
    <description>The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of number of rise during 1 minute Chair Rise Test (1CRT)</measure>
    <time_frame>At Baseline, at 2 and 8 weeks.</time_frame>
    <description>The change of total number of rise during a 1 minutes Chair Rise Test (3CRT) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Time to perform 5 sit to stand</measure>
    <time_frame>At Baseline, at 2 and 8 weeks.</time_frame>
    <description>The change of Time to perform 5 sit to stand from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Total score for the DIsability RElated to COPD Tool (DIRECT)</measure>
    <time_frame>At Baseline and at 8 weeks.</time_frame>
    <description>Total Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)</measure>
    <time_frame>At Baseline, at 2 and 8 weeks.</time_frame>
    <description>End SpO2 - End Heart Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in endurance time at constant power on cyclo ergometer,</measure>
    <time_frame>At Baseline, at 2 and 8 weeks.</time_frame>
    <description>The change of endurance time from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Voluntary Quadriceps force output</measure>
    <time_frame>At Baseline, at 2 and 8 weeks.</time_frame>
    <description>Change of Voluntary quadriceps force measurements (Mean of 3 maximal measurements) from baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Evaluations</condition>
  <condition>Rehabilitation</condition>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>COPD patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All convenient COPD patients admitted in real life for a rehabilitation program were included.&#xD;
Exercises consist on a Chair Rise Tests and short questionnaire were added to the usual tools for the evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Chair Rise Tests and short questionnaire</intervention_name>
    <description>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.&#xD;
This test is combined with a questionnaire to collect quantitative and qualitative information:&#xD;
dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise&#xD;
Saturation at rest, and at the end of the exercise&#xD;
the number of total a chair rise</description>
    <arm_group_label>COPD patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with COPD Gold II to IV&#xD;
&#xD;
          -  Patient admitted for a rehabilitation program in real life&#xD;
&#xD;
          -  Person affiliated to the Social Security or beneficiary of such a scheme&#xD;
&#xD;
          -  Informed and written consent by patient or legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient limited by reduced locomotor activity or joint pain that compromises their&#xD;
             participation in a rehabilitation program&#xD;
&#xD;
          -  Patients with a performance less than 250 meters during 6MWT&#xD;
&#xD;
          -  Non-stable cardiac disease&#xD;
&#xD;
          -  Any other lung disease than COPD&#xD;
&#xD;
          -  Person subject to a legal protection measure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard AGUILANIU, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Grenoble Alps</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Calmette, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise tests</keyword>
  <keyword>COPD</keyword>
  <keyword>Rehabilitation</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286660
org study id: 2013_58
secondary id: 2014-A00856-41
nct id: NCT03286660
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change of number of rise during 3 minutes Chair Rise Test (3CRT)
time frame: At Baseline, at 2 and 8 weeks.
description: The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline
measure: Change of number of rise during 1 minute Chair Rise Test (1CRT)
time frame: At Baseline, at 2 and 8 weeks.
description: The change of total number of rise during a 1 minutes Chair Rise Test (3CRT) from baseline
measure: Change of Time to perform 5 sit to stand
time frame: At Baseline, at 2 and 8 weeks.
description: The change of Time to perform 5 sit to stand from baseline
measure: The change of Total score for the DIsability RElated to COPD Tool (DIRECT)
time frame: At Baseline and at 8 weeks.
description: Total Score
measure: 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.
description: End SpO2 - End Heart Rate
measure: Change in endurance time at constant power on cyclo ergometer,
time frame: At Baseline, at 2 and 8 weeks.
description: The change of endurance time from baseline
measure: Change of Voluntary Quadriceps force output
time frame: At Baseline, at 2 and 8 weeks.
description: Change of Voluntary quadriceps force measurements (Mean of 3 maximal measurements) from baseline
arm group label: COPD patients
arm group type: Other
description: 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.
intervention type: Diagnostic Test
intervention name: Chair Rise Tests and short questionnaire
description: 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
arm group label: COPD patients
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bernard AGUILANIU, MD,PhD
role: Principal Investigator
affiliation: University Grenoble Alps
facility: 
facility: 
country: France
responsible party type: Sponsor