<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/NCT03793452</url>
  </required_header>
  <id_info>
    <org_study_id>PARACHUTE (29BRC18.0246)</org_study_id>
    <nct_id>NCT03793452</nct_id>
  </id_info>
  <brief_title>Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients</brief_title>
  <acronym>PARACHUTE</acronym>
  <official_title>Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of&#xD;
      falling in COPD patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">December 18, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measure of fear of falling after a pulmonary rehabilitation</measure>
    <time_frame>4 weeks</time_frame>
    <description>measure of fear of falling (FES-I) before and after a pulmonary rehabilitation program</description>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Copd</condition>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation&#xD;
        unit of CH des Pays de Morlaix&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  post surgical rehabilitation&#xD;
&#xD;
          -  neurologic or orthopedic disorders limiting walking&#xD;
&#xD;
          -  imbalance disorders&#xD;
&#xD;
          -  inability to answer to the questionnaire&#xD;
&#xD;
          -  refusal to participate.&#xD;
&#xD;
          -  inability to perform the pulmonary rehabilitation program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Beaumont, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH DES PAYS DE MORLAIX</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Pays de Morlaix</name>
      <address>
        <city>Morlaix</city>
        <zip>29672</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD, pulmonary rehabilitation, fear of falling, evaluation</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/NCT03793452
org study id: PARACHUTE (29BRC18.0246)
nct id: NCT03793452
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of
      falling in COPD patients
observational model: Cohort
time perspective: Prospective
measure: measure of fear of falling after a pulmonary rehabilitation
time frame: 4 weeks
description: measure of fear of falling (FES-I) before and after a pulmonary rehabilitation program
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Beaumont, PhD
role: Principal Investigator
affiliation: CH DES PAYS DE MORLAIX
facility: 
country: France
responsible party type: Sponsor