<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/NCT03793504</url>
  </required_header>
  <id_info>
    <org_study_id>WIIRR (29BRC18.0250)</org_study_id>
    <nct_id>NCT03793504</nct_id>
  </id_info>
  <brief_title>Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session</brief_title>
  <acronym>WIIRR</acronym>
  <official_title>Cardio-Respiratory Response of an Exercise Training Session With Ergocycle or Treadmill Compared to an Adapted Physical Activity Session on a Wii, in Patients With Pulmonary Disease</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 show that training session with nintendo WII requires the same&#xD;
      cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used&#xD;
      in pulmonary rehabilitation program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">June 17, 2019</completion_date>
  <primary_completion_date type="Actual">June 17, 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>compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII</measure>
    <time_frame>one day</time_frame>
    <description>heart rate (pulse per minute) at the end of each session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII</measure>
    <time_frame>one day</time_frame>
    <description>dyspnea (borg scale) at the end of each session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII</measure>
    <time_frame>one day</time_frame>
    <description>lower limb muscle fatigue (borg scale) at the end of each session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII</measure>
    <time_frame>one day</time_frame>
    <description>SpO2 at the end of each session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII</measure>
    <time_frame>one day</time_frame>
    <description>felt pleasure (likert scale) at the end of each session</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Pulmonary Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with pulmonary disease admitted in pulmonary rehabilitation unit of CHU Brest&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with pulmonary disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  exacerbation of the pulmonary disease&#xD;
&#xD;
          -  Weight &gt;150Kg&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  People in pre and post surgical rehabilitation&#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>CHRU de Brest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH 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 3, 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>pulmonary rehabilitation</keyword>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03793504
org study id: WIIRR (29BRC18.0250)
nct id: NCT03793504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the aim of this study is to show that training session with nintendo WII requires the same
      cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used
      in pulmonary rehabilitation program.
observational model: Cohort
time perspective: Prospective
measure: compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII
time frame: one day
description: heart rate (pulse per minute) at the end of each session
measure: compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII
time frame: one day
description: dyspnea (borg scale) at the end of each session
measure: compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII
time frame: one day
description: lower limb muscle fatigue (borg scale) at the end of each session
measure: compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII
time frame: one day
description: SpO2 at the end of each session
measure: Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII
time frame: one day
description: felt pleasure (likert scale) at the end of each session
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: CHRU de Brest
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases