<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/NCT03834545</url>
  </required_header>
  <id_info>
    <org_study_id>ARUET</org_study_id>
    <nct_id>NCT03834545</nct_id>
  </id_info>
  <brief_title>Improved Motivation for Physical Activity in an Institutionalized Geriatric Population Through a Virtual Environment</brief_title>
  <acronym>Cyclepad Pilot</acronym>
  <official_title>Improvement of Motivation for Physical Activity in an Institutionalized Geriatric Population Thanks to a Virtual Environment: Comparison of Motivation Between Classic Bike and Bike With Virtual Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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 purpose of this study is to test the interest of a virtual environment with cycling to&#xD;
      increase the motivation of physical activity practice in institutionalized older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization (WHO) recommends for people aged 65 years and over a weekly&#xD;
      practice of at least 150 minutes of moderate-intensity endurance activities or at least 75&#xD;
      minutes of activity. endurance of sustained intensity, or an equivalent combination of&#xD;
      moderate and sustained activity. However, the attractiveness for physical activity fades over&#xD;
      the years limiting the practice of physical activity. Several types of unconventional&#xD;
      approaches have already shown their effectiveness in the prevention of falls in the elderly&#xD;
      but these practices find their limits in the lack of adherence to this type of exercise,&#xD;
      especially in nursing homes. New virtual reality and gaming technologies have recently&#xD;
      emerged and are being used as tools to prevent the risk of falling. The use of these new&#xD;
      tools has advantages over conventional exercises: motivating.&#xD;
&#xD;
      The investigators aimed to test the interest of a virtual environment with cycling to&#xD;
      increase the motivation of physical activity practice in institutionalized older adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cycling distance in meters</measure>
    <time_frame>3 months</time_frame>
    <description>Primary outcome was the cycling distance measured at each session without encouragement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time spent pedaling in seconds per session</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of the time spent pedaling per session without encouragement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The average speed in meters per second per session</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of the average cycling speed per session without encouragement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean pedaling cadence per session in revolutions per minute</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of the average pedaling cadence per session without encouragement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg rating of perceived exertion scale</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of the perceived exertion after each cycling session with Borg rating of perceived exertion scale. Range 0-10. Ten corresponding to the maximal perceived exertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean pedaling power per session in Watts</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of the pedaling power per session without encouragement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Closed-ended question to know which condition they would prefer for a futur exercise session.</measure>
    <time_frame>3 months</time_frame>
    <description>Participant were asked at the end of the third session, which condition they would prefer for a futur exercice session. Possible answers: &quot;Classic ergometric bicycle Kettler E3)&quot;, &quot;Cycleo without virtual environment&quot;, &quot;Cycleo with virtual environment&quot;, &quot;None&quot;.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Motivation</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>cycling group</arm_group_label>
    <description>They attended three sessions of exercise on three different conditions : a classic ergometric bicycle without chairback, an ergometric bicycle with chairback with virtual environment and the other session without virtual environment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Institutionalized older adults over 65 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 65&#xD;
&#xD;
          -  ability to cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable cardiopathy&#xD;
&#xD;
          -  New York Heart Association classification III or IV&#xD;
&#xD;
          -  severe cognitive disorders with inability to follow simple orders (follow&#xD;
             investigator, ride on the ergometric bicycles, pedal)&#xD;
&#xD;
          -  visual disturbance preventing counting fingers at 5m&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <state>Normandy</state>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03834545
org study id: ARUET
nct id: NCT03834545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the interest of a virtual environment with cycling to
      increase the motivation of physical activity practice in institutionalized older adults.
The World Health Organization (WHO) recommends for people aged 65 years and over a weekly
      practice of at least 150 minutes of moderate-intensity endurance activities or at least 75
      minutes of activity. endurance of sustained intensity, or an equivalent combination of
      moderate and sustained activity. However, the attractiveness for physical activity fades over
      the years limiting the practice of physical activity. Several types of unconventional
      approaches have already shown their effectiveness in the prevention of falls in the elderly
      but these practices find their limits in the lack of adherence to this type of exercise,
      especially in nursing homes. New virtual reality and gaming technologies have recently
      emerged and are being used as tools to prevent the risk of falling. The use of these new
      tools has advantages over conventional exercises: motivating.

      The investigators aimed to test the interest of a virtual environment with cycling to
      increase the motivation of physical activity practice in institutionalized older adults.
observational model: Case-Crossover
time perspective: Retrospective
measure: Cycling distance in meters
time frame: 3 months
description: Primary outcome was the cycling distance measured at each session without encouragement
measure: Time spent pedaling in seconds per session
time frame: 3 months
description: Measure of the time spent pedaling per session without encouragement
measure: The average speed in meters per second per session
time frame: 3 months
description: Measure of the average cycling speed per session without encouragement.
measure: Mean pedaling cadence per session in revolutions per minute
time frame: 3 months
description: Measure of the average pedaling cadence per session without encouragement.
measure: Borg rating of perceived exertion scale
time frame: 3 months
description: Measure of the perceived exertion after each cycling session with Borg rating of perceived exertion scale. Range 0-10. Ten corresponding to the maximal perceived exertion
measure: Mean pedaling power per session in Watts
time frame: 3 months
description: Measure of the pedaling power per session without encouragement
measure: Closed-ended question to know which condition they would prefer for a futur exercise session.
time frame: 3 months
description: Participant were asked at the end of the third session, which condition they would prefer for a futur exercice session. Possible answers: "Classic ergometric bicycle Kettler E3)", "Cycleo without virtual environment", "Cycleo with virtual environment", "None".
arm group label: cycling group
description: They attended three sessions of exercise on three different conditions : a classic ergometric bicycle without chairback, an ergometric bicycle with chairback with virtual environment and the other session without virtual environment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided