xml: <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/NCT06019156</url>
    </required_header>
    <id_info>
      <org_study_id>C2022-0044</org_study_id>
      <nct_id>NCT06019156</nct_id>
    </id_info>
    <brief_title>Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults</brief_title>
    <official_title>Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hiroshima University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hiroshima University</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>
        This study explored whether exercise video distribution using metaverse space is effective in&#xD;
        increasing physical activity among young people, along with mental health and locomotive&#xD;
        function. This is a randomized parallel-group study. Participants will be assigned to 3&#xD;
        groups: a metaverse group, a YouTube group, and a control group. The metaverse group will&#xD;
        receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic&#xD;
        equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will&#xD;
        receive access to the same exercise videos as the metaverse group. The control group was&#xD;
        given no specific instructions.&#xD;
  &#xD;
        The intervention period was 8 weeks, and physical activity and other items were measured&#xD;
        before and after the intervention. These pre- and post-intervention measurements will be used&#xD;
        to determine whether the delivery of exercise videos via Metaverse is effective in increasing&#xD;
        physical activity in young adults.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 13, 2022</start_date>
    <completion_date type="Actual">February 10, 2023</completion_date>
    <primary_completion_date type="Actual">December 11, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Physical activity</measure>
      <time_frame>The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.</time_frame>
      <description>The short form of the International Physical Activity Questionnaire Short Form was used to measure the effect of an intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Well-being</measure>
      <time_frame>Pre- and post- 8 weeks intervention</time_frame>
      <description>The Japanese version of the World Health Organization Five-Well-Being Index was used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological distress</measure>
      <time_frame>Pre- and post- 8 weeks intervention</time_frame>
      <description>The 6-item Kessler Scale as a nonspecific psychological distress scale was used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Locomotive syndrome risk tests</measure>
      <time_frame>Pre- and post- 8 weeks intervention</time_frame>
      <description>We used the 25-question geriatric locomotive function scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social capital</measure>
      <time_frame>Pre- and post- 8 weeks intervention</time_frame>
      <description>The social capital questions consisted of 11 items related to civic participation, social cohesion, and reciprocity, with a perfect score of 11 and higher scores indicating stronger social connections.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QOL)</measure>
      <time_frame>Pre- and post- 8 weeks intervention</time_frame>
      <description>The Japanese version of the 26-item World Health Organization QOL measure was used to assess QOL.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">48</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>metaverse group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>YouTube group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise video distribution of Metaverse</intervention_name>
      <description>Participants received a 10-minute exercise video each week with a load of about 4 to 8 metabolic equivalents of task (METs) in the metaverse space, for eight videos delivered to encourage exercise.</description>
      <arm_group_label>metaverse group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise video distribution of YouTube</intervention_name>
      <description>Participants view exercise videos with the same content as the metaverse group.</description>
      <arm_group_label>YouTube group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  individuals aged 18-30 at the time of obtaining consent&#xD;
  &#xD;
            -  who owned a smartphone or computer and had internet access&#xD;
  &#xD;
            -  who did not belong to an exercise community, such as a sports club&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  individuals who had a history of a disease that prohibited exercise&#xD;
  &#xD;
            -  individuals whose physical activity was &gt; 3000 metabolic equivalents of task&#xD;
               (METs)/week&#xD;
  &#xD;
            -  pregnant (or possibly pregnant) women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yukio Urabe, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hiroshima University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hiroshima University</name>
        <address>
          <city>Hiroshima</city>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hiroshima University</investigator_affiliation>
      <investigator_full_name>Rami Mizuta</investigator_full_name>
      <investigator_title>Principal Investigator, Doctoral student of Graduate School of Biomedical and Health Sciences Hiroshima University</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans to make Individual Participant Data (IPD) available to other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019156
  org study id: C2022-0044
  nct id: NCT06019156
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study explored whether exercise video distribution using metaverse space is effective in
        increasing physical activity among young people, along with mental health and locomotive
        function. This is a randomized parallel-group study. Participants will be assigned to 3
        groups: a metaverse group, a YouTube group, and a control group. The metaverse group will
        receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic
        equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will
        receive access to the same exercise videos as the metaverse group. The control group was
        given no specific instructions.
  
        The intervention period was 8 weeks, and physical activity and other items were measured
        before and after the intervention. These pre- and post-intervention measurements will be used
        to determine whether the delivery of exercise videos via Metaverse is effective in increasing
        physical activity in young adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  measure: Physical activity
  time frame: The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.
  description: The short form of the International Physical Activity Questionnaire Short Form was used to measure the effect of an intervention.
  measure: Well-being
  time frame: Pre- and post- 8 weeks intervention
  description: The Japanese version of the World Health Organization Five-Well-Being Index was used.
  measure: Psychological distress
  time frame: Pre- and post- 8 weeks intervention
  description: The 6-item Kessler Scale as a nonspecific psychological distress scale was used.
  measure: Locomotive syndrome risk tests
  time frame: Pre- and post- 8 weeks intervention
  description: We used the 25-question geriatric locomotive function scale.
  measure: Social capital
  time frame: Pre- and post- 8 weeks intervention
  description: The social capital questions consisted of 11 items related to civic participation, social cohesion, and reciprocity, with a perfect score of 11 and higher scores indicating stronger social connections.
  measure: Quality of life (QOL)
  time frame: Pre- and post- 8 weeks intervention
  description: The Japanese version of the 26-item World Health Organization QOL measure was used to assess QOL.
  arm group label: metaverse group
  arm group type: Experimental
  arm group label: YouTube group
  arm group type: Active Comparator
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Exercise video distribution of Metaverse
  description: Participants received a 10-minute exercise video each week with a load of about 4 to 8 metabolic equivalents of task (METs) in the metaverse space, for eight videos delivered to encourage exercise.
  arm group label: metaverse group
  intervention type: Behavioral
  intervention name: Exercise video distribution of YouTube
  description: Participants view exercise videos with the same content as the metaverse group.
  arm group label: YouTube group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yukio Urabe, PhD
  role: Principal Investigator
  affiliation: Hiroshima University
  facility: 
  country: Japan
  responsible party type: Principal Investigator
  investigator affiliation: Hiroshima University
  investigator full name: Rami Mizuta
  investigator title: Principal Investigator, Doctoral student of Graduate School of Biomedical and Health Sciences Hiroshima University
  sharing ipd: No
  ipd description: There are no plans to make Individual Participant Data (IPD) available to other researchers.