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/NCT05973461</url>
    </required_header>
    <id_info>
      <org_study_id>2020-0376</org_study_id>
      <nct_id>NCT05973461</nct_id>
    </id_info>
    <brief_title>Effects of Exercise and Virtual Reality on Depression</brief_title>
    <official_title>Effects of Exercise With Virtual Reality on Females and Males With or Without Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas at Arlington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas at Arlington</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is evaluating the effects of riding on a cycle ergometer while experiencing&#xD;
        virtual reality to determine its effect on mood.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adults (males and females) above the age of 18 yrs will be recruited to determine if they&#xD;
        have symptoms of depression based on a questionnaire (Center for Epidemiologic Studies -&#xD;
        Depression Scale (CES-D). They will then complete a Beck Inventory before and after the&#xD;
        exercise. Participants will be divided into groups either having symptoms of depression or&#xD;
        not. They will be randomized to ride on a cycle ergometer with or without using Virtual&#xD;
        Reality (VR) that will allow them to view neighborhoods or parks during the exercise. The&#xD;
        ergometer will be set at resistance raising the heart rate to 65% of their age-predicted&#xD;
        heart rate maximum. They will ride for 20 min and then complete the Beck Inventory to&#xD;
        determine any changes in their depressive symptoms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 17, 2022</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <intervention_model_description>males and females, with and without symptoms of depression</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Beck Depression Inventory Scale of Measurement</measure>
      <time_frame>5 minutes</time_frame>
      <description>Assessment of symptoms of depression pre and post-intervention cycle exercise. The Beck Depression Inventory is a 21-item, multiple-choice, self-report survey that measures characteristic attitudes and symptoms of depression. The score range is 0-63. The higher the score the more severe the depression. Scores above 41 are considered &quot;extreme depression.&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spatial Working Memory (SWM)</measure>
      <time_frame>8 minutes</time_frame>
      <description>A measure of the key aspects of working memory and storage of information over short periods of time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neuropsychological Outcomes: Motor Screen Tasks (MOT)</measure>
      <time_frame>3 minutes</time_frame>
      <description>MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors</measure>
      <time_frame>10 minutes</time_frame>
      <description>This test is a general assessment of whether there are sensorimotor deficits or lack of comprehension. Outcome is measured by reaction time in milliseconds of the participant reaching out and touching the &quot;X&quot; correctly (in the middle of the X) on the tablet in response to the stimulus. The maximum score is 6000 milliseconds. The number of total correct touches and total errors in not touching correctly out of 10 are recorded. Ex: MOT mean latency = 927.9 ml +/- 131.43 ms; MOT Total Correct = 10; MOT Total Errors = 0.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Symptoms of Depression</condition>
    <arm_group>
      <arm_group_label>Cycle Ergometer and Virtual Reality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 min ride on cycle ergometer while viewing neighborhood scenes using virtual reality</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cycle Ergometer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 min ride on cycle ergometer</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Exercise and virtual reality</intervention_name>
      <description>Riding a cycle ergometer while experiencing virtual reality</description>
      <arm_group_label>Cycle Ergometer and Virtual Reality</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Riding a cycle ergometer</intervention_name>
      <description>Riding on a cycle ergometer without experiencing virtual reality</description>
      <arm_group_label>Cycle Ergometer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females over the age of 18 years&#xD;
  &#xD;
            -  With or without symptoms of depression&#xD;
  &#xD;
            -  Physically inactive or sedentary (less than 30 minutes per day)&#xD;
  &#xD;
            -  Normal vision and no color blindness&#xD;
  &#xD;
            -  No physical disorders such as walking with assistance&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Below the age of 18 years or over 65 years,&#xD;
  &#xD;
            -  Women who are pregnant&#xD;
  &#xD;
            -  Individuals who have been diagnosed with mental disorders&#xD;
  &#xD;
            -  Individuals with leg injuries&#xD;
  &#xD;
            -  Individuals with cardiac problems&#xD;
  &#xD;
            -  Individuals with a history of asthma&#xD;
  &#xD;
            -  Individuals with a body mass index over 30.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Judy R Wilson, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>UTArlington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Judy R Wilson, PH.D.</last_name>
      <phone>817-272-3128</phone>
      <email>jrwilson@exchange.uta.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiangli Gu, Ph.D.</last_name>
      <email>xiangli.gu@uta.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UTArlington</name>
        <address>
          <city>Arlington</city>
          <state>Texas</state>
          <zip>76019</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Judy R Wilson, Ph.D.</last_name>
        <phone>817-272-3128</phone>
        <email>jrwilson@exchange.uta.edu</email>
      </contact>
      <contact_backup>
        <last_name>Xiangli Gu, Ph.D.</last_name>
        <email>xiangli.gu@uta.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas at Arlington</investigator_affiliation>
      <investigator_full_name>Judy Wilson</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05973461
  org study id: 2020-0376
  nct id: NCT05973461
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This study is evaluating the effects of riding on a cycle ergometer while experiencing
        virtual reality to determine its effect on mood.
  Adults (males and females) above the age of 18 yrs will be recruited to determine if they
        have symptoms of depression based on a questionnaire (Center for Epidemiologic Studies -
        Depression Scale (CES-D). They will then complete a Beck Inventory before and after the
        exercise. Participants will be divided into groups either having symptoms of depression or
        not. They will be randomized to ride on a cycle ergometer with or without using Virtual
        Reality (VR) that will allow them to view neighborhoods or parks during the exercise. The
        ergometer will be set at resistance raising the heart rate to 65% of their age-predicted
        heart rate maximum. They will ride for 20 min and then complete the Beck Inventory to
        determine any changes in their depressive symptoms.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: males and females, with and without symptoms of depression
  primary purpose: Screening
  masking: None (Open Label)
  measure: Beck Depression Inventory Scale of Measurement
  time frame: 5 minutes
  description: Assessment of symptoms of depression pre and post-intervention cycle exercise. The Beck Depression Inventory is a 21-item, multiple-choice, self-report survey that measures characteristic attitudes and symptoms of depression. The score range is 0-63. The higher the score the more severe the depression. Scores above 41 are considered "extreme depression."
  measure: Spatial Working Memory (SWM)
  time frame: 8 minutes
  description: A measure of the key aspects of working memory and storage of information over short periods of time.
  measure: Neuropsychological Outcomes: Motor Screen Tasks (MOT)
  time frame: 3 minutes
  description: MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:
  measure: Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors
  time frame: 10 minutes
  description: This test is a general assessment of whether there are sensorimotor deficits or lack of comprehension. Outcome is measured by reaction time in milliseconds of the participant reaching out and touching the "X" correctly (in the middle of the X) on the tablet in response to the stimulus. The maximum score is 6000 milliseconds. The number of total correct touches and total errors in not touching correctly out of 10 are recorded. Ex: MOT mean latency = 927.9 ml +/- 131.43 ms; MOT Total Correct = 10; MOT Total Errors = 0.
  arm group label: Cycle Ergometer and Virtual Reality
  arm group type: Experimental
  description: 30 min ride on cycle ergometer while viewing neighborhood scenes using virtual reality
  arm group label: Cycle Ergometer
  arm group type: Experimental
  description: 30 min ride on cycle ergometer
  intervention type: Device
  intervention name: Exercise and virtual reality
  description: Riding a cycle ergometer while experiencing virtual reality
  arm group label: Cycle Ergometer and Virtual Reality
  intervention type: Other
  intervention name: Riding a cycle ergometer
  description: Riding on a cycle ergometer without experiencing virtual reality
  arm group label: Cycle Ergometer
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Judy R Wilson, Ph.D.
  role: Principal Investigator
  affiliation: UTArlington
  last name: Judy R Wilson, PH.D.
  phone: 817-272-3128
  email: jrwilson@exchange.uta.edu
  last name: Xiangli Gu, Ph.D.
  email: xiangli.gu@uta.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas at Arlington
  investigator full name: Judy Wilson
  investigator title: Associate Professor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No