<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/NCT03298919</url>
  </required_header>
  <id_info>
    <org_study_id>203711</org_study_id>
    <secondary_id>R01HL109116</secondary_id>
    <nct_id>NCT03298919</nct_id>
  </id_info>
  <brief_title>Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance</brief_title>
  <official_title>Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The Miriam Hospital</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 is a 3-arm trial to compare exercise videogames versus traditional standard exercise&#xD;
      using stationary bikes and treadmills versus a control condition. Results will examine&#xD;
      minutes of physical activity at 12 weeks and 6 month follow up between conditions. We will&#xD;
      also examine changes in indicators of cardiovascular health (e.g., body mass index, lipids)&#xD;
      and changes in psychological factors that may be predictive of continued exercise engagement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To test the efficacy of a 12-week supervised, laboratory based program of an exercise&#xD;
      videogame (EVG) program to increase time spent in moderate-to-vigorous physical activity&#xD;
      (MVPA) and improve cardiovascular health and fitness indices compared to Standard and Control&#xD;
      programs. Participants will be randomly assigned to (1) a supervised program of Exercise&#xD;
      Videogames (EVG); (2) a supervised standard exercise program (Standard), using aerobic&#xD;
      exercise equipment (e.g., treadmill, stationary bike); or (3) a Control condition. We will&#xD;
      also examine the effect of home-based exercise videogames compared to a home-based standard&#xD;
      PA program on MVPA maintenance during the 6-month follow up period. We will examine changes&#xD;
      in cardiorespiratory fitness (i.e., estimated VO2max), blood pressure, resting heart rate,&#xD;
      body composition and blood lipids at baseline, week 12 and at 6-months follow up. We will&#xD;
      also examine changes in theoretically-based cognitive and affective constructs associated&#xD;
      with physical activity including: enjoyment, outcome expectations, self-efficacy, motivation,&#xD;
      and goal-orientation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2012</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 29, 2016</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>3-group design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MVPA</measure>
    <time_frame>12 weeks</time_frame>
    <description>moderate to vigorous physical activity minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MVPA Maintenance</measure>
    <time_frame>6 months</time_frame>
    <description>moderate to vigorous physical activity minutes</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">283</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Exercise Videogames</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise videogames 3 times weekly for 12 weeks followed by 6 months of home practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise using aerobic equipment such as stationary bikes and treadmills 3 times weekly for 12 weeks followed by home practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Weekly mailings on general health and wellness topics for 12 weeks followed by monthly mailings for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Video Games</intervention_name>
    <description>12 weeks laboratory based exercise videogames</description>
    <arm_group_label>Exercise Videogames</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Stationary bike and/or treadmill walking for 12 weeks</description>
    <arm_group_label>Standard Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home exercise videogames</intervention_name>
    <description>videogame console and active videogames</description>
    <arm_group_label>Exercise Videogames</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Standard Exercise</intervention_name>
    <description>Personalized physical activity promotion materials</description>
    <arm_group_label>Standard Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18,&#xD;
&#xD;
          -  In generally good health&#xD;
&#xD;
          -  No medical conditions that would interfere with exercise&#xD;
&#xD;
          -  Currently engaging in less than 60 minutes of physical activity per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  body mass index over 40&#xD;
&#xD;
          -  current or planned pregnancy&#xD;
&#xD;
          -  hospitalization from a physical or mental disorder in the past 6 months&#xD;
&#xD;
          -  hypertension (defined as: blood pressure ≥ 140/90)&#xD;
&#xD;
          -  anti-hypertensive medication&#xD;
&#xD;
          -  medications that may impair physical activity tolerance (e.g., beta blockers)&#xD;
&#xD;
          -  current cardiovascular disease&#xD;
&#xD;
          -  current pulmonary disease&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  thyroid disorders&#xD;
&#xD;
          -  renal or liver disease&#xD;
&#xD;
          -  orthopedic conditions that would prevent or limit exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beth Bock, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Miriam Hospital- CORO building</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Serber ER, Ciccolo J, Palmer K, Cobb V, Tilkemeier PL, Bock BC. The feasibility of exercise videogames for cardiovascular risk reduction among adults: a pilot for &quot;Wii heart fitness&quot;. J Sports Med Phys Fitness. 2016 Mar;56(3):319-27. Epub 2015 Feb 18.</citation>
    <PMID>25692860</PMID>
  </reference>
  <results_reference>
    <citation>Bock BC, Thind H, Dunsiger SI, Serber ER, Ciccolo JT, Cobb V, Palmer K, Abernathy S, Marcus BH. Exercise videogames for physical activity and fitness: Design and rationale of the Wii Heart Fitness trial. Contemp Clin Trials. 2015 May;42:204-12. doi: 10.1016/j.cct.2015.04.007. Epub 2015 Apr 17.</citation>
    <PMID>25896114</PMID>
  </results_reference>
  <results_reference>
    <citation>Bock BC, Dunsiger SI, Ciccolo JT, Serber ER, Wu WC, Tilkemeier P, Walaska KA, Marcus BH. Exercise Videogames, Physical Activity, and Health: Wii Heart Fitness: A Randomized Clinical Trial. Am J Prev Med. 2019 Apr;56(4):501-511. doi: 10.1016/j.amepre.2018.11.026. Epub 2019 Feb 16.</citation>
    <PMID>30777705</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03298919
org study id: 203711
secondary id: R01HL109116
nct id: NCT03298919
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 3-arm trial to compare exercise videogames versus traditional standard exercise
      using stationary bikes and treadmills versus a control condition. Results will examine
      minutes of physical activity at 12 weeks and 6 month follow up between conditions. We will
      also examine changes in indicators of cardiovascular health (e.g., body mass index, lipids)
      and changes in psychological factors that may be predictive of continued exercise engagement.
To test the efficacy of a 12-week supervised, laboratory based program of an exercise
      videogame (EVG) program to increase time spent in moderate-to-vigorous physical activity
      (MVPA) and improve cardiovascular health and fitness indices compared to Standard and Control
      programs. Participants will be randomly assigned to (1) a supervised program of Exercise
      Videogames (EVG); (2) a supervised standard exercise program (Standard), using aerobic
      exercise equipment (e.g., treadmill, stationary bike); or (3) a Control condition. We will
      also examine the effect of home-based exercise videogames compared to a home-based standard
      PA program on MVPA maintenance during the 6-month follow up period. We will examine changes
      in cardiorespiratory fitness (i.e., estimated VO2max), blood pressure, resting heart rate,
      body composition and blood lipids at baseline, week 12 and at 6-months follow up. We will
      also examine changes in theoretically-based cognitive and affective constructs associated
      with physical activity including: enjoyment, outcome expectations, self-efficacy, motivation,
      and goal-orientation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3-group design
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: MVPA
time frame: 12 weeks
description: moderate to vigorous physical activity minutes
measure: MVPA Maintenance
time frame: 6 months
description: moderate to vigorous physical activity minutes
arm group label: Exercise Videogames
arm group type: Experimental
description: Exercise videogames 3 times weekly for 12 weeks followed by 6 months of home practice
arm group label: Standard Exercise
arm group type: Active Comparator
description: Exercise using aerobic equipment such as stationary bikes and treadmills 3 times weekly for 12 weeks followed by home practice
arm group label: Wellness Control
arm group type: No Intervention
description: Weekly mailings on general health and wellness topics for 12 weeks followed by monthly mailings for 6 months.
intervention type: Behavioral
intervention name: Exercise Video Games
description: 12 weeks laboratory based exercise videogames
arm group label: Exercise Videogames
intervention type: Behavioral
intervention name: Aerobic Exercise
description: Stationary bike and/or treadmill walking for 12 weeks
arm group label: Standard Exercise
intervention type: Behavioral
intervention name: Home exercise videogames
description: videogame console and active videogames
arm group label: Exercise Videogames
intervention type: Behavioral
intervention name: Home Standard Exercise
description: Personalized physical activity promotion materials
arm group label: Standard Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Beth Bock, PhD
role: Principal Investigator
affiliation: The Miriam Hospital
facility: 
country: United States
citation: Serber ER, Ciccolo J, Palmer K, Cobb V, Tilkemeier PL, Bock BC. The feasibility of exercise videogames for cardiovascular risk reduction among adults: a pilot for "Wii heart fitness". J Sports Med Phys Fitness. 2016 Mar;56(3):319-27. Epub 2015 Feb 18.
PMID: 25692860
citation: Bock BC, Thind H, Dunsiger SI, Serber ER, Ciccolo JT, Cobb V, Palmer K, Abernathy S, Marcus BH. Exercise videogames for physical activity and fitness: Design and rationale of the Wii Heart Fitness trial. Contemp Clin Trials. 2015 May;42:204-12. doi: 10.1016/j.cct.2015.04.007. Epub 2015 Apr 17.
PMID: 25896114
citation: Bock BC, Dunsiger SI, Ciccolo JT, Serber ER, Wu WC, Tilkemeier P, Walaska KA, Marcus BH. Exercise Videogames, Physical Activity, and Health: Wii Heart Fitness: A Randomized Clinical Trial. Am J Prev Med. 2019 Apr;56(4):501-511. doi: 10.1016/j.amepre.2018.11.026. Epub 2019 Feb 16.
PMID: 30777705
responsible party type: Sponsor
sharing ipd: No