<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/NCT03255499</url>
  </required_header>
  <id_info>
    <org_study_id>MC081017</org_study_id>
    <nct_id>NCT03255499</nct_id>
  </id_info>
  <brief_title>Efficacy of the MovinCog Intervention in Children</brief_title>
  <official_title>Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Auckland, New Zealand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Auckland, New Zealand</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 aims to test the efficacy of the MovinCog Intervention to enhance cognitive&#xD;
      abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise&#xD;
      regimen, based on high-intensity training, and a cognitive training component. The design&#xD;
      will contrast the intervention with an active control group, matched for expectancy effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specifically, the investigators will compare both components together (exercise and cognitive&#xD;
      training) against either one of the components (exercise alone, or cognitive training alone)&#xD;
      and against an active control group. The study will include measures of scholastic aptitude,&#xD;
      as well as of working memory and cognitive control (primary outcome measures), two cognitive&#xD;
      abilities that are critical to daily life activities, and that respond well to training. In&#xD;
      addition, the investigators will measure physiological responses to training, to monitor&#xD;
      changes associated with exercise (secondary outcome measures). Finally, the investigators&#xD;
      will relate training-specific improvements with transfer gains, to better model the&#xD;
      interaction between training and transfer. This will provide a comprehensive understanding of&#xD;
      the dynamics associated with the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline working memory capacity at 10 weeks</measure>
    <time_frame>Baseline and 10-week posttest</time_frame>
    <description>Constructs measured by multiple tasks (bds, corsi, n-back)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline cognitive control at 10 weeks</measure>
    <time_frame>Baseline and 10-week posttest</time_frame>
    <description>Constructs measured by multiple tasks (flanker, go/no-go, stroop)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline scholastic aptitude at 10 weeks</measure>
    <time_frame>Baseline and 10-week posttest</time_frame>
    <description>Constructs measured by multiple national (New Zealand), standardized tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline resting heart rate at 10 weeks</measure>
    <time_frame>Baseline and 10-week posttest</time_frame>
    <description>Measured by monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF polymorphism measured by genetic saliva kit</measure>
    <time_frame>Baseline</time_frame>
    <description>Effect of BDNF polymorphism on primary outcomes</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Learning Disorders</condition>
  <condition>Learning Disabilities</condition>
  <condition>Cognitive Change</condition>
  <arm_group>
    <arm_group_label>Exercise and cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention includes a combination of high-intensity exercise (10min/day) and computerized cognitive training (20min/day). The software for the latter has been developed by our group, and includes 8 mini-games targeting different cognitive abilities. Both are developed for the MovinCog intervention. The intervention is personalized, based on individual performance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity training regimen, 10min/day. Developed for the MovinCog intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerized cognitive training, 20min/day. Developed for the MovinCog intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Games</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active control is composed of a blend of board games, computer games, and trivia quizzes. Specific content is personalized based on individual preferences, so as to reflect the flexibility of the experimental arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercise</description>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_label>Exercise and cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive</intervention_name>
    <description>Cognitive</description>
    <arm_group_label>Cognitive training</arm_group_label>
    <arm_group_label>Exercise and cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active control</intervention_name>
    <description>Active control, including a blend of computer games, board games, quizzes, trivia</description>
    <arm_group_label>Games</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 7-15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age outside inclusion criteria&#xD;
&#xD;
          -  History of seizures, brain trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Moreau</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Auckland, New Zealand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Auckland</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Auckland, New Zealand</investigator_affiliation>
    <investigator_full_name>David Moreau</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>cognitive training</keyword>
  <keyword>physical exercise</keyword>
  <keyword>brain dynamics</keyword>
  <keyword>cognitive abilities</keyword>
  <keyword>physiological markers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Learning Disabilities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Release IPD at the time of publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Post-publication</ipd_time_frame>
    <ipd_access_criteria>Unrestricted</ipd_access_criteria>
    <ipd_url>http://github.com/davidmoreau/</ipd_url>
  </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/NCT03255499
org study id: MC081017
nct id: NCT03255499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive
      abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise
      regimen, based on high-intensity training, and a cognitive training component. The design
      will contrast the intervention with an active control group, matched for expectancy effects.
Specifically, the investigators will compare both components together (exercise and cognitive
      training) against either one of the components (exercise alone, or cognitive training alone)
      and against an active control group. The study will include measures of scholastic aptitude,
      as well as of working memory and cognitive control (primary outcome measures), two cognitive
      abilities that are critical to daily life activities, and that respond well to training. In
      addition, the investigators will measure physiological responses to training, to monitor
      changes associated with exercise (secondary outcome measures). Finally, the investigators
      will relate training-specific improvements with transfer gains, to better model the
      interaction between training and transfer. This will provide a comprehensive understanding of
      the dynamics associated with the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline working memory capacity at 10 weeks
time frame: Baseline and 10-week posttest
description: Constructs measured by multiple tasks (bds, corsi, n-back)
measure: Change from baseline cognitive control at 10 weeks
time frame: Baseline and 10-week posttest
description: Constructs measured by multiple tasks (flanker, go/no-go, stroop)
measure: Change from baseline scholastic aptitude at 10 weeks
time frame: Baseline and 10-week posttest
description: Constructs measured by multiple national (New Zealand), standardized tests
measure: Change from baseline resting heart rate at 10 weeks
time frame: Baseline and 10-week posttest
description: Measured by monitor
measure: BDNF polymorphism measured by genetic saliva kit
time frame: Baseline
description: Effect of BDNF polymorphism on primary outcomes
arm group label: Exercise and cognitive training
arm group type: Experimental
description: This intervention includes a combination of high-intensity exercise (10min/day) and computerized cognitive training (20min/day). The software for the latter has been developed by our group, and includes 8 mini-games targeting different cognitive abilities. Both are developed for the MovinCog intervention. The intervention is personalized, based on individual performance.
arm group label: Exercise
arm group type: Experimental
description: High-intensity training regimen, 10min/day. Developed for the MovinCog intervention.
arm group label: Cognitive training
arm group type: Experimental
description: Computerized cognitive training, 20min/day. Developed for the MovinCog intervention.
arm group label: Games
arm group type: Active Comparator
description: The active control is composed of a blend of board games, computer games, and trivia quizzes. Specific content is personalized based on individual preferences, so as to reflect the flexibility of the experimental arms.
intervention type: Behavioral
intervention name: Exercise
description: Exercise
arm group label: Exercise
arm group label: Exercise and cognitive training
intervention type: Behavioral
intervention name: Cognitive
description: Cognitive
arm group label: Cognitive training
arm group label: Exercise and cognitive training
intervention type: Behavioral
intervention name: Active control
description: Active control, including a blend of computer games, board games, quizzes, trivia
arm group label: Games
criteria: 
gender: All
minimum age: 7 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Moreau
role: Principal Investigator
affiliation: University of Auckland, New Zealand
facility: 
country: New Zealand
responsible party type: Principal Investigator
investigator affiliation: University of Auckland, New Zealand
investigator full name: David Moreau
investigator title: PhD
mesh term: Learning Disabilities
sharing ipd: Yes
ipd description: Release IPD at the time of publication.
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: Post-publication
ipd access criteria: Unrestricted
ipd url: http://github.com/davidmoreau/