<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/NCT03032796</url>
  </required_header>
  <id_info>
    <org_study_id>1R21MH110743-01</org_study_id>
    <nct_id>NCT03032796</nct_id>
  </id_info>
  <brief_title>Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory</brief_title>
  <acronym>BBT</acronym>
  <official_title>Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this project is to evidence potential synergistic benefits on cognitive&#xD;
      control processes using a video game (&quot;Body-Brain Trainer&quot;, or BBT) that integrates cognitive&#xD;
      and physical challenges in a complimentary fashion. Healthy adults will be recruited for a&#xD;
      longitudinal experiment and randomly assigned to one of four study groups to mechanistically&#xD;
      tease apart the possible presence of any synergistic effects on cognitive abilities through&#xD;
      the combination of cognitive &amp; physical challenges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cognitive control functions (e.g. attention, working memory, goal-management) dictate our&#xD;
      ability to learn and accomplish selected behavioral goals, with deficiencies in these&#xD;
      processes found in a range of mental illnesses. The primary goal of this project is to&#xD;
      evidence potential synergistic benefits on cognitive control processes using a video game&#xD;
      (&quot;Body-Brain Trainer&quot;, or BBT) that integrates cognitive and physical challenges in a&#xD;
      complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and&#xD;
      randomly assigned to one of four study groups: 1) BBT, 2) &quot;Brain Training&quot; (BBT played with a&#xD;
      gamepad controller), 3) &quot;Body Training&quot; (BBT without any cognitive demands), and 4) an&#xD;
      expectancy matched placebo control group. Individuals will engage in eight weeks of training&#xD;
      within our Neuroscape Laboratory, with pre- and post-training assessments evaluating&#xD;
      physical, cognitive, and neural measures. The completion of this project will result in a&#xD;
      more sophisticated understanding of how the integration of cognitive and physical training&#xD;
      potentially impacts cognitive control processes, setting the stage for more effective&#xD;
      interventions for mental illness and learning-related impairments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test of Variables of Attention (T.O.V.A.)</measure>
    <time_frame>At baseline and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>A change from baseline regarding measurement of sustained attention and impulsivity abilities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delayed Recognition Working Memory Task</measure>
    <time_frame>At baseline and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>A change from baseline regarding measurement of working memory abilities in the presence of interference</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Pressure measures</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in systolic &amp; diastolic pressure following the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>VO2max</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in VO2max following the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>MRI Structural measurement</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in structural profiles following the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>MRI functional activity</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in functional activation profiles following the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>EEG functional measures (event-related potentials)</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in event-related potentials following the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>EEG functional measure (event-related spectral perturbation)</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in event-related spectral perturbation following the intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>EEG functional measure (long-range coherence)</measure>
    <time_frame>Before and following the intervention (1 week after intervention use has ended)</time_frame>
    <description>Assessing a change in coherence following the intervention</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy Adults</condition>
  <arm_group>
    <arm_group_label>BBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Body-Brain Trainer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Body Trainer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present, while completing all of the physical aspects of BBT. Thus this will be a physical training protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brain Trainer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The &quot;Brain Trainer&quot; group will train using the same platform as the BBT group, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expectancy Matched Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Body-Brain Trainer</intervention_name>
    <description>A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks.</description>
    <arm_group_label>BBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Body Trainer</intervention_name>
    <description>A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The &quot;Body Trainer&quot; group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During &quot;Body Training&quot;, participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present</description>
    <arm_group_label>Body Trainer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain Trainer</intervention_name>
    <description>The &quot;Brain Trainer&quot; group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks.</description>
    <arm_group_label>Brain Trainer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expectancy Matched Control</intervention_name>
    <description>The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group.</description>
    <arm_group_label>Expectancy Matched Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Can walk briskly for at least 15 minutes continuously without stopping&#xD;
&#xD;
          -  Can stand up from a chair without using your hands&#xD;
&#xD;
          -  Available to come 3x/week to our UCSF Mission Bay laboratory for 8 weeks&#xD;
&#xD;
          -  Willing and able to undergo MRI, EEG procedures&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac problems&#xD;
&#xD;
          -  bypass surgery&#xD;
&#xD;
          -  pacemaker or heart valve replacement&#xD;
&#xD;
          -  stroke&#xD;
&#xD;
          -  respiratory conditions&#xD;
&#xD;
          -  head trauma with loss of consciousness for less than a few minutes&#xD;
&#xD;
          -  severe head trauma with loss of consciousness for more than a few minutes&#xD;
&#xD;
          -  high/low blood pressure&#xD;
&#xD;
          -  kidney failure&#xD;
&#xD;
          -  electroconvulsive therapy (ECT)&#xD;
&#xD;
          -  seizures&#xD;
&#xD;
          -  implanted electrodes&#xD;
&#xD;
          -  cancer/chemotherapy/radiation&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  irritable bowel syndrome&#xD;
&#xD;
          -  back problems&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  Having been diagnosed with a psychiatric or neurological disorder&#xD;
&#xD;
          -  Use of an assistive device (e.g., cane or walker) at any time to assist with&#xD;
             ambulation&#xD;
&#xD;
          -  Joint problems causing significant pain upon movement&#xD;
&#xD;
          -  Heart Disease or Cardiovascular Disease&#xD;
&#xD;
          -  Respiratory Disease (Lung Disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joaquin A. Anguera, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Neuroscape</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</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/NCT03032796
org study id: 1R21MH110743-01
nct id: NCT03032796
lead sponsor: 
has dmc: No
The primary goal of this project is to evidence potential synergistic benefits on cognitive
      control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive
      and physical challenges in a complimentary fashion. Healthy adults will be recruited for a
      longitudinal experiment and randomly assigned to one of four study groups to mechanistically
      tease apart the possible presence of any synergistic effects on cognitive abilities through
      the combination of cognitive & physical challenges.
Cognitive control functions (e.g. attention, working memory, goal-management) dictate our
      ability to learn and accomplish selected behavioral goals, with deficiencies in these
      processes found in a range of mental illnesses. The primary goal of this project is to
      evidence potential synergistic benefits on cognitive control processes using a video game
      ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a
      complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and
      randomly assigned to one of four study groups: 1) BBT, 2) "Brain Training" (BBT played with a
      gamepad controller), 3) "Body Training" (BBT without any cognitive demands), and 4) an
      expectancy matched placebo control group. Individuals will engage in eight weeks of training
      within our Neuroscape Laboratory, with pre- and post-training assessments evaluating
      physical, cognitive, and neural measures. The completion of this project will result in a
      more sophisticated understanding of how the integration of cognitive and physical training
      potentially impacts cognitive control processes, setting the stage for more effective
      interventions for mental illness and learning-related impairments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Test of Variables of Attention (T.O.V.A.)
time frame: At baseline and following the intervention (1 week after intervention use has ended)
description: A change from baseline regarding measurement of sustained attention and impulsivity abilities
measure: Delayed Recognition Working Memory Task
time frame: At baseline and following the intervention (1 week after intervention use has ended)
description: A change from baseline regarding measurement of working memory abilities in the presence of interference
measure: Blood Pressure measures
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in systolic & diastolic pressure following the intervention
measure: VO2max
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in VO2max following the intervention
measure: MRI Structural measurement
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in structural profiles following the intervention
measure: MRI functional activity
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in functional activation profiles following the intervention
measure: EEG functional measures (event-related potentials)
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in event-related potentials following the intervention
measure: EEG functional measure (event-related spectral perturbation)
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in event-related spectral perturbation following the intervention
measure: EEG functional measure (long-range coherence)
time frame: Before and following the intervention (1 week after intervention use has ended)
description: Assessing a change in coherence following the intervention
arm group label: BBT
arm group type: Experimental
description: Body-Brain Trainer
arm group label: Body Trainer
arm group type: Active Comparator
description: Participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present, while completing all of the physical aspects of BBT. Thus this will be a physical training protocol.
arm group label: Brain Trainer
arm group type: Active Comparator
description: The "Brain Trainer" group will train using the same platform as the BBT group, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects).
arm group label: Expectancy Matched Control Group
arm group type: Placebo Comparator
description: The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition
intervention type: Behavioral
intervention name: Body-Brain Trainer
description: A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks.
arm group label: BBT
intervention type: Behavioral
intervention name: Body Trainer
description: A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The "Body Trainer" group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During "Body Training", participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present
arm group label: Body Trainer
intervention type: Behavioral
intervention name: Brain Trainer
description: The "Brain Trainer" group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks.
arm group label: Brain Trainer
intervention type: Behavioral
intervention name: Expectancy Matched Control
description: The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group.
arm group label: Expectancy Matched Control Group
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joaquin A. Anguera, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No