<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/NCT02237560</url>
  </required_header>
  <id_info>
    <org_study_id>HS13083</org_study_id>
    <secondary_id>R15AG042109-01A1</secondary_id>
    <nct_id>NCT02237560</nct_id>
  </id_info>
  <brief_title>The Aerobic &amp; Cognitive Exercise Study</brief_title>
  <acronym>ACES</acronym>
  <official_title>The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Union College, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Union College, New York</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to clarify the benefits to brain health and thinking processes&#xD;
      that result from different forms of exercise. This study will examine the effectiveness of&#xD;
      cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with&#xD;
      MCI, and compare this with the individual cognitive, behavioral, and physiological effects of&#xD;
      physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will&#xD;
      be greatest for combined aerobic and cognitive exercise compared to physical and mental&#xD;
      exercise alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-site, randomized controlled trial. Participants will be randomized into one&#xD;
      of three conditions for six months: cybercycle-tour, cybercycle-game, or videogame alone.&#xD;
      Comprehensive evaluations will include: neuropsychological (e.g., executive function and&#xD;
      memory), behavioral (e.g., compliance and effort/watts), physiological (e.g.,&#xD;
      cardiorespiratory fitness), biomarker (e.g., BDNF), and an expanded neuroimaging pilot. After&#xD;
      the six-month intervention period, participants choose whether or not to continue exercising,&#xD;
      using any of the three conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in executive function at 6-months</measure>
    <time_frame>Baseline and 6-months</time_frame>
    <description>Change in executive function from baseline at 6-months will be assessed by using a composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Baseline, 3-months, 6-months, 1-year</time_frame>
    <description>Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood</measure>
    <time_frame>Baseline, 3-months, 6-months, 1-year follow-up</time_frame>
    <description>Behavioral outcomes (e.g., mood) will be assessed using the Brunel Mood Scale and exercise induced feeling inventory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in executive function at 3-months</measure>
    <time_frame>Baseline and 3-months</time_frame>
    <description>Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in executive function at 1-year follow-up</measure>
    <time_frame>Baseline and 1-year</time_frame>
    <description>Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in BDNF at 6-months</measure>
    <time_frame>Baseline and 6-months</time_frame>
    <description>BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in MRI at 6-months</measure>
    <time_frame>Baseline and 6-months</time_frame>
    <description>MRI scans collected at baseline and 6-months will be analyzed for volumetric changes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive characteristics of sample pre- and post- intervention</measure>
    <time_frame>Baseline and 6-months</time_frame>
    <description>The MoCA, ADAS-Cog word recall, complex figures, and controlled oral word association test will be used to characterize the sample based on cognitive function at pre- and post-intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of exercise behavior during intervention</measure>
    <time_frame>After each exercise session</time_frame>
    <description>Participants are asked to exercise 3-5x/week. After each exercise session subjects will record their exercise data (e.g., time, distance, power, heart rate, calories, points).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cybercycle-Game</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined aerobic &amp; cognitive exercise for 6 months, 3-5x/week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cybercyle-Tour</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerobic exercise only for 6 months, 3-5x/week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Game Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive exercise only 6 months, 3-5x/week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cybercycle-Game</intervention_name>
    <description>Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.</description>
    <arm_group_label>Cybercycle-Game</arm_group_label>
    <other_name>Expresso</other_name>
    <other_name>Dragon Chase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cybercyle-Tour</intervention_name>
    <description>Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.</description>
    <arm_group_label>Cybercyle-Tour</arm_group_label>
    <other_name>Expresso</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Game Only</intervention_name>
    <description>While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).</description>
    <arm_group_label>Game Only</arm_group_label>
    <other_name>Dragon Chase</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 50+&#xD;
&#xD;
          -  able to pedal recumbent stationary bicycle&#xD;
&#xD;
          -  available for regular exercise participation 3-5x/week for at least 6 months&#xD;
&#xD;
          -  physician permission to exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable heart condition or other significant cardiovascular history (e.g,. stroke)&#xD;
&#xD;
          -  meets criteria for Alzheimer's or other dementia&#xD;
&#xD;
          -  significant history of other neurological disease (e.g., seizures, Parkinson's, etc.)&#xD;
&#xD;
          -  physician denial to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cay Anderson-Hanley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Union College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Albert Albany Jewish Community Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stratton VA Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawthorne Ridge</name>
      <address>
        <city>East Greenbush</city>
        <state>New York</state>
        <zip>12061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guilderland YMCA</name>
      <address>
        <city>Guilderland</city>
        <state>New York</state>
        <zip>12084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glen Eddy</name>
      <address>
        <city>Niskayuna</city>
        <state>New York</state>
        <zip>12309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coburg Village</name>
      <address>
        <city>Rexford</city>
        <state>New York</state>
        <zip>12148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prestwick Chase</name>
      <address>
        <city>Saratoga Springs</city>
        <state>New York</state>
        <zip>12866</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingsway Parkland GardenApartments</name>
      <address>
        <city>Schenectady</city>
        <state>New York</state>
        <zip>12304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schaffer Heights</name>
      <address>
        <city>Schenectady</city>
        <state>New York</state>
        <zip>12308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnyview Rehabilitation Center</name>
      <address>
        <city>Schenectady</city>
        <state>New York</state>
        <zip>12308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beverwyck</name>
      <address>
        <city>Slingerlands</city>
        <state>New York</state>
        <zip>12159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Union College, New York</investigator_affiliation>
    <investigator_full_name>Cay Anderson-Hanley, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>MCI</keyword>
  <keyword>Exergaming</keyword>
  <keyword>Cognition</keyword>
  <keyword>Exercise</keyword>
  <keyword>Older Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Camphor</mesh_term>
    <mesh_term>Salicylates</mesh_term>
    <mesh_term>Methyl salicylate</mesh_term>
    <mesh_term>Menthol</mesh_term>
  </intervention_browse>
  <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/NCT02237560
org study id: HS13083
secondary id: R15AG042109-01A1
nct id: NCT02237560
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to clarify the benefits to brain health and thinking processes
      that result from different forms of exercise. This study will examine the effectiveness of
      cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with
      MCI, and compare this with the individual cognitive, behavioral, and physiological effects of
      physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will
      be greatest for combined aerobic and cognitive exercise compared to physical and mental
      exercise alone.
This is a multi-site, randomized controlled trial. Participants will be randomized into one
      of three conditions for six months: cybercycle-tour, cybercycle-game, or videogame alone.
      Comprehensive evaluations will include: neuropsychological (e.g., executive function and
      memory), behavioral (e.g., compliance and effort/watts), physiological (e.g.,
      cardiorespiratory fitness), biomarker (e.g., BDNF), and an expanded neuroimaging pilot. After
      the six-month intervention period, participants choose whether or not to continue exercising,
      using any of the three conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline in executive function at 6-months
time frame: Baseline and 6-months
description: Change in executive function from baseline at 6-months will be assessed by using a composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
measure: Change in weight
time frame: Baseline, 3-months, 6-months, 1-year
description: Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up
measure: Change in mood
time frame: Baseline, 3-months, 6-months, 1-year follow-up
description: Behavioral outcomes (e.g., mood) will be assessed using the Brunel Mood Scale and exercise induced feeling inventory.
measure: Change from baseline in executive function at 3-months
time frame: Baseline and 3-months
description: Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
measure: Change from baseline in executive function at 1-year follow-up
time frame: Baseline and 1-year
description: Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
measure: Change from baseline in BDNF at 6-months
time frame: Baseline and 6-months
description: BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels.
measure: Change from baseline in MRI at 6-months
time frame: Baseline and 6-months
description: MRI scans collected at baseline and 6-months will be analyzed for volumetric changes.
measure: Cognitive characteristics of sample pre- and post- intervention
time frame: Baseline and 6-months
description: The MoCA, ADAS-Cog word recall, complex figures, and controlled oral word association test will be used to characterize the sample based on cognitive function at pre- and post-intervention.
measure: Assessment of exercise behavior during intervention
time frame: After each exercise session
description: Participants are asked to exercise 3-5x/week. After each exercise session subjects will record their exercise data (e.g., time, distance, power, heart rate, calories, points).
arm group label: Cybercycle-Game
arm group type: Experimental
description: Combined aerobic & cognitive exercise for 6 months, 3-5x/week.
arm group label: Cybercyle-Tour
arm group type: Active Comparator
description: Aerobic exercise only for 6 months, 3-5x/week.
arm group label: Game Only
arm group type: Active Comparator
description: Cognitive exercise only 6 months, 3-5x/week.
intervention type: Behavioral
intervention name: Cybercycle-Game
description: Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
arm group label: Cybercycle-Game
other name: Expresso
other name: Dragon Chase
intervention type: Behavioral
intervention name: Cybercyle-Tour
description: Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.
arm group label: Cybercyle-Tour
other name: Expresso
intervention type: Behavioral
intervention name: Game Only
description: While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).
arm group label: Game Only
other name: Dragon Chase
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cay Anderson-Hanley, PhD
role: Principal Investigator
affiliation: Union College
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Union College, New York
investigator full name: Cay Anderson-Hanley, PhD
investigator title: Associate Professor
mesh term: Cognitive Dysfunction
mesh term: Camphor
mesh term: Salicylates
mesh term: Methyl salicylate
mesh term: Menthol
sharing ipd: No