<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/NCT01709799</url>
  </required_header>
  <id_info>
    <org_study_id>179-2010</org_study_id>
    <nct_id>NCT01709799</nct_id>
  </id_info>
  <brief_title>Village Interactive Training and Learning Study</brief_title>
  <acronym>VITAL</acronym>
  <official_title>The Village Interactive Training and Learning Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to help scientists and health care providers learn more&#xD;
      about preventing dementia and brain disease in older adults. There is an urgent need to&#xD;
      develop strategies to prevent or slow down memory loss and brain function decline in the&#xD;
      elderly.&#xD;
&#xD;
      In this study, the investigators hope to learn how physical exercise and a brain training&#xD;
      program work together to improve thinking and memory in older adults. Specifically, these&#xD;
      aims include:&#xD;
&#xD;
        -  Learning whether physical activities (like biking or treadmill walking or Wii Fit games)&#xD;
           will help improve the benefits of a brain training program. Based on preliminary results&#xD;
           and that in the literature, the investigators anticipate greater cognitive benefits in&#xD;
           the Exercise + Cognitive training groups than the Cognitive Training alone group.&#xD;
&#xD;
        -  To determine whether the benefits of adding exercise will occur quickly or develop more&#xD;
           gradually over time. The investigators suspect that a major benefit of exercise&#xD;
           pre-dosing will occur by the 12th week of the program.&#xD;
&#xD;
        -  To examine whether Wii-Fit exercise games cause similar effects on brain training as&#xD;
           traditional exercise programs such as biking or walking. Although several recent studies&#xD;
           have raised questions about the true aerobic benefit of exergames such as Wii-Fit Plus,&#xD;
           other evidence suggests that these weaker aerobic benefits may be offset by the greater&#xD;
           novelty and interest level afforded by exergames.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Participants take part in a 16 week Wellness Program, which includes either&#xD;
      traditional physical exercise with brain training(Group A), Wii exergaming with brain&#xD;
      training(Group B) or brain training alone (Group C). Participants are randomly assigned to&#xD;
      groups.&#xD;
&#xD;
      A comprehensive battery of neuropsychological tests, surveys and assessments are given prior&#xD;
      to start of the intervention, at completion of the 16 weeks, and again 3 months post&#xD;
      completion.&#xD;
&#xD;
      The program involves 4 days of physical activity each week for groups A &amp; B. The physical&#xD;
      exercise/activity portion will involve warm up stretching and then either Group A-traditional&#xD;
      exercise (like riding a stationary recumbent bicycle or walking on a treadmill), Group B-&#xD;
      playing Nintendo Wii Exergames with a television based video game, or Group C- NO exercise at&#xD;
      all.&#xD;
&#xD;
      Every 4th week the 16 week intervention period, all participants in all three groups will&#xD;
      also complete 80 minutes of brain training activities each day of the week. This is in&#xD;
      addition to the previously assigned physical activity for Groups A &amp; B. The brain training&#xD;
      regimen consists of Posit Science Insight computer based brain games.&#xD;
&#xD;
      The Insight program consists of five different modules that focus on visual processing,&#xD;
      attention, and memory. Each of the modules are described below:&#xD;
&#xD;
        1. Bird Safari: This module involves identifying and ordering simple visual stimuli that&#xD;
           flash on a screen. The goal is to improve ability to respond quickly to visual stimuli&#xD;
           and to segment rapidly changing visual pictures.&#xD;
&#xD;
        2. Jewel Diver: This module involves tracking objects as they become hidden by distractors.&#xD;
           The goal is to improve ability of visual system to rapidly identify and discriminate&#xD;
           objects in the visual periphery.&#xD;
&#xD;
        3. Master Gardener: This module involves visual working memory and matching pairs of&#xD;
           pictures.&#xD;
&#xD;
        4. Road Tour: This is a simulated driving exercise that involves divided attention to&#xD;
           oncoming cars and road signs. The goal is to improve ability of visual system to&#xD;
           continuously track multiple objects against a field of distractors.&#xD;
&#xD;
        5. Sweep Seeker: In this exercise, participants identify complex moving visual stimuli. The&#xD;
           goal is to improve rapid, sequential eye movements to salient visual targets, process&#xD;
           relevant information and then make rapid decisions to identify, discriminate and&#xD;
           classify targets.&#xD;
&#xD;
      Questionnaires regarding the participants mood before and after the brain training weekly are&#xD;
      administered. In addition, brief questionnaires on attention and memory are given to measure&#xD;
      thinking and memory progress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bird Safari Subtest of PositScience Insight</measure>
    <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
    <description>Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jewel Diver Subtest of PositScience Insight</measure>
    <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
    <description>Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Master Gardener Subtest of PositScience Insight</measure>
    <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
    <description>Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Road Tour Subtest of PositScience Insight</measure>
    <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
    <description>Participants choose which car they saw at the center of the screen, and also locate where a &quot;Route 66&quot; sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sweep Seeker Subtest of PositScience Insight</measure>
    <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
    <description>Participants watch two patterns that &quot;sweep&quot; in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed Instrumental Activities of Daily Living Task</measure>
    <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
    <description>The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Aged</condition>
  <arm_group>
    <arm_group_label>Cognitive Training plus Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Training plus Exergames</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.&#xD;
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.</description>
    <arm_group_label>Cognitive Training plus Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exergames</intervention_name>
    <description>Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.</description>
    <arm_group_label>Cognitive Training plus Exergames</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Training</intervention_name>
    <description>Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
    <arm_group_label>Cognitive Training</arm_group_label>
    <arm_group_label>Cognitive Training plus Exercise</arm_group_label>
    <arm_group_label>Cognitive Training plus Exergames</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60+&#xD;
&#xD;
          -  Generally Healthy&#xD;
&#xD;
          -  On stable does of medications&#xD;
&#xD;
          -  Absence of significant behavioral or cognitive dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive or behavioral problems or symptoms&#xD;
&#xD;
          -  History of falls &gt;2 in the past month&#xD;
&#xD;
          -  Unstable medical conditions such as uncontrolled diabetes, uncontrolled cardiac&#xD;
             disease, uncontrolled hypertension, or other that would increase risk of side effects&#xD;
             performing physical activity&#xD;
&#xD;
          -  History of substance abuse in last 6 months&#xD;
&#xD;
          -  Known structural brain abnormality, previous major debilitating strokes or seizures,&#xD;
             traumatic brain injury&#xD;
&#xD;
          -  Had complete neuropsychological testing in the last 6 months&#xD;
&#xD;
          -  Previous participation in cognitive or exercise training study within last 3 months&#xD;
&#xD;
          -  Currently engaging in moderate to heavy exercise &gt;125 mins. week at 75% Target Heart&#xD;
             Rate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dawn Bowers, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida- PHHP, CHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael M Marsiske, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida, PHHP, CHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Village Retirement Community</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>June 3, 2015</results_first_submitted>
  <results_first_submitted_qc>June 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 22, 2015</results_first_posted>
  <last_update_submitted>June 3, 2015</last_update_submitted>
  <last_update_submitted_qc>June 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Training</keyword>
  <keyword>Aging</keyword>
  <keyword>Seniors</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants in the VITAL study were all healthy elders aged 60 years or older. The VITAL participants were drawn from the independent living portion of the retirement community where the study was located as well as from the broader Gainesville community.</recruitment_details>
      <pre_assignment_details>Exclusion criteria included Mini Mental Status Examination scores less than 25, a diagnosis of dementia or neurologic condition, unstable medical conditions, low hearing or vision, inability to engage in physical exercise, or already active (for more that 125 minutes per week at 75% their maximum target heart rate).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cognitive Training Plus Exercise</title>
          <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.&#xD;
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.</description>
        </group>
        <group group_id="P2">
          <title>Cognitive Training Plus Exergames</title>
          <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.</description>
        </group>
        <group group_id="P3">
          <title>Cognitive Training</title>
          <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cognitive Training Plus Exercise</title>
          <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.&#xD;
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Participants also received cognitive training every fourth week. See &quot;Cognitive Training&quot; arm for description.</description>
        </group>
        <group group_id="B2">
          <title>Cognitive Training Plus Exergames</title>
          <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Participants also received cognitive training every fourth week. See &quot;Cognitive Training&quot; arm for description.</description>
        </group>
        <group group_id="B3">
          <title>Cognitive Training</title>
          <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="64"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.6400" lower_limit="62" upper_limit="93"/>
                    <measurement group_id="B2" value="78.1905" lower_limit="60" upper_limit="89"/>
                    <measurement group_id="B3" value="77.2778" lower_limit="65" upper_limit="88"/>
                    <measurement group_id="B4" value="78.8133" lower_limit="60" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bird Safari Subtest of PositScience Insight</title>
        <description>Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
        <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cognitive Training Plus Exercise</title>
            <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Training Plus Exergames</title>
            <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Training</title>
            <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Bird Safari Subtest of PositScience Insight</title>
          <description>Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
          <units>T-score units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bird Safari Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.043" spread="1.864"/>
                    <measurement group_id="O2" value="50.292" spread="1.987"/>
                    <measurement group_id="O3" value="49.570" spread="2.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bird Safari Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.218" spread="1.953"/>
                    <measurement group_id="O2" value="43.474" spread="2.033"/>
                    <measurement group_id="O3" value="43.143" spread="2.107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bird Safari Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.671" spread="1.997"/>
                    <measurement group_id="O2" value="43.610" spread="2.114"/>
                    <measurement group_id="O3" value="42.638" spread="2.182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; .001</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (2,90.577)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.995</p_value>
            <p_value_desc>The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Degrees of freedom are (4,90.564)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Jewel Diver Subtest of PositScience Insight</title>
        <description>Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
        <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cognitive Training Plus Exercise</title>
            <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Training Plus Exergames</title>
            <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Training</title>
            <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Jewel Diver Subtest of PositScience Insight</title>
          <description>Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
          <units>T-score units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Jewel Diver Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.940" spread="2.057"/>
                    <measurement group_id="O2" value="51.052" spread="2.202"/>
                    <measurement group_id="O3" value="50.570" spread="2.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jewel Diver Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.872" spread="2.139"/>
                    <measurement group_id="O2" value="61.577" spread="2.233"/>
                    <measurement group_id="O3" value="63.205" spread="2.332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jewel Diver Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.033" spread="2.139"/>
                    <measurement group_id="O2" value="61.121" spread="2.318"/>
                    <measurement group_id="O3" value="64.460" spread="2.467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (2,97.137)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.254</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (4,97.108)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Master Gardener Subtest of PositScience Insight</title>
        <description>Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
        <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cognitive Training Plus Exercise</title>
            <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Training Plus Exergames</title>
            <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Training</title>
            <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Master Gardener Subtest of PositScience Insight</title>
          <description>Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
          <units>T-score units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Master Gardener Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.938" spread="1.618"/>
                    <measurement group_id="O2" value="50.082" spread="1.731"/>
                    <measurement group_id="O3" value="49.833" spread="1.788"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Master Gardener Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.600" spread="1.650"/>
                    <measurement group_id="O2" value="44.851" spread="1.739"/>
                    <measurement group_id="O3" value="44.542" spread="1.838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Master Gardener Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.700" spread="1.685"/>
                    <measurement group_id="O2" value="46.896" spread="1.781"/>
                    <measurement group_id="O3" value="44.759" spread="1.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (2,99.647)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.781</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (4,99.601)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Road Tour Subtest of PositScience Insight</title>
        <description>Participants choose which car they saw at the center of the screen, and also locate where a &quot;Route 66&quot; sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
        <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cognitive Training Plus Exercise</title>
            <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Training Plus Exergames</title>
            <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Training</title>
            <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Road Tour Subtest of PositScience Insight</title>
          <description>Participants choose which car they saw at the center of the screen, and also locate where a &quot;Route 66&quot; sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
          <units>T-score units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Road Tour Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.097" spread="1.540"/>
                    <measurement group_id="O2" value="53.424" spread="1.661"/>
                    <measurement group_id="O3" value="47.427" spread="1.703"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Road Tour Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.279" spread="1.582"/>
                    <measurement group_id="O2" value="37.197" spread="1.669"/>
                    <measurement group_id="O3" value="36.622" spread="1.797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Road Tour Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.032" spread="1.604"/>
                    <measurement group_id="O2" value="38.803" spread="1.755"/>
                    <measurement group_id="O3" value="36.691" spread="1.916"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (2,102.315)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.026</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (4,102.216)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sweep Seeker Subtest of PositScience Insight</title>
        <description>Participants watch two patterns that &quot;sweep&quot; in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
        <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cognitive Training Plus Exercise</title>
            <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Training Plus Exergames</title>
            <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Training</title>
            <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Sweep Seeker Subtest of PositScience Insight</title>
          <description>Participants watch two patterns that &quot;sweep&quot; in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
          <units>T-score units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sweep Seeker Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.002" spread="1.641"/>
                    <measurement group_id="O2" value="48.784" spread="1.776"/>
                    <measurement group_id="O3" value="49.505" spread="1.814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweep Seeker Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.846" spread="1.743"/>
                    <measurement group_id="O2" value="44.003" spread="1.929"/>
                    <measurement group_id="O3" value="42.021" spread="1.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweep Seeker Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.231" spread="1.805"/>
                    <measurement group_id="O2" value="44.997" spread="1.928"/>
                    <measurement group_id="O3" value="43.304" spread="2.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (2,93.240)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.313</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (4,93.167)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timed Instrumental Activities of Daily Living Task</title>
        <description>The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
        <time_frame>Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cognitive Training Plus Exercise</title>
            <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Training Plus Exergames</title>
            <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Training</title>
            <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Timed Instrumental Activities of Daily Living Task</title>
          <description>The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.&#xD;
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:&#xD;
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)</description>
          <units>T-score units</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Timed IADL Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.065" spread="2.710"/>
                    <measurement group_id="O2" value="49.084" spread="2.956"/>
                    <measurement group_id="O3" value="48.094" spread="3.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Timed IADL Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.040" spread="2.861"/>
                    <measurement group_id="O2" value="47.540" spread="3.018"/>
                    <measurement group_id="O3" value="46.948" spread="3.465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Timed IADL Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.284" spread="3.033"/>
                    <measurement group_id="O2" value="46.941" spread="3.146"/>
                    <measurement group_id="O3" value="47.095" spread="3.465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.630</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (2,115.573)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value &gt; .05)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.498</p_value>
            <p_value_desc>P-value is not adjusted for multiple comparisons, and p &lt; .05 is the a priori threshold for statistical significance</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>degrees of freedom are (4,115.593)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cognitive Training Plus Exercise</title>
          <description>Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)&#xD;
Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:&#xD;
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.&#xD;
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.</description>
        </group>
        <group group_id="E2">
          <title>Cognitive Training Plus Exergames</title>
          <description>Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.&#xD;
Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.&#xD;
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:&#xD;
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate&#xD;
Polar Heart Rate monitors are used to measure THR and save resulting data.&#xD;
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.</description>
        </group>
        <group group_id="E3">
          <title>Cognitive Training</title>
          <description>Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.&#xD;
Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.&#xD;
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>SNOMED CT</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>363801007 Observable feature of falls</sub_title>
                <description>Participant fell during Wii gaming activity. Xrays revealed no fractures or other injury. Participant resumed research study and completed.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Dawn Bowers</name_or_title>
      <organization>University of Florida</organization>
      <phone>(352) 392-3450</phone>
      <email>dawnbowers@phhp.ufl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01709799
org study id: 179-2010
nct id: NCT01709799
lead sponsor: 
has dmc: No
The purpose of this research study is to help scientists and health care providers learn more
      about preventing dementia and brain disease in older adults. There is an urgent need to
      develop strategies to prevent or slow down memory loss and brain function decline in the
      elderly.

      In this study, the investigators hope to learn how physical exercise and a brain training
      program work together to improve thinking and memory in older adults. Specifically, these
      aims include:

        -  Learning whether physical activities (like biking or treadmill walking or Wii Fit games)
           will help improve the benefits of a brain training program. Based on preliminary results
           and that in the literature, the investigators anticipate greater cognitive benefits in
           the Exercise + Cognitive training groups than the Cognitive Training alone group.

        -  To determine whether the benefits of adding exercise will occur quickly or develop more
           gradually over time. The investigators suspect that a major benefit of exercise
           pre-dosing will occur by the 12th week of the program.

        -  To examine whether Wii-Fit exercise games cause similar effects on brain training as
           traditional exercise programs such as biking or walking. Although several recent studies
           have raised questions about the true aerobic benefit of exergames such as Wii-Fit Plus,
           other evidence suggests that these weaker aerobic benefits may be offset by the greater
           novelty and interest level afforded by exergames.
Research Participants take part in a 16 week Wellness Program, which includes either
      traditional physical exercise with brain training(Group A), Wii exergaming with brain
      training(Group B) or brain training alone (Group C). Participants are randomly assigned to
      groups.

      A comprehensive battery of neuropsychological tests, surveys and assessments are given prior
      to start of the intervention, at completion of the 16 weeks, and again 3 months post
      completion.

      The program involves 4 days of physical activity each week for groups A & B. The physical
      exercise/activity portion will involve warm up stretching and then either Group A-traditional
      exercise (like riding a stationary recumbent bicycle or walking on a treadmill), Group B-
      playing Nintendo Wii Exergames with a television based video game, or Group C- NO exercise at
      all.

      Every 4th week the 16 week intervention period, all participants in all three groups will
      also complete 80 minutes of brain training activities each day of the week. This is in
      addition to the previously assigned physical activity for Groups A & B. The brain training
      regimen consists of Posit Science Insight computer based brain games.

      The Insight program consists of five different modules that focus on visual processing,
      attention, and memory. Each of the modules are described below:

        1. Bird Safari: This module involves identifying and ordering simple visual stimuli that
           flash on a screen. The goal is to improve ability to respond quickly to visual stimuli
           and to segment rapidly changing visual pictures.

        2. Jewel Diver: This module involves tracking objects as they become hidden by distractors.
           The goal is to improve ability of visual system to rapidly identify and discriminate
           objects in the visual periphery.

        3. Master Gardener: This module involves visual working memory and matching pairs of
           pictures.

        4. Road Tour: This is a simulated driving exercise that involves divided attention to
           oncoming cars and road signs. The goal is to improve ability of visual system to
           continuously track multiple objects against a field of distractors.

        5. Sweep Seeker: In this exercise, participants identify complex moving visual stimuli. The
           goal is to improve rapid, sequential eye movements to salient visual targets, process
           relevant information and then make rapid decisions to identify, discriminate and
           classify targets.

      Questionnaires regarding the participants mood before and after the brain training weekly are
      administered. In addition, brief questionnaires on attention and memory are given to measure
      thinking and memory progress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bird Safari Subtest of PositScience Insight
time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
description: Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)
measure: Jewel Diver Subtest of PositScience Insight
time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
description: Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)
measure: Master Gardener Subtest of PositScience Insight
time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
description: Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)
measure: Road Tour Subtest of PositScience Insight
time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
description: Participants choose which car they saw at the center of the screen, and also locate where a "Route 66" sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)
measure: Sweep Seeker Subtest of PositScience Insight
time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
description: Participants watch two patterns that "sweep" in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)
measure: Timed Instrumental Activities of Daily Living Task
time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
description: The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.
These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:
T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)
arm group label: Cognitive Training plus Exercise
arm group type: Experimental
description: Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training.
arm group label: Cognitive Training plus Exergames
arm group type: Active Comparator
description: Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training.
arm group label: Cognitive Training
arm group type: Active Comparator
description: Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.
intervention type: Behavioral
intervention name: Exercise
description: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.
Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
arm group label: Cognitive Training plus Exercise
intervention type: Behavioral
intervention name: Exergames
description: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
Polar Heart Rate monitors are used to measure THR and save resulting data.
arm group label: Cognitive Training plus Exergames
intervention type: Behavioral
intervention name: Cognitive Training
description: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
INSIGHT Assessments are done at baseline, the start of each training week and at week 28.
arm group label: Cognitive Training
arm group label: Cognitive Training plus Exercise
arm group label: Cognitive Training plus Exergames
criteria: 
gender: All
minimum age: 60 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dawn Bowers, Ph.D.
role: Principal Investigator
affiliation: University of Florida- PHHP, CHP
last name: Michael M Marsiske, Ph.D.
role: Principal Investigator
affiliation: University of Florida, PHHP, CHP
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 