<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/NCT04404621</url>
  </required_header>
  <id_info>
    <org_study_id>2000026437</org_study_id>
    <nct_id>NCT04404621</nct_id>
  </id_info>
  <brief_title>Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults</brief_title>
  <official_title>Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate and compare how 18-weeks of computer-based brain&#xD;
      training and physical exercise together can improve physical performance, cognitive function&#xD;
      and mood in older adults in a cross-over design with participants randomized to receive the&#xD;
      intervention first and then be assessed before and after an 18 week period without&#xD;
      intervention, or the reverse sequence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate and compare how 18-weeks of computer-based brain&#xD;
      training and physical exercise together can improve physical performance, cognitive function&#xD;
      and mood in older adults in a cross-over design with participants randomized to receive the&#xD;
      intervention first and then be assessed before and after an 18 week period without&#xD;
      intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old&#xD;
      will be invited to participate. After providing informed consent, in the case of subjects who&#xD;
      are living on units for individuals with memory or other cognitive compromise, after assent&#xD;
      from the individual and approval from facility staff, subjects will be randomly assigned to&#xD;
      either receive the intervention for 18 weeks and then be followed for an additional 18 weeks,&#xD;
      or to be followed for 18 weeks without intervention and then do the intervention for 18&#xD;
      weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and&#xD;
      25-minute CBB training sessions 3-4 times a week.&#xD;
&#xD;
      There will be 3 assessments of participants: before and after the first 18-week period and&#xD;
      then again after the second 18-week period. Assessments will be done in 2 sessions over a&#xD;
      total of 90 minutes and will include demographic, health, physical activity and social&#xD;
      activity questionnaires as well as the self-report measures of cognitive function, emotional&#xD;
      state and weekly activities; quantitative assessments of physical balance, strength,&#xD;
      flexibility blood pressure and heart rate; and tests of cognitive function. Subject&#xD;
      medications will be recorded at each assessment. The wait-list control group will receive the&#xD;
      same assessments at the same time points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Actual">September 12, 2020</completion_date>
  <primary_completion_date type="Actual">September 12, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite cognition score</measure>
    <time_frame>18 weeks</time_frame>
    <description>Composite from: Flanker Test of Attention; Go/No-Go Test of Response Inhibition; List Sort Working Memory Test; Logical Memory Story Recall; Digit symbol coding; Digit Span Forwards and Backwards; Hopkin's Verbal Learning Test; Trail Making B; Stroop Color Word; Category Verbal Fluency; Reaction Time.&#xD;
A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for each test for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sit to Stand in one-minute</measure>
    <time_frame>18 weeks</time_frame>
    <description>Number of times able to go from sit to stand in in one minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance - stand on one foot at a time</measure>
    <time_frame>18 weeks</time_frame>
    <description>Stand on one foot with the toe of the other foot touching the calf of the standing leg - number of seconds able to maintain. The sum of right and leg foot will be added.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood and Quality of Life</measure>
    <time_frame>18 weeks</time_frame>
    <description>Composite score from WHODAS, DEMQ QLI and Beck Depression Inventory.&#xD;
A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for total score on each questionnaire for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attention and Speed of Processing</measure>
    <time_frame>18 weeks</time_frame>
    <description>Flanker Test of Attention (average reaction time on correct incongruent trials)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Inhibition</measure>
    <time_frame>18 weeks</time_frame>
    <description>Percent correct on no-go trials on Go/No-Go Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Memory</measure>
    <time_frame>18 weeks</time_frame>
    <description>Average z-scores on two tests of working memory: 1)List Sorting Working Memory (total score which is the sum of scores on parts one and two) and Digit Span (sum of longest span forward and longest span backwards)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal Memory</measure>
    <time_frame>18 weeks</time_frame>
    <description>Logical Memory Story Recall (number of details correctly recalled on initial recall)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speed of Processing</measure>
    <time_frame>18 weeks</time_frame>
    <description>Digit Symbol Coding (number of correct responses in 60 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Flexibility</measure>
    <time_frame>18 weeks</time_frame>
    <description>Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Cognitive Function</condition>
  <condition>Depression in Old Age</condition>
  <arm_group>
    <arm_group_label>Cross-Over Sequence A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be randomized to receive the 18 week program first and be in treatment as usual comparison condition in the following 18 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-Over Sequence B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be randomized to remain in treatment as usual during the first 18 week period and then receive the 18 week program during the following 18 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical exercise (PE) training and computer-based brain (CBB)</intervention_name>
    <description>18 weeks of PE and CBB.</description>
    <arm_group_label>Cross-Over Sequence A</arm_group_label>
    <arm_group_label>Cross-Over Sequence B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Associated with Whitney center as residents or participants in non-resident programs.&#xD;
&#xD;
          -  Able to understand and read English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to sit in a chair independently.&#xD;
&#xD;
          -  Not able to move both arms in simple movement sequence.&#xD;
&#xD;
          -  Hearing and vision insufficient to do the computer exercises or follow the PE&#xD;
             instructions.&#xD;
&#xD;
          -  Not able to remember 3 movements in succession.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce E Wexler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connecticut Mental Health Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04404621
org study id: 2000026437
nct id: NCT04404621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate and compare how 18-weeks of computer-based brain
      training and physical exercise together can improve physical performance, cognitive function
      and mood in older adults in a cross-over design with participants randomized to receive the
      intervention first and then be assessed before and after an 18 week period without
      intervention, or the reverse sequence.
The aim of this study is to investigate and compare how 18-weeks of computer-based brain
      training and physical exercise together can improve physical performance, cognitive function
      and mood in older adults in a cross-over design with participants randomized to receive the
      intervention first and then be assessed before and after an 18 week period without
      intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old
      will be invited to participate. After providing informed consent, in the case of subjects who
      are living on units for individuals with memory or other cognitive compromise, after assent
      from the individual and approval from facility staff, subjects will be randomly assigned to
      either receive the intervention for 18 weeks and then be followed for an additional 18 weeks,
      or to be followed for 18 weeks without intervention and then do the intervention for 18
      weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and
      25-minute CBB training sessions 3-4 times a week.

      There will be 3 assessments of participants: before and after the first 18-week period and
      then again after the second 18-week period. Assessments will be done in 2 sessions over a
      total of 90 minutes and will include demographic, health, physical activity and social
      activity questionnaires as well as the self-report measures of cognitive function, emotional
      state and weekly activities; quantitative assessments of physical balance, strength,
      flexibility blood pressure and heart rate; and tests of cognitive function. Subject
      medications will be recorded at each assessment. The wait-list control group will receive the
      same assessments at the same time points.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Composite cognition score
time frame: 18 weeks
description: Composite from: Flanker Test of Attention; Go/No-Go Test of Response Inhibition; List Sort Working Memory Test; Logical Memory Story Recall; Digit symbol coding; Digit Span Forwards and Backwards; Hopkin's Verbal Learning Test; Trail Making B; Stroop Color Word; Category Verbal Fluency; Reaction Time.
A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for each test for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.
measure: Sit to Stand in one-minute
time frame: 18 weeks
description: Number of times able to go from sit to stand in in one minute
measure: Balance - stand on one foot at a time
time frame: 18 weeks
description: Stand on one foot with the toe of the other foot touching the calf of the standing leg - number of seconds able to maintain. The sum of right and leg foot will be added.
measure: Mood and Quality of Life
time frame: 18 weeks
description: Composite score from WHODAS, DEMQ QLI and Beck Depression Inventory.
A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for total score on each questionnaire for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.
measure: Attention and Speed of Processing
time frame: 18 weeks
description: Flanker Test of Attention (average reaction time on correct incongruent trials)
measure: Response Inhibition
time frame: 18 weeks
description: Percent correct on no-go trials on Go/No-Go Test
measure: Working Memory
time frame: 18 weeks
description: Average z-scores on two tests of working memory: 1)List Sorting Working Memory (total score which is the sum of scores on parts one and two) and Digit Span (sum of longest span forward and longest span backwards)
measure: Verbal Memory
time frame: 18 weeks
description: Logical Memory Story Recall (number of details correctly recalled on initial recall)
measure: Speed of Processing
time frame: 18 weeks
description: Digit Symbol Coding (number of correct responses in 60 seconds)
measure: Cognitive Flexibility
time frame: 18 weeks
description: Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors
arm group label: Cross-Over Sequence A
arm group type: Experimental
description: Participants in this arm will be randomized to receive the 18 week program first and be in treatment as usual comparison condition in the following 18 weeks.
arm group label: Cross-Over Sequence B
arm group type: Experimental
description: Participants in this arm will be randomized to remain in treatment as usual during the first 18 week period and then receive the 18 week program during the following 18 weeks.
intervention type: Behavioral
intervention name: Physical exercise (PE) training and computer-based brain (CBB)
description: 18 weeks of PE and CBB.
arm group label: Cross-Over Sequence A
arm group label: Cross-Over Sequence B
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce E Wexler
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No