xml: <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/NCT05972265</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004558</org_study_id>
      <nct_id>NCT05972265</nct_id>
    </id_info>
    <brief_title>Childhood Trauma, Exercise, and Cognition</brief_title>
    <acronym>CTEC</acronym>
    <official_title>Exercise and Cognition in Middle-Aged Adults With Histories of Childhood Trauma and Cognitive Complaints</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas at Austin</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to identify and compare the effects of acute and chronic exercise&#xD;
        interventions on cognition in middle-aged adults with cognitive complaints and a history of&#xD;
        abuse or neglect in childhood. Each participant will be enrolled in the study for up to 78&#xD;
        days, in five parts following verification that the participant meets criteria to be included&#xD;
        in the study: 1) initial assessment; 2) first acute exercise condition in lab, symptom&#xD;
        measures, and neuropsychological testing; 3) second acute exercise condition in lab, symptom&#xD;
        measures, and neuropsychological testing; and 4) 9-week exercise intervention or activity as&#xD;
        usual outside of lab, with interview, symptom measures, and neuropsychological testing at&#xD;
        three-week intervals.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) from baseline will be compared within subjects.</measure>
      <time_frame>one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15.</time_frame>
      <description>The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test from baseline will be compared within subjects.</measure>
      <time_frame>one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15</time_frame>
      <description>The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) from baseline will be compared within subjects.</measure>
      <time_frame>exercise condition on day 8, and after acute exercise condition on day 15</time_frame>
      <description>The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) from baseline will be compared within subjects.</measure>
      <time_frame>one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15</time_frame>
      <description>The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) from baseline will be compared within subjects.</measure>
      <time_frame>one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15</time_frame>
      <description>The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Test (COWAT) from baseline will be compared within subjects.</measure>
      <time_frame>one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15</time_frame>
      <description>The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Tet (COWAT) at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Tet (COWAT) at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Tet (COWAT) at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline cognitive complaints (i.e., total number of complaints) at 3 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline cognitive complaints (i.e., total number of complaints) at 6 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline cognitive complaints (i.e., total number of complaints) at 9 weeks post-chronic exercise intervention.</measure>
      <time_frame>one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in total score on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).</measure>
      <time_frame>one week before first acute exercise condition (baseline); after acute exercise condition on day 8; after acute exercise condition on day 15; and after 3 weeks, 6 weeks, and 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) a 20-item widely used questionnaire to assess the severity of symptoms of posttraumatic stress disorder (PTSD). The minimum score on this measure is 0, and the highest score is 80. Higher scores indicate worse symptoms of PTSD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in total score on the Center for Epidemiological Studies Depression Scale Revised (CESD-R).</measure>
      <time_frame>one week before first acute exercise condition (baseline); after acute exercise condition on day 8; after acute exercise condition on day 15; and after 3 weeks, 6 weeks, and 9 weeks of the chronic exercise condition or activity as usual</time_frame>
      <description>The Center for Epidemiological Studies Depression Scale Revised (CESD-R) is a 20-item self-report measure of depression symptoms used in research. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate worse symptoms of depression.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Adverse Childhood Experiences</condition>
    <arm_group>
      <arm_group_label>Acute Exercise Moderate first</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Day 1 Assessments, Day 8 Moderate Intensity Exercise (followed by symptom measures and neuropsychological tests), Day 15 Light Intensity Exercise (symptom measures and neuropsychological tests)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Acute Exercise Light first</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control Day 1 Assessments (symptom measures, neuropsychological tests, and cognitive complaints interview), Day 8 Light Intensity Exercise (followed by symptom measures and neuropsychological tests), Day 15 Moderate Intensity Exercise (symptom measures and neuropsychological tests)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chronic Exercise Moderate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Activity as Usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>9-week activity as usual Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Moderate Intensity Exercise (one day)</intervention_name>
      <description>Participants will engage in 40 minutes of cycling at 70-75% maximum heart rate (MHR).</description>
      <arm_group_label>Acute Exercise Light first</arm_group_label>
      <arm_group_label>Acute Exercise Moderate first</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Placebo - Light Intensity Exercise (one day)</intervention_name>
      <description>Control participants will engage in 40 minutes cycling at 40-50% maximum heart rate (MHR).</description>
      <arm_group_label>Acute Exercise Light first</arm_group_label>
      <arm_group_label>Acute Exercise Moderate first</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Moderate Intensity Exercise (9 wks)</intervention_name>
      <description>Participants will be asked to engage in moderate-intensity activity four days each week, 40 minutes each time, and will wear an activity monitoring device to assess their fidelity to the intervention.</description>
      <arm_group_label>Chronic Exercise Moderate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Day 1 Assessments</intervention_name>
      <description>Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Life Events Checklist (LEC-5), and neuropsychological testing: approximately 1.50 hours</description>
      <arm_group_label>Acute Exercise Light first</arm_group_label>
      <arm_group_label>Acute Exercise Moderate first</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Symptom Measures and Neuropsychological Tests</intervention_name>
      <description>Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), and neuropsychological testing: approximately 1.25 hours</description>
      <arm_group_label>Acute Exercise Light first</arm_group_label>
      <arm_group_label>Acute Exercise Moderate first</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Day 36 Assessments</intervention_name>
      <description>Activity monitoring device charged and data downloaded, questions regarding fidelity to activity as usual or moderate-intensity exercise and any difficulties, Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), neuropsychological testing, and activity monitoring device returned to participant: approximately 2.00 hours</description>
      <arm_group_label>Chronic Exercise Moderate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Day 57 Assessments</intervention_name>
      <description>Activity monitoring device charged and data downloaded, questions regarding fidelity to activity as usual or moderate-intensity exercise and any difficulties, Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), neuropsychological testing, and activity monitoring device returned to participant: approximately 2.00 hours</description>
      <arm_group_label>Chronic Exercise Moderate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Day 78 Assessments</intervention_name>
      <description>Activity monitoring device charged and data downloaded, questions regarding fidelity to activity as usual or moderate-intensity exercise and any difficulties, Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), neuropsychological testing, and activity monitoring device returned to participant: approximately 2.00 hours</description>
      <arm_group_label>Chronic Exercise Moderate</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  between 40 and 60 years of age&#xD;
  &#xD;
            -  history of child abuse or neglect&#xD;
  &#xD;
            -  have a complaint about memory, attention, or executive function&#xD;
  &#xD;
            -  native or fluent English speaker&#xD;
  &#xD;
            -  normal or corrected to normal vision and hearing&#xD;
  &#xD;
            -  medically healthy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Score indicating a history of moderate-intensity activity, hard-intensity activity, or&#xD;
               very-hard intensity activity on the Stanford Brief Activity Survey&#xD;
  &#xD;
            -  current excessive alcohol or other substance use&#xD;
  &#xD;
            -  eating disorder, bipolar disorder, schizophrenia spectrum disorders, or those judged&#xD;
               to be an immediate suicide risk based on having an active plan with intent&#xD;
  &#xD;
            -  autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), or other&#xD;
               neurodevelopmental disorder&#xD;
  &#xD;
            -  neurocognitive disorder, or illnesses or history of neurological events known to cause&#xD;
               neurocognitive disorders (e.g., traumatic brain injury, status epilepticus, stroke)&#xD;
  &#xD;
            -  reported chest pain or dizziness during exercise; any endorsed and not controlled&#xD;
               medical condition that could make exercise contraindicated, including hypertension;&#xD;
               heart disease; heart failure; hear rhythm disorders; heart valve disease; metabolic&#xD;
               conditions; chronic obstructive pulmonary disease; pulmonary hypertension; cystic&#xD;
               fibrosis; asthma; and bone, joint, or soft tissue problems&#xD;
  &#xD;
            -  pregnancy, major medical disorders such as cancer, or any other condition believed to&#xD;
               put a participant at risk&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erin Logue, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas at Austin</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Texas at Austin</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78712</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Erin Logue</last_name>
        <phone>512-954-5510</phone>
        <email>erin.logue@austin.utexas.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
      <investigator_full_name>Erin Logue</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972265
  org study id: STUDY00004558
  nct id: NCT05972265
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to identify and compare the effects of acute and chronic exercise
        interventions on cognition in middle-aged adults with cognitive complaints and a history of
        abuse or neglect in childhood. Each participant will be enrolled in the study for up to 78
        days, in five parts following verification that the participant meets criteria to be included
        in the study: 1) initial assessment; 2) first acute exercise condition in lab, symptom
        measures, and neuropsychological testing; 3) second acute exercise condition in lab, symptom
        measures, and neuropsychological testing; and 4) 9-week exercise intervention or activity as
        usual outside of lab, with interview, symptom measures, and neuropsychological testing at
        three-week intervals.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) from baseline will be compared within subjects.
  time frame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15.
  description: The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.
  measure: Change in performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test from baseline will be compared within subjects.
  time frame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
  description: The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.
  measure: Change in performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) from baseline will be compared within subjects.
  time frame: exercise condition on day 8, and after acute exercise condition on day 15
  description: The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.
  measure: Change in performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) from baseline will be compared within subjects.
  time frame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
  description: The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.
  measure: Change in performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) from baseline will be compared within subjects.
  time frame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
  description: The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.
  measure: Change in performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Test (COWAT) from baseline will be compared within subjects.
  time frame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
  description: The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.
  measure: Change from baseline performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.
  measure: Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.
  measure: Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.
  measure: Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.
  measure: Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.
  measure: Change from baseline performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Tet (COWAT) at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.
  measure: Change from baseline performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.
  measure: Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.
  measure: Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.
  measure: Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.
  measure: Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.
  measure: Change from baseline performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Tet (COWAT) at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.
  measure: Change from baseline performance (i.e., raw score of number of words recalled, in whole numbers) on the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.
  measure: Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.
  measure: Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Trail Making Test (TMT) at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.
  measure: Change from baseline performance (i.e., raw scores of time to complete task, in seconds) on the Symbol Digit Modalities Test (SDMT) at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.
  measure: Change from baseline performance (i.e., raw score of total correct, in whole numbers) on the Paced Auditory Serial Addition Test (PASAT) at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.
  measure: Change from baseline performance (i.e., raw scores of total words generated, in whole numbers) on the Controlled Oral Word Association Tet (COWAT) at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.
  measure: Change from baseline cognitive complaints (i.e., total number of complaints) at 3 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.
  measure: Change from baseline cognitive complaints (i.e., total number of complaints) at 6 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.
  measure: Change from baseline cognitive complaints (i.e., total number of complaints) at 9 weeks post-chronic exercise intervention.
  time frame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
  description: Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.
  measure: Change in total score on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
  time frame: one week before first acute exercise condition (baseline); after acute exercise condition on day 8; after acute exercise condition on day 15; and after 3 weeks, 6 weeks, and 9 weeks of the chronic exercise condition or activity as usual
  description: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) a 20-item widely used questionnaire to assess the severity of symptoms of posttraumatic stress disorder (PTSD). The minimum score on this measure is 0, and the highest score is 80. Higher scores indicate worse symptoms of PTSD.
  measure: Change in total score on the Center for Epidemiological Studies Depression Scale Revised (CESD-R).
  time frame: one week before first acute exercise condition (baseline); after acute exercise condition on day 8; after acute exercise condition on day 15; and after 3 weeks, 6 weeks, and 9 weeks of the chronic exercise condition or activity as usual
  description: The Center for Epidemiological Studies Depression Scale Revised (CESD-R) is a 20-item self-report measure of depression symptoms used in research. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate worse symptoms of depression.
  arm group label: Acute Exercise Moderate first
  arm group type: Experimental
  description: Day 1 Assessments, Day 8 Moderate Intensity Exercise (followed by symptom measures and neuropsychological tests), Day 15 Light Intensity Exercise (symptom measures and neuropsychological tests)
  arm group label: Acute Exercise Light first
  arm group type: Active Comparator
  description: Control Day 1 Assessments (symptom measures, neuropsychological tests, and cognitive complaints interview), Day 8 Light Intensity Exercise (followed by symptom measures and neuropsychological tests), Day 15 Moderate Intensity Exercise (symptom measures and neuropsychological tests)
  arm group label: Chronic Exercise Moderate
  arm group type: Experimental
  description: 9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
  arm group label: Activity as Usual
  arm group type: No Intervention
  description: 9-week activity as usual Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
  intervention type: Behavioral
  intervention name: Moderate Intensity Exercise (one day)
  description: Participants will engage in 40 minutes of cycling at 70-75% maximum heart rate (MHR).
  arm group label: Acute Exercise Light first
  arm group label: Acute Exercise Moderate first
  intervention type: Behavioral
  intervention name: Placebo - Light Intensity Exercise (one day)
  description: Control participants will engage in 40 minutes cycling at 40-50% maximum heart rate (MHR).
  arm group label: Acute Exercise Light first
  arm group label: Acute Exercise Moderate first
  intervention type: Behavioral
  intervention name: Moderate Intensity Exercise (9 wks)
  description: Participants will be asked to engage in moderate-intensity activity four days each week, 40 minutes each time, and will wear an activity monitoring device to assess their fidelity to the intervention.
  arm group label: Chronic Exercise Moderate
  intervention type: Other
  intervention name: Day 1 Assessments
  description: Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Life Events Checklist (LEC-5), and neuropsychological testing: approximately 1.50 hours
  arm group label: Acute Exercise Light first
  arm group label: Acute Exercise Moderate first
  intervention type: Other
  intervention name: Symptom Measures and Neuropsychological Tests
  description: Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), and neuropsychological testing: approximately 1.25 hours
  arm group label: Acute Exercise Light first
  arm group label: Acute Exercise Moderate first
  intervention type: Other
  intervention name: Day 36 Assessments
  description: Activity monitoring device charged and data downloaded, questions regarding fidelity to activity as usual or moderate-intensity exercise and any difficulties, Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), neuropsychological testing, and activity monitoring device returned to participant: approximately 2.00 hours
  arm group label: Chronic Exercise Moderate
  intervention type: Other
  intervention name: Day 57 Assessments
  description: Activity monitoring device charged and data downloaded, questions regarding fidelity to activity as usual or moderate-intensity exercise and any difficulties, Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), neuropsychological testing, and activity monitoring device returned to participant: approximately 2.00 hours
  arm group label: Chronic Exercise Moderate
  intervention type: Other
  intervention name: Day 78 Assessments
  description: Activity monitoring device charged and data downloaded, questions regarding fidelity to activity as usual or moderate-intensity exercise and any difficulties, Cognitive complaints interview, Center for Epidemiological Studies Depression Scale Revised (CESD-R), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), neuropsychological testing, and activity monitoring device returned to participant: approximately 2.00 hours
  arm group label: Chronic Exercise Moderate
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erin Logue, PhD
  role: Principal Investigator
  affiliation: University of Texas at Austin
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas at Austin
  investigator full name: Erin Logue
  investigator title: assistant professor
  sharing ipd: No