Recruiting

Childhood Trauma

Sponsor:

University of Texas at Austin

Code:

NCT05972265

Conditions

Adverse Childhood Experiences

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Interventions

Moderate Intensity Exercise (one day)

Placebo - Light Intensity Exercise (one day)

Moderate Intensity Exercise (9 wks)

Day 1 Assessments

Symptom Measures and Neuropsychological Tests

Study Details

Brief summary:

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.

Conditions

Adverse Childhood Experiences

Study ID

NCT05972265

Start date

Nov 27, 2023

Status verified date

Jul, 2026

Completion date

Jun 4, 2027

Anticipated

Primary completion date

Jun 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • between 40 and 60 years of age
  • history of child abuse or neglect
  • have a complaint about memory, attention, or executive function
  • native or fluent English speaker
  • normal or corrected to normal vision and hearing
  • medically healthy

Exclusion Criteria:

  • Score indicating a history of moderate-intensity activity, hard-intensity activity, or very-hard intensity activity on the Stanford Brief Activity Survey
  • current excessive alcohol or other substance use
  • eating disorder, bipolar disorder, schizophrenia spectrum disorders, or those judged to be an immediate suicide risk based on having an active plan with intent
  • autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), or other neurodevelopmental disorder
  • neurocognitive disorder, or illnesses or history of neurological events known to cause neurocognitive disorders (e.g., traumatic brain injury, status epilepticus, stroke)
  • reported chest pain or dizziness during exercise; any endorsed and not controlled medical condition that could make exercise contraindicated, including hypertension; heart disease; heart failure; hear rhythm disorders; heart valve disease; metabolic conditions; chronic obstructive pulmonary disease; pulmonary hypertension; cystic fibrosis; asthma; and bone, joint, or soft tissue problems
  • pregnancy, major medical disorders such as cancer, or any other condition believed to put a participant at risk

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Acute Exercise Moderate first

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)

active comparator: Acute Exercise Light first

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)

experimental: Chronic Exercise Moderate

9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments

no intervention: Activity as Usual

9-week activity as usual Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments

Interventions

Moderate Intensity Exercise (one day)

Participants will engage in 40 minutes of cycling at 70-75% maximum heart rate (MHR).

Placebo - Light Intensity Exercise (one day)

Control participants will engage in 40 minutes cycling at 40-50% maximum heart rate (MHR).

Moderate Intensity Exercise (9 wks)

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.

Day 1 Assessments

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

Symptom Measures and Neuropsychological Tests

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

Day 36 Assessments

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

Day 57 Assessments

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

Day 78 Assessments

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

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. [ 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. ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Erin Logue

512-954-5510erin.logue@austin.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-07-17.