NCT05972265 · University of Texas at Austin
Childhood Trauma, Exercise, and Cognition
(CTEC)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Moderate Intensity Exercise (one day)
Participants will engage in 40 minutes of cycling at 70-75% maximum heart rate (MHR).
BEHAVIORAL
Placebo - Light Intensity Exercise (one day)
Control participants will engage in 40 minutes cycling at 40-50% maximum heart rate (MHR).
BEHAVIORAL
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.
OTHER
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
OTHER
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
OTHER
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
OTHER
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
OTHER
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 measures
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Austin, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations