Clinical trial NCT05972265: Childhood Trauma, Exercise, and Cognition
Official title: Exercise and Cognition in Middle-Aged Adults With Histories of Childhood Trauma and Cognitive Complaints
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adverse Childhood Experiences
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15.
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.
timeFrame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
timeFrame: exercise condition on day 8, and after acute exercise condition on day 15
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.
timeFrame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
timeFrame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
timeFrame: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
measure: Change from baseline cognitive complaints (i.e., total number of complaints) at 3 weeks post-chronic exercise intervention.
timeFrame: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
measure: Change from baseline cognitive complaints (i.e., total number of complaints) at 6 weeks post-chronic exercise intervention.
timeFrame: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
measure: Change from baseline cognitive complaints (i.e., total number of complaints) at 9 weeks post-chronic exercise intervention.
timeFrame: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Secondary outcomes:
measure: Change in total score on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
timeFrame: 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
measure: Change in total score on the Center for Epidemiological Studies Depression Scale Revised (CESD-R).
timeFrame: 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
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Erin Logue, PhD
role: PRINCIPAL_INVESTIGATOR
References: