NCT05972265

Childhood Trauma, Exercise, and Cognition

Exercise and Cognition in Middle-Aged Adults With Histories of Childhood Trauma and Cognitive Complaints

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2023-08-02
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States