Childhood Trauma, Exercise, and Cognition
NCT05972265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2023-12-01
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
- 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
Sponsors & Collaborators
-
University of Texas at Austin
lead OTHER
Principal Investigators
-
Erin Logue, PhD · University of Texas at Austin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-27
- Primary Completion
- 2024-12-04
- Completion
- 2024-12-04
Countries
- United States
Study Locations
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