Childhood Trauma, Exercise, and Cognition

NCT05972265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-12-01

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05972265 on ClinicalTrials.gov