Childhood Trauma, Exercise, and Cognition (CTEC)

The University of Texas System (UT)

Status: Enrolling

Conditions: Adverse Childhood Experiences

Treatments: Behavioral: Placebo - Light Intensity Exercise (one day); Behavioral: Moderate Intensity Exercise (9 wks); Other: Day 78 Assessments; Behavioral: Moderate Intensity Exercise (one day); Other: Day 1 Assessments; Other: Day 57 Assessments; Other: Symptom Measures and Neuropsychological Tests; Other: Day 36 Assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT05972265

STUDY00004558

Details and patient eligibility

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. 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

34 participants in 4 patient groups

Acute Exercise Moderate first

Experimental group

Description:

Day 1 Assessments, Day 8 Moderate Intensity Exercise (followed by symptom measures and neuropsychological tests), Day 15 Light Intensity Exercise (symptom measures and neuropsychological tests)

Treatment:

Other: Symptom Measures and Neuropsychological Tests

Behavioral: Placebo - Light Intensity Exercise (one day)

Behavioral: Moderate Intensity Exercise (one day)

Other: Day 1 Assessments

Acute Exercise Light first

Active Comparator group

Description:

Control Day 1 Assessments (symptom measures, neuropsychological tests, and cognitive complaints interview), Day 8 Light Intensity Exercise (followed by symptom measures and neuropsychological tests), Day 15 Moderate Intensity Exercise (symptom measures and neuropsychological tests)

Treatment:

Other: Symptom Measures and Neuropsychological Tests

Behavioral: Placebo - Light Intensity Exercise (one day)

Behavioral: Moderate Intensity Exercise (one day)

Other: Day 1 Assessments

Chronic Exercise Moderate

Experimental group

Description:

9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments

Treatment:

Other: Day 36 Assessments

Behavioral: Moderate Intensity Exercise (9 wks)

Other: Day 78 Assessments

Other: Day 57 Assessments

Activity as Usual

No Intervention group

Description:

9-week activity as usual Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments