Childhood Trauma, Exercise, and Cognition

Adverse Childhood Experiences Clinical Trial

— CTEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972265
• Other study ID #: STUDY00004558
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: December 4, 2024

Study information

• Verified date: November 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 4, 2024
• Est. primary completion date: December 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Childhood Experiences

Intervention

Behavioral:
• Moderate Intensity Exercise (one day)
Participants will engage in 40 minutes of cycling at 70-75% maximum heart rate (MHR).
• Placebo - Light Intensity Exercise (one day)
Control participants will engage in 40 minutes cycling at 40-50% maximum heart rate (MHR).
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.	one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15.
Primary	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.	The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.	one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
Primary	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.	The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.	exercise condition on day 8, and after acute exercise condition on day 15
Primary	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.	The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.	one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
Primary	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.	The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.	one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
Primary	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.	The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.	one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L) is a reliable, well-validated measure of verbal learning and memory. The minimum score on this measure is 0, and the highest score is 15. Higher scores indicate better memory.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span test is a reliable, well-validated measure of auditory attention and working memory. The minimum score on this measure is 0, and the highest score is 48. Higher scores indicate better attention.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Trail Making Test (TMT) is a reliable, well-validated measure of visual attention, processing speed, and executive function. The minimum score on this measure is 1, and the highest score is 300. Lower scores indicate better executive function.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Symbol Digit Modalities Test (SDMT) is a reliable, well-validated measure of visual working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 110. Higher scores indicate faster processing speed.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Paced Auditory Serial Addition Test (PASAT) is a reliable, well-validated measure of auditory working memory, processing speed, and executive function. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate better working memory.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Primary	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.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. The Controlled Oral Word Association Test (COWAT) is a reliable, well-validated measure of language and executive function. The minimum score on this measure is 0, and the highest score is 180. Higher scores indicate better ability to generate words given a phonemic cue.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Primary	Change from baseline cognitive complaints (i.e., total number of complaints) at 3 weeks post-chronic exercise intervention.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.	one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
Primary	Change from baseline cognitive complaints (i.e., total number of complaints) at 6 weeks post-chronic exercise intervention.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.	one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
Primary	Change from baseline cognitive complaints (i.e., total number of complaints) at 9 weeks post-chronic exercise intervention.	Assessed between participants assigned to 9-week intervention and those assigned to activity as usual. To assess cognitive complaints, an interview by the primary investigator, asking about symptoms of difficulties with attention, thinking speed, language, memory, and executive function.	one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
Secondary	Change in total score on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) a 20-item widely used questionnaire to assess the severity of symptoms of posttraumatic stress disorder (PTSD). The minimum score on this measure is 0, and the highest score is 80. Higher scores indicate worse symptoms of PTSD.	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
Secondary	Change in total score on the Center for Epidemiological Studies Depression Scale Revised (CESD-R).	The Center for Epidemiological Studies Depression Scale Revised (CESD-R) is a 20-item self-report measure of depression symptoms used in research. The minimum score on this measure is 0, and the highest score is 60. Higher scores indicate worse symptoms of depression.	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