Childhood Trauma, Exercise, and Cognition

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15.]
• 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. [Срок оценки: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15]
• 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. [Срок оценки: exercise condition on day 8, and after acute exercise condition on day 15]
• 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. [Срок оценки: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15]
• 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. [Срок оценки: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15]
• 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. [Срок оценки: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15]
• 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. [Срок оценки: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual]
• 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. [Срок оценки: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual]
• 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. [Срок оценки: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual]
• 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. [Срок оценки: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual]

Вторичные конечные точки (2)

• Change in total score on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). [Срок оценки: 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]
• Change in total score on the Center for Epidemiological Studies Depression Scale Revised (CESD-R). [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Texas at Austin — Austin

Идентификаторы

NCT: NCT05972265 · STUDY00004558

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗