Exercise and Cognition in Middle-Aged Adults With Histories of Childhood Trauma and Cognitive Complaints
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change from baseline cognitive complaints (i.e., total number of complaints) at 6 weeks post-chronic exercise intervention.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acute Exercise Moderate first
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)
干预措施: Moderate Intensity Exercise (one day) (Behavioral)
Activity as Usual
9-week activity as usual Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
Acute Exercise Moderate first
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)
干预措施: Placebo - Light Intensity Exercise (one day) (Behavioral)
Acute Exercise Moderate first
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)
干预措施: Day 1 Assessments (Other)
Acute Exercise Moderate first
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)
干预措施: Symptom Measures and Neuropsychological Tests (Other)
Acute Exercise Light first
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)
干预措施: Moderate Intensity Exercise (one day) (Behavioral)
Acute Exercise Light first
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)
干预措施: Placebo - Light Intensity Exercise (one day) (Behavioral)
Acute Exercise Light first
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)
干预措施: Day 1 Assessments (Other)
Acute Exercise Light first
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)
干预措施: Symptom Measures and Neuropsychological Tests (Other)
Chronic Exercise Moderate
9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
干预措施: Moderate Intensity Exercise (9 wks) (Behavioral)
Chronic Exercise Moderate
9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
干预措施: Day 36 Assessments (Other)
Chronic Exercise Moderate
9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
干预措施: Day 57 Assessments (Other)
Chronic Exercise Moderate
9-weeks Moderate Intensity Exercise Day 36 (at 3 weeks) Assessments Day 57 (at 6 weeks) Assessments Day 78 (at 9 weeks) Assessments
干预措施: Day 78 Assessments (Other)
结局指标
主要结局
Change from baseline cognitive complaints (i.e., total number of complaints) at 6 weeks post-chronic exercise intervention.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15.
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.
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.
时间窗: exercise condition on day 8, and after acute exercise condition on day 15
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.
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.
时间窗: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
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.
时间窗: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
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.
时间窗: one week before first acute exercise condition (baseline), after acute exercise condition on day 8, and after acute exercise condition on day 15
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 6 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
Change from baseline cognitive complaints (i.e., total number of complaints) at 3 weeks post-chronic exercise intervention.
时间窗: one week before first acute exercise condition (baseline) and after 3 weeks of the chronic exercise condition or activity as usual
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.
Change from baseline cognitive complaints (i.e., total number of complaints) at 9 weeks post-chronic exercise intervention.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
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.
时间窗: one week before first acute exercise condition (baseline) and after 9 weeks of the chronic exercise condition or activity as usual
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.
次要结局
- Change in total score on the Center for Epidemiological Studies Depression Scale Revised (CESD-R).(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 Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).(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)
研究者
Erin Logue
assistant professor
University of Texas at Austin