The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Change in cognitive function summary score
研究概览
简要总结
The primary objective of this study is to conduct a randomized, controlled trial to determine whether engaging in mental activity or exercise, either alone or in combination, improves cognitive function in non-demented, inactive older adults who self-report a recent decline in memory or thinking. In addition, we, the researchers at the University of California, San Francisco, plan to seek funding to follow subjects over time to determine whether these interventions are associated with changes in rate of cognitive decline or risk of dementia after the intervention period has ended.
详细描述
SPECIFIC AIMS AND HYPOTHESES
Aim 1: To determine whether a 12-week, computer-based mental activity program improves cognitive function in non-demented, inactive elders.
We hypothesize that this mental activity program will improve cognitive function-especially visuospatial function-in non-demented, inactive elders.
Aim 2: To determine whether a 12-week exercise program improves cognitive function in non-demented, inactive elders.
We hypothesize that this exercise program will improve cognitive function-especially executive function-in non-demented, inactive elders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 64
- •Self-report of recent decline in memory or thinking
- •Low/no physical activity (<2 days/week for <30 minutes/session of moderate intensity activity over past 3 months)
- •Low/no computer mental activity (<2 days/week for <30 minutes/session over past 3 months)
- •Fluent in English
- •Willingness to perform study activities
排除标准
- •Evidence of dementia (based on self-report, physician diagnosis or score < 19 on Telephone Interview for Cognitive Status)
- •Significant central nervous system disorder (Parkinson's disease, multiple sclerosis, ALS [Lou Gerig's disease])
- •Major, current psychiatric disorder (major depressive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder, psychiatric hospitalization in past 20 years)
- •Major central nervous system event (stroke, transient ischemic attack/mini-stroke, seizure, or traumatic brain injury that has left a residual deficit)
- •Significant heart disease (severe congestive heart failure, severe aortic stenosis, cardiac arrest, uncontrolled angina)
- •Significant lung disease (requiring supplemental oxygen or oral or injected steroids)
- •Other condition that would make participation potentially dangerous (cancer requiring treatment in past 3 years, severe arthritis, history of cardiac defibrillation, dialysis)
- •Lack of physician approval
- •Severe hearing or visual impairment
- •History of learning disability
- •Starting prescription medication to enhance cognitive function (e.g., memantine, aricept)
- •Dependent in any basic activity of daily living (eating, dressing, bathing, toileting, getting out of bed/chair)
- •History of alcohol abuse/heavy alcohol use
- •History of drug abuse/heavy drug use
- •Currently enrolled in another research study
- •Fibromyalgia or tremor severe enough to prevent use of a computer mouse
- •Planning to travel > 4 exercise class days during study period
- •Behaviors during screening or baseline visit that, in the judgement of research staff, are likely to present significant problems (e.g., uncooperative, anger, inappropriate physical contact)
- •Unable to perform neuropsychological evaluations
- •Unable to complete consent process
结局指标
主要结局
Change in cognitive function summary score
时间窗: 12 weeks
次要结局
- Visual processing speed summary score (mental activity group), executive function summary score (exercise group), other measures (e.g., leisure activity, physical performance, physical function, depressive symptoms, sleep quality)(12 weeks)
研究者
Deborah Barnes
Associate Professor, Psychiatry and Epidemiology & Biostatistics
University of California, San Francisco