The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 24
- 主要终点
- Change from baseline in executive function at 6-months
研究概览
简要总结
The purpose of this study is to clarify the benefits to brain health and thinking processes that result from different forms of exercise. This study will examine the effectiveness of cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with MCI, and compare this with the individual cognitive, behavioral, and physiological effects of physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will be greatest for combined aerobic and cognitive exercise compared to physical and mental exercise alone.
详细描述
This is a multi-site, randomized controlled trial. Participants will be randomized into one of three conditions for six months: cybercycle-tour, cybercycle-game, or videogame alone. Comprehensive evaluations will include: neuropsychological (e.g., executive function and memory), behavioral (e.g., compliance and effort/watts), physiological (e.g., cardiorespiratory fitness), biomarker (e.g., BDNF), and an expanded neuroimaging pilot. After the six-month intervention period, participants choose whether or not to continue exercising, using any of the three conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to pedal recumbent stationary bicycle
- •available for regular exercise participation 3-5x/week for at least 6 months
- •physician permission to exercise
排除标准
- •unstable heart condition or other significant cardiovascular history (e.g,. stroke)
- •meets criteria for Alzheimer's or other dementia
- •significant history of other neurological disease (e.g., seizures, Parkinson's, etc.)
- •physician denial to exercise
研究组 & 干预措施
Cybercycle-Game
Combined aerobic & cognitive exercise for 6 months, 3-5x/week.
干预措施: Cybercycle-Game (Behavioral)
Cybercyle-Tour
Aerobic exercise only for 6 months, 3-5x/week.
干预措施: Cybercyle-Tour (Behavioral)
Game Only
Cognitive exercise only 6 months, 3-5x/week.
干预措施: Game Only (Behavioral)
结局指标
主要结局
Change from baseline in executive function at 6-months
时间窗: Baseline and 6-months
Change in executive function from baseline at 6-months will be assessed by using a composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
次要结局
- Change from baseline in executive function at 3-months(Baseline and 3-months)
- Change in weight(Baseline, 3-months, 6-months, 1-year)
- Change from baseline in executive function at 1-year follow-up(Baseline and 1-year)
- Change in mood(Baseline, 3-months, 6-months, 1-year follow-up)
研究者
Cay Anderson-Hanley, PhD
Associate Professor
Union College, New York