Brain Exercises for Synaptic Plasticity: the BEST Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- FCSRT
研究概览
简要总结
The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. origami study arms and a placebo group without structured cognitive intervention.
详细描述
This is a randomized, placebo controlled study investigating the practical implementation and conduct of two cognitive interventions in non-demented subjects. Subjects will be randomized 1:1:1 into three groups including: 1) a Book club that includes weekly one hour meetings and daily reading assignments, 2) Origami lessons (one hour/week) with daily take home Origami activities to complete, and 3) a placebo group with unstructured lifestyle activities (normal lifestyle activities without restraint).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non demented community dwelling elders
排除标准
- •Unable to perform the reading or origami tasks for any reason
研究组 & 干预措施
Placebo
Usual lifestyle activities
干预措施: Placebo (Behavioral)
Origami
Origami lessons (one hour/week) with daily take home Origami activities to complete
干预措施: Origami (Behavioral)
Reading
Daily reading (out loud into a voice recorder) for one hour
干预措施: Reading (Behavioral)
结局指标
主要结局
FCSRT
时间窗: 8 weeks
The Free and Cued Selective Reminding Test (FCSRT) measures memory function.
MOCA
时间窗: 8 weeks
The Montreal Cognitive Assessment (MOCA) measures general cognitive function
次要结局
- Electroencephalogram(8 weeks)
- Evoked Related Potential(8 weeks)
- Adherence to protocol(8 weeks)
研究者
Gregory Jicha, 323-5550
M.D., Ph.D., Professor
University of Kentucky