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临床试验/NCT01264614
NCT01264614已完成不适用

Neuropsychological and Neuroimaging Effects of Strengthening Exercise for Early Dementia and Normative Older Adults

Union College, New York2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2010年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Digits Backwards Test Performance From Pre- to Post-intervention

研究概览

简要总结

This study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults. Participants will engage in 3 months of exercise 3-5 times per week using a chair and small weights. It is hypothesized that there will be a significant improvement in brain function.

详细描述

  1. Objective(s): This study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults.
  2. Research Design: This is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample.
  3. Methodology: The aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. Neuropsychological evaluation, resting electroencephalography (EEG), and event-related potentials (ERP) data collection will commence prior to the start of exercise. Participants will participate in an exercise class 2-3x/wk for three months. Repeat neuropsychological, EEG, and ERP evaluations will occur at the conclusion of three months of exercise. The exercises consist of low-intensity exercises, using a chair and small weights. A leader trained in the Tufts University exercise model will conduct the classes.
  4. Findings: The investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. This change will be compared with performance of normative controls who also exercise. Changes in brain function will be explored using EEG and ERP, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Day Program Participants with early dementia able to consent or assent with surrogate permission
  • Control participants (55-100+ yo) able to participate at location with doctor permission

排除标准

  • history of significant TBI, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises

结局指标

主要结局

Digits Backwards Test Performance From Pre- to Post-intervention

时间窗: Baseline and 3 months

Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).

Fuld Test Performance From Pre- to Post-intervention

时间窗: Baseline and 3 months

Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).

Neurophysiological Function Pre- & Post- Intervention

时间窗: Baseline and 3 months

Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention

Stroop Test Performance From Pre- to Post-intervention

时间窗: Baseline and 3 months

Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).

Color Trails Test Performance From Pre- to Post-intervention

时间窗: Baseline and 3 months

Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).

Figure Copy & Delayed Test Performance From Pre- to Post-intervention

时间窗: Baseline and 3 months

Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy \& Delayed possible score range is 0-36 points).

次要结局

未报告次要终点

研究者

发起方
Union College, New York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cay Anderson-Hanley

Principal Investigator

Union College, New York

研究点 (2)

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