A Telemedicine Intervention to Improve Cognitive Function in Patients With PD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
研究概览
简要总结
This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.
详细描述
Background/Rationale:
Progressive cognitive impairment leading to dementia is an important component of Parkinson's disease (PD), contributing to significant levels of disability. The number of Veterans who will develop PD and, in turn, the number of Veterans with PD who develop dementia is likely to increase substantially. Given the profound negative health and social consequences associated with the development of dementia, it is critical to identify interventions that effectively slow the decline of cognitive function to prolong the time to onset of dementia. Based on the results of prior studies, physical activity is one of the few nonpharmacological interventions that holds promise in slowing cognitive decline.
Objective:
The investigators hypothesize that a home-based physical activity intervention to promote walking will reduce cognitive decline in Veterans with mild cognitive impairment in PD (PD-MCI).
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- •At least 2 of 3 cardinal signs of PD
- •Response to dopaminergic medication
- •Mild cognitive impairment
排除标准
- •Angina pectoris
- •History of myocardial infarction within 6 months
- •History of ventricular dysrhythmia requiring current therapy
研究组 & 干预措施
Physical Activity
Structured walking program
干预措施: Structured physical activity (Behavioral)
Control
Health education attention control
干预措施: Health education (Behavioral)
结局指标
主要结局
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
时间窗: Baseline and 6 months
The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.
次要结局
- Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12(Baseline and 12 months)
- Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18(Baseline and 18 month)