NCT02196545已完成不适用
An Easily Accessible Physical Activity Training Program for Patients With Alzheimer's Dementia: Effect on Clinical and Neurobiological Parameters (MOTODEM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- activities of daily living
研究概览
简要总结
The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >55 years
- •German is the dominant language (necessary for neuropsychological testing)
- •minimum of 8 years formal school education
- •caregiver (e.g. spouse) living at home with participant
- •physical examination does not reveal contraindications to physical activity
- •stable dose of pharmacological dementia treatment according to German guidelines (DGPPN) with acetylcholinesterase inhibitor or memantin or combination for at least 6 months
- •no other medication that could influence cognitive functioning (e.g. benzodiazepines, sleep aids, neuroleptics)
排除标准
- •history of neurological or psychiatric disease other than AD
- •history of substance abuse disorder
- •history of electroconvulsive therapy (ECT) during the last 6 months
- •structural brain deficits diagnosed in the MRI scan, also without clinical relevance (incidental finding)
- •pacemaker, artificial heart valve, insulin pump or other medical implants
- •average steps/day are above 10.000 steps/day
结局指标
主要结局
activities of daily living
时间窗: change from baseline after 12 weeks
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
次要结局
- executive function and language ability(change from baseline after 12 weeks and 24 weeks)
- caregiver burden(change from baseline after 12 weeks and 24 weeks)
- behavioral symptoms of dementia(change from baseline after 12 weeks and 24 weeks)
- Reaction time, hand-eye quickness and attention(change from baseline after 12 weeks and 24 weeks)
- activities of daily living(change from baseline after 24 weeks)
- cognition(change from baseline after 12 weeks and 24 weeks)
研究者
研究点 (2)
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