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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 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
研究组 & 干预措施
Exercise
Experimental
Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)
干预措施: Exercise (Behavioral)
Treatment as usual
No Intervention
Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise
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 (1)
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