Effect of Activities and Exercise on Sleep in Dementia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Total sleep time at night and amplitude of the sleep wake rhythm.
研究概览
简要总结
The purpose of the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia.
详细描述
Elders with cognitive impairment usually do not a get a good night's sleep and wake up often during their sleep at night. Increased daytime individualized social activity and physical resistance training with walking have the potential to increase nighttime sleep in elders. This can lead to a better quality of life, a decrease in caregiver burden and decrease in nighttime falls for this population and associated fiscal savings.
Consent forms for this RCT, were written in large print, followed all the guidelines of the Institutional Review Board of the University of Arkansas for Medical Sciences, and assured the participants that their participation in the study was voluntary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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 old or older
- •Mini Mental State Examination (MMSE)of 4-26, indicating dementia or mild cognitive impairment
- •Less than seven hours of nocturnal sleep and 30 minutes of daytime sleep
- •At least two weeks residency in the nursing home
- •Medical diagnosis of dementia; AND
- •Ability to stand with assistance
排除标准
- •Documented near-terminal or unstable medical conditions
- •Unresolved malignancy
- •Treatment with chemotherapy; AND
- •Unstable cardiovascular disease
结局指标
主要结局
Total sleep time at night and amplitude of the sleep wake rhythm.
时间窗: 7 weeks
次要结局
- To explore the roles of daytime napping, muscle strength, and physical activity for mediating the effect of Physical Resistance Training (PRT) and walking on total sleep time at night.(7 weeks)