NCT02114125Unknown不适用
The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Change from Baseline Cognitive Function at 8 weeks and 16weeks
研究概览
简要总结
Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities.
The purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.
详细描述
- to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
- to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 year and older
- •Able to communicate verbally
- •Able to discern 5*5 cm2 picture from a viewing distance of 20 cm
- •Able to hear a sound of normal speech from a distance of 20 cm
- •Able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort
- •Has cognitive decline status assessing by CASI 2.0
- •Lived in long-term care facilities during the study
排除标准
- •Complete aphasia, blindness, deafness or completely dependent
- •Unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression
- •Thrombophlebitis, or malignancy of the limbs.
- •Refusal by patient or family member.
- •Others. Reason to be well documented.
结局指标
主要结局
Change from Baseline Cognitive Function at 8 weeks and 16weeks
时间窗: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Cognitive Function: Cognitive Assessment Screening Instrument (CASI) 2.0 in Chinese version
次要结局
- Change from Baseline Depression at 8 weeks and 16weeks(pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 ))
- Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:(pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 ))
研究者
研究点 (2)
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