The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 1
- 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.
研究组 & 干预措施
Usual Care Group:
Usual care consists of standard institutionalized services provided by physicians, nurses, and support staff (e.g., nurse assistants, social workers) in long-term care facilities.
High-intensity physical activity (5PA)
The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks.
干预措施: Physical Activity (Behavioral)
Low-intensity PA and CT(3PA+2CT)
The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.
干预措施: Physical Activity (Behavioral)
Low-intensity PA and CT(3PA+2CT)
The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.
干预措施: Cognitive Training (Behavioral)
High-intensity PA and CT (5PA+5CT)
The intervention conducts the individual-based, multi-domains cognitive training, 5days per- week and group-based physical activity, 5 days per- week and for 8 weeks.
干预措施: Physical Activity (Behavioral)
High-intensity PA and CT (5PA+5CT)
The intervention conducts the individual-based, multi-domains cognitive training, 5days per- week and group-based physical activity, 5 days per- week and for 8 weeks.
干预措施: Cognitive Training (Behavioral)
Low-intensity cognitive training (2CT)
The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks.
干预措施: Cognitive Training (Behavioral)
High-intensity cognitive training (5CT)
The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks.
干预措施: Cognitive Training (Behavioral)
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 ))