Active Physical Activity - Virtual Reality Cognitive Therapy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Hong Kong - Montreal cognitive assessment scale
研究概览
简要总结
The goal of this clinical trial is to learn if active Physical activity + virtual reality cognitive therapy (aPAVRCT) works to slow the progression of AD cognitive decline in older adults. It will also learn about the physical effects and mental effects of the aPAVRCT. The main questions it aims to answer are:
Does aPAVRCT slow the progression of AD cognitive decline? (e.g., HK-MoCA, ADAS-Cog) Does aPAVRCT improve physical function? (e.g., ADL) Does aPAVRCT improve mental health? (e.g., GDS-15, PANAS) Does aPAVRCT improve life satisfaction? Does aPAVRCT improve other cognitive or physical capacities? What issues and benefits do participants and stakeholders (e.g., families, caregivers, managers) have when taking aPAVRCT? (e.g., NPI-Q) Researchers will compare the intervention group (aPAVRCT) to a control group (rehabilitation bike) to see if aPAVRCT works to slow the progression of AD in cognitive decline.
Participants will:
Take aPAVRCT (interventional group) or usual physical acitvity (control group) at least twice a week, 15 minutes for each session, for 12-16 weeks Physiotherapies (assistants) and care professionals will do the intervention, research group will operate, observe, and assist the experiment.
All the experiment processes will be recorded. Visit the sites everyday for checkups and tests Keep a diary of their symptoms, the number of times, and any essential information
Sites: around 3-5 nursing homes, under one institution. Inclusion criteria: older adults in the setting who have the ability to pedal a rehabilitation bike.
详细描述
The aim of study is to investigate the effect of active Physical activity + virtual reality cognitive therapy (aPAVRCT) on cognitive function in older adults with Alzheimer's Dementia and related dementias. The investigator hypothesizes the "Physical activity + virtual environment brain stimulations' would slow the process of AD cognitive decline. The life satisfaction score in the intervention group would be higher than that of the control group.
The investigator will conduct measurements on three aspects: The Chinese version of the MoCA, physical functions, and emotional changes. Data will be collected at baseline, 4-week, 8-week, 12-week after interventions for the two groups, and a follow-up measurement. In addition, the investigator will use some qualitative methods, such as focus group, interview, observation, during and after the first 3-month intervention to identify some issues during the intervention and to probe caregivers. The investigator will use both the Ttest between the two groups (to compare cognitive decline progressions, and life satisfaction) and mixed methods to illustrate life satisfaction, especially among caregivers.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older adults in the setting who have the ability to pedal the rehabilitation bike
排除标准
- •Individuals self-reporting or identified by stakeholders as unwilling or unsuitable to participate.
研究组 & 干预措施
Experimental
干预措施: aPAVRCT (Behavioral)
control
usual care (PA)
结局指标
主要结局
Hong Kong - Montreal cognitive assessment scale
时间窗: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
MoCA is a cognitive assessment method for dementia, particularly mild stages of cognitive impairment. (range, 0-30, with lower scores indicating greater cognitive impairment)
The Integrated Alzheimer's Disease Rating Scale (iADRS)
时间窗: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
iADRS (range, 0-144, with lower scores indicating greater cognitive and functional described impairment) is to assess both cognitive and physical functions for dementia, combines the 13-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog13 ), the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL).
Mini-Mental State Examination (MMSE)
时间窗: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
For cognitive assessment, (range: 0-144, with lower scores indicating greater cognitive impairment)
次要结局
- Sit to Stand Test(at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention))
- Geriatric depression scale (GDS-15)(at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention))
- Neuropsychiatric Inventory-Questionnaire (NPI-Q)(at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention))
- Time up and Go Test(at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention))
- The Cornell Scale for Depression in Dementia (CSDD)(at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention))
- Positive Affect and Negative Affect Scale(at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention))
研究者
GE LIN KAN
Professor
Hong Kong University of Science and Technology