FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Timed Up and Go test
研究概览
简要总结
This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. FitMi AD uses embedded sensors that can track and record the patient's direction and degree of movement while performing exercises described on a computer.
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
- Single (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have MCI or mild dementia due to AD (i.e. Clinical Dementia Rating (CDR) score 1 for mild dementia or 0.5 for MCI)
- •ability to clearly see the screen and hear the audio instructions from the tablet
- •have a family member or friend who can answer questions about the participant's daily living skills
- •willing to participate in a research study.
排除标准
- •age < 50 years old
- •use of a wheelchair as a primary mobility device (use of a cane or walker is permitted)
- •presence of other neurologic conditions such as movement disorders or history of stroke
- •other severe concurrent medical conditions that may prevent the participants from completing the 3-month study
研究组 & 干预措施
Experimental: FitMi AD Exercise Program
Participants will perform exercises by interacting with FitMi pucks, as described and monitored on a tablet computer. Participants will be asked to exercise at least 30 minutes per day for 3 months.
干预措施: FitMi AD (Device)
Active Comparator: Conventional booklet of exercise program
Participants will perform exercises described in a booklet similar to what is typically provided to individuals. Participants will be asked to exercise at least 30 minutes per day for 3 months.
干预措施: Conventional exercise program (Other)
结局指标
主要结局
Change in Timed Up and Go test
时间窗: Baseline, Immediately Post-Treatment (an average of 3 months)
Time it takes to stand up from a chair and walk a short distance
Change in 30 second chair stand test
时间窗: Baseline, Immediately Post-Treatment (an average of 3 months)
How many times someone stand up from a chair in 30 seconds
Change in Functional Reach Test
时间窗: Baseline, Immediately Post-Treatment (an average of 3 months)
How far can someone reach while standing in a fixed position
Change in Timed Up and Go Test
时间窗: Baseline, Immediately Post-Treatment (an average of 3 months)
Time it takes to stand up from a chair and walk a short distance
Change in 30 Second Chair Stand Test
时间窗: Baseline, Immediately Post-Treatment (an average of 3 months)
How many times someone stand up from a chair in 30 seconds
次要结局
- Visual Analog Pain Scale(Baseline, Immediately Post-Treatment (an average of 3 months))
- Global Physical Activity Questionnaire(Baseline, Immediately Post-Treatment (an average of 3 months))
- Geriatric Depression Scale(Baseline, Immediately Post-Treatment (an average of 3 months))
- Pittsburgh Sleep Quality Index(Baseline, Immediately Post-Treatment (an average of 3 months))
- Duration of exercise performed(Immediately Post-Treatment (an average of 3 months))
- Duration of Exercise Performed(Immediately Post-Treatment (an average of 3 months))