Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- balance
研究概览
简要总结
A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 65 years old
- •Had a fall at least 3 months prior to the baseline assessment
- •Can ambulate independently
- •Has mild cognitive impairment
排除标准
- •Cannot ambulate independently and communicate with researchers
- •Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
- •Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
研究组 & 干预措施
Computerized cognitive training
The computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes.
干预措施: Computerized training (Behavioral)
Lower extremity strengthening
This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months.
Each session will last 60 min.
干预措施: Exercise (Behavioral)
Tai chi chuan
The 8-form Yang-style tai chi intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes.
干预措施: Exercise (Behavioral)
Social interaction
Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.
结局指标
主要结局
balance
时间窗: 12 months
The Tinetti balance score ranges 0\~26, with a higher score indicating a better balance ability.
Mattis Dementia Rating Scale (MDRS)
时间窗: 12 months
The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0\~37, 0\~37, 0\~6, 0\~39, and 0\~25 points, respectively, and a total score range of 0\~144 points.
falls
时间窗: 12 months
number of falls and multiple falls
mobility
时间窗: 12 months
The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
modified Telephone Interview of Cognitive Status (TICS-M)
时间窗: 12 months
The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0\~50.
次要结局
- fear of falling(12 months)
- depressive symptoms(12 months)
- activity of daily living (ADL)(12 months)