A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Change of cognition
研究概览
简要总结
This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.
详细描述
The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 to 85 years of age
- •Having at least one modifiable dementia risk factor
- •Complaints of cognitive decline by a participant or informant
- •A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
- •MMSE Z score ≥ - 1.5
- •Independent activities of daily living
- •Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
- •Having a reliable informant who could provide investigators with the requested information
- •Provide written informed consent
排除标准
- •Major psychiatric illness such as major depressive disorders
- •Other neurodegenerative disease (e.g., Parkinson's disease)
- •Malignancy within 5 years
- •Cardiac stent or revascularization within 1 year
- •Serious or unstable symptomatic cardiovascular disease
- •Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
- •Severe loss of vision, hearing, or communicative disability
- •Any conditions preventing cooperation as judged by the study physician
- •Significant laboratory abnormality that may result in cognitive impairment
- •Illiteracy
- •Unable to participate in exercise program safely
- •Coincident participation in any other intervention trial
研究组 & 干预措施
Multidomain intervention
The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.
干预措施: Multidomain intervention (Behavioral)
Control
At baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.
结局指标
主要结局
Change of cognition
时间窗: Change from Baseline at 24 weeks
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
次要结局
- Change of global cognition(Change from Baseline at 24 weeks)
- Change of quality of life(Change from Baseline at 24 weeks)
- Change of depression(Change from Baseline at 24 weeks)
- Change of sleep quality(Change from Baseline at 24 weeks)
- Change of motivation(Change from Baseline at 24 weeks. Higher scores indicate better performance.)
- Change of function(Change from Baseline at 24 weeks)
- Change of subjective memory(Change from Baseline at 24 weeks)
- Change of activities of daily living(Change from Baseline at 24 weeks)
- Change of nutritional behavior(Change from Baseline at 24 weeks)
- Change of nutrition(Change from Baseline at 24 weeks)
- Change of motor function(Change from Baseline at 24 weeks)
研究者
Seong Hye Choi, MD
Professor
Inha University Hospital