A Multicenter Clinical Study to Evaluate the Efficacy and Feasibility of a 24-week Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change of cognition
研究概览
简要总结
This study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform 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 Mediterranean-DASH Intervention for Neurodegenerative Delay diet (MIND) diet. They will be educated about vascular risk factor management every 2 weeks. 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. All intervention will be administered via tablet personal computer (PC) application at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (RCT) "Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment".
- •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; (3) physical exercise; (4) nutritional guidance; and (5) motivational training via none-face-to-face tablet PC application (app).
干预措施: Multidomain intervention (Behavioral)
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
次要结局
- Change of depression(Change from Baseline at 24 weeks)
- Quality of life assessed by the Quality of life-Alzheimer's disease(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)
- Sleep quality assessed by the Pittsburgh Sleep Quality Index(Change from Baseline at 24 weeks)
- Change of motivation(Change from Baseline at 24 weeks. Higher scores indicate better performance.)
- Change of global cognition(Change from Baseline at 24 weeks)
- Change of function(Change from Baseline at 24 weeks)
- Change of subjective memory(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