A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.
It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged 60 or older
- •A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
- •a person who can independently carry out daily life
- •If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study
排除标准
- •A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
- •A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
- •Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
- •Other cases where the researcher determines that participation in this clinical study is not appropriate
研究组 & 干预措施
Using tablets and workbooks.
Using tablets and workbooks Cognitive and physical function training self-programming for 6 weeks.
干预措施: Using tablets and workbooks cognitive function. (Device)
Using tablets and workbooks.
Using tablets and workbooks Cognitive and physical function training self-programming for 6 weeks.
干预措施: self-programming of physical function training. (Device)
Only self-programming of physical function training.
Only self-programming of physical function training is provided Implemented for 6 weeks.
干预措施: self-programming of physical function training. (Device)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: screening - 6 weeks - 3 months
K-MoCA is a measure of memory loss or other symptoms of cognitive decline. It includes 30 questions and a task that takes about 12 minutes to complete. The score can range from 0 to 30. A score of 26 or higher is considered normal.
次要结局
- Clinical Global Impressions of Change (CGIC)(Baseline - 6 weeks- 3months)
- Geriatric Quality of Life-Dementia (GQOL-D)(Baseline - 6 weeks- 3months)
- Geriatric Depression Scale (GDSd)(Baseline - 6 weeks- 3months)
- Global Deterioration Scale (GDS)(Baseline - 3months)
- Clinical Dementia Rating (CDR)(Baseline - 3months)
- Korean-Mini Mental Status Examination (K-MMSE)(Baseline - 6 weeks - 3months)
- Berg Balance Scale (BBS)(Baseline - 6 weeks- 3months)
- Instrumental Activities of Daily Living (I-ADL)(Baseline - 6 weeks- 3months)
- Electroencephalography(Baseline - 6 weeks- 3months)
研究者
MinYoung Kim, MD, PhD
Sponsor-Investigator
Bundang CHA Hospital