Patients With Mild Cognitive Impairment (MCI)
Conditions
Brief summary
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.
Interventions
DEVICEUsing tablets and workbooks cognitive function.
Cognitive training programs corresponding to memory, attention, time and space, and orientation are conducted for 35 to 60 minutes.
DEVICEself-programming of physical function training.
The fitness program consisting of stretching, muscle strength, coordination, and aerobic exercise lasts 20 to 30 minutes, and additional 3-4 times/mainly 30 to 40 minutes of aerobic exercise.
Sponsors
MinYoung Kim, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. men and women aged 60 or older 2. A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test 3. a person who can independently carry out daily life 4. 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
Exclusion criteria
1. A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.) 2. A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition 3. Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days 4. Other cases where the researcher determines that participation in this clinical study is not appropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Dementia Rating (CDR) | Baseline - 3months | CDR is a rating scale for staging patients diagnosed with dementia. The CDR evaluates cognitive, behavioral and functional aspects of Alzheimer disease and other dementias. It is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2) and severe cognitive impairment (CDR = 3) |
| Clinical Global Impressions of Change (CGIC) | Baseline - 6 weeks- 3months | CGIC is a commonly used measure to measure the severity, treatment rate, and treatment effectiveness of symptoms in the treatment process or research of patients with mental illness. |
| Instrumental Activities of Daily Living (I-ADL) | Baseline - 6 weeks- 3months | I-ADL consists of skills and behaviors necessary for social life such as money management, households, phone use, and drugs, and helps evaluate the degree of social and professional functioning of the elderly with dementia. |
| Berg Balance Scale (BBS) | Baseline - 6 weeks- 3months | BBS is a measurement of balancing function. A five-point ordinal scale, ranging from 0-4. 0 indicates the lowest level of function and 4 the highest level of function. Total score = 56 |
| Korean-Mini Mental Status Examination (K-MMSE) | Baseline - 6 weeks - 3months | K-MMSE is a measurement of cognitive level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe(≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age. |
| Geriatric Depression Scale (GDSd) | Baseline - 6 weeks- 3months | GDS is a 30-item self-report assessment used to identify depression in the elderly. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as normal, 10-19 as mildly depressed, and 20-30 as severely depressed. |
| Global Deterioration Scale (GDS) | Baseline - 3months | GDS is one of the representative rating scales that suggests the severity of dementia patients and is used as a useful test tool for clinical trials of dementia treatments and early diagnosis of dementia. |
| Electroencephalography | Baseline - 6 weeks- 3months | EEG is a measurement of electrical activity in the brain using small electrodes attached to the scalp for diagnose brain disorders. |
| Geriatric Quality of Life-Dementia (GQOL-D) | Baseline - 6 weeks- 3months | GQOL-D is a tool for evaluating the quality of life of the elderly with dementia and consists of a four-point scale of 15 items, including 13 items that measure physical health, psychological health, social relationships and environment, and two items that measure overall health and life satisfaction. |
Contacts
Primary ContactMinYoung Kim, MD, PhD
Outcome results
None listed