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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidomain intervention | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidomain intervention | Behavioral | For 24 weeks, participants will receive cognitive training twice a week, exercise 3 times a week, nutrition education 12 times, and education about vascular risk factor management every 2 weeks using the tablet PC application. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of cognition | Repeatable Battery for the Assessment of Neuropsychological Status | Change from Baseline at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of global cognition | Mini-Mental State Examination (range 0-30). Higher scores indicate better performance. | Change from Baseline at 24 weeks |
| Change of function | Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong Hye Choi, MD, PhD | Contact | 82 32 890 3659 | seonghye@inha.ac.kr | |
| Jee Hyang Jeong, MD, PhD | Contact | jjeong@ewha.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seong Hye Choi, MD, PhD | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Not yet recruiting | Gwangju | South Korea |
The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Data will be available for 2 years since March 2024.
Reasonable request
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Change from Baseline at 24 weeks |
| Change of subjective memory | Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance. | Change from Baseline at 24 weeks |
| Change of depression | Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance. | Change from Baseline at 24 weeks |
| Quality of life assessed by the Quality of life-Alzheimer's disease | Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance. | Change from Baseline at 24 weeks |
| Change of activities of daily living | Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance. | Change from Baseline at 24 weeks |
| Change of nutritional behavior | Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance. | Change from Baseline at 24 weeks |
| Change of nutrition | Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance. | Change from Baseline at 24 weeks |
| Change of motor function | Short Physical Performance Battery (range 0-12). Higher scores indicate better performance. | Change from Baseline at 24 weeks |
| Sleep quality assessed by the Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance. | Change from Baseline at 24 weeks |
| Change of motivation | Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance. | Change from Baseline at 24 weeks. Higher scores indicate better performance. |
| Inha University Hospital | Recruiting | Incheon | 22332 | South Korea |
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| Ewha Womans Seoul Hospital | Not yet recruiting | Seoul | South Korea |
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| Ajou University Hospital | Not yet recruiting | Suwon | South Korea |
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