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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.
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.
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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 and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidomain intervention | Behavioral | For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of cognition | Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance. | 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 | Affiliation | Role |
|---|---|---|
| Seong Hye Choi, MD, PhD | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea | ||||
| Pusan National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41388319 | Derived | Hwang J, Moon SY, Lee H, Lee J, Park YK, Jeong JH, Hong CH, Jung J, Na HR, Cho SH, Sung J, Lee SJ, Choi SH. Polygenicity and APOE epsilon4 shape response to intervention in mild cognitive impairment. Alzheimers Res Ther. 2025 Dec 12;17(1):262. doi: 10.1186/s13195-025-01907-3. | |
| 39840755 | Derived | Moon SY, Park YK, Jeong JH, Hong CH, Jung J, Na HR, Cho SH, Kim HS, Song HS, Choi M, Ku BD, Moon YS, Han HJ, Hong YJ, Kim EJ, Kim GH, Kim KW, Jang H, Yoon SJ, Kim HJ, Choi SH. South Korean study to prevent cognitive impairment and protect brain health through multidomain interventions via face-to-face and video communication platforms in mild cognitive impairment (SUPERBRAIN-MEET): A randomized controlled trial. Alzheimers Dement. 2025 Feb;21(2):e14517. doi: 10.1002/alz.14517. Epub 2025 Jan 22. |
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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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outcome assessor-blinded, randomized controlled trial
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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 |
| Change of quality of life | 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 |
| Change of sleep quality | 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). Higher scores of SDI indicate better performance. | Change from Baseline at 24 weeks. Higher scores indicate better performance. |
| Busan |
| South Korea |
| Eulji University Hospital | Daejeon | South Korea |
| Myungji Hospital | Goyang-si | South Korea |
| Chonnam University Hospital | Gwangju | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Catholic Kwandong University International St. Mary's Hospital | Incheon | South Korea |
| Jeonbuk National University Hospital | Jeonju | South Korea |
| Bobath Memorial Hospital | Seongnam | South Korea |
| CHA Bundang Medical Center | Seongnam | South Korea |
| Ewha Womans Seoul Hospital | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Hanyang University Hospital | Seoul | South Korea |
| Konkuk University Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |
| 38362052 | Derived | Cho SH, Kang HJ, Park YK, Moon SY, Hong CH, Na HR, Song HS, Choi M, Jeong S, Park KW, Kim HS, Chun BO, Jung J, Jeong JH, Choi SH. SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through Multidomain interventions via facE-to-facE and video communication plaTforms in mild cognitive impairment (SUPERBRAIN-MEET): Protocol for a Multicenter Randomized Controlled Trial. Dement Neurocogn Disord. 2024 Jan;23(1):30-43. doi: 10.12779/dnd.2024.23.1.30. Epub 2024 Jan 29. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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