Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Multidomain intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 to 79 years of age Having at least one modifiable dementia risk factor Complaints of cognitive decline by a participant or informant A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests MMSE Z score ≥ - 1.5 Independent activities of daily living 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 Exclusion Criteria: Major psychiatric illness such as major depressive disorders Dementia 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: outcome assessor-blinded, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidomain intervention<br>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. | Behavioral: Multidomain intervention<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |