South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

Study Overview
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Brief Summary
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This study evaluates acceptability and efficacy of multidomain intervention program to prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of participants will receive facility-based intervention for 6 months, a third will receive home-based intervention for 6 months, and a third is waiting list controls.

Detailed Description
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Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet been developed to modify the progression of AD. Therefore, it is important to manage vascular and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social activities to prevent dementia. The FINGER study showed that the multi-domain intervention program is effective to prevent cognitive impairment and disability in elderly. In South Korea, exercise and leisure programs, and brain activity for the elderly also have been conducted in welfare centers and public health centers. However, there are not enough programs that have proven effective in the studies. So the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial.

Official Title
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A Randomized Controlled Study to Evaluate Applicability of Korean Multidomain Intervention Program in the South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

Conditions
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Mild Cognitive Impairment, Aged

Intervention / Treatment
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* Other: Multidomain intervention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60-79 Having at least one among the following dementia risks, hypertension Diabetes Mellitus Dyslipidemia Obesity Abdominal obesity Metabolic syndrome Smoking educational level ≤ 9 years Physical inactivity Social inactivity Independent activities of daily living Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means Can read and write Korean 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 Substantial cognitive decline Other degenerative 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 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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Accepts Healthy Volunteers

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: They will be randomly allocated to facility-based multidomain intervention group, home-based intervention group, and a regular health advice group (referred to as control group) at a ratio of 1:1:1.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facility-based Intervention<br>A group will consist of 5 or 10 persons depending on the size of the study center. Exercise training will be guided by study exercise therapists at a gym and consist of programs for progressive muscle strength training, aerobic exercise, and exercises to improve postural balance and flexibility using elastic bands, floor plate and chairs (three times per week, 60 min per session).The cognitive training program is a program including tasks to be effective in episodic memory, executive function, attention, working memory, calculation, and visuospatial function (twice per week, 60 min per session). The nutritional intervention is conducted by study nutritionists (three individual sessions and seven group sessions). Management of metabolic and vascular risk factors will include additional meetings with the study nurse (at 0, 4, 8, 16, and 20 weeks), and the study physician (at 0 and 12 weeks). Motivational training is conducted by psychologist (four group session). | Other: Multidomain intervention program<br>* Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation<br>|
| Experimental: Home-based Intervention<br>The nutritional intervention, management of metabolic and vascular risk factors, social activity, and motivational training in the home-based intervention are similar to the facility-based intervention. The physical exercise programs consist of one group session (60 min) and two home-based sessions (60 min per session) per week in the first 2 months of the trial. During the remaining months of the 6-month study, participants in the home-based intervention attend a 1-h physical exercise group session per two weeks and two or three exercise sessions (60 min per session) alone at home per week. The cognitive training programs consist of one group session (60 min) and one home-based sessions (60 min per session) per week in the first 2 months of the trial. For the remainder of the 6-month study, participants in the home-based intervention attend a 1-h group cognitive training session per two weeks and one or two cognitive training sessions (60 min per session) alone at home per week. | Other: Multidomain intervention program<br>* Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation<br>|
| No Intervention: Controls<br>They are waiting list controls. They will receive the multi-domain intervention after this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention rate (percent) of the participants | Retention rate in each intervention group | 6 months | 
| compliance (percent) | Compliance to the protocol in each intervention group | 6 months | 
| Change of cognition | Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition. | Change at 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of global cognition | Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition. | Change at 6 months from baseline | 
| Change of function | Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function. | Change at 6 months from baseline | 
| Change of depression | Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion. | Change at 6 months from baseline | 
| Change of subjective memory complaints | Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory. | Change at 6 months from baseline | 
| Change of memory complaints | Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory. | Change at 6 months from baseline | 
| Change of prospective memory | Prospective Memory test (sum, range 0-12) / Higher scores mean better memory. | Change at 6 months from baseline | 
| Change of Quality of life (QOL) | QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL. | Change at 6 months from baseline | 
| Change of activities of daily livings (ADL) | Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL. | Change at 6 months from baseline | 
| Change of nutritional status | Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition. | Change at 6 months from baseline | 
| Change of nutrition | Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition. | Change at 6 months from baseline | 
| Change of balance | Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function. | Change at 6 months from baseline | 
| Change of physical activity | Global Physical Activity Questionnaire (This is not scoring.) | Change at 6 months from baseline | 
| Change of motivation | Motivation Questionnaire subscore 1) Situational Motivation Type Scale (sum, range 4-28) / Higher scores mean better motivation. subscore 2) Self-efficacy (sum, range 4-20) / Higher scores mean better motivation. | Change at 6 months from baseline | 
| Adverse event (number of participants) | adverse event in each group | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, dementia, intervention, mild cognitive impairment