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

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

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.

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.

Inclusion Criteria:

1. Aged 60-79

2. 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

3. Independent activities of daily living

4. Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means

5. Can read and write Korean

6. Having a reliable informant who could provide investigators with the requested information.

7. Provide written informed consent

Exclusion Criteria:

1. Major psychiatric illness such as major depressive disorders
2. Dementia
3. Substantial cognitive decline
4. Other degenerative disease (e.g., Parkinson's disease)
5. Malignancy within 5 years
6. Cardiac stent or revascularization within 1 year
7. Serious or unstable symptomatic cardiovascular disease
8. Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
9. Severe loss of vision, hearing, or communicative disability
10. Any conditions preventing cooperation as judged by the study physician
11. Significant laboratory abnormality that may result in cognitive impairment
12. Unable to participate in exercise program safely
13. Coincident participation in any other intervention trial