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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Inha University Hospital
- Enrollment
- 152
- Locations
- 6
- Primary Endpoint
- retention rate (percent) of the participants
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Inha University Hospital
Professor Seong Hye Choi
Inha University Hospital
Eligibility Criteria
Inclusion Criteria
- •Having at least one among the following dementia risks,
- •hypertension
- •Diabetes Mellitus
- •Dyslipidemia
- •Abdominal obesity
- •Metabolic syndrome
- •educational level ≤ 9 years
- •Physical inactivity
- •Social inactivity
- •Independent activities of daily living
Exclusion Criteria
- •Major psychiatric illness such as major depressive disorders
- •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
Outcomes
Primary Outcomes
retention rate (percent) of the participants
Time Frame: 6 months
Retention rate in each intervention group
compliance (percent)
Time Frame: 6 months
Compliance to the protocol in each intervention group
Change of cognition
Time Frame: Change at 6 months from baseline
Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.
Secondary Outcomes
- Change of memory complaints(Change at 6 months from baseline)
- Change of Quality of life (QOL)(Change at 6 months from baseline)
- Change of balance(Change at 6 months from baseline)
- Adverse event (number of participants)(Up to 24 weeks)
- Change of global cognition(Change at 6 months from baseline)
- Change of subjective memory complaints(Change at 6 months from baseline)
- Change of activities of daily livings (ADL)(Change at 6 months from baseline)
- Change of function(Change at 6 months from baseline)
- Change of depression(Change at 6 months from baseline)
- Change of physical activity(Change at 6 months from baseline)
- Change of prospective memory(Change at 6 months from baseline)
- Change of nutritional status(Change at 6 months from baseline)
- Change of nutrition(Change at 6 months from baseline)
- Change of motivation(Change at 6 months from baseline)