Aged, Mild Cognitive Impairment
Conditions
Keywords
prevention, dementia, intervention, mild cognitive impairment
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.
Interventions
Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
Sponsors
Korea Health Industry Development Institute
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Independent raters are blinded to the group of participants.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| retention rate (percent) of the participants | 6 months | Retention rate in each intervention group |
| compliance (percent) | 6 months | Compliance to the protocol in each intervention group |
| Change of cognition | Change at 6 months from baseline | Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of subjective memory complaints | Change at 6 months from baseline | Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory. |
| Change of memory complaints | Change at 6 months from baseline | Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory. |
| Change of prospective memory | Change at 6 months from baseline | Prospective Memory test (sum, range 0-12) / Higher scores mean better memory. |
| Change of Quality of life (QOL) | Change at 6 months from baseline | QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL. |
| Change of activities of daily livings (ADL) | Change at 6 months from baseline | Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL. |
| Change of global cognition | Change at 6 months from baseline | Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition. |
| Change of nutrition | Change at 6 months from baseline | Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition. |
| Change of balance | Change at 6 months from baseline | Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function. |
| Change of physical activity | Change at 6 months from baseline | Global Physical Activity Questionnaire (This is not scoring.) |
| Change of motivation | Change at 6 months from baseline | 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. |
| Adverse event (number of participants) | Up to 24 weeks | adverse event in each group |
| Change of nutritional status | Change at 6 months from baseline | Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition. |
| Change of function | Change at 6 months from baseline | Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function. |
| Change of depression | Change at 6 months from baseline | Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion. |
Countries
South Korea
Outcome results
None listed