Mild Cognitive Impairment Clinical Trial
— SUPERBRAINOfficial title:
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
Verified date | March 2021 |
Source | Inha University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 152 |
Est. completion date | February 25, 2020 |
Est. primary completion date | February 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Inha Univeristy Hospital | Incheon | |
Korea, Republic of | Dong-A University Hospital | Pusan | |
Korea, Republic of | Bobath Memorial Hospital | Seongnam | |
Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon |
Lead Sponsor | Collaborator |
---|---|
Inha University Hospital | Korea Health Industry Development Institute |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | retention rate (percent) of the participants | Retention rate in each intervention group | 6 months | |
Primary | compliance (percent) | Compliance to the protocol in each intervention group | 6 months | |
Primary | 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 | Change of global cognition | Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition. | Change at 6 months from baseline | |
Secondary | 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 | |
Secondary | Change of depression | Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion. | Change at 6 months from baseline | |
Secondary | 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 | |
Secondary | Change of memory complaints | Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory. | Change at 6 months from baseline | |
Secondary | Change of prospective memory | Prospective Memory test (sum, range 0-12) / Higher scores mean better memory. | Change at 6 months from baseline | |
Secondary | 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 | |
Secondary | Change of activities of daily livings (ADL) | Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL. | Change at 6 months from baseline | |
Secondary | Change of nutritional status | Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition. | Change at 6 months from baseline | |
Secondary | Change of nutrition | Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition. | Change at 6 months from baseline | |
Secondary | Change of balance | Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function. | Change at 6 months from baseline | |
Secondary | Change of physical activity | Global Physical Activity Questionnaire (This is not scoring.) | Change at 6 months from baseline | |
Secondary | 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 | |
Secondary | Adverse event (number of participants) | adverse event in each group | Up to 24 weeks |
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