Mild Cognitive Impairment
Conditions
Brief summary
This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.
Detailed description
The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.
Interventions
BEHAVIORALMultidomain intervention
For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.
Sponsors
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
outcome assessor-blinded, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 60 to 85 years of age * Having at least one modifiable dementia risk factor * Complaints of cognitive decline by a participant or informant * A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests * MMSE Z score ≥ - 1.5 * Independent activities of daily living * Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC. * 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 * Other neurodegenerative 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 * Illiteracy * Unable to participate in exercise program safely * Coincident participation in any other intervention trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of cognition | Change from Baseline at 24 weeks | Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of function | Change from Baseline at 24 weeks | Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance. |
| Change of subjective memory | Change from Baseline at 24 weeks | Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance. |
| Change of depression | Change from Baseline at 24 weeks | Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance. |
| Change of quality of life | Change from Baseline at 24 weeks | Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance. |
| Change of activities of daily living | Change from Baseline at 24 weeks | Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance. |
| Change of global cognition | Change from Baseline at 24 weeks | Mini-Mental State Examination (range 0-30). Higher scores indicate better performance. |
| Change of nutrition | Change from Baseline at 24 weeks | Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance. |
| Change of motor function | Change from Baseline at 24 weeks | Short Physical Performance Battery (range 0-12). Higher scores indicate better performance. |
| Change of sleep quality | Change from Baseline at 24 weeks | Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance. |
| Change of motivation | Change from Baseline at 24 weeks. Higher scores indicate better performance. | Self Determination Index (SDI). Higher scores of SDI indicate better performance. |
| Change of nutritional behavior | Change from Baseline at 24 weeks | Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance. |
Countries
South Korea
Outcome results
None listed