A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Inha University Hospital
- Enrollment
- 300
- Locations
- 17
- Primary Endpoint
- Change of cognition
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Seong Hye Choi, MD
Professor
Inha University Hospital
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Change of cognition
Time Frame: Change from Baseline at 24 weeks
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
Secondary Outcomes
- Change of global cognition(Change from Baseline at 24 weeks)
- Change of quality of life(Change from Baseline at 24 weeks)
- Change of depression(Change from Baseline at 24 weeks)
- Change of sleep quality(Change from Baseline at 24 weeks)
- Change of motivation(Change from Baseline at 24 weeks. Higher scores indicate better performance.)
- Change of function(Change from Baseline at 24 weeks)
- Change of subjective memory(Change from Baseline at 24 weeks)
- Change of activities of daily living(Change from Baseline at 24 weeks)
- Change of nutritional behavior(Change from Baseline at 24 weeks)
- Change of nutrition(Change from Baseline at 24 weeks)
- Change of motor function(Change from Baseline at 24 weeks)