Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Multidomain intervention
- Registration Number
- NCT05023057
- Lead Sponsor
- Inha University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multidomain intervention Multidomain intervention The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change of global cognition Change from Baseline at 24 weeks Mini-Mental State Examination (range 0-30). Higher scores indicate better 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 depression Change from Baseline at 24 weeks Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse 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 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 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 nutritional behavior Change from Baseline at 24 weeks Nutrition Quotient for elderly (range 0-100). 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.
Trial Locations
- Locations (17)
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Myungji Hospital
🇰🇷Goyang-si, Korea, Republic of
Catholic Kwandong University International St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Chonnam University Hospital
🇰🇷Gwangju, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Bobath Memorial Hospital
🇰🇷Seongnam, Korea, Republic of
Ewha Womans Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of