Mild Cognitive Impairment Clinical Trial
— EXTENDEDOfficial title:
A Multicenter Clinical Study to Evaluate the Efficacy and Feasibility of a 24-week Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment
This study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform in mild cognitive impairment.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - Subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (RCT) "Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment". - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Inha University Hospital | Incheon | |
Korea, Republic of | Ewha Womans Seoul Hospital | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon |
Lead Sponsor | Collaborator |
---|---|
Inha University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of cognition | Repeatable Battery for the Assessment of Neuropsychological Status | Change from Baseline at 24 weeks | |
Secondary | Change of global cognition | Mini-Mental State Examination (range 0-30). Higher scores indicate better performance. | Change from Baseline at 24 weeks | |
Secondary | Change of function | Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance. | Change from Baseline at 24 weeks | |
Secondary | Change of subjective memory | Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance. | Change from Baseline at 24 weeks | |
Secondary | Change of depression | Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance. | Change from Baseline at 24 weeks | |
Secondary | Quality of life assessed by the Quality of life-Alzheimer's disease | Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance. | Change from Baseline at 24 weeks | |
Secondary | Change of activities of daily living | Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance. | Change from Baseline at 24 weeks | |
Secondary | Change of nutritional behavior | Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance. | Change from Baseline at 24 weeks | |
Secondary | Change of nutrition | Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance. | Change from Baseline at 24 weeks | |
Secondary | Change of motor function | Short Physical Performance Battery (range 0-12). Higher scores indicate better performance. | Change from Baseline at 24 weeks | |
Secondary | Sleep quality assessed by the Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance. | Change from Baseline at 24 weeks | |
Secondary | Change of motivation | Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance. | Change from Baseline at 24 weeks. Higher scores indicate better performance. |
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