About this trial
A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people
Eligibility criteria
This trial accepts healthy volunteersQualifiers
People over 60 without dementia
Agree to join the study and sign the consent form
The Modified Rankin Scale (MRS) scores between 0-1 points
Education level: elementary or higher education (6 years) or can read and write Chinese
Disqualifiers
Have been diagnosed with any kind of dementia
Suspected dementia patients or others who are not suitable to participate in the research assessed by a doctor at the first visit
Diseases affecting the safety of various interventional activities (such as remaining life less than two years, symptomatic heart/cerebrovascular disease within 6 months, vascular reperfusion or reconstruction-related surgery within one year, etc., malignant tumor within one year)
Severe blindness, hearing or communication impairment, or other difficulty in cooperating or completing assessments and interventions (especially exercise) in the study
Trial design
Parallel
Treatments tested in this trial
multi-modal non-pharmacological intervention
Behavioralmulti-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
Treatment groups
Trial outcomes
Primary outcomes
Change in cognition including individual cognitive domains, unit on a scale
A composite z-score will be obtained from the neuropsychological tests evaluating multiple cognitive domains, including memory, language, process speed, visuospatial, and executive function.
Secondary outcomes
Change in physical assessment, unit on a scale
Senior Fitness Test (SFT) measures six functional areas of physical function (strength, endurance, balance, agility, and flexibility)
Change in physical assessment, unit on a scale
Short Physical Performance Battery (SPPB), score range: 0-12; higher scores mean a better outcome.
Change in physical assessment, unit on a scale
International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity
Change in physical functioning - Hand-grip strength, kg
Measured using a hand-grip dynamometer
Sponsors and contacts
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