Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235, Taiwan
Location status: Recruiting
NCT Number: NCT05407857
A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people
Interested in participating?
Request Info60 year–90 year
All sexes
Interventional
Not applicable
New Taipei City, 235, Taiwan
Location status: Recruiting
This project proposes an intervention program for dementia prevention based on the Taiwanese model. The investigator(s) will screen the elderly who are not yet demented but are at high risk of dementia and will randomly allocate them into three groups (on site intervention group, remote intervention group, and control group) for a two-year multi-modal non-pharmacological intervention. All intervention groups will be actively involved in management with nutrition, exercise and cognitive programs. The on-site intervention group requires subjects to participate in prescribed place according to the protocol. The remote intervention group is designed for reducing the chances of person-to-person contact response to the current coronavirus disease 2019 (COVID-19) pandemic and development of digital internet. It uses innovative technology combining wearable devices with inertial measurement units, blue-tooth equipment, apps, feedback technology and artificial intelligence based remote comprehensive training programs. During the study period, each group will be regularly monitored the changes of cardiovascular risk factors, physical performance and cognitive function. The results of multimodal intervention mainly from Taipei and New Taipei City will establish the Taiwan FINGER model (TaiPEI) and will have the information of the conditions and feasibility achieved in Taiwan and implementation suggestions in the face of the epidemic. It can be subsequently applied to the brain/body health care institution and to the prevention of dementia and cardiovascular disease of elderly.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
A composite z-score will be obtained from the neuropsychological tests evaluating multiple cognitive domains, including memory, language, process speed, visuospatial, and executive function.
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Senior Fitness Test (SFT) measures six functional areas of physical function (strength, endurance, balance, agility, and flexibility)
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Short Physical Performance Battery (SPPB), score range: 0-12; higher scores mean a better outcome.
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured using a hand-grip dynamometer
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Mini Nutritional Assessment-Short Form (MNA-SF), a screening scale used to assess current nutritional status. score range: 0-14, higher scores mean a better outcome.
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
food frequency questionnaire (FFQ), a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
3-day dietary record: a self-reported account of all foods and beverages consumed within recent three days
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Activities of Daily Living Questionnaire (ADLQ)
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA-Brief) -Traditional Chinese Version: two subdomains (Finances, Communication) with a total score ranging from 0 to 100.
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Florida Cognitive Activities Scale (FCAS): a 25-item scale used to assess cognitive activities in the elderly with two subscales (Higher Cognitive Abilities and Frequent Cognitive Abilities)
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
EuroQol five-dimensional (EQ-5D): an instrument for measuring quality of life regarding the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Activities of Daily Living Questionnaire (ADLQ), The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment(Traditional Chinese Version)(UPSA-Brief), Florida Cognitive Activities Scale(FCAS), EuroQol five-dimensional (EQ-5D)
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Geriatric Depression Scale-Short Form (GDS-S), score range: 0-15; higher scores mean a worse outcome.
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Epworth sleepiness scale (ESS)
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured from fasting blood sample
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured from fasting blood sample
Time frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured from fasting blood sample
Time frame: Before intervention (Baseline); During intervention (6th month and 24th month)
Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ),
Time frame: Before intervention (Baseline); During intervention (6th month and 24th month)
Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ),
Contact information is provided by the study sponsor or research team.
Taipei Medical University Shuang Ho Hospital
Other
Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention (TaiPEI)
Acronym: TaiPEI
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