Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention

ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorTaipei Medical University Shuang Ho Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • multi-modal non-pharmacological intervention

    Behavioral

    multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Treatment groups

380 Participants
are divided into 3 treatment groups
Group A: On-siteExperimental treatment 1 intervention
Group B: RemoteActive comparator 1 intervention
Group C: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

Secondary outcomes

1

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)

Time frame
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
2

Change in physical assessment, unit on a scale

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)
3

Change in physical assessment, unit on a scale

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)
4

Change in physical functioning - Hand-grip strength, kg

Measured using a hand-grip dynamometer

Time frame
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

Other outcomes

Sponsors and contacts

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