A Phase 1 interventional study of Intervention and Control in Dementia, Caregiver and Physical Activity, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by The Hong Kong Polytechnic University · Phase 1, Interventional, and Supportive care
To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.
This is a two-arm pilot randomized controlled trial evaluating the feasiblity and preliminary efficacy of the robot-assisted tailored activity programme on improving the physical inactivity of people with dementia and their caregivers. Sixty dyads will be rectuited. Participants in the intervention group will receive a 12-week tailored activity programme, while those in the control group will receive usal community care services. Outcomes including feasibility of the tailored acitivity programme, physical activity levels, self-efficacy in physical activity, dyadic quality of life, neuropsychiatric somptoms, and psychological wellbeing will be measured at baseline and immediately post intervention.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's planned enrollment of 60 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for people with dementia:
Exclusion Criteria for people with dementia:
Inclusion Criteria for caregivers:
Exclusion Criteria for caregivers:
Tweleve weeks of robot-assisted tailored activity programme
Other: Intervention
Usual care provided by community centers
Other: Control
12 weeks of robot assisted tailored activity programme
Usual care provided by community centers
Changes in physical activity
Physical activity will be measured with the Chinese version of the International Physical Activity Questionnaire short version (IPAQ-C, short). The IPAQ-C is a 9-item instrument with good reliability and validity. Objective mesures will include number of steps, movement distance, sedentary minutes, inactive minutes collected with an activity tracker.
Time frame: Pre-intervention and immediately post-intervention
Changes in self-efficacy in physical activity
Self-efficacy in physical activity will be measured with a Likert 6-point scale covering three different types of self-efficacy. This instrument demonstrated satisfactory internal consistency. Higher scores indicate higher self-efficacy in physical activity.
Time frame: Pre-intervention and immediately post-intervention
Changes in quality of life
Dyadic quality of life will be measured with the 12-item Short Form Survey (SF-12). Higher scores indicate better quality of life
Time frame: Pre-intervention and immediately post-intervention
Changes in neuropsychiatric symptoms of people with dementia
People with dementia's neuropsychiatric symptoms will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia. The Chinese version was reliable. Higher scores indicate worse symptoms
Time frame: Pre-intervention and immediately post-intervention
Changes in psychological well-being
Dyads' psychological well-being will be measured with the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 includes 3 subscales (stress, anxiety, and depression), and has demonstrated good reliability among the Chinese population. Higher scores indicate poorer psychological wellbeing and more psychological distress.
Time frame: Pre-intervention and immediately post-intervention
Plan to share: No
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The Hong Kong Polytechnic University