A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
mild to moderate stage dementia at a standardized mini-mental state examination score (MMSE) higher than 10;
be able to walk independently;
being physically inactive (categorized as "low/inactive" by the International Physical Activity Questionnaire);
free from other medical/functional conditions that would limit physical activity.
Disqualifiers
high risk of falling (Berg Balance Scale <45);
not be suitable for doing physical activity as recommended by the primary care physician;
currently involved in another interventional study involving physical exercise;
had acute hospitalization >3 times in the past year.
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention
Other intervention12 weeks of robot assisted tailored activity programme
Control
Other interventionUsual care provided by community centers
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
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-interventionSecondary outcomes
1
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-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
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Source ClinicalTrials.gov