A Robot-assisted Tailored Activity Programme for People With Dementia and Thier Caregivers

Not Applicable

Recruiting

• Conditions: Dementia; Caregiver; Physical Activity; Psychological Well Being

• Registration Number: NCT07239869
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.

Detailed Description

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.

Study Timeline

• Study Start: 2025-09-01
• Status Verified: 2025-11
• Study First Submitted: 2025-11-16
• Study First Submitted QC: 2025-11-16
• Last Update Submitted: 2025-11-16
• Study First Posted: 2025-11-20
• Last Update Posted: 2025-11-20
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in physical activity	Pre-intervention and immediately post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Changes in self-efficacy in physical activity	Pre-intervention and immediately post-intervention	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.
Changes in quality of life	Pre-intervention and immediately post-intervention	Dyadic quality of life will be measured with the 12-item Short Form Survey (SF-12). Higher scores indicate better quality of life
Changes in neuropsychiatric symptoms of people with dementia	Pre-intervention and immediately post-intervention	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
Changes in psychological well-being	Pre-intervention and immediately post-intervention	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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong