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Recruiting NCT07239869

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

Phase I Interventional Dementia Caregiver Physical Activity Psychological Well Being

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention, Control.
Who it may be relevant to
Registry conditions: Dementia, Caregiver, Physical Activity, Psychological Well Being. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers

Overview

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.

Interventions

  • Other Intervention
    12 weeks of robot assisted tailored activity programme
  • Other Control
    Usual care provided by community centers

Primary outcome measures

  • Changes in physical activity [Time frame: Pre-intervention and immediately post-intervention]
Secondary outcome measures (4)
  • Changes in self-efficacy in physical activity [Time frame: Pre-intervention and immediately post-intervention]
  • Changes in quality of life [Time frame: Pre-intervention and immediately post-intervention]
  • Changes in neuropsychiatric symptoms of people with dementia [Time frame: Pre-intervention and immediately post-intervention]
  • Changes in psychological well-being [Time frame: Pre-intervention and immediately post-intervention]

Eligibility criteria

Inclusion Criteria for people with dementia:

  • 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.

Exclusion Criteria for people with dementia:

  • 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.

Inclusion Criteria for caregivers:

  • primary informal caregivers who reside with the of the person with dementia;
  • have provided care for more than six months;
  • have no intention to send the care recipient to nursing homes in the next six months;
  • being physically inactive;
  • use a smartphone.

Exclusion Criteria for caregivers:

  • caregivers with unstable physical or mental conditions;
  • cannot communicate logically;
  • not suitable for doing physical activity as recommended by a primary care physician.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07239869 · P0044775

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗