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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Changes in physical activity [Срок оценки: Pre-intervention and immediately post-intervention]

Вторичные конечные точки (4)

• Changes in self-efficacy in physical activity [Срок оценки: Pre-intervention and immediately post-intervention]
• Changes in quality of life [Срок оценки: Pre-intervention and immediately post-intervention]
• Changes in neuropsychiatric symptoms of people with dementia [Срок оценки: Pre-intervention and immediately post-intervention]
• Changes in psychological well-being [Срок оценки: Pre-intervention and immediately post-intervention]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07239869 · P0044775

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗