An AI Robot-assisted Tailored Activity Programme for Improving the Physical Inactivity of People With Dementia and Their Informal Caregivers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in physical activity
研究概览
简要总结
To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
Tweleve weeks of robot-assisted tailored activity programme
干预措施: Intervention (Other)
Control
Usual care provided by community centers
干预措施: Control (Other)
结局指标
主要结局
Changes in physical activity
时间窗: 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.
次要结局
- Changes in self-efficacy in physical activity(Pre-intervention and immediately post-intervention)
- Changes in neuropsychiatric symptoms of people with dementia(Pre-intervention and immediately post-intervention)
- Changes in psychological well-being(Pre-intervention and immediately post-intervention)
- Changes in self-efficacy in physical activity(Pre-intervention and immediately post-intervention)
- Changes in quality of life(Pre-intervention and immediately post-intervention)
- Changes in neuropsychiatric symptoms of people with dementia(Pre-intervention and immediately post-intervention)
- Changes in psychological well-being(Pre-intervention and immediately post-intervention)