How do we Get People With MCI and Dementia to be Physically Active?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Achievement of Physical Activity
研究概览
简要总结
The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations. The primary outcome is achievement of physical activity recommendations. Secondary outcomes include cost-effectiveness and improvements in health and function.
详细描述
The aim of this trial is to compare the effectiveness of center-based versus home-based physical activity delivery among people with MCI and early dementia and to understand the influence of person and setting characteristics.
OBJECTIVES:
Primary: To compare the effectiveness of centre-based versus home-based physical activity delivery among people with MCI or early dementia, as measured by percent achievement of physical activity guidelines.
Secondary:
(i) To determine the influence of person- and setting-specific factors. (ii) To estimate the cost-effectiveness of centre-based and home-based physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MCI or mild dementia
- •Mini-Mental State Examination (MMSE)>=23 or Montreal Cognitive Assessment (MoCA)>=18
- •50 years or older
- •Stable pharmaceutical regimen >=2 months
- •Be able to travel to centre
- •Have a care partner or significant other to support home-based exercise
- •Ability to walk >=2 minutes
- •Adequate English to understand exercise training
- •Adequate hearing and vision for cognitive tests
- •Able to comply with assessment and training schedule
- •Be screened safe for exercise by a physician or certified exercise physiologist
排除标准
- •Current moderate or high intensity exercise >=3 times per week
- •Unstable cardiovascular disease that precludes exercise
- •Musculoskeletal impairments that limit ability to walk
- •Pain or other co-morbidities that would limit exercise
- •Behavioural issues that would limit exercise training
研究组 & 干预措施
Centre-based physical activity
People with Mild Cognitive Impairment (MCI) and early dementia will receive centre-based physical activity for one hour each week for three months, plus at-home prescribed exercise.
干预措施: Centre-based exercise (Behavioral)
Home-based exercise
People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls.
干预措施: Home-based exercise (Behavioral)
结局指标
主要结局
Achievement of Physical Activity
时间窗: 3 months
Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor.
Change in physical activity
时间窗: baseline to 3 months
Change in physical activity as objectively measured using an activity monitor.
次要结局
- Cost-effectiveness(3 months)