Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the 5 Times Sit to Stand Test
研究概览
简要总结
This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care.
The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility.
The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged over 65 years old
- •Ability to walk at least 20 meters, unaided or with unilateral support
- •Ability to understand motor complex commands
- •Mini-Mental State Examination (MMSE) score > 24 points
- •Functional independence for instrumental activities of daily living
- •Risk of recurrent falls, defined as 5xSST score > 15,00 seconds
排除标准
- •Patients residing in nursing homes, daycare units or assisted-living facilities
- •Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
- •Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
- •Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
- •Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
- •Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)
- •Other medical complications, which prevent the patient from complying with a home-based exercise program
结局指标
主要结局
Change in the 5 Times Sit to Stand Test
时间窗: Baseline; week 4; week 8; week 12 and then week 24
The 5 Times Sit to Stand Test is a performance test that measures the strength and the lower limb mobility. It consists of the time it takes to stand up from a chair five consecutive times. A cutoff value of 15 seconds is used to distinguish between individuals with and without risk of recurrent falls
次要结局
- Change in the Berg Balance Scale(Baseline; week 4; week 8; week 12 and then week 24)
- Change in the Timed Up and Go Test score(Baseline; week 4; week 8; week 12 and then week 24)
- Change in the Shorts Falls Efficacy Scale-International(Baseline; week 4; week 8; week 12 and then week 24)