Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.
详细描述
Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.
The study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 70 years
- •Live at your address
- •Are at risk of falls
- •Timed Up and Go Test time timed ≥ 12 seconds
- •Able to walk 200 meters without personal assistance
- •Speak and read in Spanish
排除标准
- •Perform moderate to vigorous physical activity> 150 min / week in the last 3 months
- •Present any of the following medical conditions:
- •Heart failure (New York Heart Association class III and IV)
- •Recent stroke (<6 months)
- •Parkinson's disease
- •In active cancer treatment (last 6 months)
- •Class III and IV chronic obstructive pulmonary disease
- •Unstable fracture of the lower limb
- •Lower limb amputated
- •Treatment for less than 6 months of depression
- •Uncontrolled resting blood pressure of a systolic pressure> 160 or a diastolic pressure> 100 or more
- •Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study
- •Moderate to severe cognitive impairment (Mini Mental cognitive assessment <23)
- •Current participation in another scientific intervention trial.
结局指标
主要结局
Physical activity
时间窗: 9 days
It will be evaluated with a digital pedometer
Cost-effectiveness
时间窗: 6 months
Evaluated by the incremental cost-effectiveness ratio
Health effects
时间窗: 6 months
They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5
Incidence of falls
时间窗: 6 months
Number of falls in relation to the degree of physical activity
次要结局
- Adherence to exercise(6 months)
- Fear of falling(6 months)