Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Frailty
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 daily activities carried out through group workshops (guided by a physiotherapist) and 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 sLiFE program is more effective than an usual health advice 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People older than 65 years of age
- •Living at home
- •Speak and read Spanish
排除标准
- •Heart failure (NYHA class III and IV)
- •Recent stroke (<6 months)
- •Parkinson's disease
- •In active cancer treatment (last 6 months)
- •GOLD class III and IV chronic obstructive pulmonary disease
- •Unstable lower extremity fracture
- •Amputated lower extremity
- •Treatment less than 6 months of depression
- •Uncontrolled resting blood pressure of a systolic > 160 or diastolic > 100 or more
- •Unavailability for intervention, planned travel or relocation 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 interventional clinical trial
结局指标
主要结局
Frailty
时间窗: 6 months
Frailty will be measured according to the five criteria of Fried's phenotype: 1) Low muscle strength; 2) Poor nutrition; 3) Poor endurance; 4) Slow walking and 5) Low physical activity.
Health effects
时间窗: 6 months
It will be measured using the quality of life questionnaire EQ-5D
Incidence of falls
时间窗: 6 months
Number of falls in relation to the degree of physical activity.
Physical activity
时间窗: 6 months
It will be evaluated with the Global Physical Activity Questionnaire
次要结局
- Fear of falling(6 months)
- Adherence to exercise(6 months)
- Cognitive assessment(6 months)
- Motor function(6 months)