Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline Number of Falls at 3 months, 6 months and 9 months
研究概览
简要总结
This is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized old people. The secondary objectives are to study the applicability of the intervention in improving balance, function, gait mobility, muscle strength of the lower limbs and the perception of the intervention.
详细描述
The participants will be randomized and divided into the hydrotherapy group or the control group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of duration. The study outcomes will be measured before the intervention and in 3 posterior phases to evaluate its effects in the short, medium and long terms.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be institutionalized in a care center
- •Participate voluntarily and sign the informed consent
- •Have a punctuation of 2 or more in The Downton Fall Risk Index
排除标准
- •Suffer from a condition that can be affected or hinder exercise
- •Acute disease unresolved in 10 days
- •Not controlled hypertension
- •Contagious skin disorder
- •Urinary or faecal incontinence
结局指标
主要结局
Change from baseline Number of Falls at 3 months, 6 months and 9 months
时间窗: 3 months, 6 months, 9 months
Falls follow up
次要结局
- Pain measured with Visual Analogue Scale(3 months, 6 months, 9 months)
- Muscle strength measured with Five Sit to Stand test and Handgrip Test(3 months, 6 months, 9 months)
- Mobility measured with Timed Up & Go Test(3 months, 6 months, 9 months)
- Balance measured with Performance Oriented Mobility Assessment(3 months, 6 months, 9 months)
- Daily living activities measured with Barthel Test(3 months, 6 months, 9 months)
- Intervention Perception measured with Qualitative interview(3 months)