Effect of a Multi-Component Exercise Program on Function and Health in Older People Recently Discharged From Hospital. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Changes in physical function
研究概览
简要总结
The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital. The intervention consists of 32 group-based exercise sessions, performed twice a week. In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly. The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above.
详细描述
Older people who have been hospitalized often experience loss of function, increased risk of falls and reduced health-related quality of life (HRQOL) in the post-discharge period. The reason for this is the cumulative effect of illness, bedrest during hospital stay and inactivity after discharge. Previous research indicates that exercise therapy should be an integrated part of the post-hospital treatment to prevent or postpone this functional decline and improve HRQOL. Therefore, the investigators will conduct a randomized controlled trial to investigate the effect of a multi-component exercise program consisting of high intensity exercises on physical function, physical activity and HRQOL among older people living at home after discharge from hospital after treatment of an acute medical event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •65 years or older, live in their own home, consent to participate in the program three times a week (twice a week outside their home), manage to walk with or without assistive device, and assessed by a doctor as able to tolerate the intervention.
排除标准
- •Severe cognitive impairment (Mini-Mental State Examination (MMSE) score less than 20), have an expected lifespan less than one year, exercise more than twice a week, and score above nine points on the Short Physical Performance Battery.
结局指标
主要结局
Changes in physical function
时间窗: Baseline, 4 months and 8 months
Changes in physical function will be measured with The Short Physical Performance Battery (SPPB). This test evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together side-by side, semitandem and tandem positions, time to walk 8ft and time to rise from a chair and return to the seated position five times. Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels.
次要结局
- Berg Balance Scale(Baseline, 4 months and 8 months)
- Feasibility of the intervention(Four months from baseline)
- Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)(Baseline, 4 months and 8 months)
- Muscle mass(Baseline, 4 months and 8 months)
- Amount of home-help services received(Baseline, 4 months and 8 months)
- Health-related quality of life (HRQOL)(Baseline, 4 months and 8 months)
- Compliance to the intervention(Eight months from baseline)
- Handgrip strength(Baseline, 4 months and 8 months)
- Height(Baseline)
研究者
Sylvia Sunde
Phd-student
Oslo Metropolitan University