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临床试验/NCT02374307
NCT02374307已完成不适用

Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial

Oslo Metropolitan University6 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
155
试验地点
6
主要终点
Short Form 36 Health Survey Summary Scores

研究概览

简要总结

The aim of this study is to investigate the effect of a falls-prevention exercise programme on health-related quality of life, fear of falling, falls and physical function in older people receiving home care. Participants in the intervention group perform the Otago exercise programme. Participants in the control group continue their usual activities.

详细描述

Falls and falls-related injuries are considered a serious public health issue in the older population. Strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. This randomized controlled trial investigates the effect of a falls prevention program on health-related quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home care.

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
67 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • has fallen at least one time in the last 12 months
  • receives home-help services
  • able to walk independently indoors with or without walking aid

排除标准

  • medical contraindication to exercise
  • life expectancy <1 year
  • scores under 23 points on Mini Mental Scale Examination
  • participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group

结局指标

主要结局

Short Form 36 Health Survey Summary Scores

时间窗: Baseline, 3 months, 6 months

Changes in the Short Form 36 Health Survey (SF-36) summary scores from baseline to 3-months follow-up. SF-36 measures health-related quality of life. Its summary score is comprised of a physical component summary (PCS) and a mental component summary (MCS). The scores range from 0-100 (worst-best) in each scale. A positive change in the summary score indicates a better health-related quality of life.

次要结局

  • 4-meter Walk Test(Baseline, 3 months, 6 months)
  • EQ-5D(Baseline, 3 months, 6 months)
  • Berg Balance Scale(Baseline, 3 months, 6 months)
  • Sit-to-stand Test(Baseline, 3 months, 6 months)
  • Mini Nutritional Assessment(Baseline, 3 months, 6 months)
  • No. of Participants Exercising Post-intervention(3 months and 6 months)
  • No. of Falls(3 months and 6 months)
  • Falls Efficacy Scale - International(Baseline, 3 months, 6 months)
  • Instrumental Activities of Daily Living(Baseline, 3-months, 6-months)
  • Exercise According to the Protocol. Adherence(Baseline and 3 months)
  • Walking Habits(Baseline, 3 months, 6 months)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Bjerk

PhD Research Fellow

Oslo Metropolitan University

研究点 (6)

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