一项预防跌倒计划，旨在改善接受居家护理服务的老年人的生活质量、身体功能和跌倒效能：一项随机对照试验的研究方案
A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial.
作者信息
Bjerk Maria, Brovold Therese, Skelton Dawn A, Bergland Astrid
机构信息
Department of Physiotherapy, Faculty of Health Sciences, Oslo and Akershus University College, PO box 4 St. Olavs plass, Oslo, 0130, Norway.
Institute of Applied Health Research, School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
出版信息
BMC Health Serv Res. 2017 Aug 14;17(1):559. doi: 10.1186/s12913-017-2516-5.
BACKGROUND
Falls and fall-related injuries in older adults are associated with great burdens, both for the individuals, the health care system and the society. Previous research has shown evidence for the efficiency of exercise as falls prevention. An understudied group are older adults receiving home help services, and the effect of a falls prevention programme on health-related quality of life is unclear. The primary aim of this randomised controlled trial is to examine the effect of a falls prevention programme on quality of life, physical function and falls efficacy in older adults receiving home help services. A secondary aim is to explore the mediating factors between falls prevention and health-related quality of life.
METHODS
The study is a single-blinded randomised controlled trial. Participants are older adults, aged 67 or older, receiving home help services, who are able to walk with or without walking aids, who have experienced at least one fall during the last 12 months and who have a Mini Mental State Examination of 23 or above. The intervention group receives a programme, based on the Otago Exercise Programme, lasting 12 weeks including home visits and motivational telephone calls. The control group receives usual care. The primary outcome is health-related quality of life (SF-36). Secondary outcomes are leg strength, balance, walking speed, walking habits, activities of daily living, nutritional status and falls efficacy. All measurements are performed at baseline, following intervention at 3 months and at 6 months' follow-up. Sample size, based on the primary outcome, is set to 150 participants randomised into the two arms, including an estimated 15-20% drop out. Participants are recruited from six municipalities in Norway.
DISCUSSION
This trial will generate new knowledge on the effects of an exercise falls prevention programme among older fallers receiving home help services. This knowledge will be useful for clinicians, for health managers in the primary health care service and for policy makers.
TRIAL REGISTRATION
ClinicalTrials.gov . NCT02374307 . First registration, 16/02/2015.
背景
老年人跌倒及与跌倒相关的伤害给个人、医疗保健系统和社会都带来了沉重负担。先前的研究已证明运动在预防跌倒方面具有有效性。一个研究较少的群体是接受居家护理服务的老年人，而预防跌倒计划对健康相关生活质量的影响尚不清楚。这项随机对照试验的主要目的是研究预防跌倒计划对接受居家护理服务的老年人的生活质量、身体功能和跌倒效能的影响。次要目的是探索预防跌倒与健康相关生活质量之间的中介因素。
方法
该研究是一项单盲随机对照试验。参与者为67岁及以上、接受居家护理服务、能够借助或不借助助行器行走、在过去12个月内至少经历过一次跌倒且简易精神状态检查表得分在23分及以上的老年人。干预组接受基于奥塔哥运动计划的项目，为期12周，包括家访和激励性电话随访。对照组接受常规护理。主要结局是健康相关生活质量（SF - 36）。次要结局包括腿部力量、平衡能力、步行速度、步行习惯、日常生活活动能力、营养状况和跌倒效能。所有测量均在基线、干预3个月后和6个月随访时进行。根据主要结局确定的样本量为150名参与者，随机分为两组，预计有15 - 20%的脱落率。参与者从挪威的六个市镇招募。
讨论
这项试验将产生关于预防跌倒运动计划对接受居家护理服务的老年跌倒者影响的新知识。这些知识将对临床医生、初级卫生保健服务中的卫生管理人员和政策制定者有用。
试验注册
ClinicalTrials.gov. NCT02374307. 首次注册时间：2015年2月16日。
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