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一个量身定制的运动和家庭减少危害计划能否降低社区居住的认知障碍老年人的跌倒率:i-FOCIS随机对照试验的方案文件

Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial.

作者信息

Close Jacqueline C T, Wesson Jacqueline, Sherrington Catherine, Hill Keith D, Kurrle Sue, Lord Stephen R, Brodaty Henry, Howard Kirsten, Gitlin Laura N, O'Rourke Sandra D, Clemson Lindy

机构信息

Neuroscience Research Australia, University of New South Wales, PO Box 1165, Randwick, NSW 2031, Australia.

出版信息

BMC Geriatr. 2014 Aug 15;14:89. doi: 10.1186/1471-2318-14-89.

Abstract

BACKGROUND

The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken.

METHODS AND DESIGN

Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life.

DISCUSSION

The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people.

TRIAL REGISTRATION

The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617.

摘要

背景

社区中患有认知障碍(CI)的老年人跌倒率是认知功能正常人群的两倍,每年几乎有三分之二的认知障碍患者会跌倒。研究表明,涉及平衡的运动和/或家庭危险因素减少计划对预防认知功能正常的老年人跌倒有效。然而,这些干预措施在降低认知障碍患者跌倒率方面的潜在益处尚未得到证实。这项随机对照试验将确定一项量身定制的运动和家庭危险因素减少计划是否能降低社区中患有认知障碍的老年人的跌倒率。我们将确定该干预措施是否对一系列身体和心理结局指标以及参与者及其照顾者的生活质量产生有益影响。还将进行一项健康经济学分析,考察该计划的成本和潜在益处。

方法与设计

将招募360名年龄在65岁及以上、居住在社区且患有认知障碍的人参与试验。每个人都将有一名可识别的照顾者,每周至少有3.5小时的面对面接触。参与者将在基线时接受评估,并在6个月和12个月时进行重新测试。分配到干预组的参与者将参加一项根据其认知和身体能力量身定制的运动和家庭危险因素减少计划。主要结局指标将是跌倒率,将使用每月跌倒日历进行测量。次要结局指标将包括跌倒风险、生活质量、身体和认知功能指标、跌倒恐惧以及计划内和计划外的医疗服务使用情况。将对照顾者进行随访,以确定照顾者负担、应对策略和生活质量。

讨论

该研究将确定这种量身定制的干预措施对降低社区中患有认知障碍的老年人跌倒率的影响,以及该计划的成本效益和依从性。研究结果将对针对这一高风险老年人群体的干预措施的设计和实施产生直接影响。

试验注册

本研究方案已在澳大利亚新西兰临床试验注册中心注册——ACTRN12614000603617。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/45a3/4138412/9ccfab16ccb1/1471-2318-14-89-1.jpg

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