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结合体育活动与预防跌倒干预(通过健康指导和计步器加强)对老年人身体活动水平及与行动能力相关目标有何影响?一项随机对照试验的研究方案。

What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.

作者信息

Tiedemann Anne, Paul Serene, Ramsay Elisabeth, O'Rourke Sandra D, Chamberlain Kathryn, Kirkham Catherine, Merom Dafna, Fairhall Nicola, Oliveira Juliana S, Hassett Leanne, Sherrington Catherine

机构信息

The George Institute for Global Health, Sydney, Australia.

The University of Sydney, Camperdown, Australia.

出版信息

BMC Public Health. 2015 May 9;15:477. doi: 10.1186/s12889-015-1380-7.

Abstract

BACKGROUND

Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establish the impact of a combined physical activity and fall prevention intervention compared to an advice brochure on objectively measured physical activity participation and mobility-related goal attainment among people aged 60+.

METHODS/DESIGN: A randomised controlled trial involving 130 consenting community-dwelling older people will be conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall prevention brochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fall prevention intervention enhanced with health coaching and a pedometer. Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured at both six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meeting the physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers to physical activity participation will be measured 6 months after randomisation. General linear models will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified Poisson regression models will compare groups on dichotomous outcome measures. Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach.

DISCUSSION

This trial will address a key gap in evidence regarding physical activity and fall prevention for older people and will evaluate a program that could be directly implemented within Australian health services.

TRIAL REGISTRATION

ACTRN12614000016639, 7/01/2014.

摘要

背景

老年人身体活动不足和跌倒属于重要的公共卫生问题。通过体育活动可改善的健康状况在老年人中尤为常见。每三名65岁及以上的老年人中就有一人每年至少跌倒一次,这常常会导致严重受伤和持续残疾。随着老年人口比例迅速上升,这些问题亟待解决。本试验旨在确定与一份建议手册相比,体育活动与预防跌倒相结合的干预措施对60岁以上人群客观测量的体育活动参与度和与行动能力相关目标达成情况的影响。

方法/设计:将开展一项随机对照试验,纳入130名同意参与的社区居住老年人。参与者将被随机分为对照组(n = 65),并收到一份预防跌倒手册;或干预组(n = 65),并收到该手册以及通过健康指导和计步器加强的体育活动促进与预防跌倒干预措施。主要结局将是在随机分组后6个月和12个月时客观测量的体育活动和与行动能力相关目标的达成情况。次要结局将包括:跌倒、达到体育活动指南要求的人群比例、生活质量、跌倒恐惧、情绪和行动能力受限情况。将在随机分组6个月后测量体育活动参与的障碍因素和促进因素。在调整基线分数后,将使用一般线性模型评估分组对连续评分的主要和次要结局指标的影响。将使用有序回归分析目标达成情况(主要结局)的组间差异。将使用负二项回归模型分析每人每年的跌倒次数,以估计一年后跌倒率的组间差异(次要结局)。修正泊松回归模型将在二分结局指标上比较各组。分析将预先计划,在对分组情况不知情的情况下进行,并将采用意向性分析方法。

讨论

本试验将填补老年人体育活动和预防跌倒证据方面的一个关键空白,并将评估一个可在澳大利亚卫生服务机构直接实施的项目。

试验注册

ACTRN12614000016639,2014年1月7日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9862/4429838/83a65e9252be/12889_2015_1380_Fig1_HTML.jpg

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