Tiedemann Anne, Rissel Chris, Howard Kirsten, Tong Allison, Merom Dafna, Smith Stuart, Wickham James, Bauman Adrian, Lord Stephen R, Vogler Constance, Lindley Richard I, Simpson Judy M, Allman-Farinelli Margaret, Sherrington Catherine
The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
Sydney School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2016 May 10;6(5):e012277. doi: 10.1136/bmjopen-2016-012277.
Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years.
This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach.
Protocol has been approved by the Human Research Ethics Committee at The University of Sydney, Australia (number 2015/517). Results will be disseminated via peer-reviewed journal articles, international conference presentations and participants' newsletters.
ACTRN12615001190594.
预防跌倒和促进身体活动对于老年人实现最佳健康状态至关重要。然而，有证据表明，在未提供跌倒预防建议的情况下促进老年人身体活动可能会增加跌倒发生率。本试验旨在确定与健康饮食计划相比，身体活动与跌倒预防计划对60岁及以上人群身体活动和跌倒情况的影响。
本整群随机对照试验将纳入60组60岁及以上的社区居民。参与组将被随机分为：（1）身体活动与跌倒预防干预组（30组），包括书面信息、跌倒风险评估与预防建议、基于计步器的身体活动追踪器以及基于电话的健康指导；或（2）健康饮食干预组（30组），包括书面信息和基于电话的饮食指导。主要结局指标将在随机分组后12个月客观测量身体活动情况，并在整个12个月的试验期内自我报告跌倒情况。次要结局指标包括：跌倒者比例、达到澳大利亚身体活动指南的人群比例、体重指数、饮食习惯、行动目标达成情况、与行动相关的信心、生活质量、跌倒恐惧、冒险行为、情绪、健康状态、自我报告的身体活动情况、残疾状况以及健康和社区服务使用情况。将使用负二项回归模型分析每组每年跌倒人数的组间差异。对于连续评分的主要和次要结局指标，将采用对相应基线评分进行调整的线性回归来评估分组的效果。分析将预先计划，在对分组情况设盲的情况下进行，将考虑整群随机化，并采用意向性分析方法。
方案已获得澳大利亚悉尼大学人类研究伦理委员会批准（编号2015/517）。研究结果将通过同行评审期刊文章、国际会议报告以及参与者通讯进行传播。
ACTRN12615001190594。
