Department of Primary Care & Population Health, University College London, Rowland Hill St, London NW3 2PF, UK.
Trials. 2010 Jan 18;11:6. doi: 10.1186/1745-6215-11-6.
Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention.
DESIGN/METHODS: Pragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial.
The ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk.
Trial Registration: ISRCTN43453770.
有规律的身体活动可降低全因死亡率，对降低跌倒和髋部骨折风险有显著的有益作用。然而，老年人身体活动水平较低，先前的研究表明，干预仅能适度地短期提高活动水平。
设计/方法：在初级保健中，采用基于班级的运动（FAME）、家庭为基础的运动（OEP）和常规护理的 3 组平行设计的实用、群组对照试验，对老年人（年龄 65 岁及以上）进行分组。主要结局是在干预停止后 12 个月达到推荐的身体活动目标。次要结局包括功能评估、运动依从性的预测因素、跌倒发生率、跌倒恐惧、生活质量以及干预后的身体活动持续情况，随访时间为两年。一项包括参与者和英国国家医疗服务体系成本的经济评估将嵌入临床试验中。
ProAct65 试验将探索和评估通过普通诊所招募的老年人增加身体活动的潜力。该试验将在相对未经选择的人群中进行，并将解决选择性招募、潜在的低保留率、干预措施质量的差异和跌倒风险等问题。
试验注册号：ISRCTN43453770。
