Levinger Pazit, Dunn Jeremy, Bifera Nancy, Butson Michael, Elias George, Hill Keith D
Institute of Sport, Exercise and Active Living (ISEAL), College of Sport and Exercise Science, Victoria University, PO Box 14428, Melbourne, VIC, 8001, Australia.
School of Physiotherapy and Exercise Science, Curtin University, Perth, WA, Australia.
Trials. 2017 Aug 18;18(1):384. doi: 10.1186/s13063-017-2129-7.
The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.
This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.
The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.
Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.
膝骨关节炎（OA）患者的跌倒次数几乎是无OA者的两倍。与无症状者相比，膝OA患者在阻止跌倒所需的神经肌肉功能方面受损更严重。因此，可能需要将这些功能纳入运动干预措施中，以降低跌倒风险。本研究的目的是对比对照组，检验高速阻力训练计划（有或无平衡练习）对膝OA患者的可行性、安全性和患者满意度。还将研究这些运动计划对下肢肌肉力量以及跌倒的生理和功能风险因素的影响。
本研究将是一项预试验和干预后设计的随机对照试验（在基线和参与开始8周后进行结果评估），比较三组：对照组（无干预）、高速阻力训练组和高速阻力训练加平衡练习组。将招募30名60 - 90岁的膝骨关节炎患者，并随机分为三组。通过检查对运动计划的依从性、退出率、运动期间和运动后的疼痛程度、因疼痛而停止的运动次数以及任何不良事件或妨碍参与者完成规定运动的事件来评估可行性和安全性。还将评估下肢力量、身体功能、自我报告的疼痛和功能、跌倒恐惧、执行功能和生活质量等次要指标。为了确定有效性的统计趋势，从而为全面研究提供样本量信息，将使用重复测量方差分析对次要结果进行分析，以评估组内和组间随时间（干预前后）的变化。
本研究结果将增进对何种类型运动对膝OA患者安全且有益以降低其跌倒风险的理解，从而为未来大型研究试验的开展提供依据。
澳大利亚新西兰临床试验注册中心，编号：ACTRN12616001382460。于2016年10月6日注册。
