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Video-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial)

机译:基于视频游戏的老年人练习慢性低腰疼痛:可行性随机对照试验的协议(淘汰赛试验)

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Abstract Objectives To investigate the feasibility of implementing a video-game exercise programme for older people with chronic low back pain (LBP). Design Single-centred single-blinded randomised controlled trial (RCT). Setting Physiotherapy outpatient department in a public hospital in Western Sydney, Australia. Participants We will recruit 60 participants over 55 years old with chronic LBP from the waiting list. Interventions Participants will be randomised to receive video-game exercise ( n = 30) or to remain on the waiting list ( n = 30) for 8 weeks, with follow up at 3 and 6 months. Participants engaging in video-game exercises will be unsupervised and will complete video-game exercise for 60 minutes, 3 times per week. Participants allocated to remain on the waiting list will be encouraged to maintain their usual levels of physical activity. Main outcome measure The primary outcomes for this feasibility study will be study processes (recruitment and response rates, adherence to and experience with the intervention, and incidence of adverse events) relevant to the future design of a large RCT. Estimates of treatment efficacy (point estimates and 95% confidence intervals) on pain self-efficacy, care seeking, physical activity, fear of movement/re-injury, pain, physical function, disability, falls-efficacy, strength, and walking speed, will be our secondary outcome measures. Results Recruitment for this trial began in November 2015. Conclusion This study describes the rationale and processes of a feasibility study investigating a video-game exercise programme for older people with chronic LBP. Results from the feasibility study will inform on the design and sample required for a large multicentre RCT. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12615000703505. ]]>
机译:摘要目的,调查为慢性低腰疼痛(LBP)为老年人实施视频游戏练习计划的可行性。设计单居着单盲随机对照试验(RCT)。在澳大利亚悉尼西部的公立医院设定物理疗法门诊部。与会者我们将在等候名单中招募60多个55岁以上的参与者,从等候名单中致力于慢性LBP。干预措施参与者将随机分配以接收视频游戏练习(n = 30),或保留在等候名单(n = 30)上8周,随访3个月和6个月。从事视频游戏练习的参与者将无人监督,并将完成60分钟的视频游戏练习,每周3次。将鼓励分配待在等待名单上的参与者维持其通常的身体活动水平。主要结果衡量这种可行性研究的主要结果将是与未来的大型RCT设计相关的研究进程(招聘和响应和遵守和干预,不良事件发病率)。治疗疗效估计(点估计和95%的置信区间)对疼痛自我疗效,护理寻求,体育活动,恐惧运动/再损伤,疼痛,物理功能,残疾,患有效力,力量和步行速度,将是我们的二级结果措施。结果招聘此审判于2015年11月开始。结论本研究介绍了可行性研究的理由和过程,调查慢性LBP的老年人的视频游戏练习计划。可行性研究的结果将通知大型多中心RCT所需的设计和样品。试验登记澳大利亚新西兰临床试验登记处:ACTRN12615000703505 ]]>

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