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首页> 外文期刊>Trials >The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
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The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial

机译：多模式体育活动干预，监督锻炼，健康指导和活动监测器对慢性非特异性下腰痛患者的体育活动水平的疗效（腰痛体育活动（PAyBACK）试验）：一项随机对照试验的研究方案

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Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programmes for chronic LBP is that these programmes are not designed to change patients’ behaviour toward an active lifestyle. Therefore, we will investigate the short- and long-term efficacy of a multimodal intervention, consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability, in patients with chronic, nonspecific LBP. This study will be a two-group, single-blind, randomised controlled trial. One hundred and sixty adults with chronic, nonspecific LBP will be recruited. Participants allocated to both groups will receive a group exercise programme. In addition, the intervention group will receive health coaching sessions (i.e. assisting the participants to achieve their physical activity goals) and an activity monitor (i.e. Fitbit Flex). The participants allocated to the control group will receive sham health coaching (i.e. encouraged to talk about their LBP or other problems, but without any therapeutic advice from the physiotherapist) and a sham activity monitor. Outcome measures will be assessed at baseline and at 3, 6 and 12 months post randomisation. The primary outcomes will be physical activity, measured objectively with an accelerometer, as well as pain intensity and disability at 3 months post randomisation. Secondary outcomes will be physical activity, pain intensity and disability at 6 and 12 months post randomisation as well as other self-report measures of physical activity and sedentary behaviour, depression, quality of life, pain self-efficacy and weight-related outcomes at 3, 6, and 12 months post randomisation. This study is significant as it will be the first study to investigate whether a multimodal intervention designed to increase physical activity levels reduces pain and disability, and increases physical activity levels compared to a control intervention in patients with chronic LBP. ClinicalTrials.gov, ID: NCT03200509 . Registered on 28 June 2017.
机译：身体活动在控制慢性下背痛（LBP）中起着重要作用。积极地生活与更好的预后相关。但是，有证据表明，患有慢性LBP的患者不太可能达到建议的体力活动水平。此外，尽管运动疗法已被近期的临床实践指南所认可，但系统评价的证据表明，运动疗法对疼痛和残疾的作用至多为中等程度，并且不会随时间持续。当前针对慢性LBP的锻炼计划的局限性在于，这些计划并非旨在改变患者的行为，使其成为积极的生活方式。因此，我们将研究多模式干预的短期和长期效果，包括监督锻炼，健康指导和活动监测器（即Fitbit Flex）与有监督锻炼以及假肢训练和假肢活动监测器的比较慢性非特异性LBP患者的活动水平，疼痛强度和残疾。这项研究将是一项两组，单盲，随机对照试验。将招募160名患有慢性非特异性LBP的成年人。分配给两个小组的参与者将接受小组锻炼计划。此外，干预小组还将接受健康指导课程（即协助参与者实现其体育锻炼目标）和活动监控器（即Fitbit Flex）。分配给对照组的参与者将接受假健康指导（即，鼓励他们谈论自己的LBP或其他问题，但无需理疗师的任何治疗建议）和假活动监控器。将在基线后以及随机分组后3、6和12个月评估结果指标。主要结果将是使用加速度计客观测量的身体活动，以及随机分配后3个月的疼痛强度和残疾。次要结果将是随机分组后6个月和12个月时的体育活动，疼痛强度和残疾，以及其他自我报告的体育活动和久坐行为，抑郁，生活质量，疼痛自我效能和与体重相关的结果（3岁）随机分组后的6、12个月。这项研究意义重大，因为这将是第一个研究旨在提高身体活动水平的多模式干预措施与慢性LBP患者相比，是否能够减轻疼痛和残疾，并增加身体活动水平的研究。 ClinicalTrials.gov，ID：NCT03200509。 2017年6月28日注册。

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