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50岁及以上成年人桡骨远端骨折后渐进性抗阻和柔韧性训练与常规护理建议对改善疼痛和功能的比较:WISE随机优势试验方案

Progressive resistance and flexibility exercises versus usual care advice for improving pain and function after distal radius fracture in adults aged 50 years or over : protocol for the WISE randomized superiority trial.

作者信息

Keene David J, Achten Juul, Marian Ioana, Franssen Marloes, Tutton Elizabeth, Sheehan Warren, Forde Colin, Crook Hannah, Gould Jenny, Grant Richard, Appelbe Duncan, Lamb Sarah E, Costa Matthew L

机构信息

Exeter Medical School, University of Exeter, Exeter, UK.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

出版信息

Bone Jt Open. 2025 Jul 8;6(7):764-784. doi: 10.1302/2633-1462.67.BJO-2024-0227.

Abstract

AIMS

Distal radius fractures are very common injuries; the majority affect females aged 50 years or over. Most patients experience pain and stiffness in their wrist and upper limb weakness, making activities of daily living difficult. The aim of the WISE (Wrist Injury Strengthening Exercise) trial is to assess the effectiveness of a flexibility and resistance exercise programme for the upper limb compared with usual care advice after distal radius fracture.

METHODS

This is a multicentre, parallel-group, superiority, individually randomized controlled trial. We aim to recruit 588 participants aged 50 years and older with a distal radius fracture treated surgically or non-surgically from at least 15 UK NHS hospitals. Participants will be randomized 1:1 using a web-based service to usual care advice plus a therapist-supervised exercise programme (three one-to-one therapy sessions of tailored advice and prescribed home exercise over 12 weeks) or usual care advice only. The primary outcome is participant-reported wrist-related pain and function six months after randomization, measured by the Patient-Rated Wrist Evaluation. Secondary outcomes at three and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, grip strength, complications, and resource use.

CONCLUSION

This study will assess whether a therapist-supervised exercise programme is more clinically effective than usual care advice for people aged 50 years and older after distal radius fracture. At the time of submission, the trial is currently completing recruitment; follow-up will be completed in 2025 (ISRCTN registry identifier: ISRCTN78953418).

摘要

目的

桡骨远端骨折是非常常见的损伤;大多数患者为50岁及以上的女性。大多数患者会经历手腕疼痛和僵硬以及上肢无力,这使得日常生活活动变得困难。WISE(腕部损伤强化锻炼)试验的目的是评估与桡骨远端骨折后常规护理建议相比,上肢柔韧性和阻力锻炼计划的有效性。

方法

这是一项多中心、平行组、优效性、个体随机对照试验。我们的目标是从至少15家英国国民保健服务医院招募588名50岁及以上接受手术或非手术治疗的桡骨远端骨折患者。参与者将使用基于网络的服务以1:1的比例随机分配到常规护理建议加治疗师监督的锻炼计划(在12周内进行三次一对一治疗,提供量身定制的建议并规定家庭锻炼)或仅接受常规护理建议。主要结局是随机分组六个月后参与者报告的与手腕相关的疼痛和功能,通过患者自评腕关节评估来测量。三个月和六个月时的次要结局包括与健康相关的生活质量、疼痛、身体功能、自我效能感、锻炼依从性、握力、并发症和资源使用情况。

结论

本研究将评估对于50岁及以上桡骨远端骨折患者,治疗师监督的锻炼计划在临床上是否比常规护理建议更有效。在提交本文时,该试验目前正在完成招募;随访将于2025年完成(国际标准随机对照试验编号:ISRCTN78953418)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a24d/12235327/b5202223a85e/BJO-2024-0227-galleyfig1.jpg

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