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针对接受翻修全髋关节置换术患者的髋关节强化锻炼干预效果的多中心随机对照试验研究方案。

Effect of an exercise intervention targeting hip strengthening in patients undergoing revision total hip replacement-A study protocol for a multicenter randomized controlled trial.

机构信息

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark.

出版信息

Physiother Res Int. 2024 Jul;29(3):e2101. doi: 10.1002/pri.2101.

Abstract

BACKGROUND

Limited evidence exists regarding the effectiveness of pain relief and functional improvement in patients undergoing revision total hip replacement (THR). Furthermore, there are no clinical guidelines or consensus on optimal rehabilitation after revision THR.

PURPOSE

The primary aim of this study was to compare the effectiveness of an exercise intervention targeting hip strengthening with standard community-based rehabilitation in patients undergoing revision THR.

METHODS

This multicenter randomized controlled assessor-blinded trial will be conducted at eight hospitals and multiple municipality rehabilitation centers in Denmark. A total of 84 patients undergoing revision THR are estimated to be allocated to either an exercise intervention targeting hip strengthening (NEMEX-STR) or standard community-based rehabilitation (Usual care). Recruitment was initiated in November 2022 and is expected to be completed by June 2024. The primary outcome is change in functional performance measured by the 30 s chair stand test, from baseline to 4 months after the start of intervention. Secondary outcomes include hip disability and osteoarthritis outcome score; 40 m fast-paced walk test; 9-step timed stair climb test; leg extensor muscle power; global perceived effect; and adverse events. Other outcomes include The International Physical Activity Questionnaires, pain intensity, and European quality of life-5 dimensions. An intention-to-treat approach will be used for analyzing changes in primary and secondary outcome measures. The trial was approved by the Central Denmark Region Committees on Health Research Ethics (Journal No 1-10-72-134-22) and registered on the Central Denmark Regions' internal list of research projects (Journal No 1-16-02-285-22).

DISCUSSION

To our knowledge, this study is the first to explore different rehabilitation programs after revision THR through a randomized controlled trial. The results will provide clinically relevant evidence for optimal rehabilitation after revision THR for improving functional performance, physical function, and quality of life, with great importance for patients, relatives, physiotherapists, and decision-makers.

CLINICALTRIAL

GOV: NCT05657054.

摘要

背景

在接受翻修全髋关节置换术 (THR) 的患者中,关于缓解疼痛和改善功能的效果,证据有限。此外,对于翻修 THR 后的最佳康复,目前尚无临床指南或共识。

目的

本研究的主要目的是比较针对髋关节强化的锻炼干预与翻修 THR 后基于社区的标准康复在患者中的效果。

方法

这是一项在丹麦 8 家医院和多个市立康复中心进行的多中心随机对照评估者盲法试验。预计将有 84 名接受翻修 THR 的患者被分配到针对髋关节强化的锻炼干预组(NEMEX-STR)或基于社区的标准康复组(常规护理)。招募工作于 2022 年 11 月开始,预计将于 2024 年 6 月完成。主要结局是从干预开始后 4 个月时的功能表现,通过 30 秒椅子站立测试来衡量。次要结局包括髋关节残疾和骨关节炎结局评分;40 米快速步伐步行测试;9 步计时楼梯攀登测试;腿部伸肌肌力;整体感知效果;以及不良事件。其他结局包括国际体力活动问卷、疼痛强度和欧洲生活质量-5 维度。将采用意向治疗法分析主要和次要结局测量的变化。该试验已获得丹麦中央地区健康研究伦理委员会的批准(注册号 1-10-72-134-22),并在丹麦中央地区内部研究项目清单上注册(注册号 1-16-02-285-22)。

讨论

据我们所知,这是第一项通过随机对照试验探索翻修 THR 后不同康复方案的研究。研究结果将为翻修 THR 后改善功能表现、身体功能和生活质量的最佳康复提供具有临床意义的证据,这对患者、家属、物理治疗师和决策者具有重要意义。

临床试验

GOV:NCT05657054。

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