移动康复支持与全髋关节或膝关节置换术后患者的常规护理比较:一项随机对照试验的研究方案。

Mobile rehabilitation support versus usual care in patients after total hip or knee arthroplasty: study protocol for a randomised controlled trial.

机构信息

School of Nursing and Health Management, Shanghai University of Medicine and Health Sciences, Shanghai, China.

School of Nursing and Midwifery, The University of Newcastle, Callaghan, New South Wales, 2308, Australia.

出版信息

Trials. 2022 Jul 8;23(1):553. doi: 10.1186/s13063-022-06269-x.

Abstract

BACKGROUND

The global increase in total hip or knee arthroplasty has led to concern about the provision of postoperative rehabilitation. Telerehabilitation may be a strategy to meet the patients' requirements for rehabilitation after arthroplasty. This study aims to investigate the effectiveness of a telerehabilitation programme delivered via the mobile application WeChat in patients after total hip or knee arthroplasty on the following outcomes: self-efficacy, physical function, pain, depression, anxiety and health-related quality of life.

METHODS

This is a single-centre, single-blinded, parallel-group, superiority randomised controlled trial conducted in Shanghai, China. Eighty-four eligible participants who undergo primary total hip or knee arthroplasty will be recruited preoperatively in a university teaching hospital and randomly assigned to the experimental or control group with their informed consent. Once discharged, the control group (n = 42) will receive the usual care provided by the hospital. The experimental group (n = 42) will receive usual care and a 6-week mobile application rehabilitation programme that consists of physical exercises and techniques for enhancing participants' self-efficacy for rehabilitation. Baseline assessments will be conducted on the day before hospital discharge, and outcome assessments will be conducted 6 and 10 weeks postoperatively. The primary outcomes are changes in self-efficacy and physical function 6 weeks postoperatively, and the secondary outcomes include pain, depression, anxiety and health-related quality of life. The approach of a generalised estimating equation will be used to analyse the effect of the intervention on outcomes at a significance level of 0.05.

DISCUSSION

This study is the first of its kind conducted in China to incorporate self-efficacy and learning theories as a framework to guide the development of a mobile application rehabilitation programme after arthroplasty. This study will contribute to the knowledge about the effectiveness of mobile application-based rehabilitation among patients after total hip or knee arthroplasty. If the findings are positive, they will support the implementation of mobile application-based rehabilitation in practice, which may potentially increase the accessibility of rehabilitation services as well as patient adherence to rehabilitation.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12621000867897 . Retrospectively registered on July 6, 2021.

摘要

背景

全球范围内全髋关节或全膝关节置换术的数量不断增加,这引发了人们对术后康复服务提供情况的关注。远程康复可能是满足患者关节置换术后康复需求的一种策略。本研究旨在调查通过移动应用程序微信提供的远程康复方案对全髋关节或全膝关节置换术后患者的以下结局的有效性:自我效能感、身体功能、疼痛、抑郁、焦虑和健康相关生活质量。

方法

这是一项在中国上海进行的单中心、单盲、平行组、优效性随机对照试验。将在一家大学教学医院招募 84 名符合条件的初次行全髋关节或全膝关节置换术的患者,在获得他们的知情同意后,将他们按照随机数字表法分为实验组和对照组。一旦出院,对照组(n=42)将接受医院提供的常规护理。实验组(n=42)将接受常规护理和为期 6 周的移动应用康复方案,该方案包括身体锻炼和增强患者康复自我效能的技术。将在出院前一天进行基线评估,并在术后 6 周和 10 周进行结局评估。主要结局是术后 6 周时自我效能感和身体功能的变化,次要结局包括疼痛、抑郁、焦虑和健康相关生活质量。将采用广义估计方程来分析干预对结局的影响,检验水准为 0.05。

讨论

这是中国开展的首例将自我效能感和学习理论作为指导框架来开发关节置换术后移动应用康复方案的研究。本研究将有助于了解移动应用程序为基础的康复方案对全髋关节或全膝关节置换术后患者的有效性。如果研究结果为阳性,将支持在实践中实施移动应用程序为基础的康复,这可能会增加康复服务的可及性以及患者对康复的依从性。

试验注册

澳大利亚新西兰临床试验注册中心 ACTRN12621000867897。于 2021 年 7 月 6 日进行了回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/032c/9264628/3c9b7e1cc1ee/13063_2022_6269_Fig1_HTML.jpg

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