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术前吸气肌训练联合术前教育对肺癌高危患者术后肺部并发症的影响:一项随机对照试验方案。

Effect of preoperative inspiratory muscle training combined with preoperative education on postoperative pulmonary complications in high-risk patients with lung cancer: protocol for a randomised controlled trial.

机构信息

Department of Rehabilitation Medicine, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.

Department of Rehabilitation Medicine, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China.

出版信息

BMJ Open. 2024 Nov 2;14(11):e084072. doi: 10.1136/bmjopen-2024-084072.

Abstract

INTRODUCTION

Preoperative inspiratory muscle training (IMT) is recognised as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT programme combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education ('the programme'). This study aims to evaluate the effectiveness of this programme in reducing postoperative pulmonary complications (PPCs) after lung cancer resection compared with standard care.

METHODS AND ANALYSIS

In this randomised controlled trial, 114 participants scheduled for lung cancer surgery at the First Affiliated Hospital of Fujian Medical University will be randomly assigned (1:1) to either receive usual care (information booklet) or usual care combined with the programme, which consist of short-term home-based IMT and preoperative physiotherapy education. The primary outcome measure will be PPCs using the Melbourne Group Score. Secondary outcomes will include health-related quality of life, maximal inspiratory pressure, 6 min walk distance, length of hospital stay, anxiety and depression levels, and hospital costs.

ETHICS AND DISSEMINATION

The study has received ethics approval from the ethics committee of the first affiliated hospital of Fujian Medical University (approval no: MRCTA, ECFAH of MFU [2021]569). Participants will be required to provide written informed consent. The results of the study will be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ChiCTR2300067464.

摘要

简介

术前吸气肌训练(IMT)被认为是肺癌术前管理的重要组成部分,尽管有有限的证据表明可以实施家庭为基础的 IMT 计划并结合术前教育。我们开发了一个结合短期家庭 IMT 和术前物理治疗教育的计划(“该计划”)。本研究旨在评估与标准护理相比,该计划在减少肺癌切除术后肺部并发症(PPCs)方面的有效性。

方法和分析

在这项随机对照试验中,将有 114 名在福建医科大学第一附属医院接受肺癌手术的患者被随机分配(1:1)接受常规护理(信息手册)或常规护理联合该计划,该计划包括短期家庭 IMT 和术前物理治疗教育。主要结局指标将是使用墨尔本小组评分的 PPCs。次要结局指标将包括健康相关生活质量、最大吸气压力、6 分钟步行距离、住院时间、焦虑和抑郁水平以及住院费用。

伦理和传播

该研究已获得福建医科大学第一附属医院伦理委员会的伦理批准(批准号:MRCTA,ECFAH of MFU [2021]569)。参与者将需要提供书面知情同意。研究结果将提交给同行评议的期刊发表。

试验注册号

ChiCTR2300067464。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adc1/11535684/1be7ac652cd4/bmjopen-14-11-g001.jpg

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