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基于呼吸治疗的核心训练对康复医院老年稳定期慢性阻塞性肺疾病患者的影响:一项随机对照试验的研究方案

Effects of core training based on respiratory therapy on elderly stable COPD patients in the rehabilitation hospital: a study protocol for a randomised controlled trial.

作者信息

Su Jianqing, Qu Yan, Wei Yingjun, Wang Shanshan, Zhou Jingjing, Gao Bingyang, Niu Chunlai, Zhang Zinan, Feng Wei

机构信息

Department of Pulmonary Rehabilitation, the Second Rehabilitation Hospital of Shanghai, Shanghai, China.

school of rehabilitation science, Shanghai University of Traditional Chinese Medicine, Shanghai, Shanghai, China.

出版信息

BMJ Open. 2024 Dec 9;14(12):e086837. doi: 10.1136/bmjopen-2024-086837.

Abstract

INTRODUCTION

Elderly stable chronic obstructive pulmonary disease (COPD) patients frequently experience walking dysfunction. Research indicates that balance training holds promise for enhancing walking stability in these individuals, whereas respiratory therapy (RT) can enhance walking endurance effectively. However, existing balance training regimens tailored for COPD are intricate and lack specificity, and the impact of combined RT on patients' walking function remains uncertain. This study aims to assess the influence of core training (CT) integrated with RT on walking function among elderly stable COPD patients.

METHODS AND ANALYSIS

This randomised, assessment-blinded, routine rehabilitation-controlled trial will be carried out at the Department of Respiratory and Critical Care Rehabilitation, the Second Rehabilitation Hospital of Shanghai. A total of 42 elderly patients diagnosed with stable COPD will be randomly allocated to either the study group (SG) or the control group in a 1:1 ratio. Both groups will undergo 6 weeks of standard rehabilitation training. Additionally, patients in the SG will receive CT based on RT. The primary outcome of the study is the 6 min walk test. Secondary outcomes encompass ultrasound indicators of the diaphragm and multifidus, pulmonary function tests, Berg balance scale test, trunk impairment scale test, COPD assessment test and St. George's Respiratory Questionnaire.

ETHICS AND DISSEMINATION

Ethical approval was obtained from the Ethics Committee of the Second Rehabilitation Hospital of Shanghai (2023-01-01, see online supplemental file 1). All patients will provide written informed consent before participation. The results of the trial are intended for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ChiCTR2400080276.

摘要

引言

老年稳定期慢性阻塞性肺疾病(COPD)患者经常出现行走功能障碍。研究表明,平衡训练有望提高这些患者的行走稳定性,而呼吸治疗(RT)可以有效提高行走耐力。然而,现有的针对COPD的平衡训练方案复杂且缺乏针对性,联合RT对患者行走功能的影响仍不确定。本研究旨在评估核心训练(CT)与RT相结合对老年稳定期COPD患者行走功能的影响。

方法与分析

本随机、评估盲法、常规康复对照试验将在上海市第二康复医院呼吸与危重症康复科进行。总共42例被诊断为稳定期COPD的老年患者将按1:1的比例随机分配到研究组(SG)或对照组。两组均将接受6周的标准康复训练。此外,SG组的患者将在RT的基础上接受CT。本研究的主要结局是6分钟步行试验。次要结局包括膈肌和多裂肌的超声指标、肺功能测试、伯格平衡量表测试、躯干损伤量表测试、COPD评估测试和圣乔治呼吸问卷。

伦理与传播

已获得上海市第二康复医院伦理委员会的伦理批准(2023-01-01,见在线补充文件1)。所有患者在参与前将提供书面知情同意书。试验结果拟发表在同行评审期刊上。

试验注册号

ChiCTR2400080276。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/497c/11629001/6cf7109b944b/bmjopen-14-12-g001.jpg

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