Makerere University Lung Institute, Kampala, Uganda
Department of Respiratory Sciences, University of Leicester, Leicester, UK.
BMJ Open. 2021 Aug 10;11(8):e047641. doi: 10.1136/bmjopen-2020-047641.
INTRODUCTION: The burden of post-tuberculosis (TB) lung disease (PTBLD) is steadily increasing in sub-Saharan Africa, causing disability among TB survivors. Without effective medicines, the mainstay of PTBLD treatment evolves around disease prevention and supportive treatment. Pulmonary rehabilitation (PR), a low-cost, non-pharmacological intervention has shown effectiveness in a group of PTBLD individuals but has not been tested in a clinical trial. This study aims to assess the impact of a 6-week PR programme on maximal exercise capacity and other outcomes among adults in Uganda living with PTBLD. METHODS AND ANALYSIS: This is a randomised waiting-list controlled trial with blinded outcome measures, comparing PR versus usual care for patients with PTBLD. A total of 114 participants will be randomised (1:1) to receive either usual care (on the waiting list) or PR, with follow-up assessments at 6 weeks and 12 weeks postintervention. The primary outcome is change in walking distance measured by the Incremental Shuttle Walk Test from baseline to the end of 6 weeks of PR. All secondary outcomes will be compared between the PR and usual care arms from baseline to 6-week and 12-week follow-ups. Secondary outcomes include self-reported respiratory symptoms, physical activity, psychological well-being, health-related quality of life and cost-benefit analysis. All randomised participants will be included in the intention-to-treat analysis population. The primary efficacy analysis will be based on both per-protocol and modified intention-to-treat populations. ETHICS AND DISSEMINATION: The trial has received ethical clearance from the Mulago Hospital Research and Ethics Committee (MHREC 1478), Kampala, Uganda as well as the Uganda National Council for Science and Technology (SS 5105). Ethical approval has been obtained from the University of Leicester, UK research ethics committee (Ref No. 22349). Study findings will be published in appropriate peer-reviewed journals and disseminated at appropriate local, regional and international scientific meetings and conferences. TRIAL REGISTRATION NUMBER: ISRCTN18256843. PROTOCOL VERSION: Version 1.0 July 2019.
介绍:在撒哈拉以南非洲,肺结核(TB)后肺部疾病(PTBLD)的负担稳步增加,导致 TB 幸存者残疾。如果没有有效的药物,PTBLD 治疗的主要方法是围绕疾病预防和支持性治疗展开。肺康复(PR)是一种低成本、非药物干预措施,已在一组 PTBLD 个体中显示出有效性,但尚未在临床试验中进行测试。本研究旨在评估为期 6 周的 PR 方案对乌干达 PTBLD 成年人最大运动能力和其他结果的影响。
方法和分析:这是一项随机等待名单对照试验,采用盲法结局评估,比较 PR 与 PTBLD 患者的常规护理。共有 114 名参与者将被随机(1:1)分配接受常规护理(在等待名单上)或 PR,在干预后 6 周和 12 周进行随访评估。主要结局是通过递增穿梭步行测试从基线到 PR 结束时的步行距离变化。所有次要结局将从基线到 6 周和 12 周随访比较 PR 和常规护理组之间的差异。次要结局包括自我报告的呼吸症状、身体活动、心理健康、健康相关生活质量和成本效益分析。所有随机参与者都将被纳入意向治疗分析人群。主要疗效分析将基于方案人群和修改意向治疗人群。
伦理和传播:该试验已获得乌干达坎帕拉穆拉戈医院研究和伦理委员会(MHREC 1478)以及乌干达国家科学技术委员会(SS 5105)的伦理批准。英国莱斯特大学的研究伦理委员会也已批准该试验(参考编号 22349)。研究结果将发表在适当的同行评议期刊上,并在适当的地方、区域和国际科学会议和会议上传播。
试验注册号:ISRCTN84261164。
方案版本:2019 年 7 月第 1.0 版。
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