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文化适应性肺康复治疗吉尔吉斯斯坦肺结核病后成人:一项采用盲法结局测量的随机对照试验方案。

Culturally adapted pulmonary rehabilitation for adults living with post-tuberculosis lung disease in Kyrgyzstan: protocol for a randomised controlled trial with blinded outcome measures.

机构信息

Department of Pulmonology, National Center of Cardiology and Internal Medicine named after Academician M. Mirrakhimov, Bishkek, Kyrgyzstan

Republican Research Center of Pulmonology and Rehabilitation, Bishkek, Kyrgyzstan.

出版信息

BMJ Open. 2022 Feb 21;12(2):e048664. doi: 10.1136/bmjopen-2021-048664.

Abstract

INTRODUCTION

Pulmonary rehabilitation (PR) is a programme of individually prescribed physical exercise, education and self-management activities. PR is recommended in international guidelines for managing chronic obstructive pulmonary disease (COPD) and other chronic respiratory diseases. PR is still under-recognised in tuberculosis (TB) guidelines and PR is not available in many low and middle-income countries and for people with post-TB lung disease (PTBLD). The main aims of the study are to adapt and define a culturally appropriate PR programme in Kyrgyzstan for people living with PTBLD and to test, in a fully powered randomised controlled trial (RCT), the effectiveness of PR in improving exercise capacity for people living with PTBLD.

METHODS AND ANALYSIS

The study will be divided into three stages: focus group discussions with patients living with PTBLD and interviews with PR referrers will be conducted to explore initial perceptions and inform the cultural adaptation, structure and content of PR. a single-blind RCT evaluating the effectiveness of a culturally adapted 6-week PR programme on maximal exercise capacity, assessed by the incremental shuttle walking test, before and after PR. Participants will be additionally followed-up 12 weeks postbaseline. Additional outcomes will include health-related quality of life, respiratory symptoms, psychological well-being and physical function. participants' experience of PR will be collected through interviews and using a log book and a patient evaluation form. Staff delivering PR will be interviewed to explore their experience of delivering the intervention and refining the delivery for future implementation.

ETHICS AND DISSEMINATION

The study was approved 22/07/2019 by Ethics Committee National Center for Cardiology and Internal Medicine (reference number 17) and by University of Leicester ethics committee (reference number 22293). Study results will be disseminated through appropriate peer-reviewed journals, national and international respiratory/physiotherapy conferences, social media, and through patient and public involvement events in Kyrgyzstan and in the UK.

TRIAL REGISTRATION NUMBER

ISRCTN11122503.

摘要

介绍

肺康复(PR)是一项个体化的运动、教育和自我管理活动计划。国际指南建议将其用于慢性阻塞性肺疾病(COPD)和其他慢性呼吸道疾病的管理。但在结核病(TB)指南中,PR 仍然未得到充分认可,并且在许多低收入和中等收入国家以及患有 TB 后肺部疾病(PTBLD)的人群中无法获得 PR。本研究的主要目的是在吉尔吉斯斯坦为患有 PTBLD 的人群改编和定义一种文化上适当的 PR 方案,并在一项全面的随机对照试验(RCT)中,测试 PR 对改善患有 PTBLD 的人群的运动能力的有效性。

方法和分析

该研究将分为三个阶段:与患有 PTBLD 的患者进行焦点小组讨论,并对 PR 转诊医生进行访谈,以探索初始认知并为 PR 的文化适应、结构和内容提供信息。一项单盲 RCT 将评估为期 6 周的文化适应性 PR 方案对最大运动能力的有效性,通过递增穿梭步行测试在 PR 前后进行评估。参与者还将在基线后 12 周进行额外随访。其他结果将包括健康相关生活质量、呼吸症状、心理幸福感和身体功能。通过访谈和使用日志本和患者评估表收集参与者对 PR 的体验。对提供 PR 的工作人员进行访谈,以探索他们提供干预措施的经验,并为未来的实施完善提供措施。

伦理和传播

该研究于 2019 年 7 月 22 日获得国家心脏病学和内科中心伦理委员会(编号 17)和莱斯特大学伦理委员会(编号 22293)的批准。研究结果将通过适当的同行评审期刊、国家和国际呼吸/物理治疗会议、社交媒体以及在吉尔吉斯斯坦和英国的患者和公众参与活动进行传播。

试验注册号

ISRCTN82001037。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46f7/8860058/a86f78ee6c5f/bmjopen-2021-048664f01.jpg

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