Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind implementation trial

许多患有慢性呼吸道疾病（CRDs）的人，如慢性阻塞性肺病、哮喘、结核病后损伤，会出现致残症状，特别是呼吸困难，影响他们的日常活动。呼吸困难是不舒服和可怕的，所以人们倾向于避免使呼吸困难恶化的活动。然后，因为他们没有做任何运动，肌肉变弱，他们变得“不健康”，这使得活动更加困难。这会影响生活质量，抑郁症也很常见。肺康复（pr）有何帮助？公共关系提供了一个有监督的锻炼计划来扭转这种恶性循环。公共关系结合了耐力和肌肉强化锻炼，以及关于慢性呼吸衰竭的原因和治疗的教育，以及如何应对呼吸困难。在PR疗程结束时，患有crd的人呼吸不那么急促，可以做更多的事情，提高他们的生活质量。我们为什么需要这个试验？几乎所有的公关试验都是在高收入国家进行的，那里有设备齐全的健身房，而且通常是针对患有一种疾病的人。在低收入和中等收入国家（LMICs），公共关系中心往往设备较少，获得能够准确诊断不同类型慢性肾病的检测的机会有限。另一个问题是距离；在农村的中低收入国家，在8周内前往一个中心16次可能很困难，因此以家庭为基础的公关可能是有用的。我们的问题是：*在低资源环境下进行PR是否能改善CRD患者的运动能力和生活质量？*在家里进行的公关是否与在中心进行的公关一样有效？PR的好处是否能持续6个月？* PR成本是多少？*患者、公关治疗师和专业人士对服务有什么看法？我们将从四个中心（孟加拉国，印度x2，马来西亚）招募465名患有CRD的成年人，并将他们随机分配到三个组之一：* Centre-PR：在PR中心进行每周两次的运动和教育计划，为期8周* Home-PR：每周两次的运动和教育计划，在他们自己的家中进行，通过视频电话/电话远程监督*常规护理：常规临床护理。在试验结束时，这组人将选择中心-PR或家庭-PR。结果和预期益处在PR项目结束时，我们将评估运动能力、生活质量、呼吸困难、焦虑和抑郁，并在6个月后再次评估益处是否得到维持。我们将衡量医疗资源的使用情况，以评估对医疗服务的成本影响。如果成功了，如何在mics中推广？我们将采访参与者，以了解他们对公关的看法。我们将询问治疗师在他们的中心和家中提供公关的可行性，以及他们如何克服任何问题。我们将采访转诊临床医生、卫生服务管理人员和政策制定者，以了解如何在四种不同的环境中实施和维持一项服务。利益相关者和社区参与项目团队中有两名CRD患者（Banu女士来自孟加拉国；Ku先生来自马来西亚），我们将在整个试验期间与每个中心的社区团体合作。积极的利益相关者参与将确保我们的研究结果影响专业人士和政策制定者。谁在做这项研究？我们的团队包括来自爱丁堡大学和四个中心的CRD患者、临床医生、治疗师、研究人员、统计学家、健康经济学家和健康心理学家。我们在呼吸护理、公关和开展试验方面拥有丰富的经验。与同事分享这种专门知识将有助于在所有中心建立研究能力。分享我们的发现我们是美国国立卫生研究院全球卫生研究单位RESPIRE的一部分，我们将利用他们的社交媒体和网络向人们介绍PuRe试验，并与政策制定者合作促进变革。我们将出席会议并为科学期刊撰写论文。

Many people with chronic respiratory diseases (CRDs) such as chronic obstructive pulmonary disease, asthma, post-TB damage have disabling symptoms, especially breathlessness, which affect their day-to-day activities. Breathlessness is uncomfortable and frightening, so people tend to avoid activities that make breathlessness worse. Then, because they are not doing any exercise, muscles weaken and they become 'unfit', which makes activities even harder. This affects quality of life, and depression is common.HOW CAN PULMONARY REHABILITATION (PR) HELP?PR provides a supervised programme of exercise to reverse this vicious circle. PR combines endurance and muscle strengthening exercises, with education about the causes and treatment of CRDs, and coping with breathlessness. At the end of a course of PR, people with CRDs are less breathless and can do more, improving their quality of life.WHY DO WE NEED THIS TRIAL?Almost all PR trials were done in high-income countries, with well-equipped gyms and usually for people with one disease. In low- and middle-income countries (LMICs), PR Centres often have less equipment and limited access to tests that allow accurate diagnosis of different types of CRD. Another problem is distance; travelling to a Centre 16 times in 8 weeks may be difficult in rural LMICs, so home-based PR may be useful.Our questions are:* Does PR delivered in a low resource setting improve exercise capacity and quality of life in people with CRD?* Is PR delivered at home as effective as centre-based PR?* Do benefits of PR last 6 months?* How much does PR cost?* What do patients, PR therapists and professionals think of the services? PULMONARY REHABILITATION (PuRe) TRIAL We will recruit 465 adults with CRD from four centres (Bangladesh, India x2, Malaysia) and allocate them by chance to one of three groups:* Centre-PR: a programme of exercise and education twice a week for 8 weeks at a PR Centre * Home-PR: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone* Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PROUTCOMES AND EXPECTED BENEFITSAt the end of the PR programme we will assess exercise capacity, quality of life, breathlessness, anxiety and depression, and again 6-months later to measure whether benefits are maintained. We will measure use of healthcare resources to assess the cost implications for the health service.IF SUCCESSFUL, HOW CAN THIS BE ROLLED OUT IN LMICS?We will interview participants to find out what they think of the PR. We will ask the therapists about the practicalities of delivering PR in their Centre and at home and how they overcame any problems. We will interview referring clinicians, health service managers and policymakers to understand how a service might be implemented and sustained in the four different settings.STAKEHOLDER AND COMMUNITY ENGAGEMENTTwo people with CRD are members of the project team (Ms Banu, Bangladesh; Mr Ku, Malaysia), and we will collaborate with community groups in each of the centres throughout the trial. Proactive stakeholder engagement will ensure our findings influence professionals and policymakers.WHO IS DOING THIS RESEARCH?Our team includes people with CRD, clinicians, therapists, researchers, statisticians, health economists and health psychologists from the University of Edinburgh and the four Centres. Together we have extensive experience in respiratory care, PR and conducting trials. Sharing that expertise with colleagues will help build research capacity in all the Centres. SHARING OUR FINDINGSWe are part of the NIHR Global Health Research Unit RESPIRE and will use their social media and networks to tell people about the PuRe trial and work with policymakers to promote change. We will present at conferences and write papers for scientific journals.