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（CRD）的人，如慢性阻塞性肺疾病，哮喘，结核病后损害，都有致残症状，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“不适合”，这使得活动更加困难。这会影响生活质量，抑郁症是常见的。肺康复（PR）如何帮助？公共关系提供了一个有监督的锻炼方案，以扭转这种恶性循环。PR结合了耐力和肌肉强化练习，关于CRD的原因和治疗的教育，以及应对呼吸困难。在公共关系课程结束时，CRD患者可以做更多的事情，改善他们的生活质量。为什么我们需要这个试验？几乎所有的PR试验都是在高收入国家进行的，这些国家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），PR中心的设备通常较少，并且获得允许准确诊断不同类型CRD的测试的机会有限。另一个问题是距离;在农村中低收入国家，8周内前往中心16次可能很困难，因此以家庭为基础的PR可能是有用的。我们的问题是：* 在低资源环境下提供的PR是否能改善CRD患者的运动能力和生活质量？*在家进行公关是否与中心公关一样有效？* PR的好处持续6个月吗？* PR值多少钱？”患者、公关治疗师和专业人士对这些服务有什么看法？肺康复（PuRe）试验我们将从四个中心招募465名CRD成人患者（孟加拉国，印度x2，马来西亚），并随机分配到三个组之一：* 中心-PR：一个方案的锻炼和教育，每周两次，为期8周，在PR中心 * 家庭-PR：每周两次在自己家中进行为期8周的锻炼和教育方案，并通过视频通话/电话进行远程监督。在试验结束时，这组将提供他们选择的中心PR或家庭PROUTCOMES和预期的好处在PR计划结束时，我们将评估运动能力，生活质量，呼吸困难，焦虑和抑郁，并再次6个月后，以衡量是否保持效益。我们将衡量医疗资源的使用情况，以评估医疗服务的成本影响。如果成功，如何在LMICS中推广？我们将采访参与者，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进行公关的可行性，以及他们如何克服任何问题。我们将采访转诊的临床医生、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服务。利益相关者和社区参与两名CRD患者是项目团队的成员（Banu女士，孟加拉国; Ku先生，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。利益相关者的积极参与将确保我们的研究结果能够影响专业人士和政策制定者。我们的团队包括来自爱丁堡大学和四个中心的CRD，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。与同事分享这一专门知识将有助于建设所有中心的研究能力。分享我们的发现我们是NIHR全球健康研究部门的一部分，将利用他们的社交媒体和网络告诉人们关于PureTrial的信息，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.