一项针对慢性阻塞性肺疾病和慢性心力衰竭（COHERE 试验）呼吸困难康复计划的可行性试验方案。
Protocol for a feasibility trial to inform the development of a breathlessness rehabilitation programme for chronic obstructive pulmonary disease and chronic heart failure (the COHERE trial).
机构信息
National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.
Centre for Exercise and Rehabilitation Sciences, Leicester Biomedical Research Centre-Respiratory, National Institute for Health Research, Leicester, UK.
出版信息
BMJ Open. 2019 Jul 16;9(7):e029387. doi: 10.1136/bmjopen-2019-029387.
INTRODUCTION
Adults with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) commonly suffer from exertional dyspnoea and fatigue. Exercise training is recommended in the management of both diseases, yet many of the outcome measures traditionally reported are disease specific and may not fully acknowledge the multimorbid older adult. Based on our previous research, a breathlessness rehabilitation programme for patients with COPD/CHF or combined disease has been introduced as a service improvement within University Hospital Leicester National Health Service Trust and has amalgamated aspects of cardiac and pulmonary rehabilitation. This has created an opportunity to expand the outcome measures assessed and introduce a holistic approach in a population that share common symptoms. Therefore, this multisite trial will explore the feasibility of collecting novel outcome markers as part of a comprehensive assessment prior to enrolment in a breathlessness rehabilitation programme for participants with COPD and/or CHF.
METHODS AND ANALYSIS
The rehabilitation programme consists of 12 sessions, twice weekly, over a 6-week period. In addition to usual rehabilitation outcome measures, the trial will collect measures of future cardiometabolic risk including arterial stiffness, body composition, physical activity/sedentary time, frailty and symptom burden in a comprehensive rehabilitation assessment. The primary outcome measures will centre around feasibility (eg, acceptability of the comprehensive rehabilitation assessment, intervention delivery and the experiences and attitudes of healthcare professionals and participants). Focus groups and interviews will be conducted to further explore barriers and facilitators to the operation and participation in a breathlessness rehabilitation programme and the trial. Thematic analysis will be used for the interpretation of all qualitative data.
ETHICS AND DISSEMINATION
The research ethics committee East Midlands Leicester-Central has provided ethical approval for the conduct of this trial. The results of the trial will be disseminated through appropriate conference proceedings and peer-reviewed journals.
TRIAL REGISTRATION NUMBER
ISRCTN11636308.
简介
患有慢性阻塞性肺疾病（COPD）和慢性心力衰竭（CHF）的成年人常因运动性呼吸困难和疲劳而受苦。运动训练被推荐用于这两种疾病的治疗，但传统上报告的许多结果测量都是针对特定疾病的，可能无法充分认识到多病共存的老年患者。基于我们之前的研究，莱斯特大学医院国家卫生服务信托基金会已经引入了一种针对 COPD/CHF 或合并疾病患者的呼吸急促康复计划作为服务改进，该计划融合了心脏和肺康复的各个方面。这为在共享共同症状的人群中扩展评估的结果测量指标并引入整体方法提供了机会。因此，这项多中心试验将探索在参加呼吸急促康复计划之前收集新的结果标志物的可行性，该计划适用于 COPD 和/或 CHF 患者。
方法和分析
康复计划由 12 个课程组成，每周两次，为期 6 周。除了通常的康复结果测量指标外，该试验还将收集未来心血管代谢风险的测量指标，包括动脉僵硬、身体成分、体力活动/久坐时间、虚弱和症状负担，作为综合康复评估的一部分。主要结果测量指标将集中在可行性方面（例如，全面康复评估、干预措施的提供以及医疗保健专业人员和参与者的经验和态度的可接受性）。将进行焦点小组和访谈，以进一步探讨呼吸困难康复计划的运作和参与的障碍和促进因素，以及试验的情况。将使用主题分析对所有定性数据进行解释。
伦理和传播
东米德兰兹莱斯特-中心研究伦理委员会已批准进行这项试验。试验的结果将通过适当的会议记录和同行评审期刊进行传播。
试验注册号
ISRCTN84250623.
Zotero 插件