School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia
Physiotherapy Department, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
BMJ Open Respir Res. 2020 Mar;7(1). doi: 10.1136/bmjresp-2019-000548.
Pulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence.
The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches.
Approval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines.
ANZCTR 12618000933257.
肺康复是治疗慢性阻塞性肺疾病（COPD）患者的核心组成部分；然而，随后几个月的获益会减少。维持获益的最佳策略尚不清楚，每周监督维持运动方案被提议作为一种策略。然而，维持计划的长期未来取决于高质量的证据。
ComEx3 随机对照试验将通过比较每周监督维持计划的额外 6 个月（干预组）与接受相同 10 周维持计划后 6 个月常规护理的对照组，来研究延长每周监督维持计划对初始 10 周维持计划的疗效。将招募 120 名 COPD 患者。主要目标是确定 12 个月的健康相关生活质量。次要目标是确定功能运动能力轨迹，并对干预措施对卫生系统进行经济评估。根据意向治疗和方案治疗方法，对结果进行优势分析。
已获得相关伦理委员会的批准。研究结果将在同行评议的期刊和会议上发表，针对管理 COPD 患者的人员以及制定政策和指南的人员。
ANZCTR 12618000933257。
