Stoustrup Anna Lei, Thomsen Lars Pilegaard, Andreasen Jane, Palsson Thorvaldur S, Weinreich Ulla Møller
Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark
Department of Clinical Medicine, Aalborg University, The Faculty of Medicine, Aalborg, Denmark.
BMJ Open Respir Res. 2025 Jan 19;12(1):e002573. doi: 10.1136/bmjresp-2024-002573.
Chronic obstructive pulmonary disease (COPD) is a highly prevalent respiratory disease associated with significant health decline and economic burdens. Pulmonary rehabilitation is an effective intervention, but securing adherence to exercise is difficult, particularly for frail and disabled patients, challenged by leaving their home. Home-based exercise is an emerging alternative for persons with COPD, but long-term adherence is unclear. This study aims to investigate the effects, experiences and acceptability of long-term home-based cycling for patients with COPD post exacerbation.
This cluster randomised controlled trial will recruit hospitalised patients with COPD following hospitalisation following exacerbation of COPD. Participants will be referred to acute rehabilitation for 8 weeks at discharge. After rehabilitation, participants are randomised in clusters of five into 1 year of home-based cycling with the goal of cycling from Aalborg to Paris, or into the control group, who will receive standard care. Data will be collected at baseline, postrehabilitation/intervention initiation, at 6 and 12 months. Primary outcome is physical performance, while secondary outcomes include daily activity levels, lung function, mobility, frailty, symptom severity, health-related quality of life, survival rates and readmissions. A qualitative substudy will uncover experiences from participants. Daily activity levels will be measured using leg-mounted triaxial accelerometers. Other parameters will be tested with physical tests, questionnaires and interviews. The study aims to include 50 patients, with 25 participants in each group. A cost-effectiveness analysis will assess the impact on disease prevention and hospitalisation.
This study, approved by The North Denmark Region Committee on Health Research Ethics (N-20230008) and compliant with the Helsinki Declaration, includes annual safety and progress reporting of potential adverse events. Results will be disseminated through peer-reviewed publications, conference presentations and community outreach to ensure accessibility to participants, healthcare professionals and the public.
NCT06235502 and Northern Jutland trial register (F2023-066).
慢性阻塞性肺疾病（COPD）是一种高度流行的呼吸系统疾病，与健康状况显著下降和经济负担相关。肺康复是一种有效的干预措施，但确保患者坚持锻炼很困难，尤其是对于体弱和残疾患者而言，离开家对他们来说是一项挑战。居家锻炼是COPD患者的一种新兴替代方案，但长期依从性尚不清楚。本研究旨在调查长期居家骑行对COPD急性加重期后患者的影响、体验和可接受性。
本整群随机对照试验将招募COPD急性加重期后住院的患者。参与者出院后将接受为期8周的急性康复治疗。康复治疗后，参与者将以每组5人的整群形式随机分为两组，一组进行为期1年的居家骑行，目标是从奥尔堡骑行到巴黎，另一组为对照组，接受标准护理。数据将在基线、康复后/干预开始时、6个月和12个月时收集。主要结局是身体机能，次要结局包括日常活动水平、肺功能、活动能力、虚弱程度、症状严重程度、健康相关生活质量、生存率和再入院率。一项定性子研究将揭示参与者的体验。日常活动水平将使用佩戴在腿部的三轴加速度计进行测量。其他参数将通过体能测试、问卷调查和访谈进行检测。该研究旨在纳入50名患者，每组25名参与者。成本效益分析将评估对疾病预防和住院治疗的影响。
本研究经北丹麦地区健康研究伦理委员会批准（N-20230008），并符合《赫尔辛基宣言》，包括对潜在不良事件的年度安全性和进展报告。研究结果将通过同行评审出版物、会议报告和社区宣传进行传播，以确保参与者、医疗专业人员和公众能够获取。
NCT06235502和北日德兰试验注册库（F2023-066）。
