Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Department of Medicine, Division of Cardiology, Showa University School of Medicine, Tokyo, Japan.
BMJ Open. 2023 Aug 24;13(8):e073846. doi: 10.1136/bmjopen-2023-073846.
Cardiac rehabilitation (CR) is strongly recommended as a medical treatment to improve the prognosis and quality of life of patients with heart failure (HF); however, participation rates in CR are low compared with other evidence-based treatments. One reason for this is the geographical distance between patients' homes and hospitals. To address this issue, we developed an integrated telerehabilitation platform, RH-01, for home-based CR. We hypothesised that using the RH-01 platform for home-based CR would demonstrate non-inferiority compared with traditional centre-based CR.
The E-REHAB trial aims to evaluate the efficacy and safety of RH-01 for home-based CR compared with traditional centre-based CR for patients with HF. This clinical trial will be conducted under a prospective, randomised, controlled and non-inferiority design with a primary focus on HF patients. Further, to assess the generalisability of the results in HF to other cardiovascular disease (CVD), the study will also include patients with other CVDs. The trial will enrol 108 patients with HF and 20 patients with other CVD. Eligible HF patients will be randomly assigned to either traditional centre-based CR or home-based CR in a 1:1 fashion. Patients with other CVDs will not be randomised, as safety assessment will be the primary focus. The intervention group will receive a 12-week programme conducted two or three times per week consisting of a remotely supervised home-based CR programme using RH-01, while the control group will receive a traditional centre-based CR programme. The primary endpoint of this trial is change in 6 min walk distance.
The conduct of the study has been approved by an institutional review board at each participating site, and all patients will provide written informed consent before entry. The report of the study will be disseminated via scientific fora, including peer-reviewed publications and presentations at conferences.
jRCT:2052200064.
心脏康复（CR）被强烈推荐作为改善心力衰竭（HF）患者预后和生活质量的一种医学治疗方法；然而，与其他基于证据的治疗方法相比，参与 CR 的比例较低。造成这种情况的一个原因是患者家庭和医院之间的地理距离。为了解决这个问题，我们开发了一个基于家庭的远程康复平台 RH-01。我们假设使用 RH-01 平台进行基于家庭的 CR 与传统的基于中心的 CR 相比具有非劣效性。
E-REHAB 试验旨在评估 RH-01 用于基于家庭的 CR 与传统基于中心的 CR 对 HF 患者的疗效和安全性。这项临床试验将采用前瞻性、随机、对照和非劣效性设计进行，主要关注 HF 患者。此外，为了评估 HF 中结果在其他心血管疾病（CVD）中的普遍性，该研究还将包括其他 CVD 患者。该试验将招募 108 名 HF 患者和 20 名其他 CVD 患者。符合条件的 HF 患者将以 1:1 的比例随机分配到传统的基于中心的 CR 或基于家庭的 CR 中。其他 CVD 患者不会随机分组，因为安全性评估将是主要重点。干预组将接受为期 12 周的计划，每周进行两次或三次，包括使用 RH-01 进行远程监督的基于家庭的 CR 计划，而对照组将接受传统的基于中心的 CR 计划。该试验的主要终点是 6 分钟步行距离的变化。
该研究的开展已获得每个参与地点的机构审查委员会的批准，所有患者在入组前将提供书面知情同意书。该研究的报告将通过科学论坛传播，包括同行评议的出版物和会议上的演示。
jRCT:2052200064。
