Efficacy and Safety of Remote Cardiac Rehabilitation in the Recovery Phase of Cardiovascular Diseases: Protocol for a Multicenter, Nonrandomized, Single-Arm, Interventional Trial.
Efficacy and Safety of Remote Cardiac Rehabilitation in the Recovery Phase of Cardiovascular Diseases: Protocol for a Multicenter, Nonrandomized, Single-Arm, Interventional Trial.
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DOI：
10.2196/30725
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发表时间：
2021-10-04
影响因子：
1.7
通讯作者：
Kimura Y
中科院分区：
文献类型：
--
作者：
Itoh H;Amiya E;Narita K;Shimbo M;Taya M;Komuro I;Hasegawa T;Makita S;Kimura Y
传统的基于小组的门诊心脏康复，通过监测和中心为基础的方法，在恢复阶段的患者已显示出强有力的证据，预防心血管疾病。然而，在某些情况下，维持以中心为基础的心脏康复护理是困难的。本研究旨在确定远程心脏康复（RCR）在心血管疾病患者恢复期的安全性和有效性。将从日本的多个机构（约30个）招募符合研究标准的患者。计划共招募75例患者（每家机构约2或3例患者）。入组RCR组的患者将获得RCR所需的设备（包括校准的测力计和平板电脑）。患者将在家中使用测力计进行无氧运动，每周至少3次，每次30-40分钟。在练习期间，指导员将真实的实时监测患者（使用交互式视频工具和各种重要数据的监测工具）。此外，每周将使用电子学习方法进行3次教育指导。主要终点是运动或6分钟步行试验开始后2-3个月的峰值摄氧量。将在RCR患者和无RCR的对照组之间比较提取的数据。本研究中提出的RCR系统的建立将导致更广泛的应用的发展，这是通过常规干预措施所不足以实现的。大学医院医学信息网-临床试验注册处UMIN-CTR UMIN 000042942; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000048983 DERR1-10.2196/30725
Conventional group-based outpatient cardiac rehabilitation through monitoring and center-based approaches for patients in the recovery phase has shown strong evidence for the prevention of cardiovascular diseases. However, there are some cases in which maintaining attendance of center-based cardiac rehabilitation is difficult. This study aims to ascertain the safety and efficacy of remote cardiac rehabilitation (RCR) in the recovery phase in patients with cardiovascular disease. Patients satisfying the study criteria will be recruited from multiple institutions (approximately 30) across Japan. In total, 75 patients (approximately 2 or 3 patients from each institution) are proposed to be recruited. Patients enrolled in the RCR group will be lent devices necessary for RCR (including calibrated ergometers and tablets). Patients will perform anaerobic exercise at home using ergometer for 30-40 minutes at least 3 times weekly. During exercise, an instructor will monitor the patient in real time (using interactive video tools and monitoring tools for various vital data). Moreover, educational instructions will be given 3 times weekly using e-learning methods. The primary endpoint is the peak oxygen uptake 2-3 months from the start of exercise or 6-min walk test. The extracted data will be compared between RCR patients and controls without RCR. The establishment of the system of RCR proposed in this study will lead to the development of more extensive applications, which have been insufficient through conventional interventions. University Hospital Medical Information Network—Clinical Trials Registry UMIN–CTR UMIN000042942; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048983 DERR1-10.2196/30725
影响因子：
2.1
作者：
McCartan F;Bowers N;Turner J;Mandalia M;Kalnad N;Bishop-Bailey A;Fu J;Clifford P
通讯作者：
Clifford P