针对日本冠状动脉疾病患者的在线强化心脏康复计划--一项试验性研究方案。

Circulation reports Pub Date : 2024-08-27 eCollection Date: 2024-09-10 DOI:10.1253/circrep.CR-24-0054
Neiko Ozasa, Kazuhisa Kaneda, Koichi Washida, Yoko Umeda Shiozaki, Saeko Imai, Kaoru Kitta, Yuki Higuchi, Sawako Yoshiuchi, Toshiko Yoshida, Kenji Nakatsuma, Takeshi Kimura, Koh Ono
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引用次数: 0

摘要

背景:建议冠状动脉疾病(CAD)患者进行全面的心脏康复(CR)计划。然而,许多机构没有制定饮食指导和患者教育计划,导致心脏康复计划以运动为主,对二级预防的效果有限:我们将开展一项试验性研究,为日本的 CAD 患者开发在线日式强化心脏康复(J-ICR)项目,并将对患者的依从性、安全性和有效性进行检查。24 名确诊为稳定型冠状动脉硬化症的患者将按 1 : 1 的比例随机分配到早期或晚期组。该计划将由以下四个部分组成:运动课程;以 "日本饮食 "为中心的饮食教育;正念;以及小组支持,每周一次,每次3小时,为期12周(共36小时)。主要终点是计划的可行性,通过检查计划的坚持情况来确定。体格检查和功能、压力应对技能、典型 CAD 风险(如血脂、糖耐量和血压)以及饮食变化将作为次要终点进行评估:在线 J-ICR 计划旨在为日本的 CAD 患者提供全面的 CR 计划。结论:在线 J-ICR 计划旨在为日本的 CAD 患者提供全面的 CR 计划,如果该计划显示出较高的依从性和 CAD 危险因素的改善,其二级预防效果应通过在多个中心进行适当的随机试验来验证。
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Online Intensive Cardiac Rehabilitation Program for Japanese Patients With Coronary Artery Disease - A Pilot Study Protocol.

Background: A comprehensive cardiac rehabilitation (CR) program is recommended for coronary artery disease (CAD). However, many facilities do not have established programs for dietary guidance and patient education, resulting in an exercise-based CR program and limited efficacy for secondary prevention.

Methods and results: A pilot study will be conducted to develop an online Japanese-style intensive cardiac rehabilitation (J-ICR) program for Japanese patients with CAD and will examine adherence, safety, and efficacy. Twenty-four patients diagnosed with stable CAD will be randomly assigned in a 1 : 1 ratio to either an early or late-phase group. The program will comprise the following four parts: exercise sessions; dietary education centered on "the Japan diet"; mindfulness; and group support, with a frequency of 3 h per session, once a week for 12 weeks (a total of 36 h). The primary endpoint will be program feasibility, determined by examining its adherence. Physical examination and function, stress-coping skills, risk of classic CAD (e.g., lipid profile, glucose tolerance, and blood pressure), and dietary changes will be assessed as secondary endpoints.

Conclusions: The online J-ICR program is designed as a comprehensive CR program for Japanese patients with CAD. If this program shows high adherence and an improvement in CAD risk factors, its secondary prevention effect should be verified with appropriately powered randomized trials at multiple centers.

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