School of Nursing, Jilin University, Changchun, Jilin, China.
The First Hospital of Jilin University, Changchun, Jilin, China.
BMJ Open. 2020 Jun 15;10(6):e036720. doi: 10.1136/bmjopen-2019-036720.
The benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors.
We propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks.
This study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences.
ChiCTR1900028182; Pre-results.
心脏康复（CR）可降低心脏和全因死亡率，其益处已有充分记录。然而，在中国，患者的依从性仍然不理想。显然，传统的 CR 不能满足许多合格患者的需求，需要创新来改进其应用。家庭心脏康复（HBCR）是一种具有成本效益的方法，可能对中国许多人具有重要价值。在 HBCR 中，通常难以维持既有效又在安全范围内的运动强度，这是患者安全的关键因素。移动健康干预有可能克服这些障碍，并可能有效地提高依从性。本研究旨在评估基于智能运动康复管理系统（IERMS）的 HBCR 是否能提高 CR 的依从性，并评估其对运动能力、心理健康、自我效能、生活质量和与生活方式相关的风险因素的影响。
我们提出了一项针对 70 名冠心病患者的单盲、双臂、随机对照交叉研究。参与者将以 1:1 的比例随机分配到两组中的一组。第 1 组患者将接受 IERMS 干预和常规护理 6 周，然后在最后 6 周接受常规护理，而第 2 组患者将在第 1 组接受常规护理 6 周，然后在第 2 组接受 IERMS 干预 6 周。主要结局是方案的依从性，次要结局包括运动能力、心理健康、生活质量、自我效能和与生活方式相关的风险因素。所有次要结局将在基线、6 周和 12 周进行测量。
本研究已获得吉林大学护理学院人类研究伦理委员会的批准（HREC 2019120901）。研究结果将发表在同行评议的期刊和会议上。
ChiCTR1900028182；预注册。
