Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2019 Sep 18;9(9):e031738. doi: 10.1136/bmjopen-2019-031738.
The rising prevalence of modifiable risk factors (eg, obesity, hypertension and physical inactivity) is causing an increase in possible avoidable complications in patients undergoing cardiac surgery. This study aims to assess whether a combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme) can improve functional status and reduce surgical complications, readmissions and major adverse cardiac events (MACE) as compared with standard care.
Patients (n=350) are randomised to the Heart-ROCQ programme or standard care. The Heart-ROCQ programme consists of a preoperative optimisation phase while waiting for surgery (three times per week, minimum of 3 weeks), a postoperative inpatient phase (3 weeks) and an outpatient CR phase (two times per week, 4 weeks). Patients receive multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation). Standard care consists of 6 weeks of postsurgery outpatient CR with education and physical therapy (two times per week). The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee. The secondary outcomes are length of stay, physical and psychological functioning, lifestyle risk factors, and work participation. Finally, an economic evaluation is performed. Data are collected at six time points: at baseline (start of the waiting period), the day before surgery, at discharge from the hospital, and at 3, 7 and 12 months postsurgery.
This study will be conducted according to the principles of the Declaration of Helsinki (V.8, October 2013). The protocol has been approved by the Medical Ethical Review Board of the UMCG (no 2016/464). Results of this study will be submitted to a peer-reviewed scientific journal and can be presented at national and international conferences.
NCT02984449.
可改变的风险因素（如肥胖、高血压和缺乏身体活动）的流行率不断上升，导致接受心脏手术的患者可能出现更多可避免的并发症。本研究旨在评估术前和术后多学科心脏康复（CR）计划（Heart-ROCQ 计划）是否比标准护理能改善功能状态，减少手术并发症、再入院和主要不良心脏事件（MACE）。
将 350 名患者随机分为 Heart-ROCQ 计划组或标准护理组。Heart-ROCQ 计划包括手术前的优化阶段（每周 3 次，至少 3 周）、术后住院阶段（3 周）和门诊 CR 阶段（每周 2 次，4 周）。患者接受多学科治疗（如物理治疗、饮食建议、心理治疗和戒烟）。标准护理包括术后门诊 CR，每周 2 次，持续 6 周，包括教育和物理治疗。主要结局是通过盲法终点委员会评估的功能状态、手术并发症、再入院和 MACE 的综合加权评分。次要结局包括住院时间、身体和心理功能、生活方式风险因素和工作参与情况。最后进行经济评价。数据在 6 个时间点收集：基线（等待期开始）、手术前一天、出院时、术后 3、7 和 12 个月。
本研究将根据《赫尔辛基宣言》（2013 年 10 月第 8 版）的原则进行。该方案已获得 UMCG 医学伦理审查委员会的批准（编号 2016/464）。本研究的结果将提交给同行评议的科学期刊，并可在国家和国际会议上展示。
NCT02984449。
