Department of Cardiothoracic Surgery, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, MIddlesbrough, UK
South Tees Academic Cardiovascular Unit, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
BMJ Open. 2023 Jan 5;13(1):e065992. doi: 10.1136/bmjopen-2022-065992.
Prehabilitation prior to surgery has been shown to reduce postoperative complications, reduce length of hospital stay and improve quality of life after cancer and limb reconstruction surgery. However, there are minimal data on the impact of prehabilitation in patients undergoing cardiac surgery, despite the fact these patients are generally older and have more comorbidities and frailty. This trial will assess the feasibility and impact of a prehabilitation intervention consisting of exercise and inspiratory muscle training on preoperative functional exercise capacity in adult patients awaiting elective cardiac surgery, and determine any impact on clinical outcomes after surgery.
PrEPS is a randomised controlled single-centre trial recruiting 180 participants undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to standard presurgical care or standard care plus a prehabilitation intervention. The primary outcome will be change in functional exercise capacity measured as change in the 6 min walk test distance from baseline. Secondary outcomes will evaluate the impact of prehabilitation on preoperative and postoperative outcomes including; respiratory function, health-related quality of life, anxiety and depression, frailty, and postoperative complications and resource use. This trial will evaluate if a prehabilitation intervention can improve preoperative physical function, inspiratory muscle function, frailty and quality of life prior to surgery in elective patients awaiting cardiac surgery, and impact postoperative outcomes.
A favourable opinion was given by the Sheffield Research Ethics Committee in 2019. Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer-reviewed publication.
ISRCTN13860094.
术前康复已被证明可减少术后并发症、缩短住院时间并改善癌症和肢体重建手术后的生活质量。然而，尽管这些患者通常年龄较大、合并症和虚弱更多，但在接受心脏手术的患者中，术前康复的影响数据很少。本试验将评估包括运动和吸气肌训练在内的术前康复干预对择期心脏手术成年患者术前功能运动能力的可行性和影响，并确定其对手术后临床结果的任何影响。
PrEPS 是一项随机对照单中心试验，招募了 180 名接受择期心脏手术的患者。参与者将以 1:1 的比例随机分为标准术前护理组或标准护理加术前康复干预组。主要结局将是 6 分钟步行试验距离从基线的变化来衡量的功能运动能力的变化。次要结局将评估术前和术后康复对呼吸功能、健康相关生活质量、焦虑和抑郁、虚弱以及术后并发症和资源利用的影响。本试验将评估术前康复干预是否可以改善择期心脏手术患者的术前身体功能、吸气肌功能、虚弱和生活质量，并影响术后结果。
谢菲尔德研究伦理委员会于 2019 年给出了有利的意见。试验结果将通过同行评审出版物传播给患者、临床医生、委托小组。
ISRCTN86300522。
