PREHAB研究方案——冠状动脉搭桥和心脏瓣膜手术后减少住院时间的术前康复：一项随机对照试验
Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial.
作者信息
Stammers Andrew N, Kehler D Scott, Afilalo Jonathan, Avery Lorraine J, Bagshaw Sean M, Grocott Hilary P, Légaré Jean-Francois, Logsetty Sarvesh, Metge Colleen, Nguyen Thang, Rockwood Kenneth, Sareen Jitender, Sawatzky Jo-Ann, Tangri Navdeep, Giacomantonio Nicholas, Hassan Ansar, Duhamel Todd A, Arora Rakesh C
机构信息
Faculty of Kinesiology & Recreation Management, Health, Leisure & Human Performance Research Institute, University of Manitoba, Winnipeg, Manitoba, Canada Institute of Cardiovascular Sciences, St. Boniface Hospital Research Centre, Winnipeg, Manitoba, Canada.
Divisions of Cardiology and Clinical Epidemiology, Department of Medicine, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
出版信息
BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250.
INTRODUCTION
Frailty is a geriatric syndrome characterised by reductions in muscle mass, strength, endurance and activity level. The frailty syndrome, prevalent in 25-50% of patients undergoing cardiac surgery, is associated with increased rates of mortality and major morbidity as well as function decline postoperatively. This trial will compare a preoperative, interdisciplinary exercise and health promotion intervention to current standard of care (StanC) for elective coronary artery bypass and valvular surgery patients for the purpose of determining if the intervention improves 3-month and 12-month clinical outcomes among a population of frail patients waiting for elective cardiac surgery.
METHODS AND ANALYSIS
This is a multicentre, randomised, open end point, controlled trial using assessor blinding and intent-to-treat analysis. Two-hundred and forty-four elective cardiac surgical patients will be recruited and randomised to receive either StanC or StanC plus an 8-week exercise and education intervention at a certified medical fitness facility. Patients will attend two weekly sessions and aerobic exercise will be prescribed at 40-60% of heart rate reserve. Data collection will occur at baseline, 1-2 weeks preoperatively, and at 3 and 12 months postoperatively. The primary outcome of the trial will be the proportion of patients requiring a hospital length of stay greater than 7 days.
POTENTIAL IMPACT OF STUDY
The healthcare team is faced with an increasingly complex older adult patient population. As such, this trial aims to provide novel evidence supporting a health intervention to ensure that frail, older adult patients thrive after undergoing cardiac surgery.
ETHICS AND DISSEMINATION
Trial results will be published in peer-reviewed journals, and presented at national and international scientific meetings. The University of Manitoba Health Research Ethics Board has approved the study protocol V.1.3, dated 11 August 2014 (H2014:208).
TRIAL REGISTRATION NUMBER
The trial has been registered on ClinicalTrials.gov, a registry and results database of privately and publicly funded clinical studies (NCT02219815).
引言
衰弱是一种老年综合征，其特征是肌肉质量、力量、耐力和活动水平下降。衰弱综合征在25%至50%的心脏手术患者中普遍存在，与死亡率和主要发病率的增加以及术后功能下降有关。本试验将比较术前跨学科运动和健康促进干预措施与择期冠状动脉搭桥术和瓣膜手术患者当前的标准护理（StanC），目的是确定该干预措施是否能改善等待择期心脏手术的衰弱患者群体在3个月和12个月时的临床结局。
方法与分析
这是一项多中心、随机、开放终点、对照试验，采用评估者盲法和意向性分析。将招募244名择期心脏手术患者，并随机分为接受StanC或StanC加在经认证的医学健身机构进行的为期8周的运动和教育干预。患者将每周参加两次课程，有氧运动将按心率储备的40%至60%进行安排。数据收集将在基线、术前1至2周以及术后3个月和12个月进行。试验的主要结局将是住院时间超过7天的患者比例。
研究的潜在影响
医疗团队面临着日益复杂的老年患者群体。因此，本试验旨在提供新的证据，支持一项健康干预措施，以确保衰弱的老年患者在接受心脏手术后能够茁壮成长。
伦理与传播
试验结果将发表在同行评审期刊上，并在国内和国际科学会议上展示。曼尼托巴大学健康研究伦理委员会已批准2014年8月11日的研究方案V.1.3（H2014:208）。
试验注册号
该试验已在ClinicalTrials.gov上注册，ClinicalTrials.gov是一个由私人和公共资助的临床研究注册库和结果数据库（NCT02219815）。
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