BACKGROUND:The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery. METHODS/DESIGN:This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported. DISCUSSION:The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy. TRIAL REGISTRATION:Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

译文

背景技术:正中胸骨切开术是目前世界范围内普遍采用的预防胸骨并发症限制上肢使用的胸骨预防措施的常规措施。但是,证据是有限的,主要来自尸体研究和骨科研究。胸骨预防措施可能会延迟康复,延长出院时间,并且限制过多。最近的研究表明,上肢锻炼可减轻手术后的胸骨疼痛,并通过超声测量使胸骨边缘之间的微动最小。这项研究的目的是评估改良的胸骨预防措施对心脏手术后身体机能,疼痛,恢复以及与健康相关的生活质量的影响。
方法/设计:该研究是一项II期,双盲,随机对照试验,具有隐蔽分配,患者和评估者盲目性和意向性治疗分析。心脏手术后,将通过正中胸骨切开术招募患者(n = 72)。样本量的计算是基于以下主要方面的最小重要差异(两点):身体机能短。每个小组需要三十六名参与者来应对辍学(20%)。所有参与者将被随机分配接受标准或改良的胸骨预防措施。干预小组将收到指导原则,以鼓励安全使用上肢。次要结果是上肢功能,疼痛,运动恐惧症和与健康相关的生活质量。描述性统计将用于汇总数据。主要假设将通过重复测量方差分析进行检验,以评估与常规护理组相比,干预组从基线到术后4周的变化。在将要进行的所有测试中,p值<0.05(两尾)将被认为具有统计学显着性,并将报告置信区间。
讨论:胸骨管理加速恢复试验(SMART)是一项以两中心为中心的随机对照试验,旨在研究修改胸骨预防措施(包括安全使用上肢和躯干)的影响是否影响患者的身体功能和术后康复通过正中胸骨切开术进行心脏手术。
试验注册:澳大利亚和新西兰临床试验注册标识符:ACTRN12615000968572。已于2015年9月16日注册(可能已注册)。

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