Katijjahbe Md Ali, Denehy Linda, Granger Catherine L, Royse Alistair, Royse Colin, Bates Rebecca, Logie Sarah, Clarke Sandy, El-Ansary Doa
Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Parkville, VIC, 3053, Australia.
Department of Physiotherapy, Hospital Cancelor Tuaku Mukhriz, Pusat Perubatan University Kebangsaan Malaysia, Kuala Lumpur, 56000, Malaysia.
Trials. 2017 Jun 23;18(1):290. doi: 10.1186/s13063-017-1974-8.
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.
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.
Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).
目前，在全球范围内，正中开胸术后常规采取胸骨保护措施以预防限制上肢活动的胸骨并发症。然而，相关证据有限，主要来自尸体研究和骨科研究。胸骨保护措施可能会延迟恢复、延长住院时间且限制过多。最近的研究表明，上肢运动可减轻术后胸骨疼痛，且通过超声测量发现胸骨边缘之间的微动极小。本研究的目的是评估改良胸骨保护措施对心脏手术后身体功能、疼痛、恢复情况及健康相关生活质量的影响。
方法/设计：本研究为II期双盲随机对照试验，采用隐蔽分组、患者和评估者设盲以及意向性分析。将通过正中开胸进行心脏手术的患者（n = 72）纳入研究。样本量计算基于主要结局指标“简短体能状况量表”的最小重要差异（两点）。每组需要36名参与者以应对失访（20%）。所有参与者将被随机分配接受标准或改良胸骨保护措施。干预组将收到鼓励安全使用上肢的指导方针。次要结局指标为上肢功能、疼痛、运动恐惧及健康相关生活质量。将使用描述性统计来汇总数据。主要假设将通过重复测量方差分析进行检验，以评估干预组与常规护理组在术后4周相对于基线的变化。在所有进行的检验中，p值<0.05（双侧）将被视为具有统计学意义，并将报告置信区间。
胸骨管理加速康复试验（S.M.A.R.T.）是一项双中心随机对照试验，其样本量和设计旨在研究将胸骨保护措施修改为包括安全使用上肢和躯干是否会影响正中开胸心脏手术后患者的身体功能和恢复情况。
澳大利亚和新西兰临床试验注册中心标识符：ACTRN12615000968572。于2015年9月16日注册（前瞻性注册）。
