The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) – standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial

Abstract

BackgroundThe 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/designThis 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.DiscussionThe 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 registrationAustralian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572. Registered on 16 September 2015 (prospectively registered).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1974-8) contains supplementary material, which is available to authorized users.

Orthopedic Principles to Facilitate Enhanced Recovery After Cardiac Surgery

“…Historically, physical rehabilitation programs have called for drastic restrictions on activity and upper-body mobility, dictated by the limitations imposed by patient pain and the slow pace of healing associated with the unstable, wired sternum. 17,18,20,22,23 As real-world experience with RPF proves consistent with controlled trials, surgeons are piloting new paths to patient recovery. For example, following 2 years of study participation and data review, in March 2017, Franciscan Health Heart Center (Indianapolis, Indiana, USA) made RPF the standard closure method for all sternotomies.…”

“…16 Second, the ERAS Cardiac guidelines include no specific recommendations for early postoperative enteral feeding and mobilization, even though these measures are known to work together to stimulate resumption of gut function, preserve musculoskeletal function, and promote a faster and safer return to normal activities after surgery. [17][18][19][20][21][22] A sternotomy incision limits early mobilization and rehabilitation activities. Although the ERAS Cardiac guidelines do recommend that cardiac surgery programs develop multidisciplinary institutional guidelines to address early feeding and mobilization, 14 traditional sternal precautions prioritize the stability of the bony union over patient mobility, greatly limiting opportunities for return to normal activity and physical rehabilitation in the postoperative recovery period.…”

Psychometric evaluation of the shortened version of the Functional Difficulties Questionnaire to assess thoracic physical function

“…Data were collected from nested studies within two randomized controlled trials (published previously). 6,12–14 Reliability analyses data were from four different subgroups of participants within a multisite observational study (Table 1). Test–retest reliability was measured in 55 participants for single raters, and similar raters were used in Victoria’s Southern Health and Melbourne Health (Table 1).…”

“…6 These are reported in prior publications outlining the study protocol. 6,12–14 As part of the original trials, participants also completed several other outcome measures (physical function, pain and health-related quality of life) at hospital discharge, four weeks and three months postoperatively. For this pyschometric investigation, data from all participants from the original trials were pooled and included.…”

“…Details of the description of all the outcome measures (The Short Physical Performance Battery, The Timed Up and Go test, The Numerical Pain Rating Scale, The Medical Outcomes Study 36-item Version 2 and The Global Rating of Change Scale) used in the original studies can be found in prior publications. 12–14…”