METHODS: A prospective observational study was undertaken at two tertiary care hospitals in Australia. Seventy-two (72) adults (mean age, 63±11 years) were included following cardiac surgery via a median sternotomy. Participants completed the Patient Identified Cardiac Pain using numeric and visual prompts (PICP), the McGill Pain Questionnaire-Short Form version 2 (MPQ-2) and the Medical Outcome Study 36-item version 2 (SF-36v2) Bodily Pain domain (BP), which were administered prior to hospital discharge, 4 weeks and 3 months postoperatively.

RESULTS: Participants experienced a high incidence of mild (n=45, 63%) to moderate (n=22, 31%) pain prior to discharge, which reduced at 4 weeks postoperatively: mild (n=28, 41%) and moderate (n=5, 7%) pain; at 3 months participants reported mild (n=14, 20%) and moderate (n=2, 3%) pain. The most frequent location of pain was the anterior chest wall, consistent with the location of the surgical incision and graft harvest. Most participants equated "pressure/weight" to "aching" or a "heaviness" in the chest region (based on descriptor of pain in the PICP) and the pain topography was persistent at 4 weeks and 3 months postoperatively. Each pain measurement tool provided different information on pain location, severity and description, with significant change (p<0.005) over time.

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.

METHODS AND ANALYSIS: This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants.

ETHICS AND DISSEMINATION: The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.