Initiatives to Improve Early Mobilization after Cardiac Surgery:Interim results of the T-REX Twente randomized trial

<b>INTRODUCTION / PURPOSE</b><br/>Sternotomy remains the standard access route for cardiac surgery. Consensus and evidence is lacking regarding post-operative mobilization activities and sternal precautions. The 2024 ERAS Cardiac statement recommends “early<br/>postoperative ambulation” without specifications. The aim of this randomized controlled trial is to investigate whether T-REX Twente sternal precautions impact the modified Quality of Life after Myocardial Infarction questionnaire (MacNew, QLMI-2), and physical activity in patients after full median sternotomy, compared to standard restrictive measures.<br/><b>MATERIALS AND METHOD</b><br/>: Adult patients receiving cardiac surgery with full sternotomy were included. Interim analysis was planned after 60/154 recruited patients, and includes patients from June 2024 to February 2025. After applying predefined exclusion criteria<br/>(NCT06115759), 28 patients in the usual care group and 27 patients receiving T-REX Twente guidelines were analysed. T-REX Twente patients keep their elbows at their sides (the "cylinder model") and are allowed to push, lift, and pull based on pain tolerance. Primary endpoints are QLMI-2 score development preoperatively (T0), postoperative day 4 (T2) and cardiac rehabilitation intake after 4 weeks (T4) analysed with linear mixed model, and physical activity increase as determined with accelerometer (not in interim analysis). Secondary endpoints include numerical pain rating scale (NPRS) and Tampa scale for kinesiophobia (TSK-13) changes.<br/><b>FINDINGS</b><br/>Quality of life (QLMI-2) increased after surgery (p &lt; 0.001) without additional increase in the T-REX Twente group (p=0.28, Figure 1). Pain as measured with NPRS decreased postoperatively (p &lt; 0.001), without increase in T-REX Twente group (p=0.94, Figure 2). Last, kinesiophobia measured by TSK was lower after surgery (p &lt; 0.001) without differences between groups (p=0.44, Figure 3). Findings are described in Table 1.<br/><b>DISCUSSION / CONCLUSION</b><br/>This planned interim analysis of the T-REX Twente trial shows safety of less restrictive sternal precautions, without changes in quality of life, pain or kinesiophobia. Full interpretation and potential benefits should be assessed after trial completion.