A randomized controlled study on the effects of the T-REX Twente (Thoracic Surgical Rehabilitation Experts Twente) sternal precautions on quality of life and physical activity levels in cardiac surgery patients, compared to standard care in patients following a median sternotomy: the study protocol

Background: In 2023, a majority (86%) of open-heart surgeries was performed at Thorax Centrum Twente (TCT) via a full median sternotomy. Currently, there is no consensus on post-operative sternal precautions following full median sternotomy. Research from the U.S.A. and Canada suggests that existing restrictive sternal precautions may not be necessary. More lenient sternal precautions, such as the "Keep Your Move in the Tube" principle, have shown positive outcomes, with no significant complications. Patients following this approach experienced fewer mobility issues and reported improved quality of life and reduced anxiety. This study explores the potential benefits of fewer restrictions, which could reduce patient anxiety and lead to fewer follow-up visits. This study aims to determine whether the Thoracic Surgical Rehabilitation Experts Twente (T-REX Twente) sternal precautions have a small positive effect on the Modified MacNew Quality of Life after Myocardial Infarction questionnaire (QLMI-2), physical activity, and reduction of movement-related anxiety in patients after full median sternotomy, compared to standard restrictive sternal precautions. It also assesses whether the T-REX sternal precautions result in no negative effects on pain, wound healing, or post-operative complications. Methods: This prospective, randomized, controlled, single-blind study will include adult patients undergoing full median sternotomy at TCT between June 2024 and June 2026, all participating in outpatient cardiac rehabilitation. Exclusion criteria include intensive care unit stays over 72 hours, delirium, dementia, severe cognitive impairments, language barriers, or treatment by a non-TCT-affiliated cardiologist. The control group will adhere to current restrictive sternal precautions, whereas those in the intervention group will follow the T-REX sternal precautions, which allow lifting, pushing, or pulling as long as arm movement remains within a defined “tube”. The primary endpoint is the change in QLMI-2 from baseline (T ₀ ) to start of phase II cardiac rehabilitation(T ₄ ). Discussion: The T-REX Twente sternal precautions may improve quality of life, physical activity and reduce movement-related anxiety, supporting the idea that less restrictive post-operative sternal precautions can enhance patient outcomes. Trial Registration: CCMO Trial Register NL78107.100.23 Registered on 29 February 2024. ClinicalTrials.gov: NCT06115759