Next Generation Trial Design for Intensive Care Unit Rehabilitation

Abstract The last 20 years have seen an explosion of research devoted to understanding the feasibility, safety, implementation, and patient and system outcomes of physical rehabilitation for patients who are critically ill in the intensive care unit (ICU). Multiple systematic reviews and meta-analyses have shown ICU physical rehabilitation to be feasible, safe, contribute to reduced ICU and hospital stays, reduce days on mechanical ventilation, and improve functional level outcomes at ICU and hospital discharge. These data demonstrate that ICU physical rehabilitation offers transformative potential for improving functional independence and quality of life in patients who are critically ill. However, significant barriers persist in translating evidence from randomized controlled trials (RCTs) into routine clinical practice. These barriers include patient heterogeneity, inconsistent intervention protocols and reporting, and systemic obstacles to implementation. This article provides perspective on these key challenges and proposes strategies for designing next-generation trials.