Early Mobilization Interventions in the Intensive Care Unit: Ongoing and Unpublished Randomized Trials

BACKGROUND: Critical care societies recommend early mobilization (EM) as standard practice in the intensive care unit (ICU) setting. However, there is limited randomized controlled trial (RCT) evidence supporting EM's effectiveness. Our objective was to identify ongoing or completed RCTs assessing EM's effectiveness in the ICU. METHOD: We searched ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry for ongoing or completed but not published RCTs in an ICU setting with objective outcome measures. RESULTS: There were 14 RCTs included in the analysis. All studies were in the general or mixed ICU setting (N=14). Half of the studies (N=7) were small RCTs (<100 projected participants) and half (N=7) were medium-sized RCTs (100–999 participants). Inclusion criteria included mechanical ventilation use or expected use (N=13) and prehospital functional status (N=7). Primary EM interventions were standard physiotherapist-based activities (N=4), cycling (N=9), and electrical muscle stimulation (N=1). Only one study involved nurse-led EM. The most common assessment tool was the 6-minute walk test (N=6). Primary outcome measures were physiological (N=3), clinical (N=3), patient-centered (N=7), and healthcare resource use (N=1). Most studies (N=8) involved post-ICU follow-up measures up to 1-year posthospitalization. There were no studies targeting older adults or people with acute cardiac disease. CONCLUSION: Identified studies will further the evidence base for EM's effectiveness. There is a need for studies looking at specific patient populations that may benefit from EM, such as older adults and cardiac patients, as well as for novel EM delivery strategies, such as nurse-led EM.