Abstract
INTRODUCTION: Early rehabilitation of critically ill patients is challenging due to limited staff resources. This study assessed the feasibility of delivering a randomised controlled trial of physiotherapy assistants delivering early protocolised rehabilitation plus usual care compared with usual care. METHODS: We conducted a randomised feasibility study in three U.K. mixed medical/surgical intensive care units. Eligible patients were intubated and ventilated <72 h, expected to be ventilated for a further 48 h, and functionally independent before ICU admission. Patients were randomised to protocolised early rehabilitation plus usual care or usual care. Feasibility outcomes were (i) recruitment of one to two patients/per month/site; (ii) >75% of patients commencing the intervention within 72 h of ventilation with >70% interventions delivered; and (iii) blinded outcome measures recorded at three-time points in >80% of patients. RESULTS: The study delivery was compromised by the COVID-19 pandemic: 46 patients were enrolled, of which 22 were allocated to intervention. Feasibility outcomes: (i) recruitment of 0.9 patients/month/site, (ii) 90% of patients commenced interventions within 72 h of ventilation, with 166/264 (63%) of study interventions delivered: median total 22.5 min (IQR 15-35) of therapy per day in the usual care group and 45 min (IQR 25-70) in the intervention group, and (iii) the outcome assessments were performed at three-time points for 64% of survivors, 63% of which were blinded. CONCLUSION: While delivery of protocolised rehabilitation by physiotherapy assistants is feasible, the design of a future RCT needs to consider strategies to improve recruitment and complete blinded outcome assessments.