Study Protocol: Protocol of Intensive Care Unit Graded Mobilization (PG-Motion) Study: A Randomized Clinical Trial

Intensive care unit-acquired weakness (ICU-AW) is a frequent complication among critically ill patients. Although early mobilization (EM) has been shown to improve clinical outcomes, its implementation remains limited in many settings due to staffing shortages, safety concerns, and the absence of standardized protocols. In China, the uptake of EM is particularly low, partly due to the lack of dedicated rehabilitation staff in intensive care units (ICUs) and the absence of protocols suited to local staffing structures. This multicentre randomized controlled trial (PG-Motion Study) aims to develop and evaluate a nurse-led EM protocol tailored to the Chinese ICU context, with a focus on assessing its clinical effectiveness.

We adopted a parallel-group randomized controlled design across 18 Grade III hospitals (China's highest-tier medical institutions) in Beijing. Eligible patients will be individually randomized (1:1) to receive either the PG-Motion-guided EM protocol or routine standard care. The primary effectiveness outcomes included the incidence of ICU-AW, defined by a Medical Research Council (MRC) sum score < 48, duration of mechanical ventilation, and ICU length of stay. Implementation fidelity will be assessed via protocol adherence. Safety monitoring will include adverse events such as falls, hemodynamic instability, and unplanned extubation. This study has been registered with the China Clinical Trial Registry (ChiCTR2000039425).

Implementation of the PG-Motion protocol is expected to establish an evidence-based graded mobilization framework tailored to the ICU staffing conditions in China. The findings may contribute to national expert consensus and promote standardized EM practices for ICU-AW prevention.

The PG-Motion study will generate clinical and operational evidence to support a scalable nurse-led EM protocol, potentially enhancing early rehabilitation practices in resource-constrained ICU settings. Trial Registration: China Clinical Trial Registry (ChiCTR2000039425).