Effect of early bed cycling on muscle strength and cellular immune factors in patients with intensive care unit-acquired weaknesses - a protocol for a randomized controlled clinical trial

In the intensive care unit (ICU), patients often experience restricted mobility due to their critical condition, potentially leading to negative effects on both muscle strength and immune function. Previous research has highlighted the beneficial effects of early mobilization among patients, regardless of mechanical ventilation status. Hence, early bed cycling serves as a potential facilitator for early mobilization and is considered a feasible intervention for critically ill patients within the ICU. To mitigate this concern, we propose a randomized controlled clinical trial aiming to assess the efficacy of early bed cycling for patients undergoing mechanical ventilation and analgosedation. The study will encompass 56 participants randomly assigned to either the treatment or control group, each consisting of 28 patients. Participants in both groups will receive health education. However, the control group will not receive any therapeutic intervention throughout the study. In contrast, the experimental group will undergo passive bed cycling of their lower extremities for 20 minutes at a rate of 30 revolutions per minute. Primary outcomes will focus on changes in the rectus femoris muscle area and thickness, evaluated using ultrasound, interleukin-6 (IL-6), IL-10, and nitric oxide (NO) production function. Secondary endpoints will encompass the modified Barthel index score, Medical Research Council total score at 1, 2, and 4 weeks following the final treatment session, participants' mechanical ventilation duration, rate of extubation in the second week, 28-day survival rate, and occurrence of adverse reactions. Any encountered side effects will be duly documented. Statistical analysis will be employed to compare patient outcomes between the treatment and control groups.