Multilevel Intervention of Resistance Training Combined with Beta- Hydroxy Beta-Methylbutyrate (RTCHMB) in Critical Illness during Hospitalisation: A Study Protocol of a Four-Arm, Multicentre, Randomised Controlled Trial

Abstract

Abstract Background Early rehabilitation and nutrition interventions have been extensively studied to improve the physical function of ICU patients, but optimal strategies remain unclear. ICU-acquired weakness (ICU-AW) negatively impacts both short- and long-term patient outcomes, placing a significant burden on families and society alike. Resistance training, beta-hydroxy beta-methylbutyrate (HMB), and the combined intervention have widely been used in clinical populations, and have shown positive effects in enhancing physical function. However, their application in treating ICU patients is still relatively limited. The purpose of the present study is to determine whether resistance training and/or HMB administration would also enhance outcomes in critically ill patients. Methods This four-arm, accessor-blind, multicentre randomised controlled trial will be conducted in 10 ICUs at five centres in Fujian province, China. Eligible participants will be randomised in a 1:1:1:1 ratio to receive either resistance training (hierarchical resistance training), HMB group (HMB alone), combination group (a combination of both interventions), or usual care group (conventional rehabilitation and nutritional therapy). The intervention will be administered five times per week through supervised training, with each session lasting 20–30 min during the entire hospitalisation. The four categories— physical function and structure impairment, activity limitation, participation limitation, and quality of life—will be repeatedly measured at baseline, ICU to discharge, and hospital discharge. Data will be analysed using a generalised linear mixed model and will follow the principles of intention-to-treat analysis. Discussion This multicenter with four-arm design of RCT will investigate the efficacy of resistance exercise, HMB, and their combined utilization in enhancing physical function among ICU patients. The outcomes of our study will provide optimal rehabilitation strategies for the prevention of ICU-AW for clinical application, and serve as a foundation for future research endeavors in this field. Trial registration: ChiCTR2200057685 was registered on March 15th, 2022.