Effects of an intensive mobilization program on inflammation in patients undergoing invasive mechanical ventilation

• Grant number: 25/10536-2
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: July 01, 2025
• End date: June 30, 2026
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Ada Clarice Gastaldi
• Grantee: Isabela Martins Coletti
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Associated research grant: 22/07841-0 - Rehabilitation of patients submitted to mechanical ventilation, from the ICU to the post-hospital phase: blinded randomized controlled clinical trial, with economic and multicenter evaluation, AP.TEM

Abstract

Introduction: Advances in knowledge have contributed to an increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit (ICU), and among them, severe patients who progress to Acute Respiratory Failure (ARF) and require mechanical ventilation (MV). These individuals have their mobility restricted to the bed, and may develop pulmonary and systemic complications, such as ICU-Acquired Muscle Weakness (ICU-AMF), which increases the chances of developing reduced functional capacity or death. Early mobilization in the ICU has shown benefits, such as functional improvement and reduced hospitalization days, but still with a low level of evidence. However, the type and intensity of exercise still need to be better defined and previous protocols did not offer continuous monitoring from the ICU to the ward and subsequent outpatient rehabilitation for these patients, which is considered a limitation in some studies. Objective: To evaluate the effects of an intensive mobilization program on inflammation in patients undergoing invasive mechanical ventilation. Methods: This is a Blinded Randomized Controlled Clinical Trial that will be conducted in the Intensive Care Units of the Hospital das Clínicas and the Emergency Unit of the Ribeirão Preto School of Medicine of the University of São Paulo. Patients of both sexes over 21 years of age under invasive mechanical ventilation for at least 24 hours will be recruited; patients will be allocated into: Intervention Group (IG) that will participate in the hospital intensive mobilization protocol and Control Group (CG) that will be maintained under usual care of the sector limited to 10 minutes of mobilization per day; after discharge to the ward, volunteers will be followed up according to their respective groups. According to the sample calculation, a minimum of 26 individuals per group was considered necessary to facilitate a meaningful assessment of feasibility and safety. Muscular assessment of volunteers included in the study will be performed during their hospitalization in the ICU and/or wards, using the MRC-SS, handgrip, quadriceps ultrasound and arm and thigh circumference tests. All variables analyzed will be described in the form of graphs and tables, separated by groups. The outcomes will be analyzed using parametric or nonparametric methods for comparison between groups. The results will also be analyzed by logistic regression or linear regression and will be conducted by an experienced statistician.