Cost-effectiveness of a rehabilitation program for patients undergoing mechanical ventilation, from the ICU to the post-hospital phase.

• Grant number: 24/23468-2
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: April 01, 2025
• End date: March 31, 2027
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Ada Clarice Gastaldi
• Grantee: Daniele Oliveira dos Santos
• 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 surviving prolonged stays in Intensive Care Units (ICUs), including critically ill patients who develop acute respiratory failure and require mechanical ventilation. These individuals often experience restricted mobility confined to the bed, which can lead to pulmonary and systemic complications, such as ICU-acquired weakness (ICU-AW), increasing the likelihood of reduced functional capacity or death. Early mobilization in the ICU has shown benefits, such as improved functional outcomes and reduced length of hospital stay, although evidence levels remain low. However, the type and intensity of exercise interventions need to be better defined, and previous protocols have not offered continuous follow-up from the ICU to the ward and subsequent outpatient rehabilitation, representing a limitation in some studies.Objective: To investigate the effects of an intensive early mobilization program during hospitalization and post-discharge rehabilitation on indicators of functionality, inflammation, and mortality in critically ill patients subjected to invasive mechanical ventilation.Methods: This is a randomized, blinded, 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 Medical School at the University of São Paulo. Patients of both sexes aged 21 years and older, who have been under invasive mechanical ventilation for at least 24 hours, will be recruited. Participants will be allocated into: Intervention Group (IG), which will undergo an intensive mobilization protocol during hospitalization, and Control Group (CG), which will receive standard care limited to 10 minutes of mobilization per day. Following discharge to the ward, participants will continue under their respective group protocols. After hospital discharge, participants will be re-randomized into the Intervention Group with guidance (IGor) and the Intervention Group with outpatient rehabilitation (IGreab). Similarly, the Control Group will be divided into CGor and CGreab. The primary outcomes will include muscle strength assessment, functional exercise capacity, and cost-effectiveness analysis. Volunteers will be followed up at 1, 3, and 6 months after hospital discharge.Based on sample size calculations, a minimum of 26 individuals per group is necessary to facilitate a meaningful evaluation of feasibility and safety. For the multicenter study, each participating center will include 2 groups (IG and CG) with 26 subjects per group. All analyzed variables will be presented in graphs and tables, separated by groups. Outcomes will be analyzed using parametric or non-parametric methods for between-group comparisons. Additionally, results will be examined through logistic regression or linear regression and conducted by an experienced statistician.