Comparison of a face-to-face cardiorespiratory rehabilitation protocol and a booklet of home guidance on quality of life in patients after hospitalization who were on mechanical ventilation.

• Grant number: 25/06522-6
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: May 01, 2025
• End date: April 30, 2026
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Ada Clarice Gastaldi
• Grantee: Nara Emi Hoshi
• 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), including severe patients who progress to Acute Respiratory Failure (ARF) and require mechanical ventilation (MV). These individuals have their mobility restricted to the bed, and can develop pulmonary and systemic complications, such as ICU-acquired Muscle Weakness(ICU-MWF), which increases the chances of developing reduced functional capacity or death. Early mobilization in the ICU has shown benefits, such as functional improvement and shorter hospital stays, but still with a low level of evidence. However, the type and intensity of exercise still needs to be better defined and previous protocols have not offered continuous follow-up from the ICU to the ward and subsequent outpatient rehabilitation for these patients, which is considered a limitation in some studies. Objective: To compare an in-person cardiorespiratory rehabilitation protocol and a home guidance booklet on quality of life in patients after hospitalization who had undergone mechanical ventilation. Methods: This is a blinded randomized controlled 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 of the University of São Paulo. Patients will be recruited from both sexes over the age of 21 under invasive mechanical ventilation for at least 24 hours; patients will be allocated into: Intervention Group (IG) that will participate in the intensive hospital mobilization protocol and Control Group (CG) that will be kept under care usual of the sector limited to 10 minutes of mobilization per day; after discharge to the ward the volunteers will maintain follow-up according to their respective groups. After discharge from hospital, the participants will be randomized again into the Intervention Group (GIor) and the Intervention Group outpatient rehabilitation (GIreab) and, likewise, the Control group will be divided into GCor and GCreab, with the main outcome being the assessment of muscle and functional exercise capacity. The volunteers will be followed up at 1, 3 and 6 months after discharge from hospital. According to the sample calculation, a minimum of 26 individuals per group was considered necessary to facilitate a meaningful assessment of feasibility and safety. Data will be analyzed on muscle assessment and functional exercise capacity of the patients included in the study, using the MRC-SS, Handgrip, Quadriceps Ultrasound and Arm and Thigh Circumference tests, as well as the application of the EQ-5D-5L and HADS questionnaires. All the variables analyzed will be described in the form of graphs and tables, separated by group. The outcomes will be analyzed using parametric or non-parametric methods to compare the groups. The results will also be analyzed by logistic regression or linear regression and will be conducted by an experienced statistician.