Progressive mobility program and technology to increase the level of physical activity and its benefits in respiratory, muscular system, and functionality of ICU patients: study protocol for a randomized controlled trial

Debora Stripari Schujmann,Carolina Fu,Adriana Claudia Lunardi

doi:10.1186/s13063-018-2641-4

Debora Stripari Schujmann, Carolina Fu + Show 1 more

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https://doi.org/10.1186/s13063-018-2641-4

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Abstract

BackgroundEnhanced mobility in the Intensive Care Unit (ICU) could minimize the negative effects of critical illness, such as declines in cognitive, muscular, respiratory, and functional capacity. We aim to compare the functional status at ICU discharge of patients who underwent a progressive mobilization protocol versus patients who received conventional physiotherapy. We also examine the level of physical activity in the ICU, the degree of pulmonary and muscle function, and the length of stay to analyze correlations between these variables.MethodsThis is a protocol for a randomized controlled trial with blind evaluation. Ninety-six ICU patients will be recruited from a single center and randomly assigned to a control group or an intervention group. To determine the level of protocol activity the patient will receive, the patients’ ability to participate actively and their muscle strength will be considered. The protocol consists of five phases, ranging from passive therapies to walking and climbing stairs. The primary outcome will be the functional status at ICU discharge, measured with the Barthel Index and the ICU Mobility Scale (IMS). Measured secondary outcomes will include the level of physical activity, maximal inspiratory and expiratory pressures, forced expiratory volume in 1 second, maximum voluntary ventilation, handgrip strength, surface electromyography of the lower limb muscles, and results of the Timed Up and Go and 2-Minute Walk tests. Evaluations will be made within 2 days of ICU discharge except for the level of activity, which will be evaluated daily. Physiological variables and activity level will be analyzed by chi-square and t tests, according to the intention-to-treat paradigm.DiscussionMobility and exercise in the ICU should be undertaken with intensity, quantity, duration, and frequency adjusted according to the patients’ status. The results of this study may contribute to new knowledge of early mobility in the ICU, activity level, and varying benefits in critical patients, directing new approaches to physiotherapeutic interventions in these patients.Trial registrationRecruitment will begin in February 2017, and the expected completion date is August 2018. Patients are already being recruited.ClinicalTrials.gov, ID: NCT02889146. Registered on 3 March 2016.

Highlights

Enhanced mobility in the Intensive Care Unit (ICU) could minimize the negative effects of critical illness, such as declines in cognitive, muscular, respiratory, and functional capacity
Considering a statistical power of 80% and an alpha error of 0.5, we found that the number of subjects should be 48 per group, totaling 96 patients in the study
Variation in the supply and types of treatments available within the ICU may be the main difficulty in achieving greater benefits, and standardization with early and progressive programs, with the patient being included at most appropriate level of the program, may be the key to better outcomes

Summary

Introduction

Enhanced mobility in the Intensive Care Unit (ICU) could minimize the negative effects of critical illness, such as declines in cognitive, muscular, respiratory, and functional capacity. A large number of patients who survive hospitalization in the Intensive Care Unit (ICU) experience negative effects of critical illness, even after stabilization of the condition, presenting cognitive, psychological, and physical changes as the main morbidities. Quality of life was evaluated at 1 year and 4 years after hospital discharge, with results indicating a decrease in quality of life in surviving patients due mainly to a decrease in physical function [4]. These medium and long-term consequences originate at the beginning of hospitalization and are related to changes that occurred during the stay in the ICU. The main consequences of this immobilization are atelectasis, mechanical ventilation (MV), and hospital-associated pneumonia as well as delayed removal of the MV due to muscle weakness, decreased vital capacity, and residual volume [5, 6]

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