Progressive active mobilization with dose control and training load in critically ill patients (PROMOB): Protocol for a randomized controlled trial

Abstract

The dose of progressive active mobilization is still uncertain. The purpose of this study is to identify if the addition of a protocol of progressive active mobilization with dose and training load control to usual care is effective in reducing the length of stay in intensive care unit (ICU) and the improvement of the functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate in patients hospitalized in ICU. It is Double-blind randomised clinical trial. The setting for this trial will be medical and surgical ICU of a university hospital. The study participants will be 118 patients aged> 18 years admitted to ICU for less than 72 hours. Participants will be randomized to either an experimental or control group. The experimental group will undertake addition of a protocol of progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care. The primary outcome will be length of ICU stay. The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality. All statistical analyses will be conducted following intention-to-treat principles. It has a detailed description of the dose of exercise, was designed with the strictest methodological criteria. These characteristics allow to investigate with greater certainty the results progressive active mobilization in critical patients, allowing replication and future combinations in meta-analyzes.

Fig 1. Progressive active mobilization protocol stratified by functional levels and performance.

FSS-ICU = Functional Status Score for the ICU [22]. If need minimal or moderate assistance (FSS-ICU ≥ 3) progresses at functional levels (N₁, N₂, N₃, N₄); Adequate performance = Able to perform 8 series of each movement, alternating 20 seconds of execution with 10 seconds of rest, without discomfort (Borg < 6; scale 0–10) [20], without increased pain and positive response to the questioning: "Do you feel good after you do physical activity?" [21]. If it does not have FSS-ICU ≥ 3, but has adequate performance, maintains functional level and increases training volume. The protocol is applied 5 times a week, once a day added to the usual care. If the patient reports discomfort (Borg > 6), increased pain, will rest for 5 minutes. If there is no normalization of the pain and sensation of exertion perceived in that period of time, the training session will be suspended and performed after 24 hours.