Early Mobilization in Ischemic Stroke: A Pilot Randomized Trial of Safety and Feasibility in a Public Hospital in Brazil

Abstract

Background: The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods: The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results: Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. Conclusions: This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals.

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

“…Results are presented as the OR (95% CI) of the early versus delayed mobilisation group. 65 Bernhardt 35 AVERT 31 Chippala 60 Chippala 63 Poletto 61 Herisson 62 T his project met its initial objectives of effectively delivering our VEM protocol with a resulting change in practice. 30 We observed earlier, more frequent and higher dose (amount of) out-of-bed mobility in terms of sitting, standing and walking activity.…”

“…In our systematic review of similar RCTs, we identified eight eligible trials 25,27,31,[60][61][62][63][64] that currently have data available. Of these eight trials (2618 participants), AVERT provided the most information (2104 participants).…”

Efficacy and Safety of Very Early Mobilization in Patients with Acute Stroke: A Systematic Review and Meta-analysis

“…A total of 9 articles 5, 6, 15, 16, 18–22 met our inclusion criteria and were finally included in this meta-analysis (Fig. 1).…”

“…A total of 9 RCTs published between 2008 and 2016 including 2,803 participants were examined. Of the 9 included studies, 3 16, 18, 21 were conducted in Europe, 2 19, 20 in Asia, 1 5 in South America, 1 6 in Oceania, 1 22 in 2 countries across Europe and Oceania, and 1 15 in 5 countries across multiple continents. With respect to stroke subtype, 5 6, 15, 16, 19, 22 studies included patients with any stroke type, 3 5, 18, 21 included patients with ischemic stroke (IS) only, and only 1 20 included patients with hemorrhagic stroke (HS).…”

“…Very early mobilization (VEM) after stroke onset is thought to be an important component of stroke unit treatment, which potentially contributes to improved outcomes after acute stroke 4 . VEM is usually defined as intensive out of bed (OOB) activity comprising of sitting, standing, and walking at the earliest possible time no later than 1 or 2 days after onset 5–7 .…”