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

Boletín del Servicio Meteorológico Nacional: Epoca 2ª Número 78 - 1952 Marzo 18

Introdução: A reabilitação é um componente importante do tratamento interdisciplinar em uma Unidade de AVC, especialmente a mobilização precoce com retirada do paciente do leito. Diretrizes recomendam o início da fisioterapia motora o mais precoce possível, mas os resultados dos estudos já publicados são inconclusivos quanto ao benefício desta intervenção. Objetivos: Para avaliar o benefício da mobilização precoce no AVC isquêmico foi iniciado um ensaio clinico randomizado (ECR) comparando este tratamento, iniciado dentro das primeiras 48 horas do AVC, com a fisioterapia motora de rotina do hospital. No estudo piloto, nosso objetivo foi estabelecer a exequibilidade e segurança da mobilização precoce nos pacientes com AVC isquêmico agudo atendidos no Hospital de Clínicas de Porto Alegre. Métodos: Foram incluídos pacientes com AVC isquêmico agudo até 48 horas do início dos sintomas e alocados randomicamente em dois grupos: Grupo Tratamento (GT), que realizou o programa de mobilização precoce iniciando nas primeiras 24 a 48h após o AVC, e Grupo Controle (GC), que seguiu com as rotinas do hospital. Os desfechos primários do ensaio clinico são independência funcional (escore da Escala de Rankin modificada entre 0 e 2) e mortalidade em três meses. Os desfechos primários do estudo piloto foram tempo até a primeira mobilização, tempo total de fisioterapia motora, complicações ocorridas durante a mobilização precoce, quedas durante o período de hospitalização, complicações médicas relacionadas à imobilidade e morte em 90 dias. Resultados: Trinta e sete pacientes foram incluídos, sendo 18 no GT (idade média de 64 anos) e 19 no GC (idade média de 66 anos). O GT recebeu mobilização mais precoce e em maior quantidade do que o GC. A mediana do tempo entre o ictus e a primeira mobilização foi de 43h (AIQ 28-48h) comparada com 72h no GC (AIQ 61-108h; p=0.001) e o tempo total de mobilização durante o período de hospitalização no GT foi de 135 min (AIQ 85-213 min) comparado com 0 min no GC (AIQ 0-50 min). Não houve complicações associadas à mobilização precoce dos pacientes, bem como não houve diferença estatisticamente significativa entre os grupos quanto à proporção de complicações, mortalidade e resultados funcionais, exceto pela tendência a melhor recuperação funcional em 90 dias no GT quando excluídos da análise os pacientes com sequelas prévias. Conclusão: Embora este ensaio clínico randomizado não tenha poder para comprovar a efetividade da intervenção, ele se mostrou seguro e exequível. Apesar das dificuldades encontradas, foi possível iniciar a mobilização precocemente, ainda no serviço de emergência, em qualquer grau de severidade do AVC, sem complicações. Mais estudos 8 randomizados controlados são necessários com maior número de indivíduos a fim de verificar o efeito da mobilização precoce em até 48h do início dos sintomas do AVC.Background: The rehabilitation is an important component of the interdisciplinary treatment in a stroke unit, especially early mobilization with out of bed activities. Guidelines recommend the initiation of physical therapy as early as possible, but the results of published studies are inconclusive regarding the benefit of this intervention. Objectives: To evaluate the benefit of early mobilization in ischemic stroke has started a randomized clinical trial (RCT) comparing this treatment, initiated within 48h of stroke, with the motor physical therapy routine hospital. In the pilot study, our aim was to establish the feasibility and safety of early mobilization in patients with acute ischemic stroke treated at Hospital de Clinicas de Porto Alegre. Methods: Patients with acute ischemic stroke within 48h of symptoms onset and randomly allocated into two groups: Treatment Group (TG), which carried out the program of early mobilization beginning in the first 24 to 48h after stroke, and Control Group (CG), which followed with the routines of the hospital. The primary outcomes of the clinical trial are functional independence (modified Rankin Scale score between 0 and 2) and mortality within three months. The primary outcomes of the pilot study were time to first mobilization, total duration of physical therapy, complications during early mobilization, falls during hospitalization, medical complications related to immobility and death within 90 days. Results: Thirty-seven patients were included, 18 in TG (average age 64 years) and 19 in the CG (mean age 66 years). The TG received mobilization earlier and in greater quantity than the CG. The median time between the stroke and the first mobilization was 43h in the TG (IQR 28-48h) and 72h in the CG (IQR 61-108h, p = 0.001) and the total mobilization during the period of hospitalization in TG was 135 min (IQR 85-213 min) compared with 0 min in the GC (IQR 0-50 min). There were no complications associated with early mobilization and there was no statistically significant difference between groups in the proportion of complications, mortality and functional outcomes, except for the tendency to better functional recovery at 90 days in TG when the analysis excluded patients with previous sequels. Conclusion: Although this randomized clinical trial has no power to prove the effectiveness of the intervention, it proved to be safe and feasible. Despite the difficulties, it was possible to start early mobilization, even in the emergency room, in any degree of severity of stroke, without complications. More randomized controlled trials are needed with larger numbers of subjects to verify the effect of early mobilization within 48h of onset of stroke symptoms

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