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Updated: Dec 2, 2025
Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke
Julie Bernhardt1, Karen Borschmann2, Janice M Collier2
1From Stroke Theme, Florey Institute of Neuroscience and Mental Health (J.B., K.B., J.M.C., H.M.D., F.E., C.B.), and Department of Medicine Austin Health (L.C.), University of Melbourne, Heidelberg; NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery (J.B., K.B., L.C., G.A.D.); Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences (H.M.D.), CCRE Therapeutics (C.M.R.), Faculty of Medicine, Nursing and Health Sciences (J.H.F.), and Peninsula Health & Peninsula Clinical School (V.S.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Nursing Research Institute (S.M.), St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst; Westmead Clinical School (R.I.L.), University of Sydney, Australia;Stroke Trials Unit, Division of Clinical Neuroscience (P.B.), University of Nottingham; Stroke, Nottingham University Hospitals NHS Trust (P.B.), Nottingham, UK; Physiotherapy (C.M.S.), University of Melbourne, Parkville; Physiotherapy (C.M.S.), Western Health, St Albans; School of Sciences (L.C.), RMIT University, Melbourne; Eastern Health Clinical School (C.B.), Monash University, Box Hill; School of Public Health (C.M.R.), Curtin University, Perth; Alfred Hospital (J.H.F.), Melbourne; Faculty of Medicine (S.J.R.), The University of Queensland, Herston; and University of Melbourne (G.A.D.), Melbourne Brain Centre, Parkville, Australia. julie.bernhardt@florey.edu.au.
Objective:
This tertiary analysis from A Very Early Rehabilitation Trial (AVERT) examined fatal and nonfatal serious adverse events (SAEs) at 14 days.
Method:
AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours poststroke, termed very early mobilization (VEM), to usual care (UC). Primary outcome was assessed at 3 months. Patients with ischemic or hemorrhagic stroke within 24 hours of onset were included. Treatment with thrombolytics was allowed. Patients with severe premorbid disability or comorbidities were excluded. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were nonfatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIH Stroke Scale [NIHSS] score) and age.
Results:
A total of 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (interquartile range [IQR] 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted odds ratio of 1.76 (95% confidence interval 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral hemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in nonfatal SAEs was found.
Conclusion:
While the overall case fatality at 14 days poststroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose and intensive training compared to usual care. Stroke progression was more common in VEM.
Registration:
Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.
Classification Of Evidence:
This study provides Class I evidence that very early mobilization increases mortality at 14 days poststroke.
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