Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke
Julie Bernhardt, Karen Borschmann, Janice Collier, Amanda G. Thrift, Peter Langhorne, Sandy Middleton, Richard I. Lindley, Helen M. Dewey, Philip M. Bath, Catherine M. Said, Leonid Churilov, Fiona Ellery, Christopher Bladin, Christopher M. Reid, Judith Frayne, Velandai Srikanth, Stephen Read, Geoffrey A. Donnan, Marj Moodie, Brooke Parsons, Bent Indredavik, Torunn Askim, Jan Chamberlain, Teresa Occhiodoro, Helen Palfreeman, Tara Purvis, Bernadette Sirgo, Nick Tiliacos, John Van Holsteyn, Henry Zhao, Tim Brewer, Nick Haritos, Edwin Leong, Cecilia Li, Caesar NayWin, Marcus Nicola, Liudmyla Olenka, Li Chun Quang, Rob Carter, Silvia Hope, Lauren Sheppard, Kiusiang Tay-Teo, Olívia Wu, Toby Cumming, Thomas Lindén, Beverly Armstrong, Louise Craig, Fiona Graham, Lynn Legg, Rosemary Morrison, Heather Moorhead, Lorraine O’Donohue, Susan Rogers, Myra Smith, Denise Forshaw, Jane Fitzgerald, Sheila Lennon, Guiomar Garcia-Jalon, Tara Purvis, Helen Williamson, Helen M. Dewey, C. Nall, Sue Berney, Lance Sherry, R Melling, S. Petrolo, Paul R. Adams, L Augoustakis, S Batcheler, Vera Cobani, Brett Cohen, Stefania Di Gangi, N Giofre, Christopher J. Gordon, L Hegarty, Christopher J. Gordon, L Hegarty, M Hindson, F Horváth, Scott E. Kalinowski, Appie H. Kleine, Jean M. Lawrence, S Lindquist, Nicola S. Logan, A. A. Macdonell, J Matlioski, N McDonough, Susan V. McLennan, Mike McNamee, Laura Miller, E Andrea Nelson, Kelvin K. Ng, Z Nicholas, Katharine R. Owen, Emma Plant, Emma Plant, K Rodway, S Sertori, V Sheldon, K Stansfeld
Abstract
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: = 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.