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Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Bernhardt, J., Langhorne, P., Lindley, R. i., Thrift, A. G., Ellery, F., Collier, J., Churilov, L., Moodie, Marjory, Dewey, H. and Donnan, G. 2015, Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial, The Lancet, vol. 386, no. 9988, pp. 46-55, doi: 10.1016/S0140-6736(15)60690-0.

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Title Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial
Author(s) Bernhardt, J.
Langhorne, P.
Lindley, R. i.
Thrift, A. G.
Ellery, F.
Collier, J.
Churilov, L.
Moodie, Marjory
Dewey, H.
Donnan, G.
Journal name The Lancet
Volume number 386
Issue number 9988
Start page 46
End page 55
Total pages 10
Publisher Elsevier
Place of publication Amsterdam, The Netherlands
Publication date 2015-07-04
ISSN 0140-6736
Summary Background Early mobilisation after stroke is thought to contribute to the eff ects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke.MethodsWe did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteriawere randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561.FindingsBetween July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation.InterpretationFirst mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refi ning present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations.
Language eng
DOI 10.1016/S0140-6736(15)60690-0
Field of Research 110305 Emergency Medicine
Socio Economic Objective 929999 Health not elsewhere classified
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, Elsevier
Persistent URL http://hdl.handle.net/10536/DRO/DU:30080252

Document type: Journal Article
Collection: School of Health and Social Development
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