Detailed Search Results
| Author/Association: | The AVERT Trial Collaboration group |
| Title: | Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial [with consumer summary] |
| Source: | Lancet 2015 Jul 4;386(9988):46-55 |
| Method: | clinical trial |
| Method Score: | 8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
| Consumer Summary: | RESEARCH IN CONTEXT: EVIDENCE BEFORE THIS STUDY: Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide. In our 2015 review of 30 guidelines, early mobilisation was recommended in 22 examples, but the timing and prescription of the mobilisation intervention is scarcely specified. Early mobilisation is most often recommended as a method to reduce the risk of post-stroke complications, with subsequent improvements in favourable outcome expected. Our early Cochrane review identified no evidence of benefit, but included only one small randomised controlled trial (AVERT phase 2, n = 71). A systematic review and meta-analysis by Lynch and colleagues identified three randomised controlled trials (n = 159) in which a protocol of mobilisation starting within 24 h of stroke was compared with usual care. In this review, the investigators reported improved, albeit non-significant, odds of a favourable outcome with early mobilisation (Barthel Index odds ratio (OR) 1.20, 95% CI -0.77 to 3.18; p = 0.23; OR 1.16, 95% CI 0.61 to 2.18; p = 0.66, with significant heterogeneity I2 = 66%). The odds of having no complications in the first 3 months after stroke did not differ significantly between groups (OR 0.92, 95% CI 0.46 to 1.87, p = 0.82). Fewer patients had died by 3 months after stroke in the usual care group (n = 6) than in the early mobilisation group (n = 15; OR 2.58, 95% CI 0.98 to 6.79; p = 0.06), but this finding was not significant. When data on deaths from this meta-analysis are combined with data from the present trial, with both fixed-effects and random-effects meta-analysis, the findings are not appreciably changed (fixed-effects OR 1.35, 95% CI 0.99 to 1.83; p = 0.06; random-effects OR 1.61, 0.82 to 3.14; p = 0.17, I2 = 26%). This meta-analysis represents the most recent systematic review of the topic. ADDED VALUE OF THIS STUDY: Before AVERT, evidence in trials came from three studies including 159 patients. We now have more robust evidence to inform practice. We believe that the results of AVERT are very generalisable. We have also shown that large, international, high-quality trials of complex interventions in stroke care, trials that are led by physiotherapists and nurses, are possible. INTERPRETATION: Very early mobilisation was associated with a significant reduction in the odds of little or no disability at 3 months after stroke, with no evidence of accelerated walking recovery; however, the number of patients who died or had serious adverse events at 3 months after stroke did not differ significantly between groups. Our data show that an early, lower dose out-of-bed activity regimen is preferable to very early, frequent, higher dose intervention, but clinical recommendations should be informed by the future prespecified, detailed analysis of the dose-response association. |
| Abstract: | BACKGROUND: Early mobilisation after stroke is thought to contribute to the effects 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. METHODS: We 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 criteria were 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 to 2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. FINDINGS: Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2,104 patients to receive either very early mobilisation (n = 1,054) or usual care (n = 1,050); 2,083 (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%) versus n = 525 (50%); adjusted odds ratio (OR) 0.73, 95% CI 0.59 to 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 to 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. INTERPRETATION: First 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 refining present guidelines; however, clinical recommendations should be informed by future analyses of dose-response associations. FUNDING: National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research. Full text (sometimes free) may be available at these link(s):  help |
