Introduction: A Very Early Rehabilitation Trial (AVERT) is a randomized controlled trial to test the efficacy and safety of early and frequent mobilization after stroke (The Lancet, 2015, 386, p46-55). Our pre-specified dose response analyses of the AVERT trial aims to provide practical guidance for clinicians on the timing, frequency and dose of mobilization following acute stroke.
Methods: Eligible patients were aged ≥18 years, had confirmed first (or recurrent) stroke, and were admitted to a stroke unit within 24 hours of stroke onset. Patients were randomized to receive very early and frequent mobilization, commencing within 24 hours, or usual care. The timing, frequency and amount (minutes) of all out of bed mobilization was recorded online. We used regression analyses and Classification and Regression Trees (CART®)2 to investigate the effect of timing and dose of mobilization on efficacy and safety outcomes, irrespective of assigned treatment group.
Results: 2104 patients were enrolled between 18 July 2006 and 16 October 2014, of whom 2083 (99.0%) were followed up at 3 months. No patients withdrew due to adverse events. We found a consistent pattern of improved odds of favorable outcome in efficacy and safety with increased daily frequency of out of bed sessions (OR 1.13, 95% CI 1.09 to 1.18, p<0.001) keeping time to first mobilization and amount of mobilization constant. Increased amount of mobilization reduced the odds of a good outcome (OR 0.94, 95% CI 0.91 to 0.97, p<0.001). Session frequency was the most important variable in the CART® analysis, after prognostic variables age and baseline stroke severity.
Conclusions: These data suggest that shorter, more frequent mobilization early after acute stroke is associated with a greater odds of favorable outcome at 3 months when controlling for age and stroke severity. This study provides class III evidence that shorter, more frequent early mobilization improves the chance of regaining independence after stroke.