A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility.
نویسندگان
چکیده
BACKGROUND AND PURPOSE Very early rehabilitation, with an emphasis on mobilization, may contribute to improved outcomes after stroke. We hypothesized that a very early rehabilitation protocol would be safe and feasible. METHODS We performed a randomized, controlled trial with blinded outcome assessment. Patients at <24 hours after stroke were recruited from 2 Melbourne metropolitan stroke units. Patients were randomly assigned to receive standard care (SC) or SC plus very early mobilization (VEM) until discharge or 14 days (whichever was sooner). The primary safety outcome was the number of deaths at 3 months. The primary feasibility outcome was a higher "dose" of mobilization achieved in VEM. Secondary safety outcomes included adverse events (including falls and early neurologic deterioration), compliance with physiologic monitoring criteria, and patient fatigue after interventions. Secondary feasibility outcomes included "contamination" of standard care. RESULTS Overall, 18% of patients screened were suitable for recruitment. Seventy-one patients were recruited and randomized, with 2 dropouts by 12 months. The majority experienced ischemic strokes (87%). The group mean+/-SD age was 74.7+/-12.5 years, and 58% (n=41) had a National Institutes of Health Stroke Scale score >7. There was no significant difference in the number of deaths between groups (SC, 3 of 33; VEM, 8 of 38; P=0.20). Almost all deaths occurred in patients with severe stroke. Secondary safety outcomes were similar between groups. The intervention protocol was successfully delivered, achieving VEM dose targets (double SC, P=0.003) and faster time to first mobilization (P<0.001). CONCLUSIONS VEM of patients within 24 hours of acute stroke appears safe and feasible. Intervention efficacy and cost-effectiveness are currently being tested in a large randomized, controlled trial.
منابع مشابه
Very early mobilization after stroke fast-tracks return to walking: further results from the phase II AVERT randomized controlled trial.
BACKGROUND AND PURPOSE regaining functional independence is an important goal for people who have experienced stroke. We hypothesized that introducing earlier and more intensive out-of-bed activity after stroke would reduce time to unassisted walking and improve independence in activities of daily living. METHODS a Very Early Rehabilitation Trial (AVERT) was a phase II randomized controlled t...
متن کاملEarly mobilization after stroke: an example of an individual patient data meta-analysis of a complex intervention.
BACKGROUND AND PURPOSE Very early mobilization (VEM) is a distinctive characteristic of care in some stroke units; however, evidence of the effectiveness of this approach is limited. To date, only 2 phase II trials have compared VEM with standard care: A Very Early Rehabilitation Trial (AVERT) in Australia and the recently completed Very Early Rehabilitation or Intensive Telemetry after Stroke ...
متن کاملResponse to letter by Freeman et al regarding article, “Very early mobilization after stroke fast-tracks return to walking: further results from the phase II AVERT randomized controlled trial”.
Stroke welcomes Letters to the Editor and will publish them, if suitable, as space permits. Letters must reference a Stroke published-ahead-of-print article or an article printed within the past 3 weeks. The maximum length is 750 words including no more than 5 references and 3 authors. Please submit letters typed double-spaced. Letters may be shortened or edited. Include a completed copyright t...
متن کاملMobilization after thrombolysis (rtPA) within 24 hours of acute stroke: what factors influence inclusion of patients in A Very Early Rehabilitation Trial (AVERT)?
BACKGROUND A key treatment for acute ischaemic stroke is thrombolysis (rtPA). However, treatment is not devoid of side effects and patients are carefully selected. AVERT (A Very Early Rehabilitation Trial), a large, ongoing international phase III trial, tests whether starting out of bed activity within 24 hours of stroke onset improves outcome. Patients treated with rtPA can be recruited if th...
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عنوان ژورنال:
- Stroke
دوره 39 2 شماره
صفحات -
تاریخ انتشار 2008