A Very Early Rehabilitation Trial (AVERT)

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Inthedevelopedworld,oneinfourmenandoneinfivewomencan expect to suffer a stroke if they live to 85 years (1). Strokeresults in both premature death and disability however, incontrast tocoronaryheartdiseaseand cancer,its major burdenis chronicdisability rather than death (2). We know that strokepatients who have received organised multidisciplinary care inaStrokeCareUnit(SCU)environmenthavereducedmortalityand dependency (3). However, it is uncertain which compo-nents of the SCU management strategies are responsible forimproved outcomes. The strongest evidence for the benefit ofstarting mobilisation as early as possible after stroke comesfrom a post hoc analysis of the Norwegian randomized trial ofSCU vs. general medical ward care and using discharge at sixweeks as a surrogate outcome measure (4). Patients managedin the SCU (and receiving very early mobilisation, hereafterknown as VEM) were 64% less likely to be dead or disabled.Of the factors that distinguished stroke unit from generalmedical care, VEM was found to be the strongest predictor ofimprovedoutcometogetherwithbetter bloodpressurecontrol(5).Thisanalysis indicatedthatVEMmayaccountforas muchas 78% of the SCU benefit. Starting mobilisation (i.e. sittingout of bed, standing and walking) very early after stroke andcontinuing it at frequent intervals until discharge, may reducethe levelofdisabilityexperienced by strokepatients and reducethe number of patients requiring nursing home care (5).Although preliminary, the evidence from these studies hasprompted the inclusion of early mobilisation in acute strokecare best practice guidelines both in Australia (6) and inter-nationally (7). As there is only a low level of evidence tosupporttheseguidelinesthereisanobviousneedtoconductaninterventional trial of early mobilisation to determine whetherearly mobilisation of stroke patients is safe, improves out-comes and is cost effective. In order to do this we havecommenced A Very Early Rehabilitation Trial (AVERT). Ouris to determine the efficacy and cost effectiveness of this earlyintervention.AVERT differs from many previous rehabilitation trials on anumber of levels. First, it has been designed to mirror otheracute interventional trials of stroke such as thrombolysis andneuroprotection. This design objective was imperative giventhe frequently poor methodological quality of rehabilitationtrials. Second, AVERT is a large, multicentre randomisedcontrolled trial, adequately powered to detect a benefit ofsimilar magnitude to other proven interventions, with broadinclusion criteria to be assured that the result is generalisable.Finally, a detailed economic evaluation is included to allow acost effectiveness assessment to be made to assist in healthplanning and to allow comparison with other proven inter-ventions. If positivethese features should helpdrivechanges inclinical practice.The trial design is a randomised controlled trial of VEM(intervention) vs. standard care (control), with blinded assess-ment of outcome and intention-to-treat analysis.The hypothesis is that VEM of stroke patients (in addi-tion to standard care), compared with standard care alonewill:reduce death and disability at 3-month post stroke,reduce the number and severity of complications experi-enced by stroke patients,result in better quality of life at 12 months, andbe cost-effective.The study includes patients over 18 years with confirmedstroke admitted to hospital within 24h of onset of strokesymptoms. Patients must be rouseable. Patients who aremoderately to severely disabled before stroke (modified Ran-kin Scale (8) 42) will be excluded. In addition, we will excludethoseshowingrapidearlydeteriorationofsymptoms,orwithaconcurrent diagnosis of rapidly deteriorating disease (e.g.terminal cancer). Patients with unstable coronary or othermedical conditions that would impose hazard to the patientwill also be excluded. Physiological variables (e.g. heart rate,blood pressure, O