The evidence against the use of early mobilisation interventions soon after stroke onset has been strengthened with an Australian-led study showing a higher risk of early death.
A new analysis of the AVERT (A Very Early Rehabilitation Trial) study has shown there were higher mortality rates for people with ischaemic and haemorrhagic stroke who had early mobilisation (out-of-bed activity and mobility training) started within 24 hours of stroke onset, compared to usual care.
The study randomised 2104 stroke patients to early mobilisation or usual care, and its previously released findings showed worse outcomes at three months for the patients who received ‘very early mobilisation’ (VEM). This involved a higher level of out-of-bed, task specific training of sitting, standing, and walking, commenced within 24 hours of stroke onset and continued for 14 days or hospital discharge if sooner.
The latest analysis, which focused on mortality, showed that there was a low overall case fatality rate at 14 days post-stroke of 3.8%, but there was a higher odds of death (age and severity adjusted OR 1.76).
The difference translated into 16 excess deaths in the early mobilisation group, and this difference persisted to three months. Fatalities more prominent in people aged over 80 years and those with intracerebral haemorrhage.
The analysis also found that stroke progression was more common in very early mobilisation, but no difference was seen in non-fatal severe adverse events between the two groups
Writing in Neurology, the study investigators said one hypothesis that to explain early harm with upright activity after stroke related to disturbance of cerebral autoregulation in this hyper-acute phase.
They noted there was ongoing uncertainty around the effect of head position on cerebral blood flow in stroke patients and the effect of changes in blood pressure, and more research is needed in this area.
Given the less favourable outcomes seen with early mobilisation in several studies, clinical practice guidelines have been now revised with recommendations to delay or modify mobilisation practices, they said
Study investigator Professor Julie Bernhardt, from the Florey Institute of Neuroscience and Mental Health, Melbourne, told the limbic that the information from this analysis had been used to develop refined protocols for testing in a new trial called AVERT DOSE. This aims to identify the optimal safe and effective early mobility training protocols for people with mild and moderate ischaemic stroke.
This trial is funded by the NHMRC and is now running in seven countries, testing four ‘doses’ of intervention starting within 48 hours of stroke (so later), across mild and moderate stroke patients to try identify the most promising interventions.
“The take aways here are – deaths are low in the trial overall – early deaths are low, but you can cause harm by doing too much too soon and we need to determine safe and effective protocols for people in this early phase of stroke care,” she said.