NIHR Signal Very early mobilisation following a stroke is no better than usual care

Published on 22 April 2015

The AVERT trial found very early mobilisation - such as out-of-bed sitting, standing and walking - within 24 hours of stroke onset and at increased intensity, led to 4% fewer people with good recovery than usual care. No differences were found in death rates, overall disability scores, or in the time to be able to walk. Most people in this study, even as part of usual care, started mobilising in less than 24 hours. Guidelines recommend early mobilisation when appropriate and this study may not prompt an immediate change in practice, but does provide clearer evidence that higher intensity early intervention may not be better than more slowly mobilising at around one day after a stroke.

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Why was this study needed?

Stroke is the fourth largest cause of death in the UK and the largest cause of complex disability. Each year in England, approximately 110,000 people have a first or recurrent stroke. More than 900,000 people in England are living with the effects of stroke, with half of these being dependent on other people for help with everyday activities.

Early mobilisation – including sitting out-of-bed, standing and walking – is thought to improve outcomes after a stroke. However, definitions of what “early mobilisation” interventions involve vary. Evidence for the effectiveness of early mobilisation is not strong. A 2014 meta-analysis found no significant differences between mobilisation before 24 hours and later mobilisation. The current study was then already underway to determine if earlier and more intensive mobilisation would lead to better outcomes and reduced mortality compared with usual care, and has more than five times the number of participants than the previous small trials combined.

What did this study do?

AVERT was a randomised controlled trial carried out in 56 stroke units across five countries, mainly Australia and the UK. It included 2,104 adults who had been admitted within 24 hours of the onset of their first or recurrent stroke and who could participate in mobilisation. Treatment given to break up any blood clots, called recombinant tissue plasminogen activator (rtPA), was allowed. The study compared an early mobilisation protocol, comprising more frequent (over 30 min per day) out-of-bed activity started on average 18 hours of stroke onset, with usual care, involving less frequent mobilisation (10 min per day) started on average 22 hours post-stroke. Neither the patients nor those assessing the results knew which group the patients had been assigned to, which reduces potential bias.

What did it find?

  • 46% of the early mobilisation group compared with 50% of the usual care group made a good recovery three months after the stroke (OR 0.73, 95% CI 0.59 to 0.90). This was defined as no or minimal disability (score 0-2 on the 6 point Rankin scale).
  • There was no difference in the time to it took to walk unassisted. In both groups, 50% of people were walking 50 metres unassisted seven days after the stroke and 75% by three months.
  • There were no significant differences in the number of deaths or serious side effects, or outcomes for subgroups based on age, stroke severity, stroke type, whether rtPA treatment was given, time to first mobilisation or recruitment region.

What does current guidance say on this issue?

2014 NICE guidance on the early management of stroke recommends that people with acute stroke are sat up and mobilised, “when their clinical condition permits” but does not specify a timeframe, precise mode or duration of mobilisation. NICE recommended that further research be carried out into the safety and effectiveness of early mobilisation versus usual care.

What are the implications?

This trial indicates that early mobilisation four hours earlier and for an average of 30 minutes per day may lead to slightly greater disability than starting more slowly at a median of 22 hours. This potentially has implications for practice because 2014 clinical guidance recommends early mobilisation.

The AVERT trial does not lend any support for starting intensive mobilisation much before 24 hours after a stroke, but mobilising at around that time seems safe in that outcomes in both arms of this trial compare favourably with previous audit results. Few people in this trial started mobilising after 48 hours so no conclusions can be drawn about resting for more than a day after a stroke.

Citation

The AVERT Trial Collaboration Group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Apr 16 [Epub ahead of print].

This project was funded by the National Institute for Health Research HTA Programme (project number 12/01/16).

Bibliography

Lynch E, Hillier S, Cadilhac D. When should physical rehabilitation commence after stroke: a systematic review. Int J Stroke. 2014 Jun;9(4):468-78

NICE. Stroke: Diagnosis and initial management of acute stroke and transient ischaemic attack (TIA). National Institute for Health and Care Excellence: London; 2014.

Stroke Association. State of the nation: Stroke statistics. Stroke Association: London; 2015.

Why was this study needed?

Stroke is the fourth largest cause of death in the UK and the largest cause of complex disability. Each year in England, approximately 110,000 people have a first or recurrent stroke. More than 900,000 people in England are living with the effects of stroke, with half of these being dependent on other people for help with everyday activities.

Early mobilisation – including sitting out-of-bed, standing and walking – is thought to improve outcomes after a stroke. However, definitions of what “early mobilisation” interventions involve vary. Evidence for the effectiveness of early mobilisation is not strong. A 2014 meta-analysis found no significant differences between mobilisation before 24 hours and later mobilisation. The current study was then already underway to determine if earlier and more intensive mobilisation would lead to better outcomes and reduced mortality compared with usual care, and has more than five times the number of participants than the previous small trials combined.

What did this study do?

AVERT was a randomised controlled trial carried out in 56 stroke units across five countries, mainly Australia and the UK. It included 2,104 adults who had been admitted within 24 hours of the onset of their first or recurrent stroke and who could participate in mobilisation. Treatment given to break up any blood clots, called recombinant tissue plasminogen activator (rtPA), was allowed. The study compared an early mobilisation protocol, comprising more frequent (over 30 min per day) out-of-bed activity started on average 18 hours of stroke onset, with usual care, involving less frequent mobilisation (10 min per day) started on average 22 hours post-stroke. Neither the patients nor those assessing the results knew which group the patients had been assigned to, which reduces potential bias.

What did it find?

  • 46% of the early mobilisation group compared with 50% of the usual care group made a good recovery three months after the stroke (OR 0.73, 95% CI 0.59 to 0.90). This was defined as no or minimal disability (score 0-2 on the 6 point Rankin scale).
  • There was no difference in the time to it took to walk unassisted. In both groups, 50% of people were walking 50 metres unassisted seven days after the stroke and 75% by three months.
  • There were no significant differences in the number of deaths or serious side effects, or outcomes for subgroups based on age, stroke severity, stroke type, whether rtPA treatment was given, time to first mobilisation or recruitment region.

What does current guidance say on this issue?

2014 NICE guidance on the early management of stroke recommends that people with acute stroke are sat up and mobilised, “when their clinical condition permits” but does not specify a timeframe, precise mode or duration of mobilisation. NICE recommended that further research be carried out into the safety and effectiveness of early mobilisation versus usual care.

What are the implications?

This trial indicates that early mobilisation four hours earlier and for an average of 30 minutes per day may lead to slightly greater disability than starting more slowly at a median of 22 hours. This potentially has implications for practice because 2014 clinical guidance recommends early mobilisation.

The AVERT trial does not lend any support for starting intensive mobilisation much before 24 hours after a stroke, but mobilising at around that time seems safe in that outcomes in both arms of this trial compare favourably with previous audit results. Few people in this trial started mobilising after 48 hours so no conclusions can be drawn about resting for more than a day after a stroke.

Citation

The AVERT Trial Collaboration Group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Apr 16 [Epub ahead of print].

This project was funded by the National Institute for Health Research HTA Programme (project number 12/01/16).

Bibliography

Lynch E, Hillier S, Cadilhac D. When should physical rehabilitation commence after stroke: a systematic review. Int J Stroke. 2014 Jun;9(4):468-78

NICE. Stroke: Diagnosis and initial management of acute stroke and transient ischaemic attack (TIA). National Institute for Health and Care Excellence: London; 2014.

Stroke Association. State of the nation: Stroke statistics. Stroke Association: London; 2015.

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Published on 22 April 2015

Bernhardt, J.,Langhorne, P.,Lindley, R. I.,Thrift, A. G.,Ellery, F.,Collier, J.,Churilov, L.,Moodie, M.,Dewey, H.,Donnan, G.

Lancet Volume 386 , 2015

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 0-2. 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 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (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%] vs n=525 [50%]; adjusted odds ratio [OR] 0.73, 95% CI 0.59-0.90; 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 0.93-1.93, 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.

This trial used a modified Rankin Scale to measure level of disability in people after stroke. The scale was modified to make it more applicable to people who have experienced a stroke or other cause of neurological disability. The scale categories are as follows:

  • 0-2: minimum disability
  • 3-5: moderate or severe disability
  • 6: death

Commentary

AVERT was a landmark study, demonstrating that rehabilitation trials can be conducted to the same rigour and scale as trials of drug therapies. It provides an evidence base to rehabilitation policy, where before we had only expert opinion.

The trial data suggests a policy of early and intensive mobilisation should not be universally recommended, particularly for those with intracerebral haemorrhage or severe strokes. It may be premature to change national guidelines on mobilisation while we await further, detailed analyses. However, clinicians may choose to make changes to their own practices on an individual patient level based on the evidence presented.

Jon Barrick, Chief Executive of Stroke Association