ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial

Given the lack of research into encouraging exercise after stroke, we
welcome Boysen and colleagues research paper (Boysen, et al., 2009). In
her editorial Gillian Mead (Mead, 2009) set the context and posed some of
the challenges for research in this area. However we feel opportunities
have been missed in conducting this pilot trial and therefore
inappropriate conclusions may been drawn.

We were surprised that the authors do not seem to have adopted
published guidelines on the topic of developing and evaluating complex
interventions. If this framework had been adopted, (Campbell, et al.,
2000; Craig, et al., 2008) we might have expected modelling of active
ingredients of the intervention (given that it was a pilot study) and
testing the feasibility of the approach. In our own work, we have
modelled, tested and shown success with a physical consultation approach
for the general population (Baker, et al., 2008), for people with Type 2
Diabetes (A. Kirk, Mutrie, MacIntyre, & Fisher, 2003), and in cardiac
rehabilitation (Hughes, Mutrie, & MacIntyre, 2007). Our approach to
consultation is theory driven (Kahn, et al., 2002) and person centred
(Rollnick, et al., 2005), but does not need to be any more intensive or
take more time (~30 minutes) than delivery of repeated verbal
instructions. Each consultation takes a guided approach, asks about past
and current physical activity levels, engages the patient in thinking
about their pros and cons for a change in activity levels, sets realistic
graded incremental goals, encourages the individual to consider social
support for their behaviour change, considers how to enhance self
efficacy for physical activity, and suggests relapse prevention
techniques (A Kirk & Mutrie, 2007).

Our reading of this study suggests a short term beneficial trend in
PASE scores (Table 2, Figure 2), but statistical significance was not
achieved. The study was powered to detect a minimal relevant mean
difference of 20 PASE points between the intervention and the control
groups, corresponding to an increase of physical activity such as walking
outside the home for two hours three times a week. It seems surprising
this was considered a ‘realistic goal’ given this level of activity is
more than twice the recommendation for the general population (5 x 30
minutes per week)(Department of Health, 2004). We know 71% of the adult
populations in EU member states do not achieve this recommendation
(Sjöström, Oja, Hagströmer, Smith, & Bauman, 2006). Additionally Mead
(Mead, 2009) highlights levels of physical activity in community dwelling
adults with mild motor impairment after stroke are about half those of
healthy older people.

Boysen et al concluded more intense strategies seem to be needed to
promote physical activity after ischaemic stroke. We would advise the
adoption of a person centred consultation approach, based on a theoretical
framework and working towards the current physical activity for health
recommendations before more intensive strategies are adopted. Alternative
outcome measures could also be considered, for example an objective
activity assessment using an activity monitor to assess small increases in
activities of daily living not detected by the PASE. Appropriate
conclusions on the effectiveness of counselling for physical activity in
this patient group could then be made.

Baker, G., Gray, S., Wright, A., Fitzsimons, C., Nimmo, M., Lowry,
R., et al. (2008). The effect of a pedometer-based community walking
intervention "Walking for Wellbeing in the West" on physical activity
levels and health outcomes: a 12-week randomized controlled trial.
International Journal of Behavioral Nutrition and Physical Activity, 5(1),
44.

Boysen, G., Krarup, L.-H., Zeng, X., Oskedra, A., Korv, J., Andersen,
G., et al. (2009). ExStroke Pilot Trial of the effect of repeated
instructions to improve physical activity after ischaemic stroke: a
multinational randomised controlled clinical trial. BMJ, 339(jul20_3),
b2810-.

Campbell, M., Fitzpatrick, R., Haines, A., Kinmonth, A. L.,
Sandercock, P., Spiegelhalter, D., et al. (2000). Framework for design and
evaluation of complex interventions to improve health. BMJ, 321(7262), 694
-696.

Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., &
Petticrew, M. (2008). Developing and evaluating complex interventions: new
guidance.

Department of Health (2004). At least 5 a week: Evidence of the
impact of physical activity and its relationship to health. A report from
the Chief Medical Officer. Department of Health: London.

Hughes, A. R., Mutrie, N., & MacIntyre, P. D. (2007). Effect of
an exercise consultation on maintenance of physical activity after
completion of phase III exercise-based cardiac rehabilitation. European
Journal of Cardiovascular Prevention & Rehabilitation, 14(1), 114 -
121.

Kahn, E. B., Ramsey, L. T., Brownson, R. C., Heath, G. W., Howze, E.
H., Powell, K. E., et al. (2002). The effectiveness of interventions to
increase physical activity. A systematic review. American Journal of
Preventive Medicine, 22, 73 - 107.

Kirk, A., & Mutrie, N. (2007). Physical activity consultation for
people with Type 2 diabetes. Evidence and guidelines. Diabetes Care, 26,
1186-1192.

Kirk, A., Mutrie, N., MacIntyre, P., & Fisher, M. (2003).
Increasing physical activity in people with type 2 diabetes. Diabetes
Care, 26, 1186 - 1192.

Mead, G. E. (2009). Exercise after stroke. British Medical Journal,
doi:10.1136/bmj.b2795.

Rollnick, S., Butler, C. C., McCambridge, J., Kinnersley, P., Elwyn,
G., & Resnicow, K. (2005). Consultations about changing behaviour.
BMJ, 331, 961 - 963.

Sjöström, M., Oja, P., Hagströmer, M., Smith, B. J., & Bauman, A.
(2006). Health-enhancing physical activity across European Union
countries: The Eurobarometer study Journal of Public Health, 14(5), 291-
300.

Competing interests:
None declared