The ExStroke Pilot Trial: Rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

Abstract

Introduction A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. Methods Patients with ischemic stroke above 39 years were randomized to intervention or control group. The intervention group will, over a 2-year period, receive information on and verbal instruction to exercise by a physiotherapist or a physician. The control group will receive the department's usual care. Physical activity is assessed in both groups seven times during follow-up using the Physical Activity Scale for the Elderly (PASE) questionnaire, which quantifies the amount of physical activity done in the last seven days prior to interview. The PASE score constitutes the primary outcome measure. The secondary outcome is the time from randomization to recurrent stroke, myocardial infarction, or all-cause mortality. Further outcome measures include: time from randomization to recurrent stroke, myocardial infarction, and vascular death; recurrent stroke; modified Rankin Scale; quality of life; occurrence of falls and fractures. Trial status From 9 centers in 4 countries, 314 patients were included and follow-up is ongoing. Mean age and standard deviation (SD) of the study participants was 68.4 (11.9) years and 56.4% were male. Mean (SD) PASE score was 84.1 (55.9) and median (interquartile range) Scandinavian Stroke Scale score was 54 (51–58).