Abstract
Objective: This study will investigate the efficacy of implementing either an early or delayed exercise intervention on cardiovascular and cerebrovascular health for newly diagnosed stroke and high-risk Transient Ischaemic Attack (TIA) patients. Methods: The study is a randomized, parallel group clinical trial. Patients will be recruited from a local hospital based on inclusion/exclusion criteria. Participants will attend a baseline assessment within 2 to 7 days of stroke or TIA diagnosis. The assessment will consist of a series of cardiovascular and cerebrovascular primary and secondary outcome measures which will be assessed during some or all of the following; at rest, during a postural challenge, during a cerebral autoregulation and CO2 reactivity test and/or during an incremental exercise test. Primary outcome measures include vascular risk factors (resting blood pressure, blood lipid profile etc), arterial stiffness of the carotid artery and blood velocity of the carotid artery and middle cerebral artery. Secondary outcome measures include cerebral autoregulation, physical fitness, and central and peripheral blood pressure. Following the baseline assessment, participants will be randomized to either a 12-week exercise programme which will commence within 7 days (early) or 28 days (delayed) of stroke/TIA diagnosis, or to a usual care control group. The exercise programme will consist of twice weekly, 60 minute, prescribed aerobic exercise sessions, and one 30 minute home-based aerobic exercise session. An identical assessment will be implemented post-intervention. Given the practical implications of the study, the clinical significance of early or delayed exercise engagement will be assessed for each outcome variable. Conclusion: This study will advance our knowledge concerning the timing, importance and viability of exercise as a secondary prevention strategy for improving health outcomes for stroke and TIA patients. The study will provide much needed objective data for stroke and high-risk TIA patients concerning the physiological effect of regular exercise participation.
Highlights
Stroke is a leading cause of death in the Western World, and is a prominent cause of chronic disability, causing significant physical and cognitive impairments [1]
Many people who present with a Transient Ischaemic Attack (TIA) have predisposing modifiable vascular risk factors such as hypertension, tobacco use, diabetes mellitus, hyperlipidaemia, obesity and physical inactivity [4]
The primary preventative strategy used to reduce the risk of a recurrent stroke or TIA includes the prescription of anti-platelet- or anti-coagulation agents, as well as blood pressure- and lipid lowering treatments [5]
Summary
This is a dual-centre, randomized, parallel group clinical trial. This study is designed pragmatically to ensure that it reflects a potential real life application of an exercise intervention for stroke and high risk TIA patients. Participants and the health and exercise practitioners will be aware of the allocated treatment condition, outcome assessors and data analysts will be kept blinded to the allocation For those participants randomized to the ‘delay’ exercise group, an additional assessment session will be conducted prior to the commencement of their exercise programme. These measures include stiffness and blood velocity of the carotid artery, blood velocity of the middle cerebral artery, central and peripheral blood pressures and an Electrocardiogram (ECG) These cardiovascular and cerebrovascular outcome measures will be completed during all or some of the following; 20 minutes supine rest, during a postural challenge, a cerebral autoregulation and CO2 reactivity test and/or an exercise test (Figure 2). Exercise practitioners will ensure that participants do not exercise above 95% of their age-predicted maximal heart rate, or beyond intensities defined by their cardiac risk as identified from the baseline ECG assessment. Participants will be asked to complete an additional homebased exercise session, consisting of 30 minutes walking
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