Journal of Clinical Trials
Open Access

Abstract

Effect of Early Exercise Engagement on Cardiovascular and Cerebrovascular Health in Stroke and TIA Patients: Clinical Trial Protocol

James Faulkner, Jeremy Lanford, Danielle Lambrick, Lee Stoner, Brandon Woolley, Terry O’Donnell, Lai-kin Wong and Yu-Chieh Tzeng

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.