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Effect of early exercise engagement on cardiovascular and cerebrovascular health in stroke and TIA patients: clinical trial protocol

Effect of early exercise engagement on cardiovascular and cerebrovascular health in stroke and TIA patients: clinical trial protocol
Effect of early exercise engagement on cardiovascular and cerebrovascular health in stroke and TIA patients: clinical trial protocol
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.
Faulkner, James
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Lanford, Jeremy
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Lambrick, Danielle
1deafa4b-acf3-4eff-83c9-f8274e47e993
Stoner, Lee
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Woolle, Brandon
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O’Donnell, Terry
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Wong, Lai-kin
256889b1-1e6f-4780-932b-ce32ca240ac5
Tzeng, Yu-Chieh
554e9a72-60af-462e-b53b-58a0e58d739c
Faulkner, James
1bedc0f0-8fa4-4bf3-8e31-abd084b0c148
Lanford, Jeremy
476dc023-8a28-48ee-99c6-38e080195c82
Lambrick, Danielle
1deafa4b-acf3-4eff-83c9-f8274e47e993
Stoner, Lee
0f9dd581-205f-490d-8879-7ba7cfa51450
Woolle, Brandon
77c9c714-ed6f-4149-8d0a-45231b9cd2b6
O’Donnell, Terry
7eb51860-2179-46a1-8c60-da6bca66b670
Wong, Lai-kin
256889b1-1e6f-4780-932b-ce32ca240ac5
Tzeng, Yu-Chieh
554e9a72-60af-462e-b53b-58a0e58d739c

Faulkner, James, Lanford, Jeremy, Lambrick, Danielle, Stoner, Lee, Woolle, Brandon, O’Donnell, Terry, Wong, Lai-kin and Tzeng, Yu-Chieh (2014) Effect of early exercise engagement on cardiovascular and cerebrovascular health in stroke and TIA patients: clinical trial protocol. Journal of Clinical Trials, 4 (1). (doi:10.4172/2167-0870.1000154).

Record type: Article

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.

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Accepted/In Press date: 22 January 2014
Published date: 24 January 2014
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 382257
URI: http://eprints.soton.ac.uk/id/eprint/382257
PURE UUID: eb633938-229a-4a66-a7be-4098a9f54c2e
ORCID for Danielle Lambrick: ORCID iD orcid.org/0000-0002-0325-6015

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Date deposited: 01 Oct 2015 10:19
Last modified: 15 Mar 2024 03:51

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Contributors

Author: James Faulkner
Author: Jeremy Lanford
Author: Lee Stoner
Author: Brandon Woolle
Author: Terry O’Donnell
Author: Lai-kin Wong
Author: Yu-Chieh Tzeng

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