The first week after a stroke is a particularly important time, as improving blood flow may limit secondary ischaemic damage to the brain and help reduce the overall burden neurological injury and future disability.
Small studies in patients with stroke have shown that moderate aerobic exercise increases blood flow to the brain, however, no studies have evaluated the safety of aerobic exercise within the first week after stroke, nor whether it results in changes to cerebral blood flow.
Remote ischaemic conditioning (RIC) is when ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. These changes often result in improved blood supply to various areas of the body. The use of RIC in the acute period after stroke is currently being investigated in a number of large randomised controlled trials e.g. RECAST, RESIST, however, our understanding of how RIC actually works is incomplete. Importantly, there is scarce data on the acute effects of RIC on cerebral blood flow (CBF), a potentially pivotal mechanism behind its effects.
We propose an exploratory study to evaluate whether it is feasible, acceptable and safe to undertake low and moderate intensity aerobic exercise or remote ischaemic conditioning (RIC) in patients during the acute period after stroke, and whether either of these interventions result in changes to cerebral blood flow velocity (CBFv) in the major cerebral arteries. We will compare any changes to those in a cohort of healthy volunteers.
Condition or disease | Intervention/treatment | Phase |
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Stroke, Acute | Procedure: Exercise Procedure Procedure: Remote Ischaemic Conditioning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | The Effects of Acute Exercise and Remote Ischaemic Conditioning (RIC) on Cerebral Blood Flow Velocity in Patients With Ischaemic Stroke and Healthy Controls |
Actual Study Start Date : | June 7, 2019 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
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Experimental: Exercise |
Procedure: Exercise Procedure
Patients will undergo 30 minutes of light-moderate intensity leg cycling, using the Letto-2 (Motomed, UK) in the semi-supine position.
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Experimental: Remote Ischaemic Conditioning |
Procedure: Remote Ischaemic Conditioning
Patients will undergo 4 cycles of upper limb RIC using a blood pressure cuff. Each cycle will involve inflating the blood pressure cuff to 200 mmHg for five minutes around the upper arm, followed by a period of relaxation of the cuff for a further 5 minutes. The total RIC treatment time will take 40 minutes.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alisha Patel, MSc | 0114 276 5394 | alisha.patel@sth.nhs.uk |
United Kingdom | |
Sheffield Teaching Hospitals NHS FT | Recruiting |
Sheffield, United Kingdom | |
Contact: Ali Ali, MD |
Principal Investigator: | Ali Ali, MD | Sheffield Teaching Hospitals NHS Foundation Trust |
Tracking Information | |||||
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First Submitted Date ICMJE | May 28, 2019 | ||||
First Posted Date ICMJE | May 30, 2019 | ||||
Last Update Posted Date | September 12, 2019 | ||||
Actual Study Start Date ICMJE | June 7, 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Change from baseline in cerebral blood flow velocity. [ Time Frame: 48 hours ] Cerebral blood flow velocity will be measured using Transcranial Doppler (TCD).
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Exercise and RIC and TCD | ||||
Official Title ICMJE | The Effects of Acute Exercise and Remote Ischaemic Conditioning (RIC) on Cerebral Blood Flow Velocity in Patients With Ischaemic Stroke and Healthy Controls | ||||
Brief Summary |
The first week after a stroke is a particularly important time, as improving blood flow may limit secondary ischaemic damage to the brain and help reduce the overall burden neurological injury and future disability. Small studies in patients with stroke have shown that moderate aerobic exercise increases blood flow to the brain, however, no studies have evaluated the safety of aerobic exercise within the first week after stroke, nor whether it results in changes to cerebral blood flow. Remote ischaemic conditioning (RIC) is when ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. These changes often result in improved blood supply to various areas of the body. The use of RIC in the acute period after stroke is currently being investigated in a number of large randomised controlled trials e.g. RECAST, RESIST, however, our understanding of how RIC actually works is incomplete. Importantly, there is scarce data on the acute effects of RIC on cerebral blood flow (CBF), a potentially pivotal mechanism behind its effects. We propose an exploratory study to evaluate whether it is feasible, acceptable and safe to undertake low and moderate intensity aerobic exercise or remote ischaemic conditioning (RIC) in patients during the acute period after stroke, and whether either of these interventions result in changes to cerebral blood flow velocity (CBFv) in the major cerebral arteries. We will compare any changes to those in a cohort of healthy volunteers. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Stroke, Acute | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
48 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03968068 | ||||
Other Study ID Numbers ICMJE | STH20750 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Study Sponsor ICMJE | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Collaborators ICMJE | University of Sheffield | ||||
Investigators ICMJE |
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PRS Account | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |