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Exercise and RIC and TCD

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ClinicalTrials.gov Identifier: NCT03968068
Recruitment Status : Unknown
Verified September 2019 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : May 30, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Stroke, Acute Procedure: Exercise Procedure Procedure: Remote Ischaemic Conditioning Not Applicable

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Number of Incidences of RICTreatment-Emergent Adverse Events. [ Time Frame: 48 hours ]
    Safety of the RIC intervention will be assessed by measuring the Number of Adverse Events experienced by participants that are related to the RIC intervention.

  2. Number of Incidences of Exercise Treatment-Emergent Adverse Events. [ Time Frame: 48 hours ]
    Safety of the exercise intervention will be assessed by measuring the Number of Adverse Events experienced by participants that are related to the exercise intervention.

  3. Number of participants reporting RIC associated discomfort on a likert scale [ Time Frame: 48 hours ]
    Reported grade of discomfort associated with RIC will be measured on a likert scale of 0-5, 1 being very uncomfortable to 5 being very comfortable. Acceptance of RIC will be defined as an average score of >3/5 on the likert scale.

  4. Number of participants reporting exercise associated discomfort on a likert scale [ Time Frame: 48 hours ]
    Reported grade of discomfort associated with exercise will be measured on a likert scale of 0-5, 1 being very uncomfortable to 5 being very comfortable. Acceptance of exercise will be defined as an average score of >3/5 on the likert scale.

  5. % of RIC intervention completed and recorded [ Time Frame: 48 hours ]
    Feasibility of RIC will be defined as >80% of the intervention being completed and recorded.

  6. % of exercise intervention completed and recorded [ Time Frame: 48 hours ]
    Feasibility of exercise will be defined as >80% of the intervention being completed and recorded.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (age > 18) patients who have suffered acute ischaemic stroke between 2-7 days previously, or healthy adult (>18 years).
  • Ability to provide written informed consent
  • Ability to mobilise lower body limbs (at least one leg)
  • Ability to comply with study procedures in the opinion of the treating physician.

Exclusion Criteria:

  • Haemorrhagic Stroke
  • Ischaemic stroke < 2 days or >10 days
  • Disability preventing lower extremity cycling
  • New York Heart Failure Classification stage III/IV
  • History of ischaemic stroke
  • Current diagnosis of cancer
  • Resting Blood pressure > 180 / 100 mmHg
  • Clinically unstable
  • History or presence of significant peripheral vascular disease in the upper limbs.
  • History or presence of complex neuropathic pains or peripheral neuropathy in the arms.
  • Presence of lymphoedema in the arms.
  • Presence of skin ulceration to the arms.
  • Uncontrolled arrhythmia, hypertension, diabetes or angina.
  • Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968068


Contacts
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Contact: Alisha Patel, MSc 0114 276 5394 alisha.patel@sth.nhs.uk

Locations
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United Kingdom
Sheffield Teaching Hospitals NHS FT Recruiting
Sheffield, United Kingdom
Contact: Ali Ali, MD         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
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Principal Investigator: Ali Ali, MD Sheffield Teaching Hospitals NHS Foundation Trust
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03968068    
Other Study ID Numbers: STH20750
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases