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Exercise and RIC and TCD

Primary Purpose

Stroke, Acute

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Procedure
Remote Ischaemic Conditioning
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sheffield Teaching Hospitals NHS FTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise

Remote Ischaemic Conditioning

Arm Description

Outcomes

Primary Outcome Measures

Number of Incidences of RICTreatment-Emergent Adverse Events.
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.
Number of Incidences of Exercise Treatment-Emergent Adverse Events.
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.
Number of participants reporting RIC associated discomfort on a likert scale
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.
Number of participants reporting exercise associated discomfort on a likert scale
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.
% of RIC intervention completed and recorded
Feasibility of RIC will be defined as >80% of the intervention being completed and recorded.
% of exercise intervention completed and recorded
Feasibility of exercise will be defined as >80% of the intervention being completed and recorded.

Secondary Outcome Measures

Change from baseline in cerebral blood flow velocity.
Cerebral blood flow velocity will be measured using Transcranial Doppler (TCD).

Full Information

First Posted
May 28, 2019
Last Updated
September 10, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT03968068
Brief Title
Exercise and RIC and TCD
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Remote Ischaemic Conditioning
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Exercise Procedure
Intervention Description
Patients will undergo 30 minutes of light-moderate intensity leg cycling, using the Letto-2 (Motomed, UK) in the semi-supine position.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischaemic Conditioning
Intervention Description
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 Measure Information:
Title
Number of Incidences of RICTreatment-Emergent Adverse Events.
Description
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.
Time Frame
48 hours
Title
Number of Incidences of Exercise Treatment-Emergent Adverse Events.
Description
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.
Time Frame
48 hours
Title
Number of participants reporting RIC associated discomfort on a likert scale
Description
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.
Time Frame
48 hours
Title
Number of participants reporting exercise associated discomfort on a likert scale
Description
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.
Time Frame
48 hours
Title
% of RIC intervention completed and recorded
Description
Feasibility of RIC will be defined as >80% of the intervention being completed and recorded.
Time Frame
48 hours
Title
% of exercise intervention completed and recorded
Description
Feasibility of exercise will be defined as >80% of the intervention being completed and recorded.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Change from baseline in cerebral blood flow velocity.
Description
Cerebral blood flow velocity will be measured using Transcranial Doppler (TCD).
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisha Patel, MSc
Phone
0114 276 5394
Email
alisha.patel@sth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ali, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS FT
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ali, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Exercise and RIC and TCD

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