Exercise and RIC and TCD

NCT ID: NCT03968068

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-07
• Study Completion Date: 2021-12-31

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise

Group Type: EXPERIMENTAL

Exercise Procedure

Intervention Type: PROCEDURE

Patients will undergo 30 minutes of light-moderate intensity leg cycling, using the Letto-2 (Motomed, UK) in the semi-supine position.

Remote Ischaemic Conditioning

Group Type: EXPERIMENTAL

Remote Ischaemic Conditioning

Intervention Type: PROCEDURE

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.

Interventions

Exercise Procedure

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

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Sheffield Teaching Hospitals NHS FT

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

STH20750

Identifier Type: -

Identifier Source: org_study_id