Clinical trial NCT03968068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2019-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Incidences of RICTreatment-Emergent Adverse Events.
timeFrame: 48 hours
measure: Number of Incidences of Exercise Treatment-Emergent Adverse Events.
timeFrame: 48 hours
measure: Number of participants reporting RIC associated discomfort on a likert scale
timeFrame: 48 hours
measure: Number of participants reporting exercise associated discomfort on a likert scale
timeFrame: 48 hours
measure: % of RIC intervention completed and recorded
timeFrame: 48 hours
measure: % of exercise intervention completed and recorded
timeFrame: 48 hours
Secondary outcomes:
measure: Change from baseline in cerebral blood flow velocity.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS FT
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Ali Ali, MD
role: PRINCIPAL_INVESTIGATOR
References: