Status:
COMPLETED
Remote Ischaemic Conditioning for Fatigue After Stroke
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Stroke, Ischemic
Stroke Hemorrhagic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot randomised control trial to assess the safety, compliance, and acceptability of delivering a 6-week programme of remote ischaemic conditioning (RIC) to stroke patients suffering with f...
Detailed Description
Up to 75% of stroke patients suffer from fatigue, the effect of which can be physical, cognitive or emotional, and presents a large barrier to progressing rehabilitation. Remote ischaemic conditionin...
Eligibility Criteria
Inclusion
- Adults (aged \> 18 years) who have had an ischaemic or haemorrhagic stroke at least 6 weeks prior.
- Symptoms of debilitating fatigue for at least 4 weeks (fatigues severity score of 28 or more).
Exclusion
- 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.
- Hospitalisation for cardiovascular or cerebrovascular disease within the last 4 weeks.
- Uncontrolled arrhythmia, hypertension, diabetes or angina.
- Third degree heart block or progressive heart failure.
- Acute aortic dissection, myocarditis, or pericarditis.
- Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.
- Suspected or known dissecting aneurysm.
- Uncontrolled visual or vestibular disturbance.
- Known or suspected cause of fatigue e.g. obstructive sleep apnoea (Epworth \> 15), depression (PHQ-9 \> 14).
- Modified Rankin Score \> 4.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03794947
Start Date
February 4 2019
End Date
November 14 2023
Last Update
August 21 2024
Active Locations (1)
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1
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF