MedPath

Remote Ischaemic Conditioning for Fatigue After Stroke

Not Applicable
Completed
Conditions
Stroke, Ischemic
Stroke Hemorrhagic
Fatigue
Registration Number
NCT03794947
Lead Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
19
Inclusion Criteria

Inclusion Criteria:<br><br> - Adults (aged > 18 years) who have had an ischaemic or haemorrhagic stroke at least 6<br> weeks prior.<br><br> - Symptoms of debilitating fatigue for at least 4 weeks (fatigues severity score of 28<br> or more).<br><br>Exclusion Criteria:<br><br> - History or presence of significant peripheral vascular disease in the upper limbs.<br><br> - History or presence of complex neuropathic pains or peripheral neuropathy in the<br> arms.<br><br> - Presence of lymphoedema in the arms.<br><br> - Presence of skin ulceration to the arms.<br><br> - Hospitalisation for cardiovascular or cerebrovascular disease within the last 4<br> weeks.<br><br> - Uncontrolled arrhythmia, hypertension, diabetes or angina.<br><br> - Third degree heart block or progressive heart failure.<br><br> - Acute aortic dissection, myocarditis, or pericarditis.<br><br> - Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.<br><br> - Suspected or known dissecting aneurysm.<br><br> - Uncontrolled visual or vestibular disturbance.<br><br> - Known or suspected cause of fatigue e.g. obstructive sleep apnoea (Epworth > 15),<br> depression (PHQ-9 > 14).<br><br> - Modified Rankin Score > 4.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants With Incidence of Treatment-Emergent Adverse Events.;% of RIC cycles completed;Number of participants reporting RIC associated discomfort on a likert scale;number of participants recruited within the first 2 months;Percentage of assessments completed
Secondary Outcome Measures
NameTimeMethod
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