NCT03794947Completed
Remote Ischaemic Conditioning for Fatigue After Stroke
Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a Pilot, Double-blind, Randomised, Placebo Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
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 fatigue, and study feasibility. A minimum of 34 patients who have suffered an ischeamic or haemorrhagic stroke and who suffer from fatigue, will be recruited and randomised to receive a 6-week programme of either RIC or a sham intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 29 Nov 2018
- Start date
- 4 Feb 2019
- Primary completion date
- 14 Nov 2023
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Diseases
- Stroke
- NCT number
- NCT03794947
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 4 Feb 2019 to the primary completion date, 14 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History or presence of significant peripheral vascular disease in the upper limbs.
- 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 deep vein thrombosis, pulmonary embolism or pulmonary infection.
Other
- 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.
- Acute aortic dissection, myocarditis, or pericarditis.
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.