NCT03794947

Remote Ischaemic Conditioning for Fatigue After Stroke

Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a Pilot, Double-blind, Randomised, Placebo Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 conditioning (RIC) is a procedure whereby 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. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. This may enhance the physical abilities of patients undergoing rehabilitation after stroke, particularly when aiming to improve endurance and fatigue.

Conditions

• Stroke, Ischemic
• Stroke Hemorrhagic
• Fatigue

Interventions

Type	Name	Description
PROCEDURE	Remote Ischaemic Conditioning	Induced ischaemia to a limb by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg).
PROCEDURE	Sham Intervention	The sham intervention will inflate pressure cuffs to much lower levels for the same number of cycles.

Timeline

• Start date: 2019-02-04
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2019-01-07
• Last updated: 2024-08-21

Locations

1 site across 1 country: United Kingdom