Remote Ischaemic Conditioning for Fatigue After Stroke

Last updated: August 20, 2024
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Overall Status: Completed

Phase

N/A

Condition

Cerebral Ischemia

Blood Clots

Thrombosis

Treatment

Sham Intervention

Remote Ischaemic Conditioning

Clinical Study ID

NCT03794947
STH19508
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (aged > 18 years) who have had an ischaemic or haemorrhagic stroke at least 6weeks prior.

  • Symptoms of debilitating fatigue for at least 4 weeks (fatigues severity score of 28or more).

Exclusion

Exclusion Criteria:

  • History or presence of significant peripheral vascular disease in the upper limbs.

  • History or presence of complex neuropathic pains or peripheral neuropathy in thearms.

  • Presence of lymphoedema in the arms.

  • Presence of skin ulceration to the arms.

  • Hospitalisation for cardiovascular or cerebrovascular disease within the last 4weeks.

  • 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.

Study Design

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: Sham Intervention
Phase:
Study Start date:
February 04, 2019
Estimated Completion Date:
November 14, 2023

Study 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.

Connect with a study center

  • Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

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