Remote Ischaemic Conditioning for Fatigue After Stroke

NCT ID: NCT03794947

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2023-11-14

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remote Ischaemic Conditioning

4 cycles of 5 minutes of upper or lower (depending on tolerability) limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual shygnomanometer applied to the upper arm or leg and activated to go through 4 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg (arm) and 220 mmHg (leg). RIC will be completed 3 times weekly for 4 weeks.

Group Type: EXPERIMENTAL

Remote Ischaemic Conditioning

Intervention Type: PROCEDURE

Induced ischaemia to a limb by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg).

Sham Intervention

4 cycles of 5 minutes of upper or lower (depending on tolerability) limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual shygnomanometer applied to the upper arm or leg and activated to go through 4 such cycles automatically. The arm and leg blood pressure cuffs in the sham intervention will inflate to 20mmHg. Sham will be completed 3 times weekly for 4 weeks.

Group Type: SHAM_COMPARATOR

Sham Intervention

Intervention Type: PROCEDURE

The sham intervention will inflate pressure cuffs to much lower levels for the same number of cycles.

Interventions

Remote Ischaemic Conditioning

Induced ischaemia to a limb by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg).

Intervention Type: PROCEDURE

Sham Intervention

The sham intervention will inflate pressure cuffs to much lower levels for the same number of cycles.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Ali

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STH19508

Identifier Type: -

Identifier Source: org_study_id