Remote Ischaemic Conditioning for Fatigue After Stroke

NCT03794947 | Completed

• 1 other identifier: STH19508
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Fatigue

Keywords

remote ischaemic conditioning

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Incidence of Treatment-Emergent Adverse Events.

  Safety of a 6-week RIC intervention will be assessed by measuring the Number of Participants With Adverse Events That Are Related to Treatment.

  6 weeks

• % of RIC cycles completed

  Compliance to RIC will be defined as achievement of 80% of intended RIC cycles. This will be assessed by a mobile compliance application.

  6 weeks

• Number of participants reporting RIC associated discomfort on a likert scale

  Reported grade of discomfort associated with RIC will be measured on a likert scale of 0-5, 0 being no discomfort 5 being great discomfort. Acceptance of RIC will be defined as less than 1/3 of participants reporting moderate or greater discomfort (3-4 on scale) and will be supported by qualitative interviews and diary recordings.

  6 weeks

• number of participants recruited within the first 2 months

  Study recruitment will be deemed feasible if four participants are recruited within the first 2 months.

  1 year

• Percentage of assessments completed

  Study assessments will be deemed feasible if \>80% of assessments are completed.

  1 year

Secondary Outcomes (23)

• Number of participants with abnormal changes from baseline in full blood count

  6 weeks

• number of participants with abnormal changes from baseline in urea and electrolyte (U&E) concentration

  6 weeks

• number of participants with abnormal changes from baseline in liver function

  6 weeks

• Mean change from baseline in concentration of C-reactive protein (CRP)

  6 weeks

• Mean change from baseline in erythrocyte sedimentation rate (ESR)

  6 weeks

Study Arms (2)

Remote Ischaemic Conditioning

EXPERIMENTAL

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.

Procedure: Remote Ischaemic Conditioning

Sham Intervention

SHAM COMPARATOR

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.

Procedure: Sham Intervention

Interventions

Remote Ischaemic Conditioning PROCEDURE

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

Remote Ischaemic Conditioning

Sham Intervention PROCEDURE

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

Sham Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Fatigue

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Ali

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 7, 2019
• Study Start: February 4, 2019
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

GB (1)