Clinical trial NCT03794947: Remote Ischaemic Conditioning for Fatigue After Stroke
Official title: Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a Pilot, Double-blind, Randomised, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Fatigue
Keywords: remote ischaemic conditioning
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Incidence of Treatment-Emergent Adverse Events.
timeFrame: 6 weeks
measure: % of RIC cycles completed
timeFrame: 6 weeks
measure: Number of participants reporting RIC associated discomfort on a likert scale
timeFrame: 6 weeks
measure: number of participants recruited within the first 2 months
timeFrame: 1 year
measure: Percentage of assessments completed
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with abnormal changes from baseline in full blood count
timeFrame: 6 weeks
measure: number of participants with abnormal changes from baseline in urea and electrolyte (U&E) concentration
timeFrame: 6 weeks
measure: number of participants with abnormal changes from baseline in liver function
timeFrame: 6 weeks
measure: Mean change from baseline in concentration of C-reactive protein (CRP)
timeFrame: 6 weeks
measure: Mean change from baseline in erythrocyte sedimentation rate (ESR)
timeFrame: 6 weeks
measure: Therapy Time in minutes
timeFrame: 6 weeks
measure: Mean change from baseline in activity Energy Expenditure measure in kCal
timeFrame: 6 weeks
measure: Mean change from baseline in minutes of activity per day measured by the Global Physical Activity Questionnaire (GPAQ)
timeFrame: 6 weeks
measure: Mean change from baseline in distance walked as measured by the six minute walk test (6MWT)
timeFrame: 6 weeks
measure: Mean change from baseline in peak oxygen consumption (VO2 max, ml/Kg/min)
timeFrame: 6 weeks
measure: Mean change from baseline in participant scores on the multidimensional fatigue inventory (MFI)
timeFrame: 6 weeks
measure: Mean change from baseline in participant scores on the modified rankin score (MRS)
timeFrame: 6 weeks
measure: Mean change from baseline in functional Independence as measured by the Barthel Index
timeFrame: 6 weeks
measure: Mean change from baseline in depression as measured by participant scores on PHQ9
timeFrame: 6 weeks
measure: Mean change from baseline in anxiety as measured by participant scores on the GAD7
timeFrame: 6 weeks
measure: Mean change from baseline in cognitive dysfunction as measured by participant scores on MOCA
timeFrame: 6 weeks
measure: Mean change from baseline in health related quality of life as measured by participant scores on EQ5D questionnaire.
timeFrame: 6 weeks
measure: Mean change from baseline in concentration of GLP-1 in blood sample
timeFrame: 6 weeks
measure: Mean change from baseline in heat shock protein levels
timeFrame: 6 weeks
measure: Changes from baseline in Cerebral Perfusion (ml/min)
timeFrame: 6 weeks
measure: Changes from baseline in levels of N-acetyl aspartate as measured by spectroscopy
timeFrame: 6 weeks
measure: Changes from baseline in levels of creatine as measured by spectroscopy
timeFrame: 6 weeks
measure: Changes from baseline in levels of lactate as measured by spectroscopy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Ali Ali
role: PRINCIPAL_INVESTIGATOR
References: