Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a Pilot, Double-blind, Randomised, Placebo Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Number of participants reporting RIC associated discomfort on a likert scale
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of participants reporting RIC associated discomfort on a likert scale
Time Frame: 6 weeks
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.
Number of Participants With Incidence of Treatment-Emergent Adverse Events.
Time Frame: 6 weeks
Safety of a 6-week RIC intervention will be assessed by measuring the Number of Participants With Adverse Events That Are Related to Treatment.
% of RIC cycles completed
Time Frame: 6 weeks
Compliance to RIC will be defined as achievement of 80% of intended RIC cycles. This will be assessed by a mobile compliance application.
number of participants recruited within the first 2 months
Time Frame: 1 year
Study recruitment will be deemed feasible if four participants are recruited within the first 2 months.
Percentage of assessments completed
Time Frame: 1 year
Study assessments will be deemed feasible if \>80% of assessments are completed.
Secondary Outcomes
- Number of participants with abnormal changes from baseline in full blood count(6 weeks)
- Therapy Time in minutes(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 distance walked as measured by the six minute walk test (6MWT)(6 weeks)
- Mean change from baseline in concentration of C-reactive protein (CRP)(6 weeks)
- Mean change from baseline in functional Independence as measured by the Barthel Index(6 weeks)
- Changes from baseline in levels of creatine as measured by spectroscopy(6 weeks)
- Mean change from baseline in erythrocyte sedimentation rate (ESR)(6 weeks)
- Mean change from baseline in activity Energy Expenditure measure in kCal(6 weeks)
- Mean change from baseline in minutes of activity per day measured by the Global Physical Activity Questionnaire (GPAQ)(6 weeks)
- Mean change from baseline in peak oxygen consumption (VO2 max, ml/Kg/min)(6 weeks)
- Mean change from baseline in participant scores on the modified rankin score (MRS)(6 weeks)
- Mean change from baseline in health related quality of life as measured by participant scores on EQ5D questionnaire.(6 weeks)
- Mean change from baseline in heat shock protein levels(6 weeks)
- Changes from baseline in Cerebral Perfusion (ml/min)(6 weeks)
- Mean change from baseline in participant scores on the multidimensional fatigue inventory (MFI)(6 weeks)
- Mean change from baseline in depression as measured by participant scores on PHQ9(6 weeks)
- Mean change from baseline in anxiety as measured by participant scores on the GAD7(6 weeks)
- Mean change from baseline in concentration of GLP-1 in blood sample(6 weeks)
- Changes from baseline in levels of lactate as measured by spectroscopy(6 weeks)
- Mean change from baseline in cognitive dysfunction as measured by participant scores on MOCA(6 weeks)
- Changes from baseline in levels of N-acetyl aspartate as measured by spectroscopy(6 weeks)