Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high, reflecting the urgent need for novel therapies to enhance outcomes. Common complications include infection, cardiovascular events, falls and venous thromboembolism. Remote Ischaemic Conditioning (RIC) is a treatment whereby a blood pressure cuff is inflated around an arm or leg to above systolic pressures to occlude blood flow to the limb for short periods of time, that do not result in harm, but trigger innate mechanisms that reduce inflammation, improve organ blood flow and improve bone healing. These may be beneficial effects after hip fracture.
Methods This is a single centre, feasibility study; the participants will receive RIC daily for 40 minutes for 10 days during their inpatient stay. Outcome measures relating primarily to safety, tolerability and feasibility will be collected along with compliance with the intervention. Study feasibility will be determined by success criteria based on recruitment, outcome measure assessment compliance with intervention and follow up.
Secondary outcomes including inpatient mortality, inpatient complications, length of inpatient stay, blood pressure, serum inflammatory and stress markers and functional recovery will also be collected at discharge and 3 month follow up.
Results Data collected on safety, tolerability, and feasibility will be presented descriptively and simple analysis of variance will be undertaken on quantitative data such as blood pressure and serum inflammatory and stress markers between baseline and follow up time points. The study will hopefully establish whether this therapy is feasible to deliver after acute hip fracture.
Adults (aged > 18 years)
Participant has had a hip fracture identified on X-ray or computed tomography (CT) scan.
Qualifying hip fracture has not occurred more than 7 days prior to enrollment.
Able to give written informed consent.
History or presence of significant peripheral vascular disease in the limb conditioned.
History or presence of complex neuropathic pains or peripheral neuropathy in the limb conditioned.
Presence of lymphoedema in the limb conditioned.
Presence of skin ulceration to the limb conditioned.
Single group
Remote Ischaemic Conditioning
Procedure/SurgeryBrief episodes of reversible ischaemia are applied to a particular tissue or organ 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. In this study, the treatment will be delivered on the upper arm or unaffected leg.
Safety of RIC in patients who have suffered hip fracture
This outcome measure will be assessed by review of their clinical data at baseline and daily intervention visits, review of the side effects during the intervention period and reporting of any AE's throughout the study period. Safety will be defined as; * No reported SAE's directly related to RIC * Unexpected adverse events in less than 1/3 participants
Participant acceptability - Symptom severity scores
This outcome measure will be assessed by review of side effects / adverse events reported to researchers throughout the intervention period. Acceptability will be defined as; ● Symptom severity scores of mild or moderate in less than 1/3 of participants able to report symptoms (based on Likert Scale 1-5; 1 representing no issues; 5 representing severe symptoms)
Participant acceptability - Semi-structured interviews
This outcome measure will be reviewed through the qualitative interviews undertaken in a subset of participants. Acceptability will be defined as; ● Reports from semi-structured interviews
Compliance to the intervention
This outcome measure will be assessed using the patient monitoring diaries. Compliance will be defined as; ● More than 80% of intended RIC cycles completed
Clinical Outcomes - Inpatient Mortality
Explore clinical outcomes including Inpatient mortality (n,%)
Clinical Outcomes - Inpatient Length of Stay
Explore clinical outcomes including Inpatient length of stay (days)
Clinical Outcomes - Rate of inpatient complications
Explore clinical outcomes including Rate of inpatient complications: vascular (venous thromboembolism, acute coronary syndromes, stroke, Transient Ischemic Attack (TIA), systemic embolism, heart failure), infections, renal (acute kidney injury - RIFLE), anaemia (Hb drop ≥ 2g/L) (%)
Clinical Outcomes - Blood pressure
Explore clinical outcomes including Blood pressure (mmHg)
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