Title: "Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration (FISCU)"
Funder: Department of Health (England)

Abstract: Chronic venous insufficiency (CVI) is a common condition characterised by hypertension and inadequate blood flow in the veins, usually in the legs. CVI affects 6.6-9.4% of the general population (increasing to 10-21% in adults >50 years), with 1-2% of these individuals developing venous ulceration. Venous ulcers can cause pain, impaired mobility, and reduced quality of life (QoL). Treatment of venous ulcers places a huge financial burden on the National Health Service (£198-£400 million per year). Compression hosiery is currently the most common treatment for venous ulcers. While this leads to high healing rates, improvements aren’t usually sustained. Some patients can also benefit from superficial venous surgery, which when combined with compression hosiery reduces ulceration recurrence. However, ulceration recurrence rates are high (perhaps due to microvascular abnormalities that persist after surgery), many patients are reluctant to undergo surgery (>40%), and surgical and hospitalisation costs are high. Therefore, alternative therapies need to be pursued. Supervised exercise training involving a combination of aerobic and resistance exercises might be useful adjunct to compression hosiery in the prevention and treatment of venous ulcers, via favourable effects on lower-limb muscle function, blood flow and vascular function. Exercise is a low-cost, low-risk, and effective strategy for improving physical and mental health; however, little is currently known about the feasibility and efficacy of supervised exercise training used in combination with compression hosiery in this patient group. We are proposing a feasibility study for a definitive randomised controlled trial of a combined exercise and compression hosiery intervention to improve health outcomes in patients with newly-diagnosed venous ulcers. The main aim is to identify the primary outcome and estimated sample size for the subsequent trial. A secondary aim is to investigate the suitability of our intervention, primarily in terms of compliance, acceptability, and its impact on venous ulceration healing and QoL. This is a single-centre, two-arm, parallel-group, randomised trial. Eighty patients with newly-diagnosed venous ulcers will be randomised 1:1 either to a 12-week exercise programme combined with compression stockings or usual care (compression only). The intervention group will undertake three sessions of supervised exercise each week, involving a combination of walking, cycling and leg strength and flexibility exercises. Outcomes to be assessed before randomisation include cardiopulmonary fitness, health-related quality of life (EQ-5D-5L questionnaire), ulceration size, calf circumference, time since ulcer onset, previous operations, and history of deep vein thrombosis. Assessments will be repeated at the end of the exercise intervention period (12 weeks) and also 6 months and 1 year following intervention completion, with healing rate and time, ulcer recurrence and infection incidents also documented. The costs associated with the intervention and healthcare utilisation will be calculated. Qualitative data will also be collected to assess participants' experiences. A definitive randomised trial will be considered feasible if an appropriate primary outcome variable is defined and if compliance to the exercise programme is ≥75% in ≥67% of the intervention group. For the potential primary outcomes of a definitive trial, the likely effect of the exercise intervention will be estimated via standard intervention minus control comparisons. We will examine whether the confidence intervals (CI) include potentially clinically-important effects in outcomes between groups. A prospective economic evaluation will also be rehearsed to develop and refine methods for the subsequent trial. Findings from the subsequent trial will inform future service design and practice, and we envisage that a range of benefits will emerge from the proposed intervention (e.g. reduced ulcer-healing time). Given the low cost of supervised exercise training, the potential reduction in healthcare resource utilisation would likely make this a cost-effective, adjunctive therapy to compression hosiery for the NHS.


Research activity codes: 6.3 MEDICAL DEVICES;6.7 PHYSICAL
Health categories: CARDIOVASCULAR;SKIN