Exploring the feasibility of using an exercise-based, self-managed, lifestyle intervention for venous leg-ulcer prevention in adults with a venous leg-ulcer history (FISCU III).

Research question: "Is it feasible to use FISCU, a lifestyle intervention, co-produced with people with Venous Leg Ulcers (VLUs), as a VLU recurrence-prevention tool?" Background: VLUs affect approximately 400,000 U.K. people/year over the age of 65, causing pain, mobility restrictions and social isolation. Each VLU costs up-to £13.5k/year to the NHS; total costs being about £920 million/year. Compression therapy is used to treat VLUs and prevent recurrence: although healing rates are good, up-to 69% of ulcers return within 12-months. Consequently, supportive therapies to compression are needed to reduce healing times and prevent recurrence. We recently proven the feasibility of our FISCU intervention (a 12-week, self-managed, lifestyle programme based on aerobic exercises and behaviour support), which was co-produced with people with VLUs, as a VLU-treatment tool, alongside compression, both at home and in the community. The programme was safe, having high attendance, completion and satisfaction rates, as well as potentially offering faster VLU healing and NHS cost-savings. Having proven the feasibility of FISCU intervention, as an adjunct treatment therapy to compression, we propose to assess its feasibility as a recurrence-prevention tool, before embarking to a full-scale study, in which we would examine the clinical- and cost-benefits of a wider VLU-healing and recurrence-prevention programme. Aims: a) To estimate recruitment, compliance and retention rates for a definitive trial. b) To estimate outcome completion rate at follow-up visits, to identify any potential completion differences between groups. c) To refine a framework to facilitate conducting a cost-effectiveness analysis. d) To conduct post-intervention participant interviews to refine the intervention. e) To define "stop/go" criteria for the pilot phase of a definitive trial. Methods/Timeline: This is a 36-month, Sheffield-based feasibility study. We will recruit 60 people with recently-healed (e.g., 1-month) VLUs. Following baseline assessments (assessing flexibility/fitness, VLUs-specific and general quality-of-life and ulcer history), participants will be randomly placed into one-of-two groups: Group-A will follow FISCU intervention (including aerobic, resistance and flexibility exercises and behaviour support to adapt to a healthier lifestyle), at least twice/week and have compression for 12-months; Group-B will receive compression only. The programme will be self-managed, could be performed at the community or at home, with participants having frequent face-to-face (every three-to-four weeks) and telephone contact (every two weeks) with our intervention facilitators. Participants will complete four assessments: at baseline, and then at 3-,6-and 12-months post-recruitment, in which we will repeat baseline tests and collect evidence for any potential new ulcers, VLUs-associated costs (via a FISCU-specific, resources use diary) and number of falls. We will then interview participants (intervention=8/control=4) and stakeholders(n=5; healthcare professionals and intervention facilitators), to hear about their programme experience, and adapt the intervention further before its wider roll-out. Impact/Dissemination: Study findings will inform–in combination with FISCU I&II results-a definitive trial, exploring the role of our FISCU intervention as an adjunct therapy to compression for the prevention and treatment of VLUs. The definitive trial will define prevention and treatment options for people with VLUs. We will disseminate results to healthcare professionals, policy-makers, scientists and the public via lectures, articles and press releases.