Title: Exploring the feasibility of implementing a home-based exercise training and compression hosiery intervention in patients with venous ulceration (FISCU-II)
Funder: Department of Health and Social Care

Abstract: Research question: &ldquo;Can we co-produce and evaluate the feasibility and cost of an individualised, home-based, exercise intervention for people with venous leg ulcers (VLUs)?&rdquo; Background: VLUs account for 70% of all leg ulcers, affecting 400,000 people/year; each ulcer costs up to 7.6k/year to the NHS. VLUs are typically painful and heal slowly, affecting quality of life (QoL) and causing social isolation. Compression (e.g.,stockings/bandages) is the current gold-standard treatment. However, recurrence rates may reach 56% within 4 years, while up to 30% of VLUs are non-responsive to compression, remaining open after a year's treatment. Exercise is noted in the VLUs management guidelines but is not usually promoted in practice. We recently completed FISCU, exploring the feasibility of using supervised exercise as an adjunct therapy to compression, for this group. Results were encouraging but as between 40-50% of the VLUs population cannot attend supervised sessions due to being unable to travel (despite being eligible), alternative options should be developed. We propose a 36-month, 2-phase study (comprising intervention co-design and feasibility), using both qualitative (Phase-1: co-design based on focus groups/interviews) and mixed methods (Phase-2: RCT with a nested qualitative study). Aims (Phase-1): To co-design with people with VLUs (n=18) in focus groups and interviews, a home-based, exercise intervention, modelled on the successful, community-based FISCU programme. (Phase-2): a) To estimate rates of recruitment, compliance and retention for a definitive trial, b) to estimate the outcome completion rate at follow-up visits and compare differences between groups, c) to refine a framework for a cost-effectiveness analysis, d) to conduct post-intervention interviews with participants and healthcare professionals to evaluate and refine the programme and e) to define relevant &quot;stop/go&quot; criteria for a definitive trial. Methods/Timeline: In Phase-1 we will conduct 3-4 focus groups and/or additional interviews (determined on the participants ability to travel; total n=18) to co-design the intervention's format and content, as well as the material provided to participants. Once intervention is developed, a workshop and/or additional interviews (n=6) will further refine it. Phase-2 will be conducted on a single-centre, two-arm, parallel-group, randomised basis. Forty people with VLUs will be randomised 1:1 either to a 12-week home-based, self-managed, exercise programme combined with compression therapy or compression only. The intervention group will most likely undertake two/three sessions of self-managed exercise/week, including chair-based aerobics, resistance and flexibility exercises. Outcomes to be assessed include functional ability, health-related QoL, ulceration size, calf circumference, time since ulcer onset and clinical history. We will repeat assessments at 12 weeks and also 6 months post-randomisation, when we'll document healing time, ulcer recurrence and infection incidents. Healthcare and intervention costs will be calculated. We will carry out interviews at the intervention-end to assess participants (n=16) and healthcare personnel (n=10) experiences. Impact/Dissemination: Study findings will inform &ndash; in combination with FISCU results- a definitive trial, exploring the role of exercise as an adjunct therapy to compression. The definitive trial will define 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.

Lay abstract: Venous leg ulcers (VLUs) affect almost 400,000 U.K. people over the age of 65. These are triggered by inadequate blood flow through the veins. causing pain, mobility restrictions, devastation and social isolation. Each VLU costs up to &pound;7.6k per year to the NHS, while annual healthcare costs are up to &pound;900 million. Compression therapy (usually stockings or bandages) are often used to treat VLUs: although healing rates are good, ulcers often return. Moreover, many remain open for up to 1 year, needing about 50 visits to heal. Consequently, supportive therapies to compression are needed to reduce healing times. Exercise may provide an answer. We recently completed a small study, examining if it was possible to use a 12-week, community-based exercise programme, along with compression therapy, to treat VLUs. We showed that the programme was safe, participants enjoyed it and were attending their sessions, being also happy to complete their assessments. The programme also offered reduced healing times and cost savings to the NHS of up &pound;875 per ulcer. Nevertheless, the programme didn't seem to be accessible for 40-50% of this group; these receive treatment at home and could otherwise do the exercises. Therefore, before embarking to a full-scale study to explore the clinical benefits and calculate the costs of a wider programme implementation, we need to design and explore the practicality of a home-based exercise programme, which would be offered to those who cannot travel. This is worth trying, as our findings indicate that 74% of house-bound people with VLUs would willingly try it. Our 2-phase, Sheffield-based study will last 36 months. In Phase 1, people with VLUs will help us design the home-based exercise programme via round-table discussions, interviews and a workshop. In Phase 2, we will recruit 40 people with VLUs, who receive treatment at home and although cannot travel, can do some flexibility, stretching and chair-aerobics exercises. Following assessments (measuring ulcer sizes, fitness, quality of life and associated costs among others), participants will be placed into one-of-two groups by a computer: one group will follow the Phase 1-defined, home-based exercise programme and have standard at-home compression therapy; the other will receive compression therapy only. All participants will complete 3 home-based assessment sessions: initially at recruitment, then at the intervention end and finally 6 months after group allocation. We will also talk to 18 participants and 10 healthcare professionals, to hear about their intervention experience. People with VLUs have helped us develop this grant application. They will also help us to: i) design the home-based programme, ii) best-manage the study and iii) interpret and publicise our findings. Upon completion, we will move to a full-scale study, which will provide a solution to this costly and devastating health problem.

Research activity codes: 6.7 PHYSICAL
Health categories: SKIN;CARDIOVASCULAR