Testing the feasibility of a co-designed intervention comprising self-managed, home-based exercise training with embedded behavioral support and compression therapy for people with venous leg ulcers, receiving treatment at home (FISCU-II)

Background Venous leg ulcers heal slowly, are painful and costly for healthcare systems, and also affect patients’ quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However there is a large population of people with VLUs, who are unable to access such an intervention due to frailty and age. Objective Our primary aim was to assess the feasibility of FISCU Home (a co-designed, 12-week home-based, self-managed, lifestyle programme based on exercise and behaviour support), as an adjunct therapy to compression in people with VLUs. Methods Forty people with VLUs (121 excluded/22 refused), receiving treatment at home, were recruited from community nursing and tissue viability teams and newspaper advertisement. Participants were randomized 1:1 either to exercise with behaviour support (thrice/week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events. Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e., ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated. Results Recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed their compression therapy. No serious adverse or exercise-related adverse events were reported. Median ulcer healing time was shorter in the exercise group (29 (7-108) vs 42 (6-116) weeks). Conclusions The feasibility and acceptability of both a home-based, exercise-based, lifestyle intervention in conjunction with compression therapy, and the study procedures are supported.