PMID- 37819015 OWN - NLM STAT- MEDLINE DCOM- 20240129 LR - 20240206 IS - 1365-2230 (Electronic) IS - 0307-6938 (Linking) VI - 49 IP - 2 DP - 2024 Jan 25 TI - Testing the feasibility of a co-designed intervention, comprising self-managed, home-based, exercise training with embedded behavioural support and compression therapy for people with venous leg ulcers receiving treatment at home (FISCU-II). PG - 135-142 LID - 10.1093/ced/llad342 [doi] AB - BACKGROUND: Venous leg ulcers (VLUs) heal slowly, are painful for patients and are costly for healthcare systems; they also affect patients' quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However, a large population of people with VLUs are unable to access such an intervention due to frailty and age. OBJECTIVES: 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, receiving treatment at home, were recruited from community nursing and tissue viability teams, and via a newspaper advertisement. Participants were randomized 1 : 1 either to exercise with behaviour support (three times per 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 (AEs). 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: The study recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed compression therapy. No serious AEs or exercise-related AEs were reported. Median (interquartile range) 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- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported. CI - (c) The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. FAU - Klonizakis, Markos AU - Klonizakis M AUID- ORCID: 0000-0002-8864-4403 AD - Lifestyle, Exercise and Nutrition Improvement (LENI) Research Group, Department of Nursing and Midwifery, Sheffield Hallam University, Sheffield, UK. FAU - Gumber, Anil AU - Gumber A AD - Lifestyle, Exercise and Nutrition Improvement (LENI) Research Group, Department of Nursing and Midwifery, Sheffield Hallam University, Sheffield, UK. FAU - McIntosh, Emma AU - McIntosh E AD - Lifestyle, Exercise and Nutrition Improvement (LENI) Research Group, Department of Nursing and Midwifery, Sheffield Hallam University, Sheffield, UK. AD - Research and Innovation, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK. FAU - Levesley, Maria AU - Levesley M AD - Integrated Care Team, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. FAU - Horspool, Michelle AU - Horspool M AD - Research and Innovation, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK. FAU - Logan, Pip AU - Logan P AD - Centre for Rehabilitation and Ageing Research, University of Nottingham, Nottingham, UK. AD - Nottingham CityCare Partnership, Nottingham, UK. LA - eng GR - DH_/Department of Health/United Kingdom PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Clin Exp Dermatol JT - Clinical and experimental dermatology JID - 7606847 SB - IM MH - Humans MH - Compression Bandages MH - Ulcer MH - Quality of Life MH - Feasibility Studies MH - *Self-Management MH - Neoplasm Recurrence, Local MH - Exercise MH - *Varicose Ulcer/drug therapy COIS- Conflicts of interest The authors declare no conflicts of interest. EDAT- 2023/10/11 14:42 MHDA- 2024/01/29 06:44 CRDT- 2023/10/11 08:43 PHST- 2023/04/29 00:00 [received] PHST- 2023/09/08 00:00 [revised] PHST- 2023/10/01 00:00 [accepted] PHST- 2024/01/29 06:44 [medline] PHST- 2023/10/11 14:42 [pubmed] PHST- 2023/10/11 08:43 [entrez] AID - 7306654 [pii] AID - 10.1093/ced/llad342 [doi] PST - ppublish SO - Clin Exp Dermatol. 2024 Jan 25;49(2):135-142. doi: 10.1093/ced/llad342.