Klonizakis Markos, Gumber Anil, McIntosh Emma, Levesley Maria, Horspool Michelle, Logan Pip
Lifestyle, Exercise and Nutrition Improvement (LENI) Research Group, Department of Nursing and Midwifery, Sheffield Hallam University, Sheffield, UK.
Research and Innovation, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.
Clin Exp Dermatol. 2024 Jan 25;49(2):135-142. doi: 10.1093/ced/llad342.
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.
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.
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.
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].
The feasibility and acceptability of both a home- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported.
下肢静脉溃疡（VLUs）愈合缓慢，给患者带来痛苦，对医疗系统造成高昂成本；它们还会影响患者的生活质量。先前的研究表明，将监督下的运动训练与压力治疗相结合可能具有临床益处。然而，由于身体虚弱和年龄原因，大量下肢静脉溃疡患者无法获得这种干预措施。
评估“FISCU Home”（一种基于运动和行为支持的共同设计的、为期12周的居家自我管理生活方式计划）作为下肢静脉溃疡患者压力治疗辅助疗法的可行性。
从社区护理和组织活力团队以及通过报纸广告招募了40名在家接受治疗的下肢静脉溃疡患者。参与者按1:1随机分组，一组接受行为支持下的运动（每周三次）加压力治疗，另一组仅接受压力治疗。使用包括运动出勤率、失访率、患者偏好和不良事件（AE）在内的进展标准评估该计划的可行性。在12周和6个月时重复进行基线评估。在这些时间点还记录了次要结局（即溃疡复发、愈合率和愈合时间）。计算了干预和医疗保健利用成本。
研究招募率为65%，而运动组75%的参与者参加了所有预定的运动课程。所有参与者均完成了压力治疗。未报告严重不良事件或与运动相关的不良事件。运动组的溃疡愈合时间中位数（四分位间距）较短[29（7 - 108）周对42（6 - 116）周]。
支持将基于家庭和运动的生活方式干预与压力治疗相结合的可行性和可接受性以及研究程序。
