Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomised controlled feasibility trial

Klonizakis, Markos, Tew, Garry, Gumber, Anil, Crank, Helen, King, Brenda, Middleton, Geoff and Michaels, Jonathan (2018) Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomised controlled feasibility trial. British Journal Of Dermatology, 178 (5). pp. 1072-1082. ISSN 1365-2133

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Abstract

Background:
Almost 70% of all leg ulcers have a venous component. Venous leg ulcers (VLU's) are typically painful and heal slowly, resulting in an impaired quality of life (QoL), social isolation and reduced work productivity. Compression therapy offers high healing rates, however, improvements aren't usually sustained. Exercise is a low-cost, low-risk, and effective strategy for improving physical and mental health. However, little is currently known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy in this patient group.

Objectives:
To assess the feasibility of a 12-week supervised exercise programme combining aerobic, resistance and flexibility exercises as an adjunct therapy to compression in patients with VLU's.

Methods:
This was a two-centre, two-arm, parallel-group, randomised feasibility trial. Thirty-nine patients with venous ulcers were recruited and randomised 1:1 either to exercise (3 sessions per week) and compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow-up and patients’ preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year following baseline, with healing rate and time, ulcer recurrence and infection incidents also being documented. Intervention and healthcare utilisation costs were calculated. Qualitative data was collected to assess participants’ experiences.

Results:
Overall, 72% of the exercise group participants attended all scheduled exercise sessions. No serious adverse events, and only two exercise-related adverse events (e.g., increased ulcer discharge) were reported. Loss to follow-up was 5%. At 12-months median ulcer healing time was lower in the exercise group (13 vs 34.7 weeks). Total NHS costs were calculated as £813.27 for the exercise and £2,298.57 for the control group.

Conclusions:
Our findings support the feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures. The next step will be the design and implementation of an appropriately-powered, multi-centre trial.

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