The PREPARE pilot RCT of home-based progressive resistance exercises for venous leg ulcers

OBJECTIVE: To establish the feasibility of conducting a home-based progressive resistance exercise programme to improve calf muscle pump function in community-based patients with venous leg ulcers. METHOD: Participants were randomised to receive a 12-week progressive resistance exercise programme using heel raises in addition to compression. The control was usual care in addition to compression. Randomisation was stratified by ulcer duration and ulcer size. Air plethysmography was used to determine changes in calf muscle pump function from baseline. Changes in ulcer parameters were measured using the SilhouetteMobile device. RESULTS: Forty participants were randomised. There were significantly greater improvements in ejection fraction of the calf muscle in the exercise group compared with the control (usual care) group (mean difference 18.5%, 95% CI 0.03 to 36.6%, p<0.05). Other parameters improved in the exercise group but the mean differences were not significant. Adherence with prescribed exercises was 81% and there was no significant difference in the numbers reporting adverse events. There were also no significant differences in ulcer healing parameters (change in area, percentage change in area, number healed at 12 weeks, time to healing). CONCLUSION: A community-based randomised trial of progressive resistance exercise is feasible. The prescribed exercises appeared to increase ejection fraction, but the effect of exercise on ulcer healing requires further investigation.