OBJECTIVE: To investigate the effectiveness of the Lively Legs programme on patient adherence to compression therapy, walking behaviour and leg exercising, as well as on leg ulcer recurrence. DESIGN: Randomized controlled trial (ClinicalTrials.gov identifier NCT00184873). METHOD: A total of 184 patients with leg ulcers having predominantly venous aetiologies from 11 Dutch dermatology clinics were randomized to groups receiving either interventional or standard care (control group). Randomization was stratified by centre, age, sex and aetiology (either sheerly venous or mixed). In addition to standard care, the intervention group received lifestyle counselling according to the Lively Legs programme. In terms of adherence to compression therapy and exercise, patient behaviour and wound status were assessed at baseline and every 6 months during a follow-up period of 18 months. A generalized linear mixed model was used for data analysis, based on the intention to treat principle. The programme's effect on the duration until recurrence was analyzed using a proportional hazard regression model. RESULTS: The results showed an increase in adherence to the compression therapy regimen in both groups, but no difference between the groups. The intervention group performed significantly better in terms of conducting leg exercises and walking for 10 consecutive minutes, 5 days a week. There were also less wound days; however, time to leg ulcer recurrence did not differ significantly between the groups. CONCLUSION: The Lively Legs programme did have an effect on the exercising behaviour of patients with leg ulcers. The increase in adherence to compression therapy regimens was equal in the intervention and control groups. Patients in the intervention group had fewer wound days.

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