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The Lively Legs self-management programme increased physical activity and reduced wound days in leg ulcer patients: results from a randomized controlled trial
Heinen M, Borm G, van der Vleuten C, Evers A, Oostendorp R, van Achterberg T
International Journal of Nursing Studies 2012 Feb;49(2):151-161
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Investigating the effectiveness of the Lively Legs program for promoting adherence with ambulant compression therapy and physical exercise as well as effects on leg ulcer recurrence. DESIGN: A randomized controlled trial. SETTING: Eleven outpatient clinics for dermatology in the Netherlands participated in the study. PATIENTS: 184 patients attending the outpatient clinic with leg ulcers based dominantly on a venous aetiology. Randomization was stratified by centre, age, sex and aetiology (purely venous or mixed). INTERVENTION: The intervention group received additionally to usual care, lifestyle counselling according to the Lively Legs program, the control group received care as usual. Patient behaviour on physical activity (IPAQ), adherence to compression therapy and wound status were assessed every 6 months during a follow-up period of 18 months. Data analysis was based on the intention to treat principle, using a generalized linear model with additive link function and Bernouilli distributions. Effects on recurrence were analyzed after the first ulcer had healed using proportional hazard regression. RESULTS: The results showed an increase in adherence with compression therapy in both groups, with no significant difference between the groups. The intervention group performed significantly better on conducting leg exercises (p < 0.01) and 10 min walks at five days a week (p < 0.01). There was no difference on reaching 30 min of walking on 5 days a week. The intervention group had less wound days (p < 0.01), time till recurrence did not differ significantly (p = 0.07). CONCLUSION: The Lively Legs program effectively increased the use of leg exercises and walking behaviour, and decreased wound time, however it did not significantly enhance use of compression stockings. Non significant effects regarding secondary outcomes may relate to the frailty of the sample.
With permission from Excerpta Medica Inc.

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