OBJECTIVE: To investigate whether supervised exercise therapy (SET) with or without daily feedback via an accelerometer is more effective than verbal advice only for improving walking distance and quality of life in patients with intermittent claudication during a 1-year period. DESIGN: Randomised clinical multicentre trial (www.ClinicalTrials.gov; NCT00279994). METHOD: Patients with intermittent claudication and eligible for exercise therapy were randomised to one of three groups: verbal advice, SET, or SET with feedback via an accelerometer. SET was provided by a local physiotherapist. The primary outcome measure was the change in maximal walking distance. Secondary outcome measures were the change in functional walking distance and results of the Walking Impairment Questionnaire (WIQ) and Short-Form 36 (SF-36) Health Survey. RESULTS: In total 102, 109, and 93 patients in 11 Dutch hospitals were included in the verbal advice group, the SET group, and the SET group with feedback, respectively. Data for 83, 93, and 76 patients, respectively, were available for analysis; data from both SET groups were analysed together. The median (interquartile range) change in walking distance from baseline to 12 months was 110 m (0 to 300) in the verbal advice group and 350 m (152 to 810) in the SET groups (p < 0.001). WIQ scores and relevant domains of the SF-36 improved significantly in the SET groups. CONCLUSION: SET provided by local physiotherapists was more effective than verbal advice in improving walking distance, WIQ scores, and quality of life for patients with intermittent claudication.

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