LAUSR

BACKGROUND Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise-programmes (SEP) are underutilized while home-based structured exerciseprogrammes (HSEP) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. AIMS To compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC. METHODS This three-armed, multicentre randomized clinical trial enrolled patients with IC, all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs HSEP regarding the six-minute walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the Walking Impairment Questionnaire. Outcomes were assessed at baseline, 3, 6 and 12 months by a blinded evaluator. RESULTS Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP were 24% and SEP 26% fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0-12 months was -11.6  m, 95% CI: -36.4 to 13.0  m (i.e., within the pre-specified non-inferiority margin). CONCLUSION HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at one year. CLINICAL TRIAL DATABASE ID Registration: ClinicialTrials.gov (NCT02341716). Trial registry name: Hospital- and Home-based Supervised Exercise Versus Unsupervised Walk Advice For Patients With InTermittent Claudication (SUNFIT).