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Background: Walking exercise is first line therapy for lower extremity peripheral artery disease (PAD); however, hospitalizations during therapy are common. In post-hoc analyses, we evaluated the effect of hospitalizations on benefits from the exercise interventions in the LITE trial.

Methods: In the LITE randomized clinical trial, participants with PAD were randomized to one of three groups for 12 months: home-based high intensity exercise (walking exercise inducing ischemic leg symptoms), home-based low intensity exercise (walking exercise without ischemic leg symptoms) or a control group (no exercise). The primary outcome was 12-month change in six-minute walk test (6MWT) distance. Hospitalizations were ascertained by monthly telephone calls to participants.

Results: Of the 305 PAD participants randomized, 291 (95%) participants (mean age: 69, Black race: 59%) were alive at trial ending. Overall, high …