Abstract

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 intensity exercise improved 6MWT compared to low intensity exercise (mean diff: +38.5 m [95% CI: 19.0, 58.1], P < 0.001) and compared to control (mean diff: +43.7 m [95% CI: 23.2, 64.2], P < 0.001). 95 participants had one or more hospitalization during the study period, including 37 (32%) in the high intensity group, 39 (36%) in the low intensity group, and 19 (29%) in the control group (P = 0.64). In the high intensity group, participants hospitalized during the trial had lower baseline 6MWT compared to those not hospitalized [294 meters vs. 349 meters (P = 0.005)]. Among high intensity participants, hospitalization during the trial was associated with less 6MWT improvement at 12-month follow-up (Table). Conclusion: Among people with PAD, hospitalization during an exercise intervention was associated with significantly less improvement in walking performance. Future studies should identify therapies to increase gains in walking performance in patients with PAD hospitalized during exercise interventions.

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