IMPORTANCE: Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. OBJECTIVE: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months in patients with PAD. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise versus usual care for 9 months. Final follow-up was on December 5, 2017. INTERVENTIONS: The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. MAIN OUTCOMES AND MEASURES: The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference (MCID), 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0 to 100 score; 100 best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range 3.5 to 4.5 points), and objectively measured physical activity. RESULTS: Among 200 randomized participants (mean (SD) age, 70.2 (10.4) years; 105 (52.5%) women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group versus 14.4 m in the usual care group (difference -8.9 m; 95% CI -26.0 to 8.2 m; p = 0.31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group versus -2.8 in the usual care group (difference 3.5; 95% CI 1.3 to 5.8; p = 0.002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. CONCLUSIONS AND RELEVANCE: Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02462824.

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