Abstract

Objective: In a randomized clinical trial of people with lower extremity peripheral artery disease (PAD), to test whether walking exercise conducted at a pace without ischemic leg symptoms improved physical activity more than walking exercise conducted at a pace that induced ischemic leg symptoms and more than an attention control group. Methods & Results: In the LITE multi-centered clinical trial, 305 participants with PAD (69±40 years, 181 (59%) black, 146 (48%) female) were randomized to: 1) walking exercise conducted at a comfortable pace without ischemic leg symptoms (low-intensity), 2) walking exercise conducted at a pace eliciting ischemic leg symptoms (high-intensity), or 3) an attention-control group for 12-months. Physical activity (i.e., activity counts per minute) was a pre-specified secondary outcome. Both exercise groups were asked to walk for exercise in an unsupervised setting for up to 5 times/week for up 50 minutes/session. Physical activity was measured for up to 10 days using an ActiGraph accelerometer at baseline, 6-month, and 12-month follow-up. Low intensity exercise increased physical activity significantly less than high intensity exercise at 6-month follow-up (-74 counts per minute, 95% CI: -123, -26, P=0.003; Table 1) and 12-month follow-up (-47 counts per minute, 95% CI: -79, -15, P=0.004; Table 1). High intensity exercise increased physical activity significantly more than control at 6-month follow-up (+104 counts per minute, 95% CI: 48, 162, P<0.001; Table 1) and 12-month follow-up (+55 cpm, 95% CI: 18, 93, P=0.004; Table 1). There was no difference between the low intensity group and control at 6-month or 12-month follow-up (Table 1). Conclusion: These results support home-based walking exercise conducted at a pace that induces ischemic leg symptoms, but not walking exercise conducted at a comfortable pace without ischemic leg symptoms, to improve physical activity in people with PAD.

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