Durability of Benefits From Supervised Treadmill Exercise in People With Peripheral Artery Disease

BACKGROUND: It is currently unknown whether 6 months of supervised treadmill exercise has a durable benefit on 6‐minute walk performance, even after exercise is completed, in people with peripheral artery disease. METHODS AND RESULTS: A total of 156 participants with peripheral artery disease were randomized to 1 of 3 groups: supervised treadmill exercise, supervised resistance training, or attention control. Participants received supervised sessions during months 1 to 6 and telephone contact during months 6 to 12. Primary outcomes were change in 6‐minute walk distance and short physical performance battery at 6‐month follow‐up and have been reported previously. Secondary outcomes were change in 6‐minute walk and short physical performance battery at 12‐month follow‐up and are reported here. A group of 134 participants (86%) completed the 12‐month follow‐up. At 6‐month follow‐up, compared with control, 6‐minute walk distance improved in the treadmill exercise group (+36.1 m, 95% CI=13.9‐58.3, P=0.001). Between 6‐ and 12‐month follow‐up, 6‐minute walk distance significantly declined (−28.6 m, 95% CI=−52.6 to −4.5, P=0.020) and physical activity declined −272 activity units (95% CI=−546 to +2, P=0.052) in the treadmill exercise group compared with controls. At 12‐month follow‐up, 6 months after completing supervised treadmill exercise, change in 6‐minute walk distance was not different between the treadmill exercise and control groups (+7.5, 95% CI=−17.5 to +32.6, P=0.56). There were no differences in short physical performance battery change between either exercise group and control at 6‐month or 12‐month follow‐up. CONCLUSIONS: A 6‐month supervised treadmill exercise intervention that improved 6‐minute walk distance at 6‐month follow‐up did not have persistent benefit at 12‐month follow‐up. These results do not support a durable benefit of supervised treadmill exercise in peripheral artery disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Identifier: NCT00106327.