Abstract
Background This randomized controlled trial compared long-term changes in peak walking time (PWT) and exercise time-to-minimum calf muscle oxygen saturation (StO(2)) in symptomatic participants with peripheral artery disease following a long-term home exercise program (HEP), a short-term supervised exercise therapy (SET) program that transitioned to a long-term HEP (SET/HEP), and a control intervention. Methods and Results For the first 3 months, HEP and SET/HEP groups performed intermittent walking to mild-to-moderate claudication pain, whereas the control group performed light resistance training. For the subsequent 15 months, the HEP group continued their exercise program, the SET/HEP group transitioned from SET to the HEP program, and the control group transitioned to only receive walking advice. PWT increased significantly from baseline to month 18 in the HEP group (408±279 meters to 814±393 meters, P<0.001) and in the SET/HEP group (457±288 meters to 818±313 meters, P<0.001). Exercise time-to-minimum calf muscle StO(2) increased significantly from baseline to month 18 in the HEP group (238±241 seconds to 497±485 seconds, P<0.05) and in the SET/HEP group (296±289 seconds to 620±450 seconds, P<0.001). These changes in PWT and exercise time-to-minimum calf muscle StO(2) were greater than in the control group (P<0.001 and P<0.01, respectively). Additionally, the change in exercise time-to-minimum calf muscle StO(2) was correlated with the change in PWT in both exercise groups combined (r=0.601, P=0.0015). Conclusions Long-term HEP and SET/HEP were efficacious in improving PWT and exercise time-to-minimum calf muscle StO(2) in symptomatic participants with peripheral artery disease, and these changes were correlated with each other. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00618670.