Background: This prospective, randomized controlled clinical trial determined whether an optimal exercise program length exists to efficaciously change claudication onset time (COT) and peak walking time (PWT) in patients with peripheral artery disease and claudication.
Methods: The study randomized 142 patients to supervised exercise (n = 106) or a usual care control group (n = 36), with 80 completing the exercise program and 27 completing the control intervention. The exercise program consisted of intermittent walking to nearly maximal claudication pain 3 days per week. COT and PWT were the primary outcomes obtained from a treadmill exercise test at baseline and bimonthly during the study.
Results: After exercise, changes in COT (P < .001) and PWT (P < .001) were consistently greater than changes after the control intervention. In the exercise program, COT and PWT increased from baseline to month 2 (P < .05) and from months 2 to 4 (P < .05) but did not significantly change from months 4 to 6 (P > .05). When changes were expressed per mile walked during the first 2 months, middle 2 months, and final 2 months of exercise, COT and PWT only increased during the first 2 months (P < .05).
Conclusions: Exercise-mediated gains in COT and PWT occur rapidly within the first 2 months of exercise rehabilitation and are maintained with further training. The clinical significance is that a relatively short 2-month exercise program may be preferred to a longer program to treat claudication because adherence is higher, costs associated with personnel and use of facilities are lower per patient, and more patients can be trained for a given amount of personnel time and resource utilization.
Trial registration: ClinicalTrials.gov NCT00654810.
Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.