Home‐Based Walking Exercise in Peripheral Artery Disease: 12‐Month Follow‐up of the Goals Randomized Trial

BACKGROUND: We studied whether a 6‐month group‐mediated cognitive behavioral (GMCB) intervention for peripheral artery disease (PAD) participants, which promoted home‐based walking exercise, improved 6‐minute walk and other outcomes at 12‐month follow‐up, 6 months after completing the intervention, compared to a control group. METHODS AND RESULTS: We randomized PAD participants to a GMCB intervention or a control group. During phase I (months 1 to 6), the intervention used group support and self‐regulatory skills during weekly on‐site meetings to help participants adhere to home‐based exercise. The control group received weekly on‐site lectures on topics unrelated to exercise. Primary outcomes were measured at the end of phase I. During phase II (months 7 to 12), each group received telephone contact. Compared to controls, participants randomized to the intervention increased their 6‐minute walk distance from baseline to 12‐month follow‐up, (from 355.4 to 381.9 m in the intervention versus 353.1 to 345.6 m in the control group; mean difference=+34.1 m; 95% confidence interval [CI]=+14.6, +53.5; P<0.001) and their Walking Impairment Questionnaire (WIQ) speed score (from 36.1 to 46.5 in the intervention group versus 34.9 to 36.5 in the control group; mean difference =+8.8; 95% CI=+1.6, +16.1; P=0.018). Change in the WIQ distance score was not different between the 2 groups at 12‐month follow‐up (P=0.139). CONCLUSIONS: A weekly on‐site GMCB intervention that promoted home‐based walking exercise intervention for people with PAD demonstrated continued benefit at 12‐month follow‐up, 6 months after the GMCB intervention was completed. CLINICAL TRIAL REGISTRATION: URL: ClinicalTrials.gov. Unique identifier: NCT00693940.