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.