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| Home-based walking exercise in peripheral artery disease: 12-month follow-up of the goals randomized trial |
| McDermott MM, Guralnik JM, Criqui MH, Ferrucci L, Zhao L, Liu K, Domanchuk K, Spring B, Tian L, Kibbe M, Liao Y, Lloyd Jones D, Rejeski WJ |
| Journal of the American Heart Association 2014 May 22;3(3):e000711 |
| clinical trial |
| 7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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 to +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 to +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.
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