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A group-mediated, home-based physical activity intervention for patients with peripheral artery disease: effects on social and psychological function |
Rejeski WJ, Spring B, Domanchuk K, Tao H, Tian L, Zhao L, McDermott MM |
Journal of Translational Medicine 2014 Jan 28;12(29):Epub |
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* |
BACKGROUND: PAD is a disabling, chronic condition of the lower extremities that affects approximately 8 million people in the United States. The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease (PAD) improves self-efficacy for walking, desire for physical competence, satisfaction for physical functioning, social functioning, and acceptance of PAD related pain and discomfort. METHODS: The design was a 6-month randomized controlled clinical trial of 194 patients with PAD. Participants were randomized to 1 of 2 parallel groups: a home-based group-mediated cognitive behavioral walking intervention or an attention control condition. RESULTS: Of the 194 participants randomized, 178 completed the baseline and 6-month follow-up visit. The mean age was 70.66 (+/- 9.44) and was equally represented by men and women. Close to half of the cohort was African American. Following 6-months of treatment, the intervention group experienced greater improvement on self-efficacy (p = 0.0008), satisfaction with functioning (p = 0.0003), pain acceptance (p = 0.0002), and social functioning (p = 0.0008) than the control group; the effects were consistent across a number of potential moderating variables. Change in these outcomes was essentially independent of change in 6-minute walk performance. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00693940.
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