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Efficacy of community-based exercise therapy among African American patients with peripheral artery disease: a randomized clinical trial [with consumer summary]
Collins TC, Lu L, Ahluwalia JS, Nollen NL, Sirard J, Marcotte R, Post S, Zackula R
JAMA Network Open 2019 Feb 1;2(2):e187959
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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*

IMPORTANCE: African American individuals are 2 times more likely than non-Hispanic white individuals to have peripheral artery disease (PAD). Structured community-based exercise therapy improves walking distance among patients with PAD, but these patients require motivation to adhere to therapy. OBJECTIVE: To assess whether motivational interviewing (MI) is more efficacious than Patient-Centered Assessment and Counseling for Exercise (PACE) or control to improve walking distance in African American patients with PAD. DESIGN, SETTING, AND PARTICIPANTS: In this 3-group randomized clinical trial, 174 African American patients with PAD were studied from May 1, 2012, to November 30, 2016, at health care centers, churches, and health fairs in Wichita, Kansas; Kansas City, Kansas, and Kansas City, Missouri. INTERVENTIONS: Patients were randomized in a 1:1:1 fashion to 1 of 3 groups (57 to MI, 57 to PACE, and 60 to control). The 2 counseling interventions were delivered biweekly for 3 months and monthly for 3 months followed by a 6-month maintenance phase with limited contact. Control participants received a mailing at 3 and 9 months. MAIN OUTCOMES AND MEASURES: The primary outcome was 6-month change in 6-minute walking performance. Secondary outcomes included 12-month change in walking performance and 6- and 12-month changes in quality of life. RESULTS: A total of 174 African American patients (mean (SD) age 64.2 (11.2) years; 128 (74.0%) female) were studied. At 6 months, mean (SE) change in walking distance by group was as follows: MI -3.42 (4.55) m; PACE 2.74 (6.00) m; and control -0.18 (4.40) m. At 12 months, mean (SE) change in walking distance by group was as follows: MI -7.75 (5.50) m; PACE 13.75 (6.13) m; and control -1.08 (5.73) m. Comparing each of the intervention arms (MI and PACE) with the control arm, no statistically significant increases in walking distance at 6 months (MI change -2.10 m; 95% CI -16.54 to 12.35 m; PACE change 2.31 m; 95% CI -11.36 to 15.97 m) or 12 months (MI change -5.56 m; 95% CI -21.18 to 10.06 m; PACE change 14.24 m; 95% CI -1.85 to 30.34 m) were found. Compared with MI, PACE resulted in a statistically significant increase in walking distance at 12 months of 19.80 m (95% CI 3.33 to 36.28 m). CONCLUSIONS AND RELEVANCE: In a cohort of African American patients with PAD, MI was not efficacious in improving walking distance at 6 or 12 months. The results of this study do not support the use of MI to improve walking performance in African American patients with PAD. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01321086.

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