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Comprehensive cardiac rehabilitation effectiveness in a middle-income setting: a randomized controlled trial
Lima de Melo Ghisi G, Chaves GSS, Ribeiro AL, Oh P, Britto RR, Grace SL
Journal of Cardiopulmonary Rehabilitation and Prevention 2020 Nov;40(6):399-406
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*

PURPOSE: The impact of comprehensive cardiac rehabilitation (CCR) in Latin America is not well known. Herein, the pre-specified tertiary outcomes of a cardiac rehabilitation (CR) trial are reported: disease-related knowledge, depressive symptoms, and heart-health behaviors (exercise, diet, and smoking). METHODS: This was a single-blinded, single-center (Brazil) randomized trial with three parallel arms: CCR (exercise plus education) versus exercise-only CR versus wait-list control. Eligible patients were randomized in blocks of four with 1:1:1 concealed allocation. The CR program was 6 mo long. Participants randomized to exercise-only CR received 36 exercise classes; the CCR group also received 24 educational sessions, including a workbook. All outcomes were assessed at pre-test and 6-mo later (blinded). Analysis of covariance was performed by intention-to-treat (ITT) and per-protocol (PP). RESULTS: A total of 115 (89%) patients were randomized; 93 (81%) were retained. There were significant improvements in knowledge with CCR (ITT (51.2 +/- 11.9 pre and 60.8 +/- 13.2 post) and PP; p < 0.01), with significantly greater knowledge with CCR versus control (ITT mean difference (MD) 9.5, 95% CI 2.3 to 16.8) and CCR versus exercise-only CR at post-test (ITT MD 6.8, 95% CI 0.3 to 14.0). There were also significant improvements in self-reported exercise with CCR (ITT (13.7 +/- 15.8 pre and 32.1 +/- 2 5.7 post) and PP; p < 0.001), with significantly greater exercise with CCR versus control at post-test (ITT MD 7.6, 95% CI 3.8 to 11.4). Also, there were significant improvements in diet with CCR (PP: 3.4 +/- 7.5 pre and 8.0 +/- 7.0 post; p < 0.05). CONCLUSIONS: In this first-ever randomized trial of CR for coronary artery disease in Latin America, the benefits of CCR have been supported.
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