Comprehensive Cardiac Rehabilitation Effectiveness in a Middle-Income Setting: A RANDOMIZED CONTROLLED TRIAL.

Abstract

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). This was a single-blinded, single-center (Brazil) randomized trial with three parallel arms: CCR (exercise + 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). 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 < .01), with significantly greater knowledge with CCR versus control (ITT mean difference [MD] = 9.5, 95% CI, 2.3-16.8) and CCR vs exercise-only CR at post-test (ITT MD = 6.8, 95% CI, 0.3-14.0). 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 < .001), with significantly greater exercise with CCR versus control at post-test (ITT MD = 7.6, 95% CI, 3.8-11.4). Also, there were significant improvements in diet with CCR (PP: 3.4 ± 7.5 pre and 8.0 ± 7.0 post; P < .05). In this first-ever randomized trial of CR for coronary artery disease in Latin America, the benefits of CCR have been supported.