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Maintenance of gains, morbidity, and mortality at 1 year following cardiac rehabilitation in a middle-income country: a wait-list control crossover trial [with consumer summary]
Chaves GSS, Lima de Melo Ghisi G, Britto RR, Grace SL
Journal of the American Heart Association 2019 Feb 19;8(4):e011228
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*

BACKGROUND: Despite the epidemic of cardiovascular diseases in middle-income countries, few trials are testing the benefits of cardiac rehabilitation (CR). This trial assessed (1) maintenance of functional capacity, risk factor control, knowledge, and heart-health behaviors and (2) mortality and morbidity at 6 months following CR in a middle-income country. METHODS AND RESULTS: Eligible Brazilian coronary patients were initially randomized (1:1:1 concealed) to 1 of 3 parallel arms (comprehensive CR (exercise plus education), exercise-only CR, or wait-list control). The CR programs were 6 months in duration, at which point follow-up assessments were performed. Mortality and morbidity were ascertained from chart and patient or family report (blinded). Controls were then offered CR (crossover). Outcomes were again assessed 6 months later (blinded). ANCOVA was performed for each outcome at 12 months. Overall, 115 (88.5%) patients were randomized, and 62 (53.9%) were retained at 1 year. At 6 months, 23 (58.9%) of those 39 initially randomized to the wait-list control elected to attend CR. Functional capacity, risk factors, knowledge, and heart-health behaviors were maintained from 6 to 12 months in participants from both CR arms (all p > 0.05). At 1 year, knowledge was significantly greater with comprehensive CR at either time point (p < 0.001). There were 2 deaths. Hospitalizations (p = 0.03), nonfatal myocardial infarctions (p = 0.04), and percutaneous coronary interventions (p = 0.03) were significantly fewer with CR than control at 6 months. CONCLUSIONS: CR participation is associated with lower morbidity, long-term maintenance of functional capacity, risk factors, and heart-health behaviors, as well as with greater cardiovascular knowledge compared with no CR. CLINICAL TRIAL REGISTRATION: URL http://www.ClinicalTrials.gov. Unique identifier NCT02575976.

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