1 Physical Therapy Department Federal University of Minas Gerais Belo Horizonte Minas Gerais Brazil.
2 Cardiovascular Prevention and Rehabilitation Program Toronto Rehabilitation Institute University Health Network University of Toronto Canada.
J Am Heart Assoc. 2019 Feb 19;8(4):e011228. doi: 10.1161/JAHA.118.011228.
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: NCT 02575976.
背景 尽管中低收入国家心血管疾病流行,但很少有试验测试心脏康复(CR)的益处。本试验评估了(1)中低收入国家 CR 后 6 个月的功能能力维持、危险因素控制、知识和心脏健康行为,以及(2)死亡率和发病率。
方法和结果 合格的巴西冠心病患者最初按 1:1:1 隐匿随机分配至 3 个平行组(综合 CR[运动加教育]、运动仅 CR 或等待名单对照)。CR 方案持续 6 个月,届时进行随访评估。死亡率和发病率通过图表和患者或家属报告(盲法)确定。对照组随后接受 CR(交叉)。6 个月后再次评估结局(盲法)。12 个月时对每个结局进行协方差分析。共有 115 例(88.5%)患者被随机分组,62 例(53.9%)在 1 年内保留。在 6 个月时,最初随机分配至等待名单对照组的 39 例中有 23 例(58.9%)选择参加 CR。在 6 至 12 个月期间,来自两个 CR 组的参与者均保持了功能能力、危险因素、知识和心脏健康行为(均 P>0.05)。在 1 年时,综合 CR 在任何时间点的知识均显著更高(P<0.001)。有 2 例死亡。CR 组在 6 个月时的住院率(P=0.03)、非致死性心肌梗死(P=0.04)和经皮冠状动脉介入治疗(P=0.03)明显低于对照组。
结论 与不进行 CR 相比,CR 参与与较低的发病率、功能能力、危险因素和心脏健康行为的长期维持以及与更高的心血管知识相关。
http://www.clinicaltrials.gov。唯一标识符:NCT 02575976。