综合心脏康复对中等收入国家心功能容量的影响：一项随机对照试验。
Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial.
机构信息
Physical Therapy Department, Federal University of Minas Gerais, Belo Horizonte, Brazil.
Cardiovascular Prevention and Rehabilitation Program, University Health Network, University of Toronto, Toronto, Ontario, Canada.
出版信息
Heart. 2019 Mar;105(5):406-413. doi: 10.1136/heartjnl-2018-313632. Epub 2018 Oct 3.
OBJECTIVE
Despite the growing epidemic of cardiovascular diseases in middle-income countries, there is insufficient evidence about cardiac rehabilitation (CR) in these countries. Thus, the effects of comprehensive CR on functional capacity and risk factors were investigated in Brazil, to test the hypothesis that it results in better outcomes than exercise-only or no CR.
METHODS
Single-blinded, randomised controlled trial with three parallel arms: comprehensive CR (exercise+education) versus exercise-only CR versus wait-list control. Eligible coronary patients were randomised in blocks of four with 1:1:1 concealed allocation. Participants randomised to exercise-only CR received 36 exercise classes; comprehensive CR group also received 24 educational sessions. The primary outcome was incremental shuttle walk test (ISWT) distance; secondary outcomes were cardiovascular risk factors. All outcomes were assessed at baseline and 6 months later. Analysis of covariance was performed on the basis of intention-to-treat (ITT) and per-protocol.
RESULTS
115 (88.5%) patients were randomised; 93 (80.9%) were retained. There were improvements in ISWT distance from pretest to post-test with comprehensive (from 358.4±132.6 to 464.8±121.6 m; mean change=106.4; p<0.001) and exercise-only (from 391.5±118.8 to 488.1±106.3 m; mean change=96.5, p<0.001) CR, with significantly greater functional capacity with comprehensive CR versus control (ITT: mean difference=75.6±30.7 m, 95% CI 1.4 to 150.2). There were also reductions in systolic blood pressure with comprehensive CR (ITT: reduction of 6.2±17.8 mm Hg, p=0.04). There were no significant differences for other outcomes.
CONCLUSION
Results showed clinically significant improvements in functional capacity and blood pressure with CR, and significantly greater functional capacity with comprehensive CR compared with usual care.
TRIAL REGISTRATION NUMBER
NCT02575976; Results.
目的
尽管中低收入国家心血管疾病的流行呈上升趋势，但这些国家的心脏康复（CR）证据不足。因此，本研究旨在调查综合 CR 对功能能力和危险因素的影响，以检验其结果优于单纯运动或不进行 CR 的假设。
方法
这是一项单盲、随机对照试验，设三个平行组：综合 CR（运动+教育）组、单纯运动 CR 组和等待名单对照组。合格的冠心病患者以 4 人为一组进行分组，采用 1:1:1 隐匿分组分配。随机分配至单纯运动 CR 组的患者接受 36 次运动课程；综合 CR 组还接受 24 次教育课程。主要结局指标为增量穿梭步行试验（ISWT）距离；次要结局指标为心血管危险因素。所有结局均在基线和 6 个月后进行评估。基于意向治疗（ITT）和方案进行协方差分析。
结果
115 例（88.5%）患者被随机分组，93 例（80.9%）患者保留。综合 CR 组（从 358.4±132.6 至 464.8±121.6 m；平均变化=106.4；p<0.001）和单纯运动 CR 组（从 391.5±118.8 至 488.1±106.3 m；平均变化=96.5，p<0.001）的 ISWT 距离从测试前到测试后均有改善，与对照组相比，综合 CR 组的功能能力有显著提高（ITT：平均差异=75.6±30.7 m，95%CI 1.4 至 150.2）。综合 CR 组的收缩压也有所降低（ITT：降低 6.2±17.8 mm Hg，p=0.04）。其他结局均无显著差异。
结论
结果表明，CR 可显著提高功能能力和血压，且综合 CR 比常规护理的功能能力改善更显著。
试验注册号
NCT02575976；结果。
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