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中等强度运动训练对肥厚型心肌病患者峰值摄氧量的影响:一项随机临床试验。

Effect of Moderate-Intensity Exercise Training on Peak Oxygen Consumption in Patients With Hypertrophic Cardiomyopathy: A Randomized Clinical Trial.

作者信息

Saberi Sara, Wheeler Matthew, Bragg-Gresham Jennifer, Hornsby Whitney, Agarwal Prachi P, Attili Anil, Concannon Maryann, Dries Annika M, Shmargad Yael, Salisbury Heidi, Kumar Suwen, Herrera Jonathan J, Myers Jonathan, Helms Adam S, Ashley Euan A, Day Sharlene M

机构信息

University of Michigan School of Medicine, Ann Arbor.

Stanford University School of Medicine, Palo Alto, California.

出版信息

JAMA. 2017 Apr 4;317(13):1349-1357. doi: 10.1001/jama.2017.2503.

Abstract

IMPORTANCE

Formulating exercise recommendations for patients with hypertrophic cardiomyopathy is challenging because of concern about triggering ventricular arrhythmias and because a clinical benefit has not been previously established in this population.

OBJECTIVE

To determine whether moderate-intensity exercise training improves exercise capacity in adults with hypertrophic cardiomyopathy.

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial involving 136 patients with hypertrophic cardiomyopathy was conducted between April 2010 and October 2015 at 2 academic medical centers in the United States (University of Michigan Health System and Stanford University Medical Center). Date of last follow-up was November 2016.

INTERVENTIONS

Participants were randomly assigned to 16 weeks of moderate-intensity exercise training (n = 67) or usual activity (n = 69).

MAIN OUTCOMES AND MEASURES

The primary outcome measure was change in peak oxygen consumption from baseline to 16 weeks.

RESULTS

Among the 136 randomized participants (mean age, 50.4 [SD, 13.3] years; 42% women), 113 (83%) completed the study. At 16 weeks, the change in mean peak oxygen consumption was +1.35 (95% CI, 0.50 to 2.21) mL/kg/min among participants in the exercise training group and +0.08 (95% CI, -0.62 to 0.79) mL/kg/min among participants in the usual-activity group (between-group difference, 1.27 [95% CI, 0.17 to 2.37]; P = .02). There were no occurrences of sustained ventricular arrhythmia, sudden cardiac arrest, appropriate defibrillator shock, or death in either group.

CONCLUSIONS AND RELEVANCE

In this preliminary study involving patients with hypertrophic cardiomyopathy, moderate-intensity exercise compared with usual activity resulted in a statistically significant but small increase in exercise capacity at 16 weeks. Further research is needed to understand the clinical importance of this finding in patients with hypertrophic cardiomyopathy, as well as the long-term safety of exercise at moderate and higher levels of intensity.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01127061.

摘要

重要性

由于担心引发室性心律失常,且此前尚未在肥厚型心肌病患者群体中证实运动有临床益处,因此为该类患者制定运动建议具有挑战性。

目的

确定中等强度运动训练是否能提高肥厚型心肌病成年患者的运动能力。

设计、地点和参与者:2010年4月至2015年10月期间,在美国的2个学术医疗中心(密歇根大学健康系统和斯坦福大学医学中心)进行了一项涉及136例肥厚型心肌病患者的随机临床试验。最后随访日期为2016年11月。

干预措施

参与者被随机分配至中等强度运动训练组(n = 67)或日常活动组(n = 69),为期16周。

主要结局指标

主要结局指标为从基线到16周时峰值摄氧量的变化。

结果

在136例随机分组的参与者中(平均年龄50.4 [标准差,13.3]岁;42%为女性),113例(83%)完成了研究。在16周时,运动训练组参与者的平均峰值摄氧量变化为+1.35(95%可信区间,0.50至2.21)mL/kg/min,日常活动组参与者为+0.08(95%可信区间,-0.62至0.79)mL/kg/min(组间差异为1.27 [95%可信区间,0.17至2.37];P = 0.02)。两组均未发生持续性室性心律失常、心脏骤停、适当的除颤器电击或死亡。

结论与意义

在这项涉及肥厚型心肌病患者的初步研究中,与日常活动相比,中等强度运动在16周时使运动能力有统计学意义但幅度较小的提高。需要进一步研究以了解这一发现对肥厚型心肌病患者的临床重要性,以及中等强度及更高强度运动的长期安全性。

试验注册

clinicaltrials.gov标识符:NCT01127061。

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