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高强度间歇训练、中等持续训练或基于指南的体力活动建议对射血分数保留心力衰竭患者峰值耗氧量的影响:一项随机临床试验。

Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.

机构信息

Department of Prevention and Sports Medicine, University Hospital Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.

DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.

出版信息

JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.

Abstract

IMPORTANCE

Endurance exercise is effective in improving peak oxygen consumption (peak V̇o2) in patients with heart failure with preserved ejection fraction (HFpEF). However, it remains unknown whether differing modes of exercise have different effects.

OBJECTIVE

To determine whether high-intensity interval training, moderate continuous training, and guideline-based advice on physical activity have different effects on change in peak V̇o2 in patients with HFpEF.

DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at 5 sites (Berlin, Leipzig, and Munich, Germany; Antwerp, Belgium; and Trondheim, Norway) from July 2014 to September 2018. From 532 screened patients, 180 sedentary patients with chronic, stable HFpEF were enrolled. Outcomes were analyzed by core laboratories blinded to treatment groups; however, the patients and staff conducting the evaluations were not blinded.

INTERVENTIONS

Patients were randomly assigned (1:1:1; n = 60 per group) to high-intensity interval training (3 × 38 minutes/week), moderate continuous training (5 × 40 minutes/week), or guideline control (1-time advice on physical activity according to guidelines) for 12 months (3 months in clinic followed by 9 months telemedically supervised home-based exercise).

MAIN OUTCOMES AND MEASURES

Primary end point was change in peak V̇o2 after 3 months, with the minimal clinically important difference set at 2.5 mL/kg/min. Secondary end points included changes in metrics of cardiorespiratory fitness, diastolic function, and natriuretic peptides after 3 and 12 months.

RESULTS

Among 180 patients who were randomized (mean age, 70 years; 120 women [67%]), 166 (92%) and 154 (86%) completed evaluation at 3 and 12 months, respectively. Change in peak V̇o2 over 3 months for high-intensity interval training vs guideline control was 1.1 vs -0.6 mL/kg/min (difference, 1.5 [95% CI, 0.4 to 2.7]); for moderate continuous training vs guideline control, 1.6 vs -0.6 mL/kg/min (difference, 2.0 [95% CI, 0.9 to 3.1]); and for high-intensity interval training vs moderate continuous training, 1.1 vs 1.6 mL/kg/min (difference, -0.4 [95% CI, -1.4 to 0.6]). No comparisons were statistically significant after 12 months. There were no significant changes in diastolic function or natriuretic peptides. Acute coronary syndrome was recorded in 4 high-intensity interval training patients (7%), 3 moderate continuous training patients (5%), and 5 guideline control patients (8%).

CONCLUSIONS AND RELEVANCE

Among patients with HFpEF, there was no statistically significant difference in change in peak V̇o2 at 3 months between those assigned to high-intensity interval vs moderate continuous training, and neither group met the prespecified minimal clinically important difference compared with the guideline control. These findings do not support either high-intensity interval training or moderate continuous training compared with guideline-based physical activity for patients with HFpEF.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02078947.

摘要

重要性

耐力运动在改善射血分数保留的心力衰竭(HFpEF)患者的峰值摄氧量(peak V̇o2)方面是有效的。然而,尚不清楚不同的运动模式是否具有不同的效果。

目的

确定高强度间歇训练、中等连续训练和基于指南的体力活动建议对 HFpEF 患者 peak V̇o2 变化是否有不同的影响。

设计、地点和参与者:2014 年 7 月至 2018 年 9 月在德国柏林、莱比锡和慕尼黑、比利时安特卫普和挪威特隆赫姆的 5 个地点进行的随机临床试验。从 532 名筛选出的患者中,纳入了 180 名患有慢性、稳定的 HFpEF 的久坐患者。核心实验室对结果进行了分析,尽管治疗组的患者和工作人员没有进行分析,但他们是盲目的;然而,进行评估的患者和工作人员没有被蒙蔽。

干预措施

患者被随机分配(1:1:1;每组 60 人)接受高强度间歇训练(3×38 分钟/周)、中等连续训练(5×40 分钟/周)或指南对照(根据指南进行一次体力活动建议)治疗 12 个月(3 个月在诊所,随后 9 个月在家进行远程医疗监督的基于家庭的运动)。

主要结局和测量

主要终点是 3 个月时 peak V̇o2 的变化,最小临床重要差异设定为 2.5mL/kg/min。次要终点包括 3 个月和 12 个月时心肺功能、舒张功能和利钠肽变化的指标。

结果

在随机分组的 180 名患者中(平均年龄 70 岁;120 名女性[67%]),分别有 166 名(92%)和 154 名(86%)在 3 个月和 12 个月时完成了评估。与指南对照组相比,高强度间歇训练组的 peak V̇o2 在 3 个月内的变化为 1.1 比-0.6mL/kg/min(差异为 1.5[95%CI,0.4 至 2.7]);中等连续训练组为 1.6 比-0.6mL/kg/min(差异为 2.0[95%CI,0.9 至 3.1]);高强度间歇训练组与中等连续训练组相比,为 1.1 比 1.6mL/kg/min(差异为-0.4[95%CI,-1.4 至 0.6])。12 个月后,没有比较具有统计学意义。舒张功能或利钠肽没有明显变化。高强度间歇训练组有 4 例(7%)、中等连续训练组有 3 例(5%)和指南对照组有 5 例(8%)患者记录到急性冠状动脉综合征。

结论和相关性

在 HFpEF 患者中,与高强度间歇训练或中等连续训练相比,在 3 个月时 peak V̇o2 的变化在统计学上没有显著差异,与指南对照组相比,两组均未达到预定的最小临床重要差异。这些发现不支持高强度间歇训练或中等连续训练与基于指南的体力活动相比,HFpEF 患者。

试验注册

ClinicalTrials.gov 标识符:NCT02078947。

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