心肺运动能力和生活质量的心力衰竭患者接受功能训练计划:随机临床试验研究方案。

Cardiopulmonary exercise capacity and quality of life of patients with heart failure undergoing a functional training program: study protocol for a randomized clinical trial.

机构信息

Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.

National Institute of Science and Technology for Health Technology Assessment (IATS) - CNPq/Brazil, Hospital de Clínicas de Porto Alegre, Clinical Research Center, Rua Ramiro Barcelos, Porto Alegre, RS, 2350, Brazil.

出版信息

BMC Cardiovasc Disord. 2020 Apr 25;20(1):200. doi: 10.1186/s12872-020-01481-6.

DOI:10.1186/s12872-020-01481-6

PMID:32334527

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7183632/

Abstract

BACKGROUND

Exercise intolerance is a common finding in heart failure that generates a vicious cycle in which the individual starts to limit his activities even more due to progressive fatigue. Regular physical exercise can increase the cardiopulmonary exercise capacity of these individuals. A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population. This randomized trial will compare the effects of 36 sessions of functional training versus strength training in heart failure patients.

METHODS

This randomized parallel-design examiner-blinded clinical trial includes individuals of both sexes aged ≥40 years receiving regular follow-up at a single academic hospital. Subjects will be randomly allocated to an intervention group (for 12-week functional training) or an active comparator group (for 12-week strength training). The primary outcomes will be the difference from baseline to the 3-month time point in peak oxygen consumption on cardiopulmonary exercise testing and quality of life assessed by the Minnesota Living with Heart Failure Questionnaire. Secondary outcome measures will include functionality assessed by the Duke Activity Status Index and gait speed test; peripheral and inspiratory muscular strength, assessed by hand grip and manovacuometry testing, respectively; endothelial function by brachial artery flow-mediated dilation; lean body mass by arm muscle circumference; and participant adherence to the exercise programs classified as a percentage of the prescribed exercise dose.

DISCUSSION

The functional training program aims to improve the functional capacity of the individual using exercises that relate to his specific physical activity transferring gains effectively to one's daily life. In this context, we believe that that functional training can increase the cardiopulmonary exercise capacity and quality of life of patients with heart failure. The trial has been recruiting patients since October 2017.

TRIAL REGISTRATION

NCT03321682. Registered on October 26, 2017.

摘要

背景

运动不耐受是心力衰竭的常见表现，会导致恶性循环，使个体因进行性疲劳而进一步限制活动。有规律的体育锻炼可以增加这些个体的心肺运动能力。一种新的体育锻炼方法，即功能训练，可以改善心力衰竭患者的耗氧量和生活质量；然而，目前尚无关于这种运动方式对心力衰竭患者影响的信息。这项随机试验将比较 36 次功能训练与力量训练对心力衰竭患者的影响。

方法

这项随机平行设计、观察者设盲的临床试验纳入了在一家学术医院接受常规随访的≥40 岁的男女两性患者。受试者将被随机分配到干预组（进行 12 周的功能训练）或阳性对照组（进行 12 周的力量训练）。主要结局指标将是心肺运动试验中峰值摄氧量从基线到 3 个月时间点的差异以及明尼苏达州心力衰竭生活质量问卷评估的生活质量。次要结局指标将包括通过杜克活动状态指数和步态速度试验评估的功能；通过握力和手动肺活量试验分别评估的外周和吸气肌力量；通过肱动脉血流介导的扩张评估的内皮功能；通过手臂肌肉周长评估的瘦体重；以及参与者对运动方案的依从性，以规定运动剂量的百分比表示。