研究方案：一项针对肺动脉高压（ExTra_PH）的运动训练的随机对照试验。

Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH).

机构信息

Allied Health Collaborative, The Prince Charles Hospital, Brisbane, Australia.

School of Allied Health Sciences, Griffith University, Gold Coast, QLD, Australia.

出版信息

BMC Pulm Med. 2018 Mar 1;18(1):40. doi: 10.1186/s12890-018-0586-8.

DOI:10.1186/s12890-018-0586-8

PMID:29490637

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5831614/

Abstract

BACKGROUND

Exercise training is an integral component of evidence-based management programs for many chronic cardiac and respiratory conditions. Despite this, there are limited high-quality studies available on the significance of exercise training in pulmonary hypertension (PH). The aim of this study is to evaluate the short and long-term effectiveness of exercise training in PH patients in terms of exercise capacity, quality of life, cardiac function and disease progression.

METHODS

This randomized control trial will aim to recruit 50 medically stable PH patients categorised as New York Heart Association functional classification II-III. Participants will be randomly allocated to either the supervised exercise training group or usual care group for the 8-week study period. Exercise training will be conducted in an outpatient setting. Measurements at baseline and following the 8-week study period include exercise capacity (6 min walk distance and cardiopulmonary exercise test), cardiac function (exercise cardiac magnetic resonance imaging [CMRI] and echocardiography), health-related quality of life (Cambridge Pulmonary Hypertension Outcome Review), adverse responses to exercise training and time to clinical worsening. In addition, participants will be followed up for a minimum of 2 year period from commencement of the study so as to monitor long-term clinical outcomes i.e. time to clinical worsening.

DISCUSSION

This study will determine whether an 8-week outpatient based supervised exercise training program is safe and beneficial for medically stable PH patients in the short and long term. This will be the first study to examine the impact of exercise training on right heart function using exercise CMRI. Results from the study will contribute new knowledge in relation to the impact of exercise training on cardiac function, long-term prognosis and inform clinical practice guidelines for this patient population. Moreover, the study will add to our understanding regarding the efficacy of exercise training in individuals with PH in an outpatient setting.

TRIAL REGISTRATION

Australia and New Zealand Clinical Trials Registry: ACTRN12616001467426 . Registered 21st October, 2016.

摘要

背景

运动训练是许多慢性心脏和呼吸系统疾病循证管理方案的一个组成部分。尽管如此，关于运动训练在肺动脉高压（PH）中的意义，仍缺乏高质量的研究。本研究旨在评估 PH 患者运动训练在运动能力、生活质量、心脏功能和疾病进展方面的短期和长期效果。

方法

本随机对照试验将招募 50 名医学上稳定的 PH 患者，分为纽约心脏协会功能分类 II-III 级。参与者将被随机分配到监督运动训练组或常规护理组进行 8 周的研究期。运动训练将在门诊环境中进行。基线和 8 周研究期后的测量包括运动能力（6 分钟步行距离和心肺运动试验）、心脏功能（运动心脏磁共振成像[CMRI]和超声心动图）、健康相关生活质量（剑桥肺动脉高压预后审查）、运动训练的不良反应和临床恶化时间。此外，参与者将从研究开始至少随访 2 年，以监测长期临床结局，即临床恶化时间。

讨论

本研究将确定 8 周门诊监督运动训练计划在短期和长期内对医学稳定的 PH 患者是否安全和有益。这将是第一项使用运动 CMRI 检查运动训练对右心功能影响的研究。该研究的结果将为运动训练对心脏功能、长期预后的影响提供新的知识，并为该患者群体的临床实践指南提供信息。此外，该研究将增加我们对门诊环境中 PH 患者运动训练疗效的理解。