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中文标题: 肺康复综合指导运动训练对 COPD 患者的影响:一项随机对照试验的研究方案。

Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial.

机构信息

Department of Pulmonary Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, Guangdong Province, China.

The Second Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510403, Guangdong Province, China.

出版信息

Trials. 2023 Jan 30;24(1):69. doi: 10.1186/s13063-022-07058-2.

Abstract

BACKGROUND

Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease creating an immense burden on social health care systems. Pulmonary rehabilitation (PR) has proven to be effective in patients with COPD. However, exercise training as the basis of PR becomes extremely tedious, occasionally causing a loss of perseverance in patients. Therefore, we considered an approach that makes this technique interesting and easier to persist. The aim of this project was to explore an exercise training approach based on PR-integrated coached exercise training to promote the new exercise training approach as a form of group rehabilitation activity in the future.

METHODS

Participants will be randomly divided into the trial and control groups. The trial group will be treated with PR-integrated coached exercise training (plus usual care). All exercise programs will be guided by sports coaches with a physical education background. Meanwhile, the control group will receive traditional PR and home exercises, including walking and swimming. The study will last for 12 weeks. The primary outcome measure is exercise tolerance using the 6-min walking test and secondary outcomes are the peak oxygen uptake of cardiopulmonary exercise tests, the COPD Assessment Test, and the St. Georges Respiratory Questionnaire. Other evaluated outcomes include changes in postbronchodilator forced expiratory volume at 1 second, forced vital capacity, body fat and muscle composition, and mental status measured using the Hamilton Anxiety and Depression Scales.

DISCUSSION

This study provides a simple, feasible, repeatable, and fun exercise training approach. To the best of our knowledge, there are no randomized controlled trials in the existing literature on PR-integrated coached exercise. The protocol shared in our study can be used as a reference for exercise training in patients with COPD.

TRIAL REGISTRATION

Ethical approval (BF2020-236-02) was obtained from the Guangdong Provincial Hospital of Chinese Medicine Human Research Ethics Committee. All participants signed an informed consent form. ChiCTR-2100043543. The registration date is 2021/02/21 and it is the third version.

摘要

背景

慢性阻塞性肺疾病(COPD)是最常见的慢性肺部疾病,给社会医疗保健系统带来了巨大的负担。肺康复(PR)已被证明对 COPD 患者有效。然而,作为 PR 基础的运动训练变得非常乏味,有时会导致患者失去毅力。因此,我们考虑采用一种使这种技术更有趣且更容易坚持的方法。本项目的目的是探索一种基于 PR 整合指导运动训练的运动训练方法,以便将来将这种新的运动训练方法作为一种团体康复活动形式推广。

方法

参与者将被随机分为试验组和对照组。试验组将接受 PR 整合指导运动训练(加常规护理)。所有运动方案都将由具有体育背景的运动教练指导。同时,对照组将接受传统的 PR 和家庭运动,包括散步和游泳。研究将持续 12 周。主要结局测量是 6 分钟步行试验的运动耐量,次要结局是心肺运动试验的峰值摄氧量、COPD 评估测试和圣乔治呼吸问卷。其他评估结果包括支气管扩张剂后 1 秒用力呼气量、用力肺活量、体脂肪和肌肉成分以及使用汉密尔顿焦虑和抑郁量表测量的精神状态的变化。

讨论

本研究提供了一种简单、可行、可重复且有趣的运动训练方法。据我们所知,现有的 PR 整合指导运动训练文献中没有随机对照试验。我们分享的方案可以作为 COPD 患者运动训练的参考。

试验注册

广东中医药大学附属医院人类研究伦理委员会已批准(BF2020-236-02)。所有参与者均签署了知情同意书。ChiCTR-2100043543。注册日期为 2021 年 2 月 21 日,为第三版。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fe7/9887849/261053a99858/13063_2022_7058_Fig1_HTML.jpg

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