高强度吸气肌训练、阻力训练及有氧运动对慢性阻塞性肺疾病心血管健康的影响（HIRAC-COPD）：一项随机对照试验方案
Effectiveness of high-intensity inspiratory muscle training, and resistance and aerobic exercise for cardiovascular health in chronic obstructive pulmonary disease (HIRAC-COPD): a randomized controlled trial protocol.
作者信息
Yu Bin, Liu Wenbin, Hu Yuekong, Huang Yuling, Dai Qin, Yang Yuting, Fu Chunmei, Zeng Zhen, Li Lingyan, Yang Bo, Lei Zhiying, Fan Yunzhe, Li Yuchen, Wu Jiang, Zhu Jinxiang, Yu Peng, Yang Jiqi, Zuo Haojiang, Jia Peng, Yang Shujuan
机构信息
Institute for Disaster Management and Reconstruction, Sichuan University-The Hongkong Polytechnic University, Chengdu, 610207, China.
West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China.
出版信息
BMC Pulm Med. 2024 Dec 20;24(1):627. doi: 10.1186/s12890-024-03385-z.
BACKGROUND
Cardiovascular diseases are among the most common and clinically significant comorbidities of chronic obstructive pulmonary disease (COPD). Exercise has been shown to reduce the risk of cardiovascular diseases, and high-intensity inspiratory muscle training (H-IMT) has emerged as a promising intervention for improving arterial stiffness in individuals with COPD. Yet, there is limited evidence from randomized controlled trials (RCTs) regarding the impact of H-IMT alone or in combination with exercise on reducing arterial stiffness in COPD. We designed a three-arm RCT to evaluate the effectiveness of H-IMT, both alone and in combination with exercise, in reducing brachial-ankle pulse wave velocity (baPWV) in individuals with stable COPD within a community setting.
METHODS
This is a three-arm, parallel-group, assessor-blinded, randomized controlled trial with an eight-week intervention period and a 24-week follow-up. The trial will recruit a total of at least 162 participants with stable COPD. All participants will undergo arterial stiffness assessment using an atherosclerosis detector. Eligible participants will then be randomized into either a control group or one of two intervention groups: an H-IMT group combined with aerobic and resistance trainin, or an H-IMT group alone. The primary outcome is the baPWV at eight weeks. Secondary outcomes include baPWV at 4, 16, and 32 weeks, along with self-reported lifestyle factors, sleep quality, mental health outcomes, self-efficacy, implicit health attitudes, quality of life, and clinical outcomes at 4, 8, 16, and 32 weeks. The main analysis will follow the intention-to-treat principle, with the difference in outcome between groups analyzed using multi-level regression at eight weeks.
DISCUSSION
This study will provide evidence on the effects of H-IMT and combined exercise interventions for individuals with COPD in a community setting, offering insights into the use of integrated approaches to enhance cardiovascular health among community-dwelling residents.
TRIAL REGISTRATION NUMBER
ChiCTR2400085483. Date of registration: June 7, 2024. https://www.chictr.org.cn/index.aspx .
背景
心血管疾病是慢性阻塞性肺疾病（COPD）最常见且具有临床意义的合并症之一。运动已被证明可降低心血管疾病风险，而高强度吸气肌训练（H-IMT）已成为改善COPD患者动脉僵硬度的一种有前景的干预措施。然而，关于H-IMT单独或与运动联合对降低COPD患者动脉僵硬度影响的随机对照试验（RCT）证据有限。我们设计了一项三臂RCT，以评估H-IMT单独及与运动联合在社区环境中降低稳定期COPD患者肱踝脉搏波速度（baPWV）的有效性。
方法
这是一项三臂、平行组、评估者盲法的随机对照试验，干预期为8周，随访期为24周。该试验将总共招募至少162名稳定期COPD患者。所有参与者将使用动脉粥样硬化检测仪进行动脉僵硬度评估。符合条件的参与者将被随机分为对照组或两个干预组之一：H-IMT组联合有氧运动和抗阻训练，或单独的H-IMT组。主要结局是8周时的baPWV。次要结局包括4、16和32周时的baPWV，以及自我报告的生活方式因素、睡眠质量、心理健康结局、自我效能感、隐性健康态度、生活质量，以及4、8、16和32周时的临床结局。主要分析将遵循意向性分析原则，使用多水平回归分析8周时组间结局差异。
讨论
本研究将为社区环境中COPD患者的H-IMT及联合运动干预效果提供证据，为采用综合方法促进社区居民心血管健康提供见解。
试验注册号
ChiCTR2400085483。注册日期：2024年6月7日。https://www.chictr.org.cn/index.aspx 。
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