Six Months of Inspiratory Muscle Training to Lower Blood Pressure and Improve Endothelial Function in Middle-Aged and Older Adults With Above-Normal Blood Pressure and Obstructive Sleep Apnea: Protocol for the CHART Clinical Trial.
Six Months of Inspiratory Muscle Training to Lower Blood Pressure and Improve Endothelial Function in Middle-Aged and Older Adults With Above-Normal Blood Pressure and Obstructive Sleep Apnea: Protocol for the CHART Clinical Trial.
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DOI：
10.3389/fcvm.2021.760203
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发表时间：
2021
影响因子：
3.6
通讯作者：
Bailey EF
中科院分区：
文献类型：
--
作者：
Tavoian D;Ramos-Barrera LE;Craighead DH;Seals DR;Bedrick EJ;Alpert JS;Mashaqi S;Bailey EF
背景：心血管疾病是一个主要的全球性健康问题，并且在患有阻塞性睡眠呼吸暂停（OSA）的成年人中患病率很高。降低血压（BP）可以大大降低心血管疾病的风险，而体力活动是实现这一目标的常规处方。不幸的是，由于睡眠质量差和夜间低氧血症，许多患有OSA的成年人患有疲劳、白天嗜睡和运动不耐受，并且难以启动和维持运动计划。高阻力吸气肌肉力量训练（IMST）是一种简单、省时的呼吸练习，据报道，它可以降低健康和高危成人的血压。在此，我们提出了一项随机临床试验的研究方案，以确定在中老年OSA患者中定期进行IMST 24周的长期疗效。主要结局为偶发收缩压。次要结果是24小时收缩压和循环血浆去甲肾上腺素浓度。其他结局包括血管内皮功能（内皮依赖性和非依赖性舒张）、主动脉僵硬度、偶发和24小时舒张压以及循环因子对内皮细胞一氧化氮和活性氧产生的影响。总的来说，这项试验将确定高阻力IMST降低血压和改善中老年OSA患者心血管健康的疗效。方法：这是一项单中心、双盲、随机临床试验。将入组至少92名和最多122名年龄在50-80岁之间的患有OSA和高于正常血压的男性和女性成人。完成基线评估后，受试者将以1：1的比例随机分配参加高阻力或假（低阻力）对照IMST，在家中进行，5分钟/天，5天/周，持续24周。在24周干预后以及自由生活4周和12周后将进行重复评估。讨论：本研究旨在评估24周IMST对血压和血管功能的影响。结果将表征IMST在较长时间内（即，6个月）比以前评估的要长。此外，这项研究将有助于确定驱动IMST诱导的BP降低的潜在机制，以前已经报道过。临床试验注册：本试验在ClinicalTrials.gov注册（注册号：NCT 04932447;注册日期：2021年6月21日）。
Background: Cardiovascular disease is a major global health concern and prevalence is high in adults with obstructive sleep apnea (OSA). Lowering blood pressure (BP) can greatly reduce cardiovascular disease risk and physical activity is routinely prescribed to achieve this goal. Unfortunately, many adults with OSA suffer from fatigue, daytime sleepiness, and exercise intolerance—due to poor sleep quality and nocturnal hypoxemia—and have difficulty initiating and maintaining an exercise program. High-resistance inspiratory muscle strength training (IMST) is a simple, time-efficient breathing exercise consistently reported to reduce BP in small, selective groups of both healthy and at-risk adults. Herein we present the study protocol for a randomized clinical trial to determine the long-term efficacy of IMST performed regularly for 24 weeks in middle-aged and older adults with OSA. The primary outcome is casual systolic BP. Secondary outcomes are 24-h systolic BP and circulating plasma norepinephrine concentration. Other outcomes include vascular endothelial function (endothelial-dependent and -independent dilation), aortic stiffness, casual and 24-h diastolic BP, and the influence of circulating factors on endothelial cell nitric oxide and reactive oxygen species production. Overall, this trial will establish efficacy of high-resistance IMST for lowering BP and improving cardiovascular health in middle-aged and older adults with OSA. Methods: This is a single-site, double-blind, randomized clinical trial. A minimum of 92 and maximum of 122 male and female adults aged 50–80 years with OSA and above-normal BP will be enrolled. After completion of baseline assessments, subjects will be randomized in a 1:1 ratio to participate in either high-resistance or sham (low-resistance) control IMST, performed at home, 5 min/day, 5 days/week, for 24 weeks. Repeat assessments will be taken after the 24-week intervention, and after 4 and 12 weeks of free living. Discussion: This study is designed to assess the effects of 24 weeks of IMST on BP and vascular function. The results will characterize the extent to which IMST can reduce BP when performed over longer periods (i.e., 6 months) than have been assessed previously. Additionally, this study will help to determine underlying mechanisms driving IMST-induced BP reductions that have been reported previously. Clinical Trial Registration: This trial is registered with ClinicalTrials.gov (Registration Number: NCT04932447; Date of registration June 21, 2021).
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影响因子：
1.9
作者：
Ahmad M;Makati D;Akbar S
通讯作者：
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