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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.

ABSTRACT: 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).

SUBMITTER: Tavoian D

PROVIDER: S-EPMC8652071 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background High-resistance inspiratory muscle strength training (IMST) is a novel, time-efficient physical training modality. Methods and Results We performed a double-blind, randomized, sham-controlled trial to investigate whether 6 weeks of IMST (30 breaths/day, 6 days/week) improves blood pressure, endothelial function, and arterial stiffness in midlife/older adults (aged 50-79 years) with systolic blood pressure ≥120 mm Hg, while also investigating potential mechanisms and long-lasting effects. Thirty-six participants completed high-resistance IMST (75% maximal inspiratory pressure, n=18) or low-resistance sham training (15% maximal inspiratory pressure, n=18). IMST was safe, well tolerated, and had excellent adherence (≈95% of training sessions completed). Casual systolic blood pressure decreased from 135±2 mm Hg to 126±3 mm Hg (P<0.01) with IMST, which was ≈75% sustained 6 weeks after IMST (P<0.01), whereas IMST modestly decreased casual diastolic blood pressure (79±2 mm Hg to 77±2 mm Hg, P=0.03); blood pressure was unaffected by sham training (all P>0.05). Twenty-four hour systolic blood pressure was lower after IMST versus sham training (P=0.01). Brachial artery flow-mediated dilation improved ≈45% with IMST (P<0.01) but was unchanged with sham training (P=0.73). Human umbilical vein endothelial cells cultured with subject serum sampled after versus before IMST exhibited increased NO bioavailability, greater endothelial NO synthase activation, and lower reactive oxygen species bioactivity (P<0.05). IMST decreased C-reactive protein (P=0.05) and altered select circulating metabolites (targeted plasma metabolomics) associated with cardiovascular function. Neither IMST nor sham training influenced arterial stiffness (P>0.05). Conclusions High-resistance IMST is a safe, highly adherable lifestyle intervention for improving blood pressure and endothelial function in midlife/older adults with above-normal initial systolic blood pressure. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03266510.

Project description:Hypertension in childhood may continue into adulthood and lead to adverse cardiovascular outcomes. Evidence suggests that adenotonsillectomy for childhood obstructive sleep apnea (OSA) may be associated with blood pressure (BP) improvement. However, how adenotonsillectomy is associated with BP in hypertensive and nonhypertensive children with OSA remains unclear.To investigate disparities in BP changes after adenotonsillectomy in hypertensive and nonhypertensive children with OSA.From January 1, 2010, to April 30, 2016, children (aged <18 years) with symptoms of OSA treated at National Taiwan University Hospital were enrolled in this retrospective case series study.Children underwent polysomnography for diagnosis of OSA (apnea-hypopnea index >1). All children with OSA underwent adenotonsillectomy.Preoperative and postoperative overnight polysomnographic data were obtained. Office BP was measured in a sleep center before (nocturnal BP) and after (morning) polysomnography.A total of 240 nonobese children (mean [SD] age, 7.3 [3.0] years; 160 [66.7%] male and 80 [33.3%] female) with OSA were recruited. Postoperatively, the apnea-hypopnea index decreased significantly from 12.1 to 1.7 events per hour (95% CI of difference, -12.3 to -8.4 events per hour). The whole cohort had a significant decrease in nocturnal diastolic BP (66.9 to 64.5 mm Hg; 95% CI of difference, -4.1 to -0.7 mm Hg) and morning diastolic BP (66.9 to 64.4 mm Hg; 95% CI of difference, -4.2 to -0.8 mm Hg). The number (percentage) of patients with diastolic BP in the greater than 95th percentile decreased significantly nocturnally (48 [20.0%] to 33 [13.8%]; 95% CI of difference, -12.1% to -0.4%) and in the morning (52 [21.7%] to 34 [14.2%]; 95% CI of difference, -13.6% to -1.4%). Postoperatively, hypertensive children had a significant decrease in all BP measures, including mean (SD) nocturnal and morning systolic BP (nocturnal: 107.5 [8.6] mm Hg; morning: 106.0 [9.4] mm Hg), systolic BP index (nocturnal: -4.3 [8.6]; morning: -5.7 [8.5]), diastolic BP (nocturnal: 65.1 [11.5] mm Hg; morning: 64.4 [10.1] mm Hg), and diastolic BP index (nocturnal: -10.7 [17.3]; morning: -11.6 [15.7]), whereas the nonhypertensive group had a slight increase in nocturnal systolic BP (103.8 to 105.9 mm Hg; 95% CI of difference, 0.4-3.9 mm Hg). A generalized estimating equation model for subgroup comparisons revealed that children with hypertension, compared with those without, had greater improvement in all BP measures.Hypertensive children with OSA had a significant improvement in BP after adenotonsillectomy. Hypertensive children with OSA should be screened and treated by adenotonsillectomy because proper treatment not only eases OSA symptoms but also potentially prevents future cardiovascular and end-organ disease.

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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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