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

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...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Dallin Tavoian, Lupita E. Ramos-Barrera, Daniel H. Craighead, Douglas R. Seals, Edward J. Bedrick, Joseph S. Alpert, Saif Mashaqi, E. Fiona Bailey
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	obstructive sleep apnea hypertension inspiratory exercise older adults blood pressure Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/4dd758ee9016457b9c2a91ade99ab5bb
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:4dd758ee9016457b9c2a91ade99ab5bb
record_format	dspace
spelling	oai:doaj.org-article:4dd758ee9016457b9c2a91ade99ab5bb2021-11-30T18:09:49ZSix 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 Trial2297-055X10.3389/fcvm.2021.760203https://doaj.org/article/4dd758ee9016457b9c2a91ade99ab5bb2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fcvm.2021.760203/fullhttps://doaj.org/toc/2297-055XBackground: 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).Dallin TavoianLupita E. Ramos-BarreraDaniel H. CraigheadDouglas R. SealsEdward J. BedrickJoseph S. AlpertJoseph S. AlpertSaif MashaqiSaif MashaqiSaif MashaqiE. Fiona BaileyFrontiers Media S.A.articleobstructive sleep apneahypertensioninspiratoryexerciseolder adultsblood pressureDiseases of the circulatory (Cardiovascular) systemRC666-701ENFrontiers in Cardiovascular Medicine, Vol 8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	obstructive sleep apnea hypertension inspiratory exercise older adults blood pressure Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	obstructive sleep apnea hypertension inspiratory exercise older adults blood pressure Diseases of the circulatory (Cardiovascular) system RC666-701 Dallin Tavoian Lupita E. Ramos-Barrera Daniel H. Craighead Douglas R. Seals Edward J. Bedrick Joseph S. Alpert Joseph S. Alpert Saif Mashaqi Saif Mashaqi Saif Mashaqi E. Fiona Bailey 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
description	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).
format	article
author	Dallin Tavoian Lupita E. Ramos-Barrera Daniel H. Craighead Douglas R. Seals Edward J. Bedrick Joseph S. Alpert Joseph S. Alpert Saif Mashaqi Saif Mashaqi Saif Mashaqi E. Fiona Bailey
author_facet	Dallin Tavoian Lupita E. Ramos-Barrera Daniel H. Craighead Douglas R. Seals Edward J. Bedrick Joseph S. Alpert Joseph S. Alpert Saif Mashaqi Saif Mashaqi Saif Mashaqi E. Fiona Bailey
author_sort	Dallin Tavoian
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/4dd758ee9016457b9c2a91ade99ab5bb
work_keys_str_mv	AT dallintavoian sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT lupitaeramosbarrera sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT danielhcraighead sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT douglasrseals sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT edwardjbedrick sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT josephsalpert sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT josephsalpert sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT saifmashaqi sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT saifmashaqi sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT saifmashaqi sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial AT efionabailey sixmonthsofinspiratorymuscletrainingtolowerbloodpressureandimproveendothelialfunctioninmiddleagedandolderadultswithabovenormalbloodpressureandobstructivesleepapneaprotocolforthechartclinicaltrial
_version_	1718406377022423040

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

Ejemplares similares