Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06127147
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-11-06
Brief Title:
High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Effects of High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation Intervention on Cardiovascular Functions in Patients With Heart Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Backgroundaim Endothelial function is closely associated with coronary artery health among individuals being treated for heart disease An impairment in endothelial function promotes arterial stiffening that directly contributes to elevated systolic blood pressure as a result of increased vascular resistance Inspiratory muscle training is simply a form of training consisting of repeated inspirations against resistance Inspiratory muscle training has also been applied to patients with chronic disease or as an additional therapy for cardiac rehabilitation and it has proven to be safe in these groups Few studies in the literature examined the effects of high-intensity inspiratory muscle training in this population however these studies did not examine the direct effects of inspiratory muscle training on vascular function To the best of our knowledge the effects of inspiratory muscle training in patients with heart disease on endothelial function and arterial stiffness prior to starting cardiac rehabilitation have not been investigated This study aims to investigate and interpret whether high-intensity inspiratory muscle training beyond the usual care of heart disease improves endothelial function and arterial stiffness
Methods The study was designed as a randomized controlled trial Patients will be allocated for inspiratory muscle training IMT with 60 of maximum inspiratory pressure MIP or sham inspiratory muscle training Sham-control for 4 weeks In both groups before and after 4-week training cardiovascular functions will be measured and compared
Methods The study was designed as a randomized controlled trial Patients will be allocated for inspiratory muscle training IMT with 60 of maximum inspiratory pressure MIP or sham inspiratory muscle training Sham-control for 4 weeks In both groups before and after 4-week training cardiovascular functions will be measured and compared
Detailed Description:
Background Cardiovascular diseases CVD remain a leading cause of morbidity and mortality in both men and women in developed and developing societies Joseph et al 2017 Some degree of pulmonary dysfunction is highly likely in patients with heart disease compared to those withoutCalles et al 2016 Cahalin and Arena 2015 This can affect pulmonary function and gas exchange as well as decrease maximum inspiratory and expiratory pressures MIP and MEP respectivelyDos Santos et al 2019 Haeffener et al 2008 Roncada et al 2015 Cahalin and Arena 2015
Inspiratory muscle training has been shown to be an effective form of training that enhances lung function It consists of repetitive breath cycles where one inspires against resistance placed by a device and expires against no resistance Studies that have applied this form of training in patients with heart disease have found significant improvements in MIP-MEP tidal volume vital capacity and 6-minute walking distance Few studies have examined the effects of high-intensity between 50-80 of MIP inspiratory muscle training in patients with heart disease Dos Santos et al 2019 Dos Santos et al 2021 Laoutaris et al 2007 Miozzo et al 2018 Sadek et al 2022 This level of training has been associated with greater improvements in the aferomentioned outcomes of interest however no study has explored the effects of high-intensity inspiratory muscle training in patients with heart disease on measures of cardiovascular function
Aim This study aims to investigate and interpret whether high-intensity inspiratory muscle training beyond the usual care improves endothelial function and arterial stiffness on cardiovascular function in patients with heart disease
Methods The study was designed as a randomized controlled trial After coronary artery bypass graft surgery patients will be invited to the study The demographic and clinical characteristics of the patients will be recorded after consent is obtained from the volunteer patients who meet the inclusion criteria Subsequently patients will be randomly divided into two groups for inspiratory muscle training IMT with 60 maximum inspiratory pressure MIP or sham inspiratory muscle training Sham-control for 4 weeks In both groups before and after 4-week training resting blood pressure systolicdiastolic resting heart rate endothelial function arterial stiffness functional exercise capacity the severity of dyspnea and inspiratory muscle functions will be measured
Inspiratory muscle training has been shown to be an effective form of training that enhances lung function It consists of repetitive breath cycles where one inspires against resistance placed by a device and expires against no resistance Studies that have applied this form of training in patients with heart disease have found significant improvements in MIP-MEP tidal volume vital capacity and 6-minute walking distance Few studies have examined the effects of high-intensity between 50-80 of MIP inspiratory muscle training in patients with heart disease Dos Santos et al 2019 Dos Santos et al 2021 Laoutaris et al 2007 Miozzo et al 2018 Sadek et al 2022 This level of training has been associated with greater improvements in the aferomentioned outcomes of interest however no study has explored the effects of high-intensity inspiratory muscle training in patients with heart disease on measures of cardiovascular function
Aim This study aims to investigate and interpret whether high-intensity inspiratory muscle training beyond the usual care improves endothelial function and arterial stiffness on cardiovascular function in patients with heart disease
Methods The study was designed as a randomized controlled trial After coronary artery bypass graft surgery patients will be invited to the study The demographic and clinical characteristics of the patients will be recorded after consent is obtained from the volunteer patients who meet the inclusion criteria Subsequently patients will be randomly divided into two groups for inspiratory muscle training IMT with 60 maximum inspiratory pressure MIP or sham inspiratory muscle training Sham-control for 4 weeks In both groups before and after 4-week training resting blood pressure systolicdiastolic resting heart rate endothelial function arterial stiffness functional exercise capacity the severity of dyspnea and inspiratory muscle functions will be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None