Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02885077
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2016-08-21
Brief Title:
Effects of High-intensity Inspiratory Muscle Training in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Sponsor:
Universidade Federal de Santa Maria
Organization:
Universidade Federal de Santa Maria
Study Overview
Official Title:
Effects of High-intensity Inspiratory Muscle Training Associated With Aerobic and Resistance Exercise in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Even with the advances in clinical therapy and percutaneous interventions coronary artery bypass grafting CABG is still widely used in the treatment of patients with coronary artery disease CAD However it is a complex procedure that triggers important organic implications especially on pulmonary function In relation to the treatment of patients undergoing CABG the recovery is linked to the cardiac rehabilitation programs These programs can also be associated with other muscle training measures among these there is inspiratory muscle training IMT Most studies has been implemented moderate-intensity IMT daily but there are few studies about the effects of high intensity training loads performed on alternate days In this context is justified the use of a device such as the recent Powerbreathe which uses higher training loads that would provide greatest benefits whereas the magnitude of the response to training tends to increase with load
OBJECTIVE To investigate the efficiency of high intensity IMT associated with combined aerobic and resistance training on maximal exercise capacity submaximal exercise capacity respiratory muscle strenght pulmonary function oxidative stress quality of life and endothelial function in patients who underwent CABG in phase II cardiac rehabilitation program
METHODOLOGY This is a clinical trials controlled randomizeddouble-blind being developed in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria HUSM Santa Maria RS Brazil Patients will undergo the evaluation of pulmonary function and respiratory muscle strength spirometry and digital manovacuometry as well on the maximal exercise capacity Ergospirometry submaximal functional capacity 6MWT and 6MST of quality of live MLHFQ of Oxidative stress and endothelial function blood biomarkers After the evaluation will be randomly allocated into two groups the control group will perform cardiac rehabilitation associated with the Sham of IMT and the experimental group cardiac rehabilitation associated with the IMT High-intensity The intervention will last twelve weeks for both groups and after this phase patients will be submitted again to the assessment tools
EXPECTED RESULTS The high intensity IMT potentiates the effects of cardiac rehabilitation phase II after coronary artery bypass surgery patients
OBJECTIVE To investigate the efficiency of high intensity IMT associated with combined aerobic and resistance training on maximal exercise capacity submaximal exercise capacity respiratory muscle strenght pulmonary function oxidative stress quality of life and endothelial function in patients who underwent CABG in phase II cardiac rehabilitation program
METHODOLOGY This is a clinical trials controlled randomizeddouble-blind being developed in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria HUSM Santa Maria RS Brazil Patients will undergo the evaluation of pulmonary function and respiratory muscle strength spirometry and digital manovacuometry as well on the maximal exercise capacity Ergospirometry submaximal functional capacity 6MWT and 6MST of quality of live MLHFQ of Oxidative stress and endothelial function blood biomarkers After the evaluation will be randomly allocated into two groups the control group will perform cardiac rehabilitation associated with the Sham of IMT and the experimental group cardiac rehabilitation associated with the IMT High-intensity The intervention will last twelve weeks for both groups and after this phase patients will be submitted again to the assessment tools
EXPECTED RESULTS The high intensity IMT potentiates the effects of cardiac rehabilitation phase II after coronary artery bypass surgery patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None