Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05499650
Status:
RECRUITING
Last Update Posted:
2023-09-11
First Post:
2022-08-03
Brief Title:
The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection
Status:
RECRUITING
Status Verified Date:
2023-09
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:
Aerobic exercise and physical activity improve patient health in patients in a variety of aspects of life and disease It also improves patients mental well-being and quality of life However the safety of this physical activity and its potential benefits remain uncertain for patients after aortic dissection a tear in the main blood vessel delivering blood to all of the bodys organs
The goal of this study is to facilitate the translation of pre-clinical findings by the Principal Investigator and published literature that demonstrates light to moderate exercise is safe and beneficial in patients with thoracic aortic dissection This will be accomplished by using both imaging-based analyses of aortic wall responses to a 3- month exercise program patient surveys of quality of life metrics functional fitness assessments and clinical outcomes
The goal of this study is to facilitate the translation of pre-clinical findings by the Principal Investigator and published literature that demonstrates light to moderate exercise is safe and beneficial in patients with thoracic aortic dissection This will be accomplished by using both imaging-based analyses of aortic wall responses to a 3- month exercise program patient surveys of quality of life metrics functional fitness assessments and clinical outcomes
Detailed Description:
This is a pilot longitudinal study with the primary goal of validating preclinical results and demonstrating the safety and feasibility of moderate aerobic exercise in patients with aortic dissection The study will enroll 5 patients with a history of aortic dissection 90 days from inciting event treated either operatively or non-operatively Future studies will recruit a larger cohort of patients
In addition to standard therapy subjects will undergo supervised aerobic exercise with a set goal mean energy expenditure of at least 1000 kcalwk
Based on the literature and preliminary data it is anticipated that exercise therapy initiated in conjunction with standard of care medical and surgical management of type B thoracic aortic dissection is safe and improves patient quality of life Subjects will undergo supervised aerobic exercise Baseline testing includes a CT with a standard protocol for high resolution imaging of the vasculature called a CT angiogram CTA cardiopulmonary exercise testing maximal oxygen consumption peak VO2 during a treadmill test and arterio-venous differences a quality-of-life questionnaire and an assessment of activity at baseline with the 7- day activity recall questionnaire this will be obtained between the clinic visit at which informed consent is obtained and initiation of the study In addition to baseline testing cardiopulmonary testing a quality-of-life questionnaire and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months CTA will occur at baseline if none exists within 30 days and at 3 months 3-month data will be compared with baseline data and analyzed by a paired T-test for continuous data In addition to baseline testing cardiopulmonary testing a quality-of-life questionnaire and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months as well as a CTA The 3-month data will be compared with baseline data and analyzed by a pair of T-tests for continuous data
Patients will also receive standard therapy for the management of chronic aortic dissection This includes adequate blood pressure control and heart rate control with beta-blockers or calcium-channel blockers A standard therapy will allow the real-world practice of standard of care for the medical goals of maintenance of systolic blood pressure between 100-120 mm Hg And heart rates with 60-80 beats per minute Patients will be directed not to partake in strenuous resistance exercises such as weight-lifting but will also not be given direction regarding the amount of activity they should adhere to on a weekly basis
In addition to standard therapy subjects will undergo supervised aerobic exercise with a set goal mean energy expenditure of at least 1000 kcalwk
Based on the literature and preliminary data it is anticipated that exercise therapy initiated in conjunction with standard of care medical and surgical management of type B thoracic aortic dissection is safe and improves patient quality of life Subjects will undergo supervised aerobic exercise Baseline testing includes a CT with a standard protocol for high resolution imaging of the vasculature called a CT angiogram CTA cardiopulmonary exercise testing maximal oxygen consumption peak VO2 during a treadmill test and arterio-venous differences a quality-of-life questionnaire and an assessment of activity at baseline with the 7- day activity recall questionnaire this will be obtained between the clinic visit at which informed consent is obtained and initiation of the study In addition to baseline testing cardiopulmonary testing a quality-of-life questionnaire and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months CTA will occur at baseline if none exists within 30 days and at 3 months 3-month data will be compared with baseline data and analyzed by a paired T-test for continuous data In addition to baseline testing cardiopulmonary testing a quality-of-life questionnaire and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months as well as a CTA The 3-month data will be compared with baseline data and analyzed by a pair of T-tests for continuous data
Patients will also receive standard therapy for the management of chronic aortic dissection This includes adequate blood pressure control and heart rate control with beta-blockers or calcium-channel blockers A standard therapy will allow the real-world practice of standard of care for the medical goals of maintenance of systolic blood pressure between 100-120 mm Hg And heart rates with 60-80 beats per minute Patients will be directed not to partake in strenuous resistance exercises such as weight-lifting but will also not be given direction regarding the amount of activity they should adhere to on a weekly basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None