Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05499650 |
| Other study ID # |
HP-00099260 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 3, 2023 |
| Est. completion date |
July 31, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Maryland, Baltimore |
| Contact |
Areck A Ucuzian, MD, PhD |
| Phone |
4103285840 |
| Email |
aucuzian[@]som.umaryland.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 body's 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.
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 kcal/wk.
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.
