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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Subjects will undergo supervised aerobic exercise. There will be a set goal mean energy expenditure of at least 1000 kcal/wk after a two-week ramp-up period. The protocol will include 30 minutes of moderate-intensity exercise with a treadmill and cycle ergometry, two times weekly. Strenuous resistance training and swimming will be withheld from this protocol due to the potential concerns for safety in exacerbating dissections. Heart rate and ratings of perceived exertion will be quantified during the therapy with a standard set heart rate ad pulse pressure threshold for discontinuing exercise protocols.
Baltimore VA Medical Center
Baltimore, Maryland, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Health related Quality of Life (HRQOL) scores
0-30 Unhealthy days, lower being better
Time frame: 3 months
Physical Activity Scale for the Elderly (PASE) scores
0-400, Higher being better
Time frame: 3 months
Aortic Shear Stress
Pascal; CT-based Computation fluid dynamics will determine pre and post-exercise regimen change in aortic shear stress
Time frame: 3 months
Maximal oxygen consumption during Exercise (V02 Max)
A fitness measurement (higher number indicates higher fitness). This estimate uses the ratio of maximum heart rate (HRmax) to resting heart rate (HRrest) to predict V̇O2 max (mL/kg/min).
Time frame: 3 months
Number of aortic related hospitalization
Observational aortic related hospitalizations (admission requirement secondary to acute aortic pathology)
Time frame: 1 year
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