The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection

Phase

N/A

Condition

Chest Pain

Occlusions

Cardiovascular Disease

Treatment

Supervised Exercise Regiment

Clinical Study ID

NCT05499650

HP-00099260

Ages 18-88
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 to 88
History of aortic dissection > 90 Days from acute event
Previous operative or non-operative management of aortic dissection
Ability to undergo basic level of activity and exercise
Able to consent
Capable of basic communication and recall

Exclusion

Exclusion Criteria:

History of surgically untreated Type A Dissection
Patients within 90 days of acute dissection event
Patients with unstable coronary artery disease
Patients with severe cardiopulmonary disability (class III/IV heart failure and/orejection fraction < 20%),
Patients with malignant hypertension
Patients with previous stroke with significant persistent motor deficit
Patients with any orthopedic or podiatric conditions altering their ambulationstatus will be excluded.
Patients with any other health reasons which preclude exercise tolerance such asmorbid obesity (BMI > 39 kg/m2), severe hepatic dysfunction, critical aorticstenosis, or active pericarditis or myocarditis.
Patients with allergies to iodinated contrast as would be used for CT scansurveillance.
Patients who have significant barriers for reliable follow-up
Patients with significant cognitive impairment, or who are unable to carry-out basiccommunication and recall.
Patients belonging to vulnerable populations
Patients with connective tissue disorders such as Marfan's syndrome, Ehlers-DanlosType IV, or Loesz-Dietz syndrome
Patients who are unable or unwilling to consent
Age less than 18 or over 88.

Study Design

Supervised Exercise Regiment

October 04, 2021

May 31, 2024

Study 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.

Connect with a study center

Baltimore VA Medical Center
Baltimore, Maryland 21201
United States
Site Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.