Trial of Exercise in Aortic Dissection Survivors

Status unconfirmed · Not applicable

Conditions studied: Thoracic Aortic Dissection

In brief

The primary objective of this study is to test the safety and mental health benefits of a guided exercise program for people who survived an acute aortic dissection. This study is designed to answer several questions: 1. Can supervised exercise improve confidence and mental health in dissection survivors?; 2. How safe are different types of exercise for people who are living with severe aortic disease?; 3. Can tests be developed to determine rational and safe limits to guide exercise recommendations for individual patients?; 4. Does the blood pressure response to exercise predict risks for aortic enlargement or dissection in unique ways that other tests may not detect? The long-term goal of this research is to develop new guidelines for exercise and daily activities that promote the safety and well-being of all TAD patients. All participants will be required to: * Complete online questionnaires (demographic survey, 2009 Behavioral Risk Factor Surveillance Survey, the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) v2.0 profile questionnaire) * Exercise (\>150 minutes/week) * Receive all usual clinically indicated care, including diagnostic tests and medications. Recommendations for tests or interventions will not change based on the assigned study arm. Participants who are randomized to guided exercise group will undergo initial training that consists of: one video demonstration, one exercise training session or group session, one follow up home visit, and virtual check-ins. Participants who are randomized to usual care will attend routine clinic visits but will not receive any teaching or supervision and will not participate in any in-person or virtual exercise sessions. Instead, they will receive standardized counseling about exercise, including an exercise pamphlet that is given to all TAD patients.

Key facts

Study ID

NCT05610462

Run by

The University of Texas Health Science Center, Houston

People needed

126

Starts

2023-01-28

Expected to finish

2024-10-31

Last updated by the study team

2024-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who survived a thoracic aortic dissection (Type A or B) at least 3 months prior to study.

You may not qualify if…

• Routine participation in > 150 minutes per week of moderate intensity exercises
• Unable to attend at least one exercise training session in person
• Uncontrolled hypertension: mean SBP > 160 mmHg at rest
• Symptomatic aortic, coronary, or vascular disease
• Unable to complete exercise circuit due to physical limitations, equipment, space, or time commitment
• Do not own a treadmill or stationary cycle or have regular access to one at a gym.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Texas Health Science Center, Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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