Trial of Exercise in Aortic Dissection Survivors

Summary

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.

Conditions

• Thoracic Aortic Dissection

Interventions

BEHAVIORAL

Guided Exercise Training Program

The guided exercise program training consists of: a video demonstration, an exercise training session or group session, a follow up home visit, and virtual check-ins. The exercises include treadmill, wall sits, straight leg raise, bicep curls, hand grips with dynamometer at 40% maximal voluntary contraction (MVC), and Stationary cycling at moderate intensity (100 Watts).

BEHAVIORAL

Usual Care

Usual care consists of routine clinic visits and standardized counseling about exercise, including an exercise pamphlet that is given to all thoracic aortic dissection (TAD) patients.

Sponsors & Collaborators

• Washington University School of Medicine

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• John Ritter Foundation for Aortic Health

  collaborator UNKNOWN

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Siddharth Prakash, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-28

Primary Completion

2024-10-31

Completion

2024-10-31

Countries

• United States

Study Locations