What side effects are associated with this type of intervention?

Common treatments for Thoracic Aortic Dissection include surgical interventions like open repair and endovascular stent grafting, which can lead to side effects such as infection, bleeding, stroke, and paraplegia. Non-surgical treatments typically involve medications like beta-blockers and antihypertensives, with side effects including fatigue, dizziness, and gastrointestinal issues. Exercise programs, as studied in the trial, aim to improve mental health and confidence but may pose risks of musculoskeletal injuries, cardiovascular strain, and blood pressure fluctuations.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned for the treatment of Thoracic Aortic Dissection (TAD) in the provided context. However, the trial of a guided exercise program for TAD survivors aims to improve mental health and confidence through supervised physical activity. This approach assesses the safety and physiological responses to exercise, which is crucial for developing new guidelines for safe exercise and daily activities for TAD patients. Generally, TAD management includes medical therapy to control blood pressure and heart rate, surgical interventions, and lifestyle modifications, including supervised exercise programs to enhance overall well-being.

What other types of research exist?

Promising alternatives to a Guided Exercise Program for TAD patients include: 1) Telehealth-based exercise programs that offer remote supervision and personalized feedback, 2) Virtual reality (VR) exercise platforms that provide immersive and engaging physical activity experiences, 3) Wearable technology for real-time monitoring of physiological responses and safety during exercise, and 4) Biofeedback and heart rate variability (HRV) training to enhance autonomic function and stress management. These alternatives leverage technology to provide safe, effective, and accessible exercise options for TAD patients.

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Guided Exercise for Aortic Dissection

N/A

Waitlist Available

Led By Siddharth Prakash, MD, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Symptomatic aortic, coronary, or vascular disease

Unable to attend at least one exercise training session in person

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a guided exercise program for people who have survived an acute aortic dissection. The goal is to see if supervised exercise can boost their confidence and mental health while ensuring it's safe. Participants will follow a structured exercise routine, and their blood pressure will be monitored to set safe exercise limits.

Who is the study for?

This trial is for survivors of a thoracic aortic dissection who are at least 3 months post-event. It's not for those already doing moderate exercise over 150 minutes weekly, with uncontrolled high blood pressure, symptomatic heart or artery disease, physical limitations preventing exercise, or without access to a treadmill or stationary bike.

What is being tested?

The study tests if guided exercise can improve mental health and confidence in people who've had an aortic dissection. It checks the safety of exercises and aims to set safe limits on activity levels. Participants will either join the guided exercise program or receive usual care with standard advice.

What are the potential side effects?

While specific side effects aren't listed, there may be risks associated with exercising when having severe aortic disease such as increased blood pressure during exertion which could potentially affect the diseased area.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms from heart or blood vessel problems.

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I cannot attend at least one exercise session in person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in exercise minutes between study enrollment and 3 months, 9 months and 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with clinically important difference (CID) in the PROMIS-29 T score or the PROMIS mental health summary score

Secondary study objectives

Change in ambulatory nocturnal dipping

Antihypertensive Agents

Change in aortic augmentation index

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Guided Exercise Training ProgramExperimental Treatment1 Intervention

Participants who are randomized to the 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.

Group II: Usual Care ControlActive Control1 Intervention

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 thoracic aortic dissection (TAD) patients.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Thoracic Aortic Dissection (TAD) include endovascular repair and guided exercise programs. Endovascular repair involves placing a stent-graft within the aorta to reinforce the weakened area, preventing further dissection or rupture and stabilizing blood flow. Guided exercise programs aim to improve mental health and confidence through supervised physical activity, assessing safety and physiological responses to exercise. This is crucial for TAD patients as it helps develop safe exercise guidelines and monitor blood pressure responses to prevent complications, addressing both the structural integrity of the aorta and the overall well-being of the patient.

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