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NCT05610462 · ClinicalTrials.gov registry record · NA
Trial of Exercise in Aortic Dissection Survivors
A NA study of Thoracic Aortic Dissection, sponsored by The University of Texas Health Science Center, Houston.
- Active
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 3
- Study locations
NCT05610462 is a NA study of Thoracic Aortic Dissection that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 126 participants, below the 756-participant average among 5 other Thoracic Aortic Dissection trials with a reported enrollment target (83% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05610462, a NA study of Thoracic Aortic Dissection, is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Guided Exercise Training Program
Study Locations (3)
Michigan
- University of Michigan - Ann Arbor
Missouri
- Washington University in St. Louis - St Louis
Texas
- University of Texas Health Science Center, Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2023-01-28 |
| Est. Completion | 2024-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05610462
The ClinicalTrials.gov registry entry for NCT05610462 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 756-participant average among 5 other Thoracic Aortic Dissection trials with a reported enrollment target (83% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Thoracic Aortic Dissection appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT05610462 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Michigan, Missouri, Texas.
Frequently Asked Questions
What is clinical trial NCT05610462 about?
NCT05610462 is a clinical study titled "Trial of Exercise in Aortic Dissection Survivors". 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 sur...
What is the current status of trial NCT05610462?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2023-01-28. Estimated completion is 2024-10-31.
What conditions does trial NCT05610462 study?
This clinical trial studies the following conditions: Thoracic Aortic Dissection.
What interventions are being tested in trial NCT05610462?
The interventions under investigation include: Usual Care (BEHAVIORAL), Guided Exercise Training Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05610462?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05610462 being conducted?
This trial has 3 study locations across Michigan, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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