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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
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
Study Summary
This trial tests how supervised exercise can improve confidence and mental health, and safety of exercise for people living with severe aortic disease, with the goal of developing guidelines for safer exercise.
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.Check my eligibility
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.See study design
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with clinically important difference (CID) in the PROMIS-29 T score or the PROMIS mental health summary score
Secondary outcome measures
Change in ambulatory nocturnal dipping
Antihypertensive Agents
Change in aortic augmentation index
+12 moreTrial 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.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
906 Previous Clinical Trials
322,988 Total Patients Enrolled
Washington University School of MedicineOTHER
1,940 Previous Clinical Trials
2,303,269 Total Patients Enrolled
University of MichiganOTHER
1,800 Previous Clinical Trials
6,379,014 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is consistently higher than 160 over 90 when you are not active.I have symptoms from heart or blood vessel problems.I cannot complete exercise routines due to physical limits or lack of resources.I survived a major artery tear in my chest at least 3 months ago.You do not have a treadmill or stationary cycle at home or regular access to one at a gym.You regularly do more than 150 minutes of moderate exercise each week.I cannot attend at least one exercise session in person.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Control
- Group 2: Guided Exercise Training Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the opportunity for enrolment in this study still available?
"According to clinicaltrials.gov, this medical study has ceased recruiting new patients as of November 4th 2022; the trial was first available on January 1st 2023. Nevertheless, there are currently 52 other trials that are still taking participants."
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