Trial of Exercise in Aortic Dissection Survivors

NCT05610462 | Active Not Recruiting

• 1 other identifier: HSC-MS-22-0936
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief 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:

• 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

Keywords

Thoracic Aortic Disease; Ambulatory Blood Pressure; Arterial stiffness; Aortic Dissection; Mental Health; Exercise

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome is a clinically significant change in the PROMIS-29 T score or the PROMIS mental health summary score, a subset of PROMIS questions that primarily assess emotional distress (anxiety and depressive symptoms). The minimum clinically important difference (CID) is 5 points.

  Change from baseline PROMIS-29 T score at 12 months

Secondary Outcomes (15)

• Change in office blood pressure

  Change in office systolic and diastolic blood pressure at 12 months

• Change in daytime ambulatory hypertensive burden

  Change in systolic and diastolic hypertensive burden by ABPM at 12 months

• Change in nighttime ambulatory hypertensive burden

  Change in systolic and diastolic hypertensive burden by ABPM at 12 months

• Prevalence of exertional hypertension

  1 month, at study visit 2

• Change in ambulatory nocturnal dipping

  Change in nocturnal dipping by ABPM at 12 months

Study Arms (2)

Usual Care Control

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Guided Exercise Training Program

EXPERIMENTAL

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.

Behavioral: Guided Exercise Training Program

Interventions

Guided Exercise Training Program BEHAVIORAL

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).

Guided Exercise Training Program

Usual Care BEHAVIORAL

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.

Usual Care Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Washington University School of Medicine: collaborator
• University of Michigan: collaborator
• John Ritter Foundation for Aortic Health: collaborator

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109-5852, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Dissection, Thoracic Aorta; Aortic Dissection; Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Personal Satisfaction; Behavior

Study Officials

• Siddharth Prakash, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 9, 2022
• Study Start: January 28, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)