The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection

NCT05499650 | Withdrawn DMC

• 1 other identifier: HP-00099260
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Aerobic exercise and physical activity improve patient health in patients in a variety of aspects of life and disease. It also improves patients' mental well-being and quality of life. However, the safety of this physical activity and its potential benefits remain uncertain for patients after aortic dissection, a tear in the main blood vessel delivering blood to all of the body's organs. The goal of this study is to facilitate the translation of pre-clinical findings by the Principal Investigator and published literature that demonstrates light to moderate exercise is safe and beneficial in patients with thoracic aortic dissection. This will be accomplished by using both imaging-based analyses of aortic wall responses to a 3- month exercise program, patient surveys of quality of life metrics, functional fitness assessments, and clinical outcomes.

Conditions

Aortic Dissection

Keywords

Exercise; Fluid Dynamics; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Health related Quality of Life (HRQOL) scores

  0-30 Unhealthy days, lower being better

  3 months

• Physical Activity Scale for the Elderly (PASE) scores

  0-400, Higher being better

  3 months

Secondary Outcomes (3)

• Aortic Shear Stress

  3 months

• Maximal oxygen consumption during Exercise (V02 Max)

  3 months

• Number of aortic related hospitalization

  1 year

Study Arms (1)

Exercise Group

EXPERIMENTAL

Patients will be required to undergo an exercise program. Pre-intervention and post-intervention outcomes will be compared in each patient.

Behavioral: Supervised Exercise Regiment

Interventions

Supervised Exercise Regiment BEHAVIORAL

Subjects will undergo supervised aerobic exercise. There will be a set goal mean energy expenditure of at least 1000 kcal/wk after a two-week ramp-up period. The protocol will include 30 minutes of moderate-intensity exercise with a treadmill and cycle ergometry, two times weekly. Strenuous resistance training and swimming will be withheld from this protocol due to the potential concerns for safety in exacerbating dissections. Heart rate and ratings of perceived exertion will be quantified during the therapy with a standard set heart rate ad pulse pressure threshold for discontinuing exercise protocols.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 88
• History of aortic dissection \> 90 Days from acute event
• Previous operative or non-operative management of aortic dissection
• Ability to undergo basic level of activity and exercise
• Able to consent
• Capable of basic communication and recall

You may not qualify if:

• History of surgically untreated Type A Dissection
• Patients within 90 days of acute dissection event
• Patients with unstable coronary artery disease
• Patients with severe cardiopulmonary disability (class III/IV heart failure and/or ejection fraction \< 20%),
• Patients with malignant hypertension
• Patients with previous stroke with significant persistent motor deficit
• Patients with any orthopedic or podiatric conditions altering their ambulation status will be excluded.
• Patients with any other health reasons which preclude exercise tolerance such as morbid obesity (BMI \> 39 kg/m2), severe hepatic dysfunction, critical aortic stenosis, or active pericarditis or myocarditis.
• Patients with allergies to iodinated contrast as would be used for CT scan surveillance.
• Patients who have significant barriers for reliable follow-up
• Patients with significant cognitive impairment, or who are unable to carry-out basic communication and recall.
• Patients belonging to vulnerable populations
• Patients with connective tissue disorders such as Marfan's syndrome, Ehlers-Danlos Type IV, or Loesz-Dietz syndrome
• Patients who are unable or unwilling to consent
• Age less than 18 or over 88.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Maryland, College Park: collaborator

Study Sites (2)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Aortic Dissection; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 12, 2022
• Study Start: October 4, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)