Aortic DissectionNCT05499650
The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection
A study testing Supervised Exercise Regiment in people with Aortic Dissection, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Supervised Exercise Regiment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center
Baltimore, Maryland, 21201
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
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.
Read the detailed description
This is a pilot longitudinal study with the primary goal of validating preclinical results and demonstrating the safety and feasibility of moderate aerobic exercise in patients with aortic dissection. The study will enroll 5 patients with a history of aortic dissection >90 days from inciting event treated either operatively or non-operatively. Future studies will recruit a larger cohort of patients.
In addition to standard therapy, subjects will undergo supervised aerobic exercise, with a set goal mean energy expenditure of at least 1000 kcal/wk.
Based on the literature, and preliminary data, it is anticipated that exercise therapy initiated in conjunction with standard of care medical and surgical management of type B thoracic aortic dissection is safe and improves patient quality of life. Subjects will undergo supervised aerobic exercise. Baseline testing includes a CT with a standard protocol for high resolution imaging of the vasculature called a CT angiogram (CTA), cardiopulmonary exercise testing, maximal oxygen consumption (peak VO2) during a treadmill test, and arterio-venous differences, a quality-of-life questionnaire, and an assessment of activity at baseline with the 7- day activity recall questionnaire, this will be obtained between the clinic visit at which informed consent is obtained and initiation of the study. In addition to baseline testing, cardiopulmonary testing, a quality-of-life questionnaire, and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months. CTA will occur at baseline (if none exists within 30 days) and at 3 months. 3-month data will be compared with baseline data and analyzed by a paired T-test for continuous data. In addition to baseline testing cardiopulmonary testing, a quality-of-life questionnaire and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months, as well as a CTA. The 3-month data will be compared with baseline data and analyzed by a pair of T-tests for continuous data.
Patients will also receive standard therapy for the management of chronic aortic dissection. This includes adequate blood pressure control and heart rate control with beta-blockers or calcium-channel blockers. A standard therapy will allow the real-world practice of standard of care for the medical goals of maintenance of systolic blood pressure between 100-120 mm Hg. And heart rates with 60-80 beats per minute. Patients will be directed not to partake in strenuous resistance exercises such as weight-lifting, but will also not be given direction regarding the amount of activity they should adhere to on a weekly basis.
- Conditions
- Aortic Dissection
- Being tested
- Supervised Exercise Regiment
- Keywords
- Exercise, Fluid Dynamics, Quality of Life
- Medical subject headings
- Aortic Dissection, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise RegimentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Patients will be required to undergo an exercise program. Pre-intervention and post-intervention outcomes will be compared in each patient. Receives: Behavioral: Supervised Exercise Regiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related Quality of Life (HRQOL) scores
0-30 Unhealthy days, lower being better
Measured: 3 months
Physical Activity Scale for the Elderly (PASE) scores
0-400, Higher being better
Measured: 3 months
Secondary outcomes (3)
Aortic Shear Stress
Pascal; CT-based Computation fluid dynamics will determine pre and post-exercise regimen change in aortic shear stress
Measured: 3 months
Maximal oxygen consumption during Exercise (V02 Max)
A fitness measurement (higher number indicates higher fitness). This estimate uses the ratio of maximum heart rate (HRmax) to resting heart rate (HRrest) to predict V̇O2 max (mL/kg/min).
Measured: 3 months
Number of aortic related hospitalization
Observational aortic related hospitalizations (admission requirement secondary to acute aortic pathology)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start4 Oct 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: No sufficient eligible participants identified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park
- Responsible party
- Principal investigator, Areck Ucuzian, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499650
- Sponsor's protocol ID
- HP-00099260
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection
- ClinicalTrials.gov ID
- NCT05499650
- Acronym / sponsor ID
- HP-00099260
- Conditions
- Aortic Dissection
- Keywords
- Exercise, Fluid Dynamics, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No sufficient eligible participants identified.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Maryland, College Park
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot longitudinal study with the primary goal of validating preclinical results and demonstrating the safety and feasibility of moderate aerobic exercise in patients with aortic dissection. The study will enroll 5 patients with a history of aortic dissection >90 days from inciting event treated either operatively or non-operatively. Future studies will recruit a larger cohort of patients.
In addition to standard therapy, subjects will undergo supervised aerobic exercise, with a set goal mean energy expenditure of at least 1000 kcal/wk.
Based on the literature, and preliminary data, it is anticipated that exercise therapy initiated in conjunction with standard of care medical and surgical management of type B thoracic aortic dissection is safe and improves patient quality of life. Subjects will undergo supervised aerobic exercise. Baseline testing includes a CT with a standard protocol for high resolution imaging of the vasculature called a CT angiogram (CTA), cardiopulmonary exercise testing, maximal oxygen consumption (peak VO2) during a treadmill test, and arterio-venous differences, a quality-of-life questionnaire, and an assessment of activity at baseline with the 7- day activity recall questionnaire, this will be obtained between the clinic visit at which informed consent is obtained and initiation of the study. In addition to baseline testing, cardiopulmonary testing, a quality-of-life questionnaire, and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months. CTA will occur at baseline (if none exists within 30 days) and at 3 months. 3-month data will be compared with baseline data and analyzed by a paired T-test for continuous data. In addition to baseline testing cardiopulmonary testing, a quality-of-life questionnaire and an assessment of activity at baseline with the 7-day activity recall questionnaire will occur at 3 months, as well as a CTA. The 3-month data will be compared with baseline data and analyzed by a pair of T-tests for continuous data.
Patients will also receive standard therapy for the management of chronic aortic dissection. This includes adequate blood pressure control and heart rate control with beta-blockers or calcium-channel blockers. A standard therapy will allow the real-world practice of standard of care for the medical goals of maintenance of systolic blood pressure between 100-120 mm Hg. And heart rates with 60-80 beats per minute. Patients will be directed not to partake in strenuous resistance exercises such as weight-lifting, but will also not be given direction regarding the amount of activity they should adhere to on a weekly basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Supervised Exercise RegimentPatients will be required to undergo an exercise program. Pre-intervention and post-intervention outcomes will be compared in each patient. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Exercise RegimentSubjects 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. | Behavioural | Exercise Group |
Primary outcome
Health related Quality of Life (HRQOL) scores
Time frame: 3 months
0-30 Unhealthy days, lower being better
Physical Activity Scale for the Elderly (PASE) scores
Time frame: 3 months
0-400, Higher being better
3 secondary outcomes
Aortic Shear Stress
Time frame: 3 months
Maximal oxygen consumption during Exercise (V02 Max)
Time frame: 3 months
Number of aortic related hospitalization
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Regiment in people with Aortic Dissection, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related Quality of Life (HRQOL) scores (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.