Thoracic Aortic DissectionNCT05610462
Trial of Exercise in Aortic Dissection Survivors
A study testing Guided Exercise Training Program in people with Thoracic Aortic Dissection, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Dissection
- What is being tested?
- Guided Exercise Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jan 2023to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients who survived a thoracic aortic dissection (Type A or B) at least 3 months prior to study.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109-5852
University of Texas Health Science Center, Houston
Houston, Texas, 77030
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: A Multicenter Randomized Controlled 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:
- Can supervised exercise improve confidence and mental health in dissection survivors?;
- How safe are different types of exercise for people who are living with severe aortic disease?;
- Can tests be developed to determine rational and safe limits to guide exercise recommendations for individual patients?;
- Does the blood pressure response to exercise predict risks for aortic enlargement or dissection in unique ways that other tests may not detect?
Read more
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.
Read the detailed description
Required number of study visits: 6 (3 in-person, 3 virtual)
Estimated total visit time per participant: 8 hours (guided exercise arm), 4 hours (control arm)
- Visit 1 (Enrollment): After confirmation of eligibility and consent, participants will complete a demographic survey (age, sex, race, ethnicity) and the PROMIS-29 v2.0 profile questionnaire, which is validated to assess seven health domains (physical function, fatigue, pain, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). Arterial pressure waveform and pulse wave velocity analysis will be performed (Sphygmocor, AtCor Medical, Inc.) and one set of orthostatic vital signs will be recorded (sitting x 3, lying, standing). Consent will also be obtained to extract additional outcome data from health records.
- Visit 2 (Supervised training session): Participants will be fitted with ambulatory blood pressure monitors (ABPM, OnTrak, Space Labs, Inc.) and will complete an exercise circuit under the supervision of basic life support (BLS)-certified personnel. Participants will maintain each exercise at target intensity for at least 1 minute, or long enough to record at least one measurement. At steady state exertion, spotters will manually trigger OnTrak readings. Participants will pause between each exercise long enough to complete one ABPM reading (3 minutes). The circuit will be repeated once so that there will be two sets of measurements per exercise. Participants will rate their perceived level of exertion on a modified Borg scale.
- In all cases, a spotter will brace the arm during ABPM measurements and ensure that pressures are recorded: Modified treadmill, wall sits, straight leg raises, bicep curls, hand grips with dynamometer at 40% maximum voluntary contraction (MVC) on the dominant arm.
Participants will then receive individualized instruction about how to implement this exercise protocol at home. The study team will promote a weekly target 5 days or at least 150 total minutes of exercise. Participants will complete a survey about where they intend to exercise (in their home or in a gym) and the type of equipment that they plan to use (a treadmill, a bicycle, or both). They will also be counseled to record their activities in an exercise diary. If they have a home blood pressure cuff or wearable device that can record fitness data, they will send the digital files to the study team at UTHealth. The instructional video and a diary template document will be emailed to all participants.
- Visit 3 (Long Virtual Check-in): In the first month after enrollment, the study teams will conduct one video check-in with each participant to assess their home exercise setup, reinforce teaching about the exercise circuit, and answer questions about exercise. During the check-in, they will also observe and correct participants while they perform each exercise.
- Visits 4 and 5 (Short Virtual Check-ins): Shorter video visits without exercise demonstrations will be repeated at 3 and 9 months after enrollment. These visits will be conducted in group sessions where participants will be encouraged to share their experiences with the exercise protocol and to troubleshoot potential obstacles to exercise. Participants will also transmit home blood pressure or fitness data to UTHealth if they are available. The study teams will promote the target of more than 150 minutes of moderate exercises per week at each interaction. All participants will also receive digital REDCap surveys about the intensity and frequency of their activities at 1, 3, and 9 months, and at the conclusion of the study. The content will be the same as the initial survey with an additional link to send messages directly to the study team.
- Visit 6 (End of study visit): All study participants will undergo office blood pressure and Sphygmocor measurements and complete the same BRFSS activity and PROMIS-29 v2.0 questionnaires as at enrollment. They will be asked to wear an ABPM for 24 hours.
- Conditions
- Thoracic Aortic Dissection
- Being tested
- Guided Exercise Training Program, Usual Care
- Keywords
- Thoracic Aortic Disease, Ambulatory Blood Pressure, Arterial stiffness, Aortic Dissection, Mental Health, Exercise
- Medical subject headings
- Dissection, Thoracic Aorta, Aortic Dissection, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Exercise Training ProgramBehavioural
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).
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Guided Exercise Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline PROMIS-29 T score at 12 months
Secondary outcomes (15)
Change in office blood pressure
The mean of three seated brachial measurements will be measured in the non-dominant arm.
Measured: Change in office systolic and diastolic blood pressure at 12 months
Change in daytime ambulatory hypertensive burden
In 24 hour ambulatory blood pressures, the % of daytime systolic readings > 135 or diastolic readings > 80 mmHg
Measured: Change in systolic and diastolic hypertensive burden by ABPM at 12 months
Change in nighttime ambulatory hypertensive burden
In 24 hour ambulatory blood pressures, the % of nighttime systolic readings > 120 or diastolic readings > 65 mmHg
Measured: Change in systolic and diastolic hypertensive burden by ABPM at 12 months
Prevalence of exertional hypertension
Any systolic pressure > 180 mmHg, any diastolic pressure > 110 mmHg, or > 50 mmHg increase in systolic or diastolic pressures with exercise
Measured: 1 month, at study visit 2
Change in ambulatory nocturnal dipping
In 24 hour ambulatory blood pressure, the % drop in mean nighttime pressures compared to mean daytime pressures.
Measured: Change in nocturnal dipping by ABPM at 12 months
Change in aortic augmentation index
Aortic augmentation index will be measured using the Sphygmocor XCEL device
Measured: Change in aortic augmentation index at 12 months
Change in pulse wave velocity
Carotid-femoral pulse wave velocity will be measured using the Sphygmocor XCEL device.
Measured: Change in pulse wave velocity at 12 months
Change in exercise minutes
Minutes of moderate or high intensity exercise per week, as self-assessed by patients on BRFSS questionnaires
Measured: Change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.
Change in grip strength
Maximum grip strength as measured by dynamometer in Kg
Measured: Change in grip strength at 12 months
Change in antihypertensive medications
Number of antihypertensive medications x total dosage in mg
Measured: Change in antihypertensive medications at 12 months
Total study time as a proportion of clinical time
Logged time of all study-specific encounters divided by the estimated total time spent in clinically indicated interactions for TAD surveillance or treatment, ascertained from medical records
Measured: 12 months
Change in systolic blood pressure with exercise
Measured: From baseline to end of study visit (12 months after baseline)
Change in diastolic blood pressure with exercise
Measured: From baseline to end of study visit (12 months after baseline)
Post-guided exercise program heart rate
Measured: Baseline
Systolic blood pressure recovery times
This is the time taken for the post work out blood pressure to get back to at least 10 percent of baseline blood pressure at enrollment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start28 Jan 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic DissectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, University of Michigan, John Ritter Foundation for Aortic Health
- Responsible party
- Principal investigator, Siddharth Prakash, The University of Texas Health Science Center, Houston
- Investigators
- Siddharth Prakash, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610462
- Sponsor's protocol ID
- HSC-MS-22-0936
- Status last verified
- Apr 2024
- First submitted
- 27 Oct 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Januzzi JL, Isselbacher EM, Fattori R, Cooper JV, Smith DE, Fang J, Eagle KA, Mehta RH, Nienaber CA, Pape LA; International Registry of Aortic Dissection (IRAD). Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD). J Am Coll Cardiol. 2004 Feb 18;43(4):665-9. doi: 10.1016/j.jacc.2003.08.054.
PubMed 14975480Chaddha A, Eagle KA, Braverman AC, Kline-Rogers E, Hirsch AT, Brook R, Jackson EA, Woznicki EM, Housholder-Hughes S, Pitler L, Franklin BA. Exercise and Physical Activity for the Post-Aortic Dissection Patient: The Clinician's Conundrum. Clin Cardiol. 2015 Nov;38(11):647-51. doi: 10.1002/clc.22481.
PubMed 26769698Braverman AC. Medical management of thoracic aortic aneurysm disease. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S2-6. doi: 10.1016/j.jtcvs.2012.11.062. Epub 2012 Dec 20.
PubMed 23260459Milewicz DM, Prakash SK, Ramirez F. Therapeutics Targeting Drivers of Thoracic Aortic Aneurysms and Acute Aortic Dissections: Insights from Predisposing Genes and Mouse Models. Annu Rev Med. 2017 Jan 14;68:51-67. doi: 10.1146/annurev-med-100415-022956.
PubMed 28099082Milewicz D, Hostetler E, Wallace S, Mellor-Crummey L, Gong L, Pannu H, Guo DC, Regalado E. Precision medical and surgical management for thoracic aortic aneurysms and acute aortic dissections based on the causative mutant gene. J Cardiovasc Surg (Torino). 2016 Apr;57(2):172-7. Epub 2016 Feb 2.
PubMed 26837258Franz IW, Behr U, Ketelhut R. Resting and exercise blood pressure with atenolol, enalapril and a low-dose combination. J Hypertens Suppl. 1987 Aug;5(3):S37-41.
PubMed 2822879Virtanen K, Janne J, Frick MH. Response of blood pressure and plasma norepinephrine to propranolol, metoprolol and clonidine during isometric and dynamic exercise in hypertensive patients. Eur J Clin Pharmacol. 1982;21(4):275-9. doi: 10.1007/BF00637613.
PubMed 7056271Chen X, Hassan MO, Jones JV, Sleight P, Floras JS. Baroreflex sensitivity and the blood pressure response to beta-blockade. J Hum Hypertens. 1999 Mar;13(3):185-90. doi: 10.1038/sj.jhh.1000786.
PubMed 10204815Hamer M, Bauman A, Bell JA, Stamatakis E. Examining associations between physical activity and cardiovascular mortality using negative control outcomes. Int J Epidemiol. 2019 Aug 1;48(4):1161-1166. doi: 10.1093/ije/dyy272.
PubMed 30541040Gibson C, Nielsen C, Alex R, Cooper K, Farney M, Gaufin D, Cui JZ, van Breemen C, Broderick TL, Vallejo-Elias J, Esfandiarei M. Mild aerobic exercise blocks elastin fiber fragmentation and aortic dilatation in a mouse model of Marfan syndrome associated aortic aneurysm. J Appl Physiol (1985). 2017 Jul 1;123(1):147-160. doi: 10.1152/japplphysiol.00132.2017. Epub 2017 Apr 6.
PubMed 28385916Nakayama A, Morita H, Nagayama M, Hoshina K, Uemura Y, Tomoike H, Komuro I. Cardiac Rehabilitation Protects Against the Expansion of Abdominal Aortic Aneurysm. J Am Heart Assoc. 2018 Feb 27;7(5):e007959. doi: 10.1161/JAHA.117.007959.
PubMed 29487112Bartee S, Shrestha S, Ramos B, Bilbrey T, Carbone P, Schussler JM, Deutsch R, Adams J. Specificity of testing in a cardiac rehabilitation setting resulting in a patient's return to high-intensity outdoor activity following aortic dissection repair. Proc (Bayl Univ Med Cent). 2016 Apr;29(2):151-3. doi: 10.1080/08998280.2016.11929395.
PubMed 27034550Corone S, Iliou MC, Pierre B, Feige JM, Odjinkem D, Farrokhi T, Bechraoui F, Hardy S, Meurin P; Cardiac Rehabilitation working Group of the French Society of Cardiology. French registry of cases of type I acute aortic dissection admitted to a cardiac rehabilitation center after surgery. Eur J Cardiovasc Prev Rehabil. 2009 Feb;16(1):91-5. doi: 10.1097/HJR.0b013e32831fd6c8.
PubMed 19237998Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative. Circ Cardiovasc Qual Outcomes. 2020 Jan;13(1):e005902. doi: 10.1161/CIRCOUTCOMES.119.005902. Epub 2020 Jan 14.
PubMed 31931615Robicsek F, Thubrikar MJ. Hemodynamic considerations regarding the mechanism and prevention of aortic dissection. Ann Thorac Surg. 1994 Oct;58(4):1247-53. doi: 10.1016/0003-4975(94)90523-1.
PubMed 7944800
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Exercise in Aortic Dissection Survivors
- ClinicalTrials.gov ID
- NCT05610462
- Acronym / sponsor ID
- HSC-MS-22-0936
- Conditions
- Thoracic Aortic Dissection
- Keywords
- Thoracic Aortic Disease, Ambulatory Blood Pressure, Arterial stiffness, Aortic Dissection, Mental Health, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, University of Michigan, John Ritter Foundation for Aortic Health
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 9 Nov 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.
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:
- Can supervised exercise improve confidence and mental health in dissection survivors?;
- How safe are different types of exercise for people who are living with severe aortic disease?;
- Can tests be developed to determine rational and safe limits to guide exercise recommendations for individual patients?;
- 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.
Detailed description
Required number of study visits: 6 (3 in-person, 3 virtual)
Estimated total visit time per participant: 8 hours (guided exercise arm), 4 hours (control arm)
- Visit 1 (Enrollment): After confirmation of eligibility and consent, participants will complete a demographic survey (age, sex, race, ethnicity) and the PROMIS-29 v2.0 profile questionnaire, which is validated to assess seven health domains (physical function, fatigue, pain, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). Arterial pressure waveform and pulse wave velocity analysis will be performed (Sphygmocor, AtCor Medical, Inc.) and one set of orthostatic vital signs will be recorded (sitting x 3, lying, standing). Consent will also be obtained to extract additional outcome data from health records.
- Visit 2 (Supervised training session): Participants will be fitted with ambulatory blood pressure monitors (ABPM, OnTrak, Space Labs, Inc.) and will complete an exercise circuit under the supervision of basic life support (BLS)-certified personnel. Participants will maintain each exercise at target intensity for at least 1 minute, or long enough to record at least one measurement. At steady state exertion, spotters will manually trigger OnTrak readings. Participants will pause between each exercise long enough to complete one ABPM reading (3 minutes). The circuit will be repeated once so that there will be two sets of measurements per exercise. Participants will rate their perceived level of exertion on a modified Borg scale.
- In all cases, a spotter will brace the arm during ABPM measurements and ensure that pressures are recorded: Modified treadmill, wall sits, straight leg raises, bicep curls, hand grips with dynamometer at 40% maximum voluntary contraction (MVC) on the dominant arm.
Participants will then receive individualized instruction about how to implement this exercise protocol at home. The study team will promote a weekly target 5 days or at least 150 total minutes of exercise. Participants will complete a survey about where they intend to exercise (in their home or in a gym) and the type of equipment that they plan to use (a treadmill, a bicycle, or both). They will also be counseled to record their activities in an exercise diary. If they have a home blood pressure cuff or wearable device that can record fitness data, they will send the digital files to the study team at UTHealth. The instructional video and a diary template document will be emailed to all participants.
- Visit 3 (Long Virtual Check-in): In the first month after enrollment, the study teams will conduct one video check-in with each participant to assess their home exercise setup, reinforce teaching about the exercise circuit, and answer questions about exercise. During the check-in, they will also observe and correct participants while they perform each exercise.
- Visits 4 and 5 (Short Virtual Check-ins): Shorter video visits without exercise demonstrations will be repeated at 3 and 9 months after enrollment. These visits will be conducted in group sessions where participants will be encouraged to share their experiences with the exercise protocol and to troubleshoot potential obstacles to exercise. Participants will also transmit home blood pressure or fitness data to UTHealth if they are available. The study teams will promote the target of more than 150 minutes of moderate exercises per week at each interaction. All participants will also receive digital REDCap surveys about the intensity and frequency of their activities at 1, 3, and 9 months, and at the conclusion of the study. The content will be the same as the initial survey with an additional link to send messages directly to the study team.
- Visit 6 (End of study visit): All study participants will undergo office blood pressure and Sphygmocor measurements and complete the same BRFSS activity and PROMIS-29 v2.0 questionnaires as at enrollment. They will be asked to wear an ABPM for 24 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | Active comparator | Behavioral: Usual CareParticipants 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. |
| Guided Exercise Training Program | Experimental | Behavioral: Guided Exercise Training ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients who survived a thoracic aortic dissection (Type A or B) at least 3 months prior to study.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Guided Exercise Training ProgramThe 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). | Behavioural | Guided Exercise Training Program |
| Usual CareUsual 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. | Behavioural | Usual Care Control |
Primary outcome
Number of participants with clinically important difference (CID) in the PROMIS-29 T score or the PROMIS mental health summary score
Time frame: Change from baseline PROMIS-29 T score at 12 months
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.
15 secondary outcomes
Change in office blood pressure
Time frame: Change in office systolic and diastolic blood pressure at 12 months
Change in daytime ambulatory hypertensive burden
Time frame: Change in systolic and diastolic hypertensive burden by ABPM at 12 months
Change in nighttime ambulatory hypertensive burden
Time frame: Change in systolic and diastolic hypertensive burden by ABPM at 12 months
Prevalence of exertional hypertension
Time frame: 1 month, at study visit 2
Change in ambulatory nocturnal dipping
Time frame: Change in nocturnal dipping by ABPM at 12 months
Change in aortic augmentation index
Time frame: Change in aortic augmentation index at 12 months
Change in pulse wave velocity
Time frame: Change in pulse wave velocity at 12 months
Change in exercise minutes
Time frame: Change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.
Change in grip strength
Time frame: Change in grip strength at 12 months
Change in antihypertensive medications
Time frame: Change in antihypertensive medications at 12 months
Total study time as a proportion of clinical time
Time frame: 12 months
Change in systolic blood pressure with exercise
Time frame: From baseline to end of study visit (12 months after baseline)
Change in diastolic blood pressure with exercise
Time frame: From baseline to end of study visit (12 months after baseline)
Post-guided exercise program heart rate
Time frame: Baseline
Systolic blood pressure recovery times
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 14975480Januzzi JL, Isselbacher EM, Fattori R, Cooper JV, Smith DE, Fang J, Eagle KA, Mehta RH, Nienaber CA, Pape LA; International Registry of Aortic Dissection (IRAD). Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD). J Am Coll Cardiol. 2004 Feb 18;43(4):665-9. doi: 10.1016/j.jacc.2003.08.054.
- Background: PubMed 26769698Chaddha A, Eagle KA, Braverman AC, Kline-Rogers E, Hirsch AT, Brook R, Jackson EA, Woznicki EM, Housholder-Hughes S, Pitler L, Franklin BA. Exercise and Physical Activity for the Post-Aortic Dissection Patient: The Clinician's Conundrum. Clin Cardiol. 2015 Nov;38(11):647-51. doi: 10.1002/clc.22481.
- Background: PubMed 23260459Braverman AC. Medical management of thoracic aortic aneurysm disease. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S2-6. doi: 10.1016/j.jtcvs.2012.11.062. Epub 2012 Dec 20.
- Background: PubMed 28099082Milewicz DM, Prakash SK, Ramirez F. Therapeutics Targeting Drivers of Thoracic Aortic Aneurysms and Acute Aortic Dissections: Insights from Predisposing Genes and Mouse Models. Annu Rev Med. 2017 Jan 14;68:51-67. doi: 10.1146/annurev-med-100415-022956.
- Background: PubMed 26837258Milewicz D, Hostetler E, Wallace S, Mellor-Crummey L, Gong L, Pannu H, Guo DC, Regalado E. Precision medical and surgical management for thoracic aortic aneurysms and acute aortic dissections based on the causative mutant gene. J Cardiovasc Surg (Torino). 2016 Apr;57(2):172-7. Epub 2016 Feb 2.
- Background: PubMed 2822879Franz IW, Behr U, Ketelhut R. Resting and exercise blood pressure with atenolol, enalapril and a low-dose combination. J Hypertens Suppl. 1987 Aug;5(3):S37-41.
- Background: PubMed 7056271Virtanen K, Janne J, Frick MH. Response of blood pressure and plasma norepinephrine to propranolol, metoprolol and clonidine during isometric and dynamic exercise in hypertensive patients. Eur J Clin Pharmacol. 1982;21(4):275-9. doi: 10.1007/BF00637613.
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- 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.
Siddharth Prakash, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Exercise Training Program in people with Thoracic Aortic Dissection, run by The University of Texas Health Science Center, Houston at 3 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Number of participants with clinically important difference (CID) in the PROMIS-29 T score or the PROMIS mental health summary score (time frame: Change from baseline PROMIS-29 T score at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610462, which also lists 32 linked publications.
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 17 Apr 2024.