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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| University of Michigan | OTHER |
| John Ritter Foundation for Aortic Health | UNKNOWN |
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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:
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:
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.
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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office blood pressure | The mean of three seated brachial measurements will be measured in the non-dominant arm. | Change in office systolic and diastolic blood pressure at 12 months |
| Change in daytime ambulatory hypertensive burden |
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Inclusion Criteria:
-Patients who survived a thoracic aortic dissection (Type A or B) at least 3 months prior to study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siddharth Prakash, MD, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109-5852 | United States | ||
| Washington University in St. Louis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14975480 | Background | 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. | |
| 26769698 |
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| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| D000784 | Aortic Dissection |
| D000092862 | Psychological Well-Being |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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. |
|
In 24 hour ambulatory blood pressures, the % of daytime systolic readings > 135 or diastolic readings > 80 mmHg
| 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 | 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 | 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. | 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 | 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. | 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 | 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 | Change in grip strength at 12 months |
| Change in antihypertensive medications | Number of antihypertensive medications x total dosage in mg | 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 | 12 months |
| Change in systolic blood pressure with exercise | From baseline to end of study visit (12 months after baseline) |
| Change in diastolic blood pressure with exercise | From baseline to end of study visit (12 months after baseline) |
| Post-guided exercise program heart rate | 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 | Baseline |
| St Louis |
| Missouri |
| 63130 |
| United States |
| University of Texas Health Science Center, Houston | Houston | Texas | 77030 | United States |
| Chaddha 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. |
| 23260459 | Background | Braverman 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. |
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| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |