An interventional study of Guided Exercise Training Program and Usual Care in Thoracic Aortic Dissection, sponsored by The University of Texas Health Science Center, Houston. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Other
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.
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's planned enrollment of 126 is above the median of 87 across 13 interventional studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Patients who survived a thoracic aortic dissection (Type A or B) at least 3 months prior to study.
Exclusion Criteria:
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
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
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 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.
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.
Time frame: Change from baseline PROMIS-29 T score at 12 months
Change in office blood pressure
The mean of three seated brachial measurements will be measured in the non-dominant arm.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Change in grip strength at 12 months
Change in antihypertensive medications
Number of antihypertensive medications x total dosage in mg
Time frame: 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
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
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
Time frame: Baseline
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Oct 2024, 21 months after the start.
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →