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Toy et al. Vessel Plus 2024;8:22 https://dx.doi.org/10.20517/2574-1209.2023.149 Page 3 of 10

METHODS
Ethics
The study protocol was reviewed and approved by the Committee for the Protection of Human Subjects at
the University of Texas Health Science Center at Houston (UTHealth Houston), University of Michigan,
and Washington University School of Medicine in St. Louis. The protocol number is HSC-MS-22-0936 and
the approval date was November 28, 2022. All subjects signed a written informed consent document prior
to enrollment.

Inclusion/exclusion criteria
This nonblinded randomized controlled clinical trial (clinicaltrials.gov NCT05610462) was designed to
proceed for 18 months: an anticipated 6 months to complete enrollment (May-September 2023) and 12
months of follow up for each participant [Figure 1]. Aortopathy clinics at UTHealth Houston, Washington
University in St. Louis, and the University of Michigan will recruit a total of 126 patients (42 at each site),
male and female, through clinician referral, medical records, databases, and social media campaigns.
Patients who survived a thoracic aortic dissection (Type A or B) at least three months prior to study
enrollment were eligible for inclusion. All potential participants were required to complete the 2009
Behavioral Risk Factor Surveillance Survey (BRFSS) about the amount of time spent weekly on moderate
and strenuous physical activities [Supplementary Text 1]. Patients were excluded if any of the following
apply: routine participation in greater than 150 min per week of moderate-intensity exercises (as assessed by
the BRFSS); unable to attend at least one exercise training session in person; uncontrolled hypertension
(mean SBP greater than 160 mmHg at rest); symptomatic aortic, coronary, or vascular disease; unable to
complete exercise program due to physical limitations, equipment or space limitations, or time
commitment; do not own a treadmill or stationary cycle or have regular access to one at a gym. If patients
are participating in cardiac rehabilitation, enrollment is delayed until after discharge from the rehabilitation
program.

Study design
After confirmation of eligibility and consent, all participants completed a demographic survey (age, sex,
race, ethnicity), and the PROMIS-29 v2.0 profile questionnaire (Patient-Reported Outcomes Measurement
Information System), 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)
[Supplementary Text 2]. At enrollment, all participants were fitted with ambulatory blood pressure
monitors to wear for 24 h (ABPM, OnTrak, Space Labs, Inc.) with the cuff on the non-dominant arm. We
performed arterial pressure waveform and pulse wave velocity analysis (Sphygmocor, AtCor Medical, Inc.)
and recorded one set of orthostatic vital signs (sitting × 3, supine, standing). We also obtained consent to
extract additional outcome data from health records. The study team at UTHealth Houston (KH) randomly
allocated participants in a 1:1 ratio to receive the guided exercise program or usual care on the day of
enrollment. Randomization was stratified according to sex and enrollment site using the randomization
module in REDCap. Participants in both study arms received all usual clinically indicated care, including
diagnostic tests and medications. Recommendations for tests or interventions did not change based on the
assigned study arm. At the concluding study visit 12 months after enrollment, all study participants will
repeat blood pressure measurements and complete the same BRFSS activity and PROMIS-29 v2.0
questionnaires as at enrollment.

Guided exercise
At enrollment, participants who were randomized to the guided exercise arm completed a supervised
exercise protocol that included two circuits of six moderate-intensity exercises: bicep curls, wall sits, hand
grips, leg raises, stationary cycling and treadmill. Bicep curls were performed with the dominant hand using