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Toy et al. Vessel Plus 2024;8:22 https://dx.doi.org/10.20517/2574-1209.2023.149 Page 5 of 10

received individualized instruction about how to implement the exercise program at home, with the weekly
target of 5 days or at least 150 total min of moderate-intensity exercise. They were also counseled to record
their activities in a monthly exercise diary and share fitness data recorded by home blood pressure cuffs or
wearable devices.

After enrollment, the study teams followed up on participants via video check-ins and surveys. All
participants completed BFRSS surveys about the intensity and frequency of their activities at 1, 3, and
9 months, and at the conclusion of the study. In the first month after enrollment, the study teams conducted
one video check-in with each participant to assess any changes in health status, obtain information about
clinic visits, track exercise progress, reinforce teaching about the exercise circuit, and answer questions
about exercise. During the check-in, the study team also observed and corrected participants as they
performed one exercise. Shorter video visits without exercise demonstrations were repeated at 3 and 9
months after enrollment, in which participants were encouraged to share their experiences with the exercise
protocol and to troubleshoot potential obstacles to exercise. Participants also transmitted home blood
pressure or fitness data to UTHealth if they were available. The study teams promoted the target of more
than 150 min of moderate exercises per week at each interaction.

Usual care
Participants who were randomized to usual care completed 24-h ABPM but did not receive any teaching
regarding exercise and did not participate in any in-person or virtual exercise sessions. Instead, they
attended routine clinic visits and received standardized counseling about exercise, including a pamphlet
with guidelines about living with aortic disease. Participants were not contacted by the study team after the
initial enrollment visit.

Data analysis
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 general population mean of PROMIS T scores is standardized at 50 points with
a standard deviation of 10 points. The minimum clinically important difference (CID) is 5 points. To detect
a change in 5 T score points with beta = 0.80 and alpha = 0.05, target sample size is 63 patients per study arm
(126 total).

ABPM outcomes included mean 24-h, daytime, and nocturnal blood pressures. Pulse pressure, nocturnal
dipping status, blood pressure variability, AASI, and peak systolic pressure were also included in the
analysis because they have been identified as independent predictors of cardiovascular mortality [18,19] . Study
thresholds were derived from published data on ABPM norms: mean 24-h pressure > 125/75 mmHg, mean
daytime pressure > 130/80 mmHg, mean nighttime pressure > 110/65 mmHg, ambulatory arterial stiffness
index (AASI) ≥ 0.70, nocturnal dipping < 10%, peak daytime systolic pressure >180 mmHg, 24-h pulse
pressure > 53 mmHg, and increased blood pressure variability, defined as a coefficient of variation > 11.1.
Postural orthostasis was defined as a > 20 mm Hg decrease in systolic blood pressure and/or a > 10 mm Hg
decrease in diastolic blood pressure when sitting or standing from a supine position. ABP data were
analyzed using Sentinel software (v11, Space Labs, Inc., Snoqualmie, WA). Multiple comparisons were
assessed using one-way ANOVA with the Tukey method.

RESULTS
Study cohort
A total of 445 individuals were screened and 250 were found to be eligible for the study. The major reasons
why individuals were excluded were: unable to attend in-person study visits (55), exercise equipment