Page 255 - Read Online
P. 255
Page 6 of 10 Toy et al. Vessel Plus 2024;8:22 https://dx.doi.org/10.20517/2574-1209.2023.149
inaccessibility (49), and physical inability to exercise (42). To date, a total of 81 trial participants were
enrolled with complete study data [Table 1]. No participants were excluded after randomization.
Participants who had Type A dissections (n = 51) received TEVAR (n = 2), had open repairs (n = 44), or had
no interventions (n = 5). Participants who had Type B dissections (n = 25) received TEVAR (n = 10), had
open repairs (n = 4), or had no interventions (n = 11). Participants who had more than one dissection
underwent only open repairs (n = 5). There were no significant differences in demographic characteristics
by intervention type [Supplementary Table 2].
PROMIS questionnaire
Evaluation of seven PROMIS domains found that mean T scores for anxiety (51 ± 9), pain (51 ± 7), and
impairment of participation in social activities (54 ± 8) were increased. Scores for depression, fatigue, and
sleep disturbance were within normal limits. There were no significant differences between PROMIS scores
for participants with and without exertional hypertension, between guided exercise and control groups, or
by intervention type [Supplementary Material].
Grip strength
At baseline, the mean maximum grip strength was 64 lbs (IQR 12.9). At the first follow-up visit, grip
strength increased by a mean of 7.8 lb (IQR 6.9). There were no significant differences in grip strength by
intervention type [Supplementary Material].
Orthostatic and ambulatory blood pressure
At baseline, seven participants (9%) exhibited postural orthostasis. The most prevalent adverse ABPM
characteristics were nocturnal hypertension (83%), blunted nocturnal dipping (40%), and elevated mean
24-h pulse pressure (40%). Participants who developed significant exertional hypertension had higher peak
blood pressure values and greater ambulatory blood pressure variability [Table 2]. There were no significant
differences in ABPM characteristics when participants were stratified by intervention type
[Supplementary Table 3]. There was no association between postural orthostasis and exertional
hypertension.
Safety of exercise protocol
All participants completed the study protocol. To date, there have been no participant deaths during the
trial observation period. One in-person exercise session was temporarily delayed after a participant
developed severe exertional hypertension (SBP > 210), but they were able to complete the protocol after
medication adjustment. Exercises that caused SBP to exceed 180 mmHg were: bicep curls (3/37, 8%), wall
sits (7/35, 20%), hand grips (1/37, 3%), leg raise (1/37, 3%), stationary bicycling (4/32, 13%), and treadmill
(3/36, 8%). Exercises that caused DBP to exceed 100 mmHg were: bicep curls (5/37, 14%), wall sits (11/35,
31%), hand grips (7/37, 19%), leg raise (6/37, 16%), stationary bicycling (1/32, 3%), and treadmill (3/36, 8%).
There were no significant differences in the prevalence of exertional hypertension when participants were
stratified according to intervention type [Supplementary Material].
Participant feedback
A total of 35 participants returned surveys about their enrollment experiences (see Supplementary Text 3
for survey details). More than half of respondents (n = 23) agreed that participating in the clinical trial
improved their outlook on exercise. Participants expressed increased confidence to engage in physical
activities and optimism about participating in exercise after attending an in-person clinical trial visit.
Technical issues
Mean individual exercise completion rates from highest to lowest were bicep curls (100%), hand grip