Trial of Exercise in Aortic Dissection Survivors

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05610462

Collaborator

Washington University School of Medicine (Other), University of Michigan (Other), John Ritter Foundation for Aortic Health (Other)

126

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

Can supervised exercise improve confidence and mental health in dissection survivors?;
How safe are different types of exercise for people who are living with severe aortic disease?;
Can tests be developed to determine rational and safe limits to guide exercise recommendations for individual patients?;
Does the blood pressure response to exercise predict risks for aortic enlargement or dissection in unique ways that other tests may not detect?

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:

Complete online questionnaires (demographic survey, 2009 Behavioral Risk Factor Surveillance Survey, the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) v2.0 profile questionnaire)
Exercise (>150 minutes/week)
Receive all usual clinically indicated care, including diagnostic tests and medications. Recommendations for tests or interventions will not change based on the assigned study arm.

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Dissection	Behavioral: Guided Exercise Training Program Behavioral: Usual Care	N/A

Detailed Description

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)

Visit 1 (Enrollment): After confirmation of eligibility and consent, participants will complete a demographic survey (age, sex, race, ethnicity) and the PROMIS-29 v2.0 profile questionnaire, 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). Arterial pressure waveform and pulse wave velocity analysis will be performed (Sphygmocor, AtCor Medical, Inc.) and one set of orthostatic vital signs will be recorded (sitting x 3, lying, standing). Consent will also be obtained to extract additional outcome data from health records.
Visit 2 (Supervised training session): Participants will be fitted with ambulatory blood pressure monitors (ABPM, OnTrak, Space Labs, Inc.) and will complete an exercise circuit under the supervision of basic life support (BLS)-certified personnel. Participants will maintain each exercise at target intensity for at least 1 minute, or long enough to record at least one measurement. At steady state exertion, spotters will manually trigger OnTrak readings. Participants will pause between each exercise long enough to complete one ABPM reading (3 minutes). The circuit will be repeated once so that there will be two sets of measurements per exercise. Participants will rate their perceived level of exertion on a modified Borg scale.
In all cases, a spotter will brace the arm during ABPM measurements and ensure that pressures are recorded: Modified treadmill, wall sits, straight leg raises, bicep curls, hand grips with dynamometer at 40% maximum voluntary contraction (MVC) on the dominant 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.

Visit 3 (Long Virtual Check-in): In the first month after enrollment, the study teams will conduct one video check-in with each participant to assess their home exercise setup, reinforce teaching about the exercise circuit, and answer questions about exercise. During the check-in, they will also observe and correct participants while they perform each exercise.
Visits 4 and 5 (Short Virtual Check-ins): Shorter video visits without exercise demonstrations will be repeated at 3 and 9 months after enrollment. These visits will be conducted in group sessions where participants will be encouraged to share their experiences with the exercise protocol and to troubleshoot potential obstacles to exercise. Participants will also transmit home blood pressure or fitness data to UTHealth if they are available. The study teams will promote the target of more than 150 minutes of moderate exercises per week at each interaction. All participants will also receive digital REDCap surveys about the intensity and frequency of their activities at 1, 3, and 9 months, and at the conclusion of the study. The content will be the same as the initial survey with an additional link to send messages directly to the study team.
Visit 6 (End of study visit): All study participants will undergo office blood pressure and Sphygmocor measurements and complete the same BRFSS activity and PROMIS-29 v2.0 questionnaires as at enrollment. They will be asked to wear an ABPM for 24 hours.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Multicenter Randomized Controlled Trial of Exercise in Aortic Dissection Survivors

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care Control 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 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.
Experimental: Guided Exercise Training Program 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).

Arm

Intervention/Treatment

Active Comparator: Usual Care Control

Behavioral: Usual Care

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.

Experimental: Guided Exercise Training Program

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).

Outcome Measures

Primary Outcome Measures

Number of participants with clinically important difference (CID) in the PROMIS-29 T score or the PROMIS mental health summary score [Change from baseline PROMIS-29 T score at 12 months]
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.

Secondary Outcome Measures

Change in office blood pressure [Change in office systolic and diastolic blood pressure at 12 months]
The mean of three seated brachial measurements will be measured in the non-dominant arm.
Change in daytime ambulatory hypertensive burden [Change in systolic and diastolic hypertensive burden by ABPM at 12 months]
In 24 hour ambulatory blood pressures, the % of daytime systolic readings > 135 or diastolic readings > 80 mmHg
Change in nighttime ambulatory hypertensive burden [Change in systolic and diastolic hypertensive burden by ABPM at 12 months]
In 24 hour ambulatory blood pressures, the % of nighttime systolic readings > 120 or diastolic readings > 65 mmHg
Prevalence of exertional hypertension [1 month, at study visit 2]
Any systolic pressure > 180 mmHg, any diastolic pressure > 110 mmHg, or > 50 mmHg increase in systolic or diastolic pressures with exercise
Change in ambulatory nocturnal dipping [Change in nocturnal dipping by ABPM at 12 months]
In 24 hour ambulatory blood pressure, the % drop in mean nighttime pressures compared to mean daytime pressures.
Change in aortic augmentation index [Change in aortic augmentation index at 12 months]
Aortic augmentation index will be measured using the Sphygmocor XCEL device
Change in pulse wave velocity [Change in pulse wave velocity at 12 months]
Carotid-femoral pulse wave velocity will be measured using the Sphygmocor XCEL device.
Change in exercise minutes [Change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.]
Minutes of moderate or high intensity exercise per week, as self-assessed by patients on BRFSS questionnaires
Change in grip strength [Change in grip strength at 12 months]
Maximum grip strength as measured by dynamometer in Kg
Change in antihypertensive medications [Change in antihypertensive medications at 12 months]
Number of antihypertensive medications x total dosage in mg
Total study time as a proportion of clinical time [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

-Patients who survived a thoracic aortic dissection (Type A or B) at least 3 months prior to study.

Exclusion Criteria:

Routine participation in > 150 minutes per week of moderate intensity exercises
Unable to attend at least one exercise training session in person
Uncontrolled hypertension: mean SBP > 160 mmHg at rest
Symptomatic aortic, coronary, or vascular disease
Unable to complete exercise circuit due to physical limitations, equipment, space, or time commitment
Do not own a treadmill or stationary cycle or have regular access to one at a gym.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109-5852
2	Washington University in St. Louis	Saint Louis	Missouri	United States	63130
3	University of Texas Health Science Center, Houston	Houston	Texas	United States	77030