Trial of Exercise in Aortic Dissection Survivors

Thoracic Aortic Dissection Clinical Trial

Official title:

A Multicenter Randomized Controlled Trial of Exercise in Aortic Dissection Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05610462
• Other study ID #: HSC-MS-22-0936
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 28, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. Can supervised exercise improve confidence and mental health in dissection survivors?;

2. How safe are different types of exercise for people who are living with severe aortic disease?;

3. Can tests be developed to determine rational and safe limits to guide exercise recommendations for individual patients?;

4. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Aortic Dissection

Intervention

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
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Texas Health Science Center, Houston	Houston	Texas
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	John Ritter Foundation for Aortic Health, University of Michigan, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline PROMIS-29 T score at 12 months
Secondary	Change in office blood pressure	The mean of three seated brachial measurements will be measured in the non-dominant arm.	Change in office systolic and diastolic blood pressure at 12 months
Secondary	Change in daytime ambulatory hypertensive burden	In 24 hour ambulatory blood pressures, the % of daytime systolic readings > 135 or diastolic readings > 80 mmHg	Change in systolic and diastolic hypertensive burden by ABPM at 12 months
Secondary	Change in nighttime ambulatory hypertensive burden	In 24 hour ambulatory blood pressures, the % of nighttime systolic readings > 120 or diastolic readings > 65 mmHg	Change in systolic and diastolic hypertensive burden by ABPM at 12 months
Secondary	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	1 month, at study visit 2
Secondary	Change in ambulatory nocturnal dipping	In 24 hour ambulatory blood pressure, the % drop in mean nighttime pressures compared to mean daytime pressures.	Change in nocturnal dipping by ABPM at 12 months
Secondary	Change in aortic augmentation index	Aortic augmentation index will be measured using the Sphygmocor XCEL device	Change in aortic augmentation index at 12 months
Secondary	Change in pulse wave velocity	Carotid-femoral pulse wave velocity will be measured using the Sphygmocor XCEL device.	Change in pulse wave velocity at 12 months
Secondary	Change in exercise minutes	Minutes of moderate or high intensity exercise per week, as self-assessed by patients on BRFSS questionnaires	Change in exercise minutes between study enrollment and 3 months, 9 months and 12 months.
Secondary	Change in grip strength	Maximum grip strength as measured by dynamometer in Kg	Change in grip strength at 12 months
Secondary	Change in antihypertensive medications	Number of antihypertensive medications x total dosage in mg	Change in antihypertensive medications at 12 months
Secondary	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	12 months
Secondary	Change in systolic blood pressure with exercise		From baseline to end of study visit (12 months after baseline)
Secondary	Change in diastolic blood pressure with exercise		From baseline to end of study visit (12 months after baseline)
Secondary	Post-guided exercise program heart rate		Baseline
Secondary	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	Baseline