Exercise for Thoracic Aortic Aneurysm

(EXTRA Trial)

Overseen By Audrey Auclair, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Aortic valve bicuspidy, Marfan syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise can benefit individuals with a thoracic ascendant aortic aneurysm, a bulging in a major blood vessel near the heart. Researchers aim to determine if a supervised exercise program can lower blood pressure and improve fitness without worsening the aneurysm. Participants will be divided into two groups: one will follow an exercise routine, while the other will continue their usual activities. Suitable candidates for this trial are those interested in a supervised exercise program, with an aortic bulge between 3.5 and 5 cm, and without related surgery or conditions. As an unphased trial, this study offers a unique opportunity to contribute to understanding the benefits of exercise for heart health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for patients with thoracic aortic aneurysm?

Research has shown that light to moderate exercise is usually safe for people with aortic aneurysms. Studies have found that moderate exercise is safe and manageable for many with thoracic aortic aneurysms. This type of exercise can help control blood pressure, a known risk factor for aneurysm complications.

In some studies, patients who exercised improved their heart health without worsening their aneurysms. Tools like the Borg scale, which helps gauge exercise intensity, can ensure individuals stay within a safe range.

Overall, current research supports that moderate exercise is well-tolerated by patients with thoracic aortic aneurysms. However, since individual experiences can differ, consulting a healthcare provider before starting any exercise program is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores exercise as a treatment for thoracic aortic aneurysm, a condition typically managed with careful monitoring and surgery in severe cases. Unlike standard care, which often involves passive observation until surgery is necessary, this trial examines whether a structured exercise program can proactively improve patient outcomes. By introducing physical activity specifically designed for these patients, the trial aims to determine if exercise can safely benefit heart health and potentially delay or reduce the need for surgical intervention. This approach could offer a non-invasive, lifestyle-based strategy that empowers patients to actively contribute to their own health management.

What evidence suggests that exercise is effective for thoracic aortic aneurysm?

This trial will compare an exercise program to no exercise intervention for individuals with thoracic aortic aneurysms. Research has shown that exercise might benefit people with thoracic aortic aneurysms. Studies have found that light to moderate physical activities are safe for these patients. Exercise can help lower blood pressure, a risk factor for aneurysm rupture. Although the effects of exercise on aneurysm size are not fully understood, it can improve heart health and overall fitness. This might help stabilize the aneurysm and enhance quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Poirier, MD

Principal Investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Are You a Good Fit for This Trial?

This trial is for individuals with non-surgical thoracic aortic aneurysms who are interested in participating in a supervised exercise program. They must have had a CT scan confirming an aortic diameter between 4 and 5 cm within the last six months, and they need to understand and agree to the study by signing consent forms.

Inclusion Criteria

I have read and signed the consent form.

I am interested in joining a supervised exercise program.

My CT scan shows my aorta is 4 to 5 cm wide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements including anthropometric measures, blood pressure monitoring, and cardiopulmonary exercise test

1 week

1 visit (in-person)

Treatment

Participants in the exercise group follow a 24-week structured supervised exercise program, while the control group continues daily activities with consultations

24 weeks

3 visits per week (exercise group), 2 visits (control group)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT scans and final assessments

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The trial studies how regular exercise affects blood pressure, muscle strength, aerobic capacity (VO2max), and the size of thoracic aneurysms over time. Participants will be randomly placed into two groups: one that exercises regularly and one control group that does not. Their health will be checked before starting, then after 3 and 6 months.

How Is the Trial Designed?

Group I: Exercise group Experimental Treatment 1 Intervention

Exercise: 12 week, supervised exercise program. 3x/week.

Group II: Control goup Active Control 1 Intervention

No exercise program. Continuation of the daily life activities. Consultation with a kinesiologist at baseline, 3 months and 6 months for advice on physical activities and lifestyle habits.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11677462/

Exercise, Sports, and Cardiac Rehabilitation ... Conclusions: Light to moderate physical activity appears safe and beneficial for patients with aortic aneurysms and post-aortic repair. Given ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04197648

NCT04197648 | Effects of Exercise on Thoracic Aneurysms The effects of exercise on the progression of the aneurysm dilation in patients with thoracic ascendant aortic aneurysm are unknown.

3. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2022.888534/full

Safety of exercise for adults with thoracic aortic aneurysms ... Moderate intensity exercise is safe and feasible for many TAD patients. Our data confirms that the Borg score may be a useful proxy for exercise intensity.

4. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-023-02180-x

Outcomes after cardiac rehabilitation in patients following ... Cardiac rehabilitation could be a promising strategy to improve outcomes such as daily functioning and quality of life following thoracic aortic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0890509624008732

The Impact of Physical Activity on Abdominal Aortic ... Physical activity reduces inflammation and improves blood pressure; effects on aneurysm unclear. •. Optimal exercise for aneurysm patients needs more research ...

6. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1600&context=cardiology_articles

Aortic Aneurysm: DIAGNOSIS, MANAGEMENT, EXERCISE ... Effect of short-term exercise training on aerobic fitness in patients with abdominal aortic aneurysms: a pilot study. Br J Anaesthesia. 2009 ...

7. acc.org acc.org/Latest-in-Cardiology/Articles/2024/09/09/10/21/CV-Sports-Chat-Dilated-Aortas-in-Athletes

CV Sports Chat: Dilated Aortas in Athletes Moderate recreational aerobic exercise is recommended. Athletes with bicuspid aortic valve aortopathy are considered to be at low risk to ...