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Exercise group for Thoracic Aortic Aneurysm (EXTRA Trial)

N/A
Waitlist Available
Led By Paul Poirier, MD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months of intervention
Awards & highlights

Summary

Thoracic aneurysm incidence is estimated to 4.5 cases per 100 000. The manifestation as well as natural history of thoracic aneurysm depend on many factors such as its localisation, its diameter, presence of collagen disease and family history. For the ascendant aortic aneurysm, it is often linked to a degeneration of the media arterial layer of the arterial wall. The media degeneration is cause by the degeneration of the elastic fibres, which lead to a weakening of the arterial wall accompanied with dilation. This process is often due to age and is accelerated by high blood pressure. Amongst the numerous factors causing the aneurysm, the investigators find: hypertension, aortic bicuspid valve, smoking, atherosclerosis, trauma and genetic predisposition. The average growth rate of thoracic aneurysm is 0.1-0.2 cm/year. The risk of rupture is associated to the size of the aneurysm as well as patient's symptoms. The ruptures and dissections rates are accounted for 2-3/year for thoracic aneurysm between 5.5-6.0 cm in diameter. The patients are often limited in their daily life activities considering their concern and risk of rupture and/or dissect. The effects of exercise on the progression of the aneurysm dilation in patients with thoracic ascendant aortic aneurysm are unknown. It is well known that high blood pressure is a risk factor for rupture of the aortic aneurysm. Many studies have demonstrated the benefits of physical exercise regarding the lowering impact of blood pressure in a cardiac hypertensive population. At 3 and 6 months of the intervention, the subjects in the exercise group will have: 1) a lowered blood pressure at rest and during exercise, 2) maintenance/ improvement of muscle strength, 3) improvement of aerobic exercise capacity (VO2max), and 4) aortic dilation that remained stable or comparable to the control group. The research objective is to measure and compare to a control group, the effects of an exercise program on the following parameters: blood pressure response at rest and during exercise, as well as the VO2max at 3 and 6 months time of the intervention. This randomised and prospective study will take place at the " Institut Universitaire de Cardiologie et de Pneumologie du Québec (IUCPQ) " and will include patients who have a non-surgical ascendant thoracic aortic aneurysm (ATAA). The selected subjects will be randomised into two groups: 1) exercise group (n=15), and 2) control group (n=15). Both groups will be met prior to the intervention (baseline) and at 3 and 6 months time of the intervention, and measures described below will be recorded.

Eligible Conditions
  • Thoracic Aortic Aneurysm

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aneurysm diameter

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise groupExperimental Treatment1 Intervention
24 week, supervised exercise program at the PPMC (pavillon de prevention des maladies cardiaques). 3x/week. Blood pressure response evaluated during every session.
Group II: Control goupActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise group
2023
Completed Phase 2
~4020

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
423 Previous Clinical Trials
173,028 Total Patients Enrolled
Paul Poirier, MDPrincipal InvestigatorFondation IUCPQ
~0 spots leftby Sep 2025