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Thoracic Aortic AneurysmEXTRANCT04197648

Effects of Exercise on Thoracic Aneurysms

A study testing Exercise group in people with Thoracic Aortic Aneurysm, run by Laval University at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thoracic Aortic Aneurysm
What is being tested?
Exercise group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesCanada
Study dates
10 Jun 2025to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years and older
  • Have an interest in participating in a supervised exercise training program
  • Aortic diameter between 3,5 and 5 cm

Who cannot join

  • Glomerular filtration rate below 30 mL/min/1.73m²
  • Aortic diameter greater than or equal to 5.1 cm
  • Progression of aortic diameter greater than or equal to 0.5 cm per year
  • Allergy to iodine
  • Aortic valve bicuspidy
  • History of aortic surgery or cardiac surgery
Show all 15Show fewer
  • Presence of an aortic dissection, penetrating aortic ulcer, or intra-mural hematoma of the aorta
  • Presence of Marfan syndrome or other genetic and/or congenital disease explaining the thoracic aortic aneurysm
  • History of stroke
  • Presence of peripheral artery disease
  • History and/or presence of aortitis
  • Known diagnosis of temporal arteritis or rheumatoid arthritis
  • Presence of a pacemaker
  • Major cognitive limitation that may affect adherence to visits
  • Musculoskeletal limitation that restricts participation in the training program

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada2 sites, 2 recruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec, Quebec, G1V 4G5

    Audrey Auclair, PhD, 418-656-8711 ext. 3213, audrey.auclair@criucpq.ulaval.ca

    Recruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec, Quebec, G1V4G5

    Audrey Auclair, PhD, 4186568711 ext. 3213, audrey.auclair@criucpq.ulaval.ca

    Not yet recruiting

Other trials in Canada

About this study

Official title: The Effect of Exercise on Thoracic Aortic Aneurysm and Blood Pressure Control.

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.

Read more

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.

Read the detailed description

To this day, the impact and influence of physical activity in this population has been reported in very few studies, and all have been led in a population with abdominal aorta aneurysm (AAA). These studies conclude that patients should avoid lifting heavy loads as well as performing isometric muscular exercises since these maneuvers increase significantly intra-thoracic pressure as well as blood pressure. As for aerobic exercise, it is recommended that all patient wanting to participate in high intensity activities must perform a cardiopulmonary exercise test (VO2max) to ensure that the systolic blood pressure does no exceed 180 mmHg.

This study will enable us to know the effects of a moderate to high intensity exercise program (80% of anaerobic threshold) on blood pressure response in this population. This will also allow the quantification and qualification of the blood pressure changes following an exercise program as well as the safeness of such an intervention.

Anthropometric measures will be taken for both groups before, at 3 months and 6 months intervention. Firstly, the subjects will be measured using a stadiometer scaled in cm. Then, they will be weighed using a bio-impedance scale of the type InBody (InBody 520, Body Composition Analyzer) in order to measure body composition. The mass values and height will be used to calculate the body mass index (BMI). Finally, waist circumference will be measured directly on the abdomen on the level of the iliac crest using a measuring tape scaled in cm. Waist circumference will be used to assess indirectly abdominal obesity.

In order to measure blood pressure variations and the hypotensive effect of exercise, a 24-hour ambulatory blood pressure monitoring (ABPM) in both groups will be performed at baseline, at 3 months and at 6 months intervention. In the exercise group, the ABPM will also be performed on a consecutive first training session. The measure will be performed over a period of 24 hours. The measures will be taken every 30 minutes during the day and every hour during the night.

A cardiopulmonary exercise test will be performed before, at 3 months and at 6 months intervention, in order to asses the maximum aerobic capacity (VO2max) of the subjects in both groups. This test will take place on an ergometer cycle with electromagnetic brakes (Lode Recumbent, Groningen, Nederland) which allows to determine the work (watts) independently of the rpm. Subjects will breathe in a mouthpiece related to a gas analyser (MedGraphics, St-Paul, MN). Furthermore, a 12 derivation electrocardiogram (Cardioperfect Welch-Allyn, Skaneateles Falls, NY) measuring cardiac activity and an oximeter (N-395 Nellcor, Boulder, CO) measuring the blood oxygen saturation will be installed on the subject for the entire duration of the test. Finally, every two minutes during the test, blood pressure measure will be taken followed by the effort perception based on the modified Borg scale. This test is administered by a certified Clinical Exercise Specialist from the American College of Sport Medicine (ACSM) and supervised by a physician.

A strength evaluation will be performed for both groups before, 3 months and at 6 months intervention. In order to obtain a specific and reliable exercise prescription for each subject, the 1 maximal repetition (MR) will be estimated using linear equations <10 MR since it is not recommended to asses 1 MR in this population due to the high blood pressure that this type of evaluation generates.

Handgrip strength will be measured. In a standing position, the patient will perform a maximum muscle contraction of the hand (hand dynamometer). This test will be performed with the right and left hand alternately. Strength evaluation, including the preparation and explanations, will last approximately 45 minutes.

In order to note the energy expense of each participant in both groups, a wireless portable monitor SenseWearPro2 (SWA; Body Media, Pittsburgh, USA) will be used. This monitor is an armband that subjects will use at baseline, at 3 months and 6 months. It will be worn during 3 consecutive days, 2 weekdays and 1 day during the weekend. The subjects will wear the armband as soon as they wake up in the morning and will remove it at bedtime.

A CT scan will be performed prior to the study (inclusion criteria; recent CT scan < 6 months), and at the end of the intervention, at 6 months. These CT scans are clinically required for follow up of the aneurysm dilation measure post intervention.

Subjects randomized in the exercise group will follow a 24-week structured supervised exercise program at the "Pavillon de Prévention des Maladies Cardiaques (PPMC) ". Each subject will have a personalized program. The goal is to perform this program 3x/week, and each session will last approximately 60 minutes: 40 minutes high intensity intervals training on cycle ergometer and 20 minutes strength training (2-3 sets, 10-15 repetitions). If needed, every week, the kinesiologist will adjust each participant's exercise program accordingly. The kinesiologist will be certified clinical exercise specialist from the ACSM.

During every session, blood pressure will be monitored at rest, following 5 minutes seated, before and after the session. Blood pressure will be taken during the high intensity interval and one during the low intensity interval. Heart rate will also be monitored during the intervals in order to calculate the double product (HR x SBP).

Subjects in the control group will have a consultation at 3 and 6 months time of the intervention with the kinesiologist. The consultation will last 1 hour. They will be given general advice regarding physical activity as well as healthy lifestyle.

Being tested
Exercise group
Medical subject headings
Aortic Aneurysm, Thoracic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise groupDevice

    24 week supervised exercise program (strength and cardiovascular program).

Study groups in NCT04197648
Study groupRoleWhat they receive
Exercise groupExperimentalExercise: 12 week, supervised exercise program. 3x/week.
Receives: Device: Exercise group
Control goupNo interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aneurysm diameter

    Aneurysm dilation diameter is stable or comparable to control group

    Measured: At 3 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start10 Jun 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Just before the intervention and baseline evaluation, each subject will be randomized either in the exercise or the control group. Experimental group (exercise): 12 week supervised exercise program. Control group: Daily life activities
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197648
Sponsor's protocol ID
2025-4350
Acronym
EXTRA
Status last verified
Jun 2025
First submitted
11 Dec 2019
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not yet approve by our ERB. If we want/plan to share individual participant data, we need to obtain approval from our ERB.

Publications

  • Isselbacher EM. Thoracic and abdominal aortic aneurysms. Circulation. 2005 Feb 15;111(6):816-28. doi: 10.1161/01.CIR.0000154569.08857.7A. No abstract available.

    PubMed 15710776
  • Carvalho RS, Pires CM, Junqueira GC, Freitas D, Marchi-Alves LM. Hypotensive response magnitude and duration in hypertensives: continuous and interval exercise. Arq Bras Cardiol. 2015 Mar;104(3):234-41. doi: 10.5935/abc.20140193. Epub 2014 Dec 16.

    PubMed 25517389
  • Reynolds JM, Gordon TJ, Robergs RA. Prediction of one repetition maximum strength from multiple repetition maximum testing and anthropometry. J Strength Cond Res. 2006 Aug;20(3):584-92. doi: 10.1519/R-15304.1.

    PubMed 16937972
  • Nakayama A, Morita H, Nagayama M, Hoshina K, Uemura Y, Tomoike H, Komuro I. Cardiac Rehabilitation Protects Against the Expansion of Abdominal Aortic Aneurysm. J Am Heart Assoc. 2018 Feb 27;7(5):e007959. doi: 10.1161/JAHA.117.007959.

    PubMed 29487112

Questions about this trial

What is this clinical trial studying?

A study testing Exercise group in people with Thoracic Aortic Aneurysm, run by Laval University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul Poirier, MD ((418) 656-4767, paul.poirier@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aneurysm diameter (time frame: At 3 months of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197648, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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