Testing Exercise group for thoracic aortic aneurysm
Official title: Effects of Exercise on Thoracic Aneurysms
The Effect of Exercise on Thoracic Aortic Aneurysm and Blood Pressure Control.
- 2 groups
- 2 sites in Québec
- Recruiting
Interventions
- Medical device
Exercise group
24 week supervised exercise program (strength and cardiovascular program).
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec
- Not yet recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Allergy to iodine
- +18 years and older
- +Have an interest in participating in a supervised exercise training program
- +Aortic diameter between 3,5 and 5 cm
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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
- +Aortic valve bicuspidy
- +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
- +History of aortic surgery or cardiac surgery
Exclusion
- −Allergy to iodine
- −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
- −Aortic valve bicuspidy
- −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
- −History of aortic surgery or cardiac surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Exercise group.
Registry label: A: Exercise group
Group B receives no study treatment and is followed for comparison.
Registry label: B: Control goup
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around April 2027.
The main measurement is taken over: At 3 months of intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Aneurysm diameter — measured over At 3 months of intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04197648 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Exercise groupDevice
24 week supervised exercise program (strength and cardiovascular program).
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At 3 months of intervention.
The study as a whole is currently expected to finish around 2027-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.