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Effects of Exercise on Thoracic Aneurysms (EXTRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197648
Recruitment Status : Unknown
Verified February 2020 by Paul Poirier, Laval University.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Poirier, Laval University

Brief 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.


Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysm Device: Exercise group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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): 24 week supervised exercise program. Control group: Daily life activities

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a 6 Months Exercise Program on Blood Pressure Response in Patients With Non-surgical Ascendant Thoracic Aneurysms
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: Exercise group
24 week, supervised exercise program at the PPMC (pavillon de prevention des maladies cardiaques). 3x/week. Blood pressure response evaluated during every session.
Device: Exercise group
24 week supervised exercise program (strength and cardiovascular program).

No Intervention: Control goup
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.



Primary Outcome Measures :
  1. Aneurysm diameter [ Time Frame: At 6 months of intervention ]
    Aneurysm dilation diameter is stable or comparable to control group



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • Have an interest in participating in a supervised exercise training program
  • Have read and signed the information and consent form
  • CT scan, confirming aortic diameter between 4 and 5 cm (<6 months)

Exclusion Criteria

  • Having a aortic ascendant or other heart surgery
  • Marfan syndrome or other genetic disease/syndrome explaining the thoracic aortic aneurysm
  • Having a major cognitive limitation that could possibly influence the presence to visits
  • Having a cardiac stimulator
  • Having physical limitations that limit the participation to the strength exercises
  • Aortic diameter greater than 5.0 cm
  • Diameter progression of more than 0.5 cm/year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197648


Contacts
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Contact: Paul Poirier, MD (418) 656-4767 paul.poirier@criucpq.ulaval.ca
Contact: François Dagenais, MD (418) 656-4717 francois.dagenais@fmed.ulaval.ca

Locations
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Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada, G1V4G5
Contact: Marie Thibault, BSc       marie.thibault@criucpq.ulaval.ca   
Contact: Audrey Auclair, PhD    4186568711 ext 3213    audrey.auclair@criucpq.ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Paul Poirier, MD Fondation IUCPQ
Publications of Results:
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Responsible Party: Paul Poirier, Cardiologist, Laval University
ClinicalTrials.gov Identifier: NCT04197648    
Other Study ID Numbers: 21794
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases