Effects of Exercise on Thoracic Aneurysms

NCT04197648 | Recruiting

• 1 other identifier: 2025-4350
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Thoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Aneurysm diameter

  Aneurysm dilation diameter is stable or comparable to control group

  At 3 months of intervention

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Device: Exercise group

Control goup

NO 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.

Interventions

Exercise group DEVICE

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

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (2)

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

Québec, Quebec, G1V 4G5, Canada

RECRUITING

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

Québec, Quebec, G1V4G5, Canada

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 15710776 BACKGROUND

• 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.

  PMID: 25517389 BACKGROUND

• 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.

  PMID: 16937972 BACKGROUND

• 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.

  PMID: 29487112 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Paul Poirier, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Poirier, MD

CONTACT

(418) 656-4767; paul.poirier@criucpq.ulaval.ca

Audrey Auclair, PhD

CONTACT

(418) 656-8711; audrey.auclair@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 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

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: June 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)