The Effect of Exercise on Thoracic Aortic Aneurysm and Blood Pressure Control.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Aneurysm diameter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Have an interest in participating in a supervised exercise training program
- •Aortic diameter between 3,5 and 5 cm
排除标准
- •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
研究组 & 干预措施
Exercise group
Exercise: 12 week, supervised exercise program. 3x/week.
干预措施: Exercise group (Device)
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.
结局指标
主要结局
Aneurysm diameter
时间窗: At 3 months of intervention
Aneurysm dilation diameter is stable or comparable to control group
次要结局
未报告次要终点