The Inter and Intra Reliability of Cardiopulmonary Exercise Testing in Abdominal Aortic Aneurysm Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Anaerobic threshold
研究概览
简要总结
Exercise testing is commonly being used in patients before surgery to test their overall fitness. One group it is being used in is patients who have an enlarged blood vessel in their stomach. This is known as an abdominal aortic aneurysm. The exercise test used is known as a cardiopulmonary exercise test as it looks at both heart and lung function at the same time. Whilst this test is commonly used there have been no studies (to date) which have looked at how reliable this test is; this means how well the investigators can obtain the same (or very similar) results after multiple tests. The investigators would like to test this reliability both between patients and the clinicians performing the testing.
详细描述
Background Research:
The definition of an 'aneurysm' is permanent, localised dilatation of a blood vessel or heart chamber. The abdominal aorta is the largest blood vessel in the human body and usually has a diameter of 1.8 -2.0 centimetres (cm), dependant on age, sex and body habitus. Aortic dilatation is generally classed as an 'aneurysm' when dilation of the vessel is 1.5 times the normal size. An abdominal aortic aneurysm (AAA) affects any part of the aorta below the diaphragm with 80 % typically being found between the renal artery and aortic bifurcation.
Risk Factors There are many factors that relate to the development of AAA. Gender is one of the biggest non-modifiable risk factors, as an AAA is four to six times more likely in males compared with females. Furthermore, the development of AAA in females occurs approximately ten years later than males. The risk of AAA also increases if there is family history of the disease, especially if the relative is first degree. There is also evidence to suggest there is an association between AAA and coronary heart disease. Hypertension has also been found to closely correlate with the development of AAA. Additionally, there is also a strong link between smoking and the likelihood of AAA development. Conversely, whilst the risk of AAA development in women is less than men, women have been shown to be more vulnerable to developing AAA than their male counterparts. The risk of AAA's also increases after the age of 65 years.
If AAA are left undetected or untreated there is an increase in the likelihood of a rupture occurring. This causes critical internal bleeding and often results in death. Rupture of AAA is the cause of approximately 6000 deaths per year in the United Kingdom. Figures between 1997- 2005 have shown a decrease in mortality but this is due to an earlier detection (of around five to ten years). The likelihood of rupture increases due to age, sex, smoking, hypertension and size and growth rate of the aneurysm. The size of the aneurysm is the strongest predictor of risk of rupture, smoking also contributes to an acceleration in expansion rate.
Ultrasound Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Must be over the age of 45
- •The patients must have the ability to walk unaided
- •Must be considered for open or endovascular repair
- •Have an AAA diameter of 5.4 cm or over.
- •English speaking and able to follow simple protocol instructions
排除标准
- •• Active cancer treatment.
- •Patients whom are not able to give informed consent
- •Severe cardiovascular, musculo-skeletal or pulmonary illness precluding ability to partake in CPEX testing.
研究组 & 干预措施
Treadmill-Test operator A
Randomised to motorised treadmill group A for inter reliability, observer A will perform both exercise tests
干预措施: Observer (Other)
Treadmill-Test operator B
Randomised to motorised treadmill group B for intra reliability, observer A will perform one exercise test, followed by observed B
干预措施: Observer (Other)
Cycle-Test operator A
Randomised to cycle group B for inter reliability, observer A will perform both exercise tests
干预措施: Observer (Other)
Cycle-Test operator B
Randomised to cycle group B for intra reliability, observer A will perform one exercise test, followed by observed B
干预措施: Observer (Other)
结局指标
主要结局
Anaerobic threshold
时间窗: Up to One week
The anaerobic threshold is a physiological measurement which is generated via breath by breath analysis and determined by the v-slope method as described in the summary.
次要结局
- Quality of life Questionnaire(Up to One week)
- Minute ventilation(Up to One week)
- Respiratory exchange ratio(Up to One week)
- Total time of exercise(Up to One week)
- Time to anaerobic threshold(Up to One week)
- Maximal oxygen uptake(Up to One week)