Surviving Aneurysm Surgery: A Pilot Randomised Controlled Trial on Exercise Training in Abdominal Aortic Aneurysm Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cardiopulmonary Exercise Test Score
研究概览
简要总结
An abdominal aortic aneurysm (AAA) is an enlargement or ballooning of the main artery supplying high pressure blood from the heart to the body. AAAs may continue to stretch until they burst (rupture) causing 7000 deaths per year in the United Kingdom (UK); 2.1% of all deaths in men over 65. Planned repair before rupture is critical and the National AAA Screening Programme (NAAASP) is being introduced to identify AAAs in men before rupture. Screening will identify over 9000 men per year with a previously undiagnosed AAA. More than 90% of screen detected AAAs are small, do no require repair, enter ultrasound follow-up (surveillance) and may benefit from exercise to improve fitness before repair.
Over 4000 elective AAA repairs per year are performed in the UK and it has been suggested that exercise training and weight loss may reduce mortality and complications of AAA repair. This pilot study will examine the feasibility of supervised exercise training for patients with AAAs and determine the optimal duration of training to achieve worthwhile improvements in fitness.
详细描述
Abdominal aortic aneurysm (AAA) affects 4% of men aged 65-79, a prevalence rising as our population ages. As most patients suffering rupture die immediately, elective AAA repair is critical and the National AAA Screening Programme (NAAASP) is being implemented across the UK to identify AAAs for elective repair. Manchester is the first major urban population to be screened. The UK had the highest mortality rates following elective open AAA repair in Europe (7% v 3.5%); the AAA Quality Improvement Programme's (AAAQIP) target is to reduce this to under 3.5% by 2013.
The benefits of exercise across a broad spectrum of medical conditions are now increasingly recognised; especially in the elderly. Exercise training may reduce mortality and complications in major surgery. Cardiopulmonary exercise testing (CPET) measures cardiopulmonary reserve and predicts outcome in major surgery. The Manchester CPET study group demonstrated that anaerobic threshold (AT) and peak oxygen consumption (VO2 peak) predict 30 and 90-day mortality in elective AAA repair.
The investigators propose a pilot randomised controlled trial (RCT) to determine whether a structured exercise programme improves fitness measured by CPET, and the optimal duration of training for AAA surgery. As over 90% of AAAs detected by screening are < 5.5cm and enter surveillance, these patients offer a unique opportunity to explore the ideal duration of exercise training as surgery is not indicated for months or years.
100 participants on AAA surveillance will be recruited and randomised to either exercise training or standard preoperative care (50 in each arm) to answer the following research questions:
- Can a supervised exercise programme improve performance in CPET measures that predict outcome in AAA surgery?
- What is the optimal period of training needed to achieve a significant improvement in CPET scores?
- How long is any exercise-induced improvement in fitness sustained?
- The economic and health costs of a supervised exercise training programme
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women with an AAA ≥3.5cm to <5.5cm in men and ≥3.5cm to <5.0cm in women
- •Age 50-85 years and willing to consider exercise training
- •Fit for either open or Endovascular Aneurysm Repair AAA repair
排除标准
- •Unable to participate in an exercise test or inability to exercise consistently because of musculoskeletal or other health problems
- •History of severe liver disease (INR>2, serum albumin <3.0g/dL, jaundice)
- •Unstable angina: Patients with angina of less than 2 months' duration, severe or occurring three or more times per day, or angina that is becoming either more frequent of precipitated by less exertion or angina at rest
- •Uncontrolled atrial fibrillation (AF) or other arrhythmia: Untreated episodes of paroxysmal AF in the last 3 months
- •Moderate or severe aortic valve stenosis (peak systolic pressure gradient > 40mmHg and with an aortic valve area of <1cm^
- •Class III/IV heart failure and / or an ejection fraction <25%
- •Active pericarditis or myocarditis
- •CPET induced ischaemia
- •Diagnosis or treatment for a malignancy (excluding skin) over the previous 12 months
结局指标
主要结局
Cardiopulmonary Exercise Test Score
时间窗: 18 weeks
The investigators will determine if supervised exercise training improves cardiopulmonary fitness. Peak oxygen uptake and ventilatory threshold will be assessed during an incremental-load cycling test.
次要结局
- Quality of Life(18 weeks)
- Cost(18 weeks)
- Cardiopulmonary Exercise Test Score(36 weeks)
- Health-related quality of life(18 weeks)