Surviving Aneurysm Surgery (SAS Trial) V1
Research type
Research Study
Full title
Surviving Aneurysm Surgery: A pilot randomised controlled trial on exercise training in abdominal aortic aneurysm patients
IRAS ID
121320
Contact name
Charles McCollum
Contact email
Sponsor organisation
University Hospital of South Manchester NHS Foundation Trust
Clinicaltrials.gov Identifier
Research summary
An abdominal aortic anuerysm (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/year in the UK; 2.1% of all deaths in men aged over 65. Planned repair before rupture is therefore critical and the National AAA Screening Programme (NAAASP) has been introduced to identify AAAs in men before rupture. Screening will identify over 9000 men/year with a previously undiagnosed AAA. More than 90% of screen-detected AAAs are small, do not require immediate repair, enter ultrasound follow-up (surveillance) and may benefit from exercise to improve fitness before repair.
Over 4000 elective AAA repairs/year are performed in the UK with a mortality of 5-8%. Exercise training and weight loss may reduce the mortality and complications of AAA repair. For cancer patients, the time available for exercise is limited by the urgency of surgery. Patients on AAA surveillance offer a unique opportunity to study the efficacy of different training programmes over varying time intervals as repair may not be needed for months or years.
We aim to determine the optimal duration of training to achieve worthwhile improvements in fitness. 100 surveillance patients will be randomised to either exercise training or standard care. Exercise subjects will attned 50 minute supervised exercise programmes of modertate intensity X3/week at a local gym. Improvements in fitness will be measured using objective exercise testing that is known to predict the risk of mortality in major surgery. Other important health outcomes that will be measured include health related quality of life and risk factors for heart attack and stroke.
The information collected from this study will help design a definitive clnical trial on whether exercise training to improve fitness before surgery reduces mortality and complications.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0293
Date of REC Opinion
24 May 2013
REC opinion
Further Information Favourable Opinion