The AAA Get Fit Trial ver1
Research type
Research Study
Full title
The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise to Improve Fitness and Reduce Morbidity and Mortality of Patients with Abdominal Aortic Aneurysms.
IRAS ID
162347
Contact name
Charles McCollum
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
One in 25 older men will develop an aneurysm (AAA) or ‘ballooning’ of the abdominal aorta which supplies high pressure blood from the heart to the rest of the body. As the AAA enlarges it can eventually rupture which causes 9000 deaths/year in the UK. Pre-emptive surgery to prevent rupture can be performed but even this carries an overall 2.4% risk of death. Low patient fitness has been shown to predict the risk of complications including death, so it follows that improving fitness through exercise before surgery may reduce this risk. However, little is known about what type and what duration of exercise programme is optimal for an elderly population, particularly those with cardiovascular disease.
In the UK, patients known to have AAA but not at a size which would necessitate repair (5.5cm) are placed on a surveillance programme. Patients with these smaller AAA are uniquely motivated as they are likely to need repair, but possibly not for months or even years, meaning they are afforded the time to optimise their health in anticipation of surgery.
In this study, patients will be randomly allocated to either control (usual care consisting of verbal and written advice on exercise, weight loss, diet and smoking) or a 20-week community-based exercise programme, where patients can choose between gym-based or home-based training.
An established test of the heart and lungs (CPET), results of which are frequently used to assess fitness for surgery and can predict risk of complications and death, will measure changes in fitness at 10, 20 and 30 weeks. Changes in quality of life and other markers of heart disease will also be monitored. Our results will help design exercise programmes to reduce complications in AAA and other major surgery with a potential wider application for improved general health in our elderly population.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0188
Date of REC Opinion
17 May 2017
REC opinion
Further Information Favourable Opinion