The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms

Launched by UNIVERSITY OF MANCHESTER · Dec 19, 2016

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men with an AAA ≥ 3.0 and \< 5.0 cm and women with a AAA ≥ 3.0 and \< 4.5 cm
• • 2. Aged 60 - 85 years inclusive
• • 3. Willing and able to engage in gym- and/or home-based exercise training and undertake CPET
• Exclusion Criteria:
• • 1. Unable or unwilling to undertake CPET or exercise training Patients unwilling will not be able to give informed consent and those who are unable would not be able to be randomised to the intervention study group nor undergo satisfactory testing to obtain our outcome measures.
• • 2. High levels of habitual physical activity (those scoring "high" on the PASE questionnaire) These patients already have a high level of physical activity and therefore it may not be possible to improve their fitness any further which is the primary objective of the study.
• • Exclusion criteria 3-10 are all based on medical conditions which would mean either exercise training may be unsafe, they would require further investigation and treatment of that medical condition or are likely to need upcoming intervention for their medical condition which would take priority over any participation in a research study. If any medical conditions are discovered during the study, these patients will be withdrawn from the study and referred to the necessary health professional.
• • 3. Severe liver disease (INR \> 2, serum albumin \< 3.0g/dL, bilirubin \> 50µmol/L)
• • 4. Unstable angina, angina of \< 2 month's duration, occurring more than twice daily, angina that is increasing in frequency or precipitated by less exertion, angina at rest
• • 5. Uncontrolled atrial fibrillation (AF) or other arrhythmia: untreated paroxysmal AF
• • 6. Moderate or severe aortic valve stenosis (peak systolic pressure gradient \>40mmHg or with an aortic valve area \< 1cm2)
• • 7. Class II/III/IV heart failure and/or left ventricular ejection fraction \< 25%
• • 8. Pericarditis or myocarditis within last six months
• • 9. Patients with \> 2mm ST depression on exercise ECG will not be eligible to take part and will be referred to a cardiologist for further assessment.
• • 10. Diagnosis or treatment for a malignancy over the previous 12 months