Aortic Aneurysm, Abdominal
Conditions
Brief summary
Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen uptake(peakVO2)\<15ml/kg/min and anaerobic threshold(AT)\<10.2ml/kg/min identifying patients at increased risk of early death after AAA repair.3 These variables can therefore be used as surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA surgery; optimising these markers should improve fitness and decrease this risk. The optimal duration and type of exercise training for improving peak VO2 and AT in AAA patients is not known. AAA patients are unique as they are motivated to reduce the risk of impending surgery but are afforded the time to improve their fitness as repair may not be needed for months or even years. The investigators propose a pilot randomised controlled trial to explore the effectiveness of a 20-week community (either home or gym-based) exercise programme to achieve sustained improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL, habitual activity levels and cardiovascular risk will also be assessed. The results will inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly patients with cardiovascular disease and AAA.
Interventions
BEHAVIORALCommunity based exercise programme
20 week community (home or gym based) exercise programme
OTHERControl
Usual care consisting of advice.
Sponsors
Manchester University NHS Foundation Trust
University of Manchester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak VO2 as measured by CPET | at 20 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of Cardiovascular disease risk | at 20 weeks | — |
| Other risk factors of Cardiovascular disease risk | at 20 weeks | Weight, BMI, Waist Circumference and Blood Pressure |
| Subjective measure of habitual activity levels (PASE questionnaire) | at 20 weeks | — |
| Anaerobic Threshold as measured by CPET | at 20 weeks | — |
| Health-related quality of life | at 20 weeks | — |
| Early changes in outcome measures | at 10 weeks | All outcome measures will also be measured at 10 weeks and compared with other time intervals. |
| Sustainability of changes in outcome measures | at 30 weeks | All outcome measures recorded 10 weeks post cessation of exercise at 30 weeks and compared with the other time intervals. |
| Objective measure of habitual activity levels (via Accelerometry) | at 20 weeks | — |
Contacts
Primary ContactAdam Haque, MBChB, MRCS
Outcome results
None listed