FLEX AAA
Research type
Research Study
Full title
Feasibility and acceptability of a remote community exercise and lifestyle change intervention in patients with smaller abdominal aortic aneurysms.
IRAS ID
366358
Contact name
Gerard Stansby
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
This feasibility study aims to determine whether a six-month remote, community-based exercise and lifestyle program, in addition to usual care, can be implemented effectively for both men and women with small and medium Abdominal Aortic Aneurysms (AAAs) less than 5.5cmsand to collect the key health parameters needed for designing a future definitive trial. For patients with small and medium AAAs, structured exercise and lifestyle interventions delivered remotely may improve cardiovascular health and slow aneurysm progression.
AAAs occur in approximately 5–7.5% of men aged 65 and older, with a smaller but more severe risk profile in women; once an AAA exceeds 5.5 cm in diameter, the risk of rupture escalates significantly, resulting in high morbidity and mortality. Although current management strategies focus on routine ultrasound surveillance and general lifestyle advice, many patients struggle to adopt or sustain the recommended behavioural changes that could mitigate cardiovascular risk.
In this study, 70 participants with AAAs measuring under 5.5 cm will be randomly assigned (1:1) to an intervention or a control group. The intervention group will participate in twice-weekly exercise sessions (comprising aerobic and resistance training, delivered via video conferencing) and will receive weekly behaviour change counselling (addressing smoking cessation, dietary modifications, alcohol reduction, and mental well-being) over a three-month period, followed by monthly support calls for an additional three months. A quarter of the intervention group (n=8/9) will have a follow-up for an extra six months, totalling 12 months of support. Control participants will receive usual care per standard AAA guidelines for 6 months.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
26/WM/0072
Date of REC Opinion
9 Apr 2026
REC opinion
Favourable Opinion