Prehabiliation of AAA patients - multi-centre pilot study
Research type
Research Study
Full title
Multi-centre, pilot study evaluating the feasibility, acceptability and short-term outcomes of a tailored, virtual, home-based, multicomponent prehabilitation programme in patients undergoing abdominal aortic aneurysms (AAA) repair.
IRAS ID
291828
Contact name
Majd Rawashdeh
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Remote 6-week prehabilitation programme for patients awaiting AAA surgery is feasible with acceptable recruitment rates. It also improves the functional capacity of such high-risk patients, associated with improvement in health-related and disease-specific quality of life measures. Participant feedback shows that it is reasonable to implement such a programme in the regular practice of AAA surgery. However, this pilot study has demonstrated that open surgery patients are more accepting of the idea of prehabilitation. As a result, this justifies a large-scale, national randomised controlled study to assess the effectiveness of a remote, tailored prehabilitation programme to improve AAA surgery outcomes.Abdominal aortic aneurysm (AAA) is a common condition affecting the main artery in the body (the aorta). It is a symptom free “ballooning” from the normal size of <2cm to an aneurysmal 3cm and beyond. This ballooning is more common with increasing age and in men and normally increases by 2-3 millimetres a year. The main risk is bursting (aneurysm rupture), and this risk increases as the size increases. Therefore, AAA patients receive preventive surgery to avoid rupture.
The two intervention options available are open aneurysm repair (OAR) and endovascular stent graft repair (EVAR - keyhole surgery). OAR requires a large cut in the abdomen and replacement of the ballooned section with a stitched in polyester graft. EVAR requires cuts in the groins where wires are inserted into the leg arteries and a spring-mounted graft is passed to the aneurysm, sealing it off.
Surgery has a significant impact on patients’ health and quality of life, despite it being a preventative operation for a symptomless disease; patients require rehabilitation after discharge. In other areas of surgery, there is evidence that preparing patients for surgery (“prehabilitation”) improves outcomes, and NICE has recommended research into prehabilitation programmes for AAA patients.
The aim of this pilot study is to see if a home-based prehabilitation programme is acceptable to patients (e.g. do they take part in it and do they enjoy it). We will also be looking at whether the prehabilitation programme can impact outcomes before and after surgery (e.g. patients quality of life and levels of physical activity).
Participants will be assessed at the start of the programme, after completion prior to surgery, discharge, 6 weeks and 3 months after surgery. These assessments will include questionnaires and standardised assessment of fitness.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0261
Date of REC Opinion
10 May 2021
REC opinion
Further Information Favourable Opinion