The PREHAAAB Trial
Research type
Research Study
Full title
Multimodal prehabilitation for patients awaiting open Abdominal Aortic Aneurysm repair: An international randomized controlled trial
IRAS ID
331189
Contact name
David Yates
Contact email
Sponsor organisation
York & Scarborough Teaching Hospitals NHs Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
In the study country of origin, it is estimated that 20000 people are diagnosed yearly with an abdominal aortic aneurysm (AAA). AAAs are usually asymptomatic until they rupture, which carries an 80-90% overall mortality. To prevent rupture, AAAs are repaired when they reach a diameter of 5.5cm in men and 5.0cm in women. Patients with AAA are highly comorbid, often have poor functional status and are considered high risk for surgery.
Functional status is an individual's ability to perform the normal daily activities required to meet basic needs, fulfil usual roles, and maintain health and well-being. It has been shown to be a true measure of perioperative risk, and when poor, it is associated with worse perioperative outcomes. Fortunately, functional status is a modifiable perioperative risk factor that, if improved before surgery, leads to a decrease in postoperative morbidity.
In all participating centres, participant selection will begin after a high probability of having open AAA repair is established by the perioperative vascular team. This is a randomized controlled trial with an allocation ratio 1:1 comparing standard of care versus 6 weeks of a multimodal prehabilitation program, targeting the three main pillars of functional status, physical, nutritional, and psychological well-being. Recruitment of participants will take approximately three years and the follow-up will be one year.
This is an international trial with three sites participating in England, two in Canada and one in Spain.
While there is high-quality evidence that backs up the feasibility and safety of HIIT training on patients scheduled to undergo elective AAA repair, the evidence supporting prehabilitation’s capacity to reduce complications in AAA surgery is insufficient and mixed, with no trial using the multimodal approach and most of the trials mixing cohorts of open and endovascular repair.
REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/1006
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion