Mentored multimodal prehabilitation for aortic aneurysm surgery: a pilot randomised controlled trial

Abstract

Objectives There is increasing evidence that prehabilitation before surgery may improve patient outcomes and should be established in perioperative care pathways. We aimed to explore the logistics of running a randomised controlled study in prehabilitation of patients having aortic aneurysm repair. Our primary objective was to assess the feasibility of recruitment, retention, and adherence to study interventions. Secondary objectives were patient outcomes such as function, quality of life and postoperative complications. Design : A feasibility, assessor-blinded, parallel-group, randomised controlled trial. Methods Following ethical approval, adults scheduled for elective open or endovascular abdominal aortic aneurysm repair were randomised to one of three groups: 1) control, current standard practice with no prehabilitation workshop; 2) non-mentored prehabilitation, a prehabilitation workshop with no further patient contact; and 3) mentored prehabilitation, a prehabilitation workshop with addition of regular mentoring for up to eight weeks after the workshop. Primary feasibility outcomes included: screening and recruitment; retention to eight-week follow-up; and maintenance of blinding. Secondary patient outcomes included complications; mortality; length of stay; quality of life; and functional outcomes. Results In total, 60 patients were screened, 45 were enrolled and randomised, and 43 were included in the intention-to-treat analyses. Feasibility of screening and recruitment was achieved, with 45/60 (75%) patients screened being recruited. Participant retention was achieved, with 40/43 (93.0%) of participants attending their eight-week follow-up and 23/43 (53.5%) wearing trackers for > 80% of the time. Maintenance of blinding was achieved in all patients. There were no significant differences in secondary patient outcomes. Conclusions A full randomised controlled trial is feasible. However, further modifications on study design and interventions are required to deliver a clinically meaningful randomised controlled trial. Trial Registration: clinicaltrials.gov ID: NCT04169217)