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

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 delivering multimodal prehabilitation (exercise and lifestyle modification) 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. 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: adherence to study interventions (wearing trackers for >80% of the time, attendance to workshop if allocated) and 30% more activity in intervention groups than in control group); screening and recruitment; retention to eight-week follow-up; and maintenance of blinding to the outcome assessor. Secondary exploratory 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, usually due to device failure. Maintenance of blinding was achieved. Participants did not demonstrate a 30% increase in activity levels across the 3 groups. There were no significant differences in secondary patient outcomes. CONCLUSIONS: The primary feasibility targets were partially met in terms of recruitment, retention, wearing of trackers, workshop attendance and completion of follow up procedures. However, the participants did not achieve 30% more activity in the workshop groups compared to the control group. A full randomised controlled trial is feasible with modifications to study design and prehabilitation interventions. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT04169217).