Study protocol for a multicenter prospective randomized-controlled trial to test a systematic remote and app-based prehabilitation program in comparison to education-only before major surgery: the LUMOS Study

Abstract Background Recent studies have demonstrated significant benefits associated with prehabilitation prior to major surgery. However, digital solutions in this domain are currently lacking. Our previous study, the Protego Maxima trial, reported positively assessed usability, validity, and safety of a prehabilitation application. In this randomized-controlled multicenter study, we aim to ascertain whether a digital prehabilitation program can reduce perioperative morbidity and costs in patients undergoing major surgery. Methods The LUMOS trial is a multicenter prospective randomized-controlled trial comparing a 3-to-6-week interventional digital prehabilitation program with a digitized informational app, against a control group receiving only the informational application. The trial seeks to enroll 382 participants who will be block-randomized based on diagnosis into either the intervention or control group. The primary endpoint is the reduction of 90-day morbidity from 60 to 45% (Dindo–Clavien I–V). Secondary objectives include the 1-year overall survival, quality of life, length of hospital stay (including ICU, IMC, and general ward), readmission rates, compliance, and program adherence, product malfunction, vigilance reporting, improvement of the 6-min walking test by at least 20%, and hospital cost assessment. Discussion The LUMOS trial aims to evaluate the effectiveness of a digital prehabilitation program compared to an informational app only, prior to major surgery. The objective is to demonstrate the significant value of a digitized remote prehabilitation program in reducing perioperative morbidity, as well as addressing cost considerations. Trial registration Trial registered in the European Database on Medical Devices (EUDAMED) (CIV-24-02-046162) and German Clinical Trial Registry (DRKS00033612, 13.05.2024), DMIDS-Number: 00015083, https://drks.de/search/en/trial/DRKS00033612 . Goethe University Frankfurt: 024-1681-MDR/MPDG-zuständig multizentrisch, 06.05.2024.