Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial

• DOI: 10.1186/s13063-022-06401-x
• Publication Date: 2022-06-06T06:02:29Z
• Authors: Stefan J. Schaller; Jörn Kiselev; Verena Loidl; Wilm Quentin; Katrin Schmidt; Rudolf Mörgeli; Tanja Rombey; Reinhard Busse; Ulrich Mansmann; Claudia Spies; ; Claudia Spies; Ursula Marschall; Rahel Eckardt-Fel...; Irmgard Landgraf; Ulrich Schwantes; Reinhard Busse; Ulrich Mansmann; ; Friedrich Borchers; Rudolf Mörgeli; Eva Schönenberger; Philipp Klassen; Bernadette Kleikamp; Philipp Brandhorst; Anna-Lena H. Spiegel; Bernhard Papenfuß; Jens Dowideit; Caroline Oefele; Volker Gebhardt; Kristina Zappel; Mehmet Gövercin; Thomas König; Claudio Chesi; Anett Reißhauer; Adrian Rosada; Ursula Müller-Werdan; Anja Heymann; Marion Hanke; Jens Leymann; Thomas Saller; Ann-Cathrin Bischof; Angelika Reisner; Wolf Leopold Albr...; Julia Wojciechowski; Martina Schuldt; Michael Baum; Dijana Brnabic; Björn von Pickardt; Agnieszka Deutsch...; Carsten Scholz; Lars May; Rahel Eckardt-Fel...; Isabell Wenghöfer; Manfred Blobner; Sima Sattari; Michael Dummert; Carla Nau; Mareike Otto; Ute Voß-Lümers; Danny Lang; Daniel Wiggert
• Keywords: Prehabilitation; Clinical endpoint

Abstract Background Frailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty present up to 42% of the older surgical population, with an increased risk for peri- postoperative complications. Consequently, these patients often suffer from delayed or limited recovery, loss autonomy quality life, decrease functional cognitive capacities. Since frailty modifiable, prehabilitation may improve physiological reserves reduce care dependency 12 months after surgery. Methods Patients ≥ 70 years old scheduled elective surgery intervention will be recruited this multicenter, randomized controlled study, target 1400 participants allocation ratio 1:1. The consists (1) shared decision-making process patient, relatives, interdisciplinary interprofessional team (2) 3-week multimodal, individualized program including exercise therapy, nutritional intervention, mobility balance training, psychosocial interventions medical assessment. frequency supervised 5 times/week 3 weeks. primary endpoint defined as level intervention. Discussion Prehabilitation has been proven effective different populations, colorectal, transplant, cardiac patients. In contrast, evidence older, frail not clearly established. To best our knowledge, currently largest study on people undergoing general Trial registration ClinicalTrials.gov NCT04418271 . Registered June 2020. Universal Number (UTN): U1111-1253-4820