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. 2022 Jun 6;23(1):468.
doi: 10.1186/s13063-022-06401-x.

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

Stefan J Schaller #  1 , Jörn Kiselev #  1 , Verena Loidl  2 , Wilm Quentin  3 , Katrin Schmidt  1 , Rudolf Mörgeli  1 , Tanja Rombey  3 , Reinhard Busse  3 , Ulrich Mansmann  2 , Claudia Spies  4 ; PRAEP-GO consortium,; PRAEP-GO investigators
Collaborators, Affiliations

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

Stefan J Schaller et al. Trials. .

Erratum in

Abstract

Background: Frailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty is present in up to 42% of the older surgical population, with an increased risk for peri- and postoperative complications. Consequently, these patients often suffer from a delayed or limited recovery, loss of autonomy and quality of life, and a decrease in functional and cognitive capacities. Since frailty is modifiable, prehabilitation may improve the physiological reserves of patients and reduce the care dependency 12 months after surgery.

Methods: Patients ≥ 70 years old scheduled for elective surgery or intervention will be recruited in this multicenter, randomized controlled study, with a target of 1400 participants with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with the patient, relatives, and an interdisciplinary and interprofessional team and (2) a 3-week multimodal, individualized prehabilitation program including exercise therapy, nutritional intervention, mobility or balance training, and psychosocial interventions and medical assessment. The frequency of the supervised prehabilitation is 5 times/week for 3 weeks. The primary endpoint is defined as the level of care dependency 12 months after surgery or intervention.

Discussion: Prehabilitation has been proven to be effective for different populations, including colorectal, transplant, and cardiac surgery patients. In contrast, evidence for prehabilitation in older, frail patients has not been clearly established. To the best of our knowledge, this is currently the largest prehabilitation study on older people with frailty undergoing general elective surgery.

Trial registration: ClinicalTrials.gov NCT04418271 . Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820.

Keywords: Decision-making, Shared; Frail elderly; Frailty; Health services research; Perioperative care; Preoperative exercise; Randomized controlled trial.

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Conflict of interest statement

SJS received grants from Reactive Robotics GmbH (Munich, Germany); grants and non-financial support from STIMIT AG (Biel, Switzerland), Liberate Medical LLC (Crestwood USA), and ESICM (Geneva, Switzerland); grants, personal fees, and non-financial support from Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany); personal fees from Springer Verlag GmbH (Vienna, Austria) for educational purposes; and non-financial support from Technical University of Munich (Munich, Germany) and from national and international societies (and their congress organizers) in the field of anesthesiology and intensive care medicine, outside the submitted work. Dr. Schaller held stocks in small amounts from Rhön-Klinikum AG and holds stocks in small amounts from Alphabeth Inc., Bayer AG, and Siemens AG; these holdings have not affected any decisions regarding his research or this study.

J Kiselev declares no competing interests.

V Loidl declares no competing interests.

W Quentin declares no competing interests.

K Schmidt declares no competing interests.

R Mörgeli declares no competing interests.

T Rombey received honorary fees for commissioned research by the Statutory Health Insurance Medical Review Board.

R Busse declares no competing interests.

U Mannsmann declares no competing interests.

C Spies reports grants from Gemeinsamer Bundesausschuss/Federal Joint Committee (G-BA) during the conduct of the study, grants from BMG/RKI, grants from Deutsche Forschungsgemeinschaft/German Research Society, grants from Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)/German Aerospace Center, grants from Einstein Stiftung Berlin/Einstein Foundation Berlin, grants from Inneruniversitäre Forschungsförderung/Inner University Grants, grants from Projektträger im DLR/Project Management Agency, grants from Stifterverband/Non-Profit Society Promoting Science and Education, grants from European Society of Anaesthesiology and Intensive Care, grants from Baxter Deutschland GmbH, grants from Cytosorbents Europe GmbH, grants from Edwards Lifesciences Germany GmbH, grants from Fresenius Medical Care, grants from Grünenthal GmbH, grants from Masimo Europe Ltd., grants from Pfizer Pharma PFE GmbH, personal fees from Georg Thieme Verlag, grants from Dr. F. Köhler Chemie GmbH, grants from Sintetica GmbH, grants from Stifterverband für die deutsche Wissenschaft Þ.V./PhilipsÐ grants from Stiftung Charité, grants from AGUETTANT Deutschland GmbH, grants from AbbVie Deutschland GmbH & Co. KG, grants from Amomed Pharma GmbH, grants from InTouch Health, grants from Copra System GmbH, grants from Correvio GmbH, grants from Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V., grants from Deutsche Gesellschaft für Anästhesiologie & Intensivmedizin (DGAI, grants from Stifterverband für die deutsche Wissenschaft e.V./Metronic, grants from Philips Electronics Nederland BV, grants from BMG/RKI, grants from BMBF, grants from Deutsche Forschungsgemeinschaft/German Research Society, and grants from Drägerwerk AG & Co. KGaA, outside the submitted work. In addition, Dr. Spies has a patent 10 2014 215 211.9 licensed, a patent 10 2018 114 364.8 licensed, a patent 10 2018 110 275.5 licensed, a patent 50 2015 010 534.8Ð licensed, a patent 50 2015 010 347.7 licensed, and a patent 10 2014 215 212.7 licensed.

Figures

Fig. 1
Fig. 1
PRAEP-GO flowchart
Fig. 2
Fig. 2
Exercise progression in prehabilitation (adapted from [42])
See this image and copyright information in PMC

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