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

Trials

Study Protocol

Stefan J. Schaller¹  Jörn Kiselev¹  Katrin Schmidt¹  Claudia Spies¹  Rudolf Mörgeli¹  Wilm Quentin²  Tanja Rombey²  Reinhard Busse²  Ulrich Mansmann³  Verena Loidl³ 

[1]Department of Anesthesiology and Operative Intensive Care Medicine (CVK/CCM), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Chariteplatz 1, 10117, Berlin, Germany

[2]Department of Health Care Management, Technische Universität Berlin, Berlin, Germany

[3]Institute for Medical Information Processing, Biometry, and Epidemiology - IBE, Ludwig-Maximilians-Universität München, Munich, Germany

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

DOI  :  10.1186/s13063-022-06401-x

 received in 2022-04-11, accepted in 2022-05-12,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundFrailty 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.MethodsPatients ≥ 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.DiscussionPrehabilitation 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 registrationClinicalTrials.gov NCT04418271. Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820

【 授权许可】

CC BY   
© The Author(s) 2022

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