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

Abstract Background Frailty is accompanied with a reduced physical capacity, mobility, muscle strength and endurance. (Pre-)Frailty is present in an older surgical population in up to 50% with an increased risk for peri- and post-surgical complications. Consequently, these patients often suffer from a delayed or diminished recovery, loss of autonomy and quality of life, as well as a decrease of functional and cognitive capacity. As frailty is modifiable, we hypothesize that prehabilitation is able to improve the physiological reserves of surgical patients ≥ 70 years old and reduce the care dependency 12 months postoperatively. Methods Patients ≥ 70 years old scheduled for elective surgery or intervention will be investigated in this multicentre, randomized controlled study. We aim at including 1400 participants in our study with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with an interdisciplinary and interprofessional shared decision making conference as well as (2) a 3-week multimodal prehabilitation program including exercise therapy, nutritional intervention, mobility and balance training as well as psychosocial interventions and medical assessment. Frequency of the prehabilitation is 5 times / week for 3 weeks. The primary endpoint is defined as level of care dependency 12 months after surgery or intervention. Discussion Prehabilitation has been proven to be effective for different patient populations, including colorectal, transplant, and cardiac surgery, among other. In contrast, evidence for prehabilition in older, frail patients is not established yet. To the best of our knowledge, this is the largest study on prehabilitation for older people with frailty in a general elective surgery patient cohort. Trial registration: Clinical Trials. NCT04418271. Registered 5 June 2020, https://clinicaltrials.gov/ct2/show/NCT04418271), Universal Trial Number (UTN): U1111-1253-4820