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

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 468
• Main Authors: Schaller, Stefan J, Kiselev, Jörn, Loidl, Verena, Quentin, Wilm, Schmidt, Katrin, Mörgeli, Rudolf, Rombey, Tanja, Busse, Reinhard, Mansmann, Ulrich, Spies, Claudia
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 06-06-2022; BioMed Central; BMC
• Subjects: Aged; Care and treatment; Consent; Decision making; Decision-making, Shared; Delirium; Demographic aspects; Elective surgery; Elective Surgical Procedures; Exercise; Exercise therapy; Frail Elderly; Frailty; Frailty - diagnosis; Health insurance; Health services research; Hospitals; Humans; Intervention; Long term health care; Methods; Mortality; Multicenter Studies as Topic; Muscle strength; Participation; Patients; Perioperative care; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Preoperative care; Preoperative Exercise; Quality of Life; Randomized Controlled Trials as Topic; Rehabilitation; Study Protocol; Testing; Germany; Berlin Germany; Frail elderly; Perioperative care; Preoperative exercise; Frailty; Randomized controlled trial; Decision-making, Shared; Health services research
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06401-x

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