Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-01
466
Participants Needed
1
Research Sites
21 weeks
Total Duration
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
The trial investigates the effects of a multimodal, multidisciplinary prehabilitation program designed to reduce complications and increase cost effectiveness after major surgery in elderly, frail patients. It focuses on patients aged 65 and older who often experience higher rates of postoperative complications, longer recoveries, and decreased physiological and functional capacity. The study also considers cancer patients with reduced functional health after treatment as potential beneficiaries of the program. Participants are randomly assigned to one of two groups: a control group receiving standard perioperative care based on established ERAS guidelines, and an intervention group undergoing a prehabilitation program. This program includes exercise training, nutritional support, anemia correction, and smoking cessation tailored by a multidisciplinary team. The program is implemented for a minimum of two weeks and up to four weeks before surgery. During the study, participants undergo assessments such as cardio-pulmonary exercise testing, grip strength measurement, nutritional risk evaluation, and questionnaires on recovery and anxiety. Researchers monitor outcomes including the comprehensive complication index 30 days after surgery, physical and nutritional parameters, smoking behavior, hemoglobin levels, days spent at home within 30 days post-surgery, and quality of recovery. The trial runs until December 2026, with detailed monitoring before and after surgery to evaluate the program's impact.
CONDITIONS
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks
Participants in the intervention group undergo a multimodal prehabilitation program including exercise training, nutritional intervention, correction of anemia, and smoking cessation before surgery.
Multiple visits during prehabilitation period
Duration - Day of surgery and immediate perioperative period
Participants undergo major surgery with perioperative care; the control group receives standardized perioperative care based on ERAS recommendations.
1 surgical visit (in-person)
Duration - 30 days after surgery
Participants are monitored for postoperative recovery and complications through assessments of physical parameters, nutrition, anemia, smoking behavior, and questionnaires.
Approximately 2 to 3 visits during recovery
Total: 1 location
1
Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
D
Dominique A Engel, Dr
P
Patrick Wuethrich, Prof
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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