Randomized Multicenter Trial of Multimodal Prehabilitation to Reduce Complications and Costs After Major Surgery in Frail Elderly Patients
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-01
466
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
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 programs impact.
CONDITIONS
Brief Title
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial
Research Team
D
Dominique A Engel, Dr
P
Patrick Wuethrich, Prof
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Pre-existing fitness deficit defined by specific cardio-pulmonary exercise testing values
Scheduled for major urologic, thoracic, visceral, orthopaedic, or cardiovascular surgery
Screening conducted at least 2 weeks before surgery
You will not qualify if you...
Paralysis or mobility issues preventing exercise
Premorbid conditions or orthopedic impairments that contraindicate exercise
Cognitive disabilities
Chronic renal failure requiring dialysis
Emergency surgical procedures
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
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
Treatment
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)
Follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Inspiratory muscle training as part of multimodal prehabilitation improves maximal inspiratory pressure in elderly surgical patients: an exploratory secondary analysis of a randomised controlled trial.
Simone Wen-Shi Dueblin, Patrick Y Wuethrich, Dominique Engel...
Effect of multimodal home-based prehabilitation on objectively measured physical activity in patients undergoing elective cardiac or non-cardiac major surgery: secondary outcomes from a randomised controlled trial.
Thomas Vetsch, Simone Wen-Shi Dueblin, Prisca Eser...
Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial).
Christian M Beilstein, Gabija Krutkyte, Thomas Vetsch...