About this trial
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
comorbid (≥ASA 3)
pre-existing fitness deficit: AT<11ml/kg/min respectively VO2peak<14ml/kg/min if AT unavailable or VE/VCO2 slope > 33
scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery
Disqualifiers
Paralysis or patients with mobility problems (who are unable to exercise),
Premorbid conditions or orthopaedic impairments that contraindicate exercise,
Cognitive disabilities,
Chronic renal failure (need for dialysis)
Trial design
Parallel
Treatments tested in this trial
Multimodal Prehabilitation
Procedure/SurgeryA multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).
Treatment groups
Trial outcomes
Primary outcomes
Comprehensive Complication Index (CCI)
The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.
Secondary outcomes
Cardiovascular & Pulmonary
Cardio-Pulmonary Exercise Test (CPET): Peak VO2, VO2 at VT1, peak VE, VE/VCO2 slope, O pulse, FEV1, FEV1/FVC, resting HR, HR reserve, resting systolic and diastolic BP, CPAx ICUD and CPAX HosD in case of ICU admission, Maximum inspiratory pressure , Grip strength, NTproBNP, serial hsTroponin in case of raised NTproBNP, change in preoperative P-POSSUM score
Nutrition & Bioimpendance
Nutritional Risk Score (NRS), Bio impedance: weight, muscle mass, fat mass, percent body fat, extracellular water/intracellular water, and phase angle, Fat Free Body Mass (FFM) and Lean body Mass (LBM), Days nil per mouth
Anaemia
Presence of anaemia, Transfusion rates in the first 30 days after surgery.
Smoking
Successful smoking cessation rate, Exhaled CO measured.
Other outcomes
Other outcomes of interest
Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
Department of clinical research, Bern
Collaborator