Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorInsel Gruppe AG, University Hospital Bern

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Multimodal Prehabilitation

    Procedure/Surgery

    A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).

Treatment groups

466 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days after surgery

Secondary outcomes

1

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

Time frame
Before and after 2-4 weeks of prehabilitation, at 30 days
2

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

Time frame
At the beginning of study, before and after surgery, at 30 days.
3

Anaemia

Presence of anaemia, Transfusion rates in the first 30 days after surgery.

Time frame
30 days after surgery
4

Smoking

Successful smoking cessation rate, Exhaled CO measured.

Time frame
At the beginning of study, before and after surgery, at 30 days.

Other outcomes

1

Other outcomes of interest

Length of hospital stay, Days at home at 30 days, Predicted costs for visceral interventions, CCI at 90 days

Time frame
At 30/90 days

Sponsors and contacts

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Insel Gruppe AG, University Hospital Bern

Lead sponsor

University of Bern

Collaborator

Department of clinical research, Bern

Collaborator