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

NCT04461301 | Recruiting DMC

• 1 other identifier: PREHAB2020
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frail Elderly Syndrome; Major Surgery

Keywords

Comprehensive Complication Index

Outcome Measures

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.

  30 days after surgery

Secondary Outcomes (5)

• Cardiovascular & Pulmonary

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

• Nutrition & Bioimpendance

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

• Anaemia

  30 days after surgery

• Smoking

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

• Questionnaires for recovery, anxiety and cardiac risk

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

Other Outcomes (1)

• Other outcomes of interest

  At 30/90 days

Study Arms (2)

Intervention

EXPERIMENTAL

Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist.

Procedure: Multimodal Prehabilitation

Control

NO INTERVENTION

Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics.

Interventions

Multimodal Prehabilitation PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• screening at least 2 weeks prior to surgery

You may not qualify if:

• 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)
• Emergency procedures.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• Department of clinical research, Bern: collaborator

Study Sites (1)

Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Related Publications (2)

• Vetsch T, Dueblin SW, Eser P, Beilstein CM, Wuethrich PY, Wilhelm M, Engel D. 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. Perioper Med (Lond). 2025 Jul 4;14(1):69. doi: 10.1186/s13741-025-00554-4.

  PMID: 40615882 DERIVED

• Beilstein CM, Krutkyte G, Vetsch T, Eser P, Wilhelm M, Stanga Z, Bally L, Verra M, Huber M, Wuethrich PY, Engel D. Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial). BMJ Open. 2023 Jan 3;13(1):e070253. doi: 10.1136/bmjopen-2022-070253.

  PMID: 36596634 DERIVED

Study Officials

• Dominique A Engel, Dr

  Department of Anaesthesiology and Pain Therapy, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique A Engel, Dr

CONTACT

0041316322111; dominique.engel@insel.ch

Patrick Wuethrich, Prof

CONTACT

0041316322111; patrick.wuethrich@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Model Details: Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: February 1, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)