High Intensity PreHab Before Major Abdominal Surgery

Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery

The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE <1%), moderate risk (MACE 1-5%) and high risk (MACE > 5%). In addition with patient related risk factors it can raise to values of 40%.

The preoperative aerobic fitness [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery.

However some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients.

The aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.

Study Overview

• Status: Recruiting
• Conditions: Prehabilitation
• Intervention / Treatment: Procedure: Individualized high intensity preoperative fitness training

Detailed Description

The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE <1%), moderate risk (MACE 1-5%) and high risk (MACE > 5%). In addition with patient related risk factors it can raise to values of 40%.

The preoperative aerobic fitness [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery.

However some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients.

The aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukas Gasteiger, MD, PD; Phone Number: 0043-512-504-24000; Email: lukas.gasteiger@tirol-kliniken.at
• Study Contact Backup: Name: Helmut Raab, MD; Phone Number: 0043-512-504-24000; Email: helmut.raab@tirol-kliniken.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medical University Hospital
      • Contact: lukas gasteiger; Phone Number: +4351250480512; Email: lukas.gasteiger@tirol-kliniken.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-III
• BMI 18 - 35kg/m2
• Signed informed consent
• Elective abdominal surgery with moderate to high risk

Exclusion Criteria:

• Pregnancy of lactation
• Major trauma or massive haemorrhage with the last two weeks
• Inclusion of the patient in a interventional study
• Contraindication for preoperative fitness training or ergometry
• Transplantation surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: controll group; Standard of care without preoperative fitness program
Experimental: Interventional group; After randomisation the patients will obtain a two week personalised fitness program to improve the preoperative fitness	Procedure: Individualized high intensity preoperative fitness training; The individualised training program consists of stamina training, interval training and strength training. The personalised fitness training will be designed based on the FITT-VP (frequency, intensity, time, type, volume, progression) of the American College of Sports Medicine (ACSM) and will contain 6 training session within 2 weeks under supervision of professional sport physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative fitness based on [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min]	(VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min] between inclusion and end of personalised training hervor surgery.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life 36 (QoL-36) describes the quality of life of the patient with a scale ranging from 0 (worst outcome) to 100 (best outcome) between randomisation and end of training hervor surgery	Difference in Quality of Life 36 (QoL-36) describes the quality of life of the patient with a scale ranging from 0 (worst outcome) to 100 (best outcome) between randomisation and end of training hervor surgery	2 weeks

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Helmut Raab, MD, Medical University Innsbruck, Departement of Anaesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: ventilatory anaerobic threshold, Prehabilitation
• Other Study ID Numbers: PreHab in abdominal Surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No