High Intensity PreHab Before Major Abdominal Surgery

NCT ID: NCT05355909

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Prehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

controll group

Standard of care without preoperative fitness program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional group

After randomisation the patients will obtain a two week personalised fitness program to improve the preoperative fitness

Group Type: EXPERIMENTAL

Individualized high intensity preoperative fitness training

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Raab, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck, Departement of Anaesthesiology and Intensive Care

Locations

Medical University Hospital

Innsbruck, Tyrol, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Lukas Gasteiger, MD, PD

Role: CONTACT

lukas.gasteiger@tirol-kliniken.at

0043-512-504-24000

Helmut Raab, MD

Role: CONTACT

helmut.raab@tirol-kliniken.at

0043-512-504-24000

Facility Contacts

lukas gasteiger

Role: primary

lukas.gasteiger@tirol-kliniken.at

+4351250480512

Other Identifiers

PreHab in abdominal Surgery

Identifier Type: -

Identifier Source: org_study_id