High Intensity PreHab Before Major Abdominal Surgery

Medical University Innsbruck

Status: Enrolling

Conditions: Prehabilitation

Treatments: Procedure: Individualized high intensity preoperative fitness training

Study type: Interventional

Funder types: Other

Identifiers

NCT05355909

PreHab in abdominal Surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

controll group

No Intervention group

Description:

Standard of care without preoperative fitness program

Interventional group

Experimental group

Description:

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

Treatment:

Procedure: Individualized high intensity preoperative fitness training