Clinical trial NCT05355909: High Intensity PreHab Before Major Abdominal Surgery
Official title: Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Keywords: ventilatory anaerobic threshold, Prehabilitation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, single blinded (patient-blinded) with two study groups
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Preoperative fitness based on [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min]
timeFrame: 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Hospital
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck, Departement of Anaesthesiology and Intensive Care
name: Helmut Raab, MD
role: PRINCIPAL_INVESTIGATOR
References: