High Intensity PreHab Before Major Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery

Conditions
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Prehabilitation

Intervention / Treatment
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* Procedure: Individualized high intensity preoperative fitness training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomised, single blinded (patient-blinded) with two study groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: controll group<br>Standard of care without preoperative fitness program | |
| Experimental: Interventional group<br>After randomisation the patients will obtain a two week personalised fitness program to improve the preoperative fitness | Procedure: Individualized high intensity preoperative fitness training<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilatory anaerobic threshold, Prehabilitation, oxygen uptake, preoperative fitness