About this trial
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
This trial does not accept healthy volunteersQualifiers
ASA I-III
BMI 18 - 35kg/m2
Signed informed consent
Elective abdominal surgery with moderate to high risk
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Individualized high intensity preoperative fitness training
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.