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High Intensity PreHab Before Major Abdominal Surgery

Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05355909
Enrollment
60
Registered
2022-05-02
Start date
2022-08-01
Completion date
2026-12-31
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehabilitation

Keywords

ventilatory anaerobic threshold, Prehabilitation

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.

Interventions

PROCEDUREIndividualized 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.

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Prospective, randomised, single blinded (patient-blinded) with two study groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preoperative fitness based on [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min]2 weeks(VO2) at the ventilatory anaerobic threshold (VAT) \<11 mL/kg/min\] between inclusion and end of personalised training hervor surgery.

Secondary

MeasureTime frameDescription
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 surgery2 weeksDifference 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

Countries

Austria

Contacts

Primary ContactLukas Gasteiger, MD, PD
lukas.gasteiger@tirol-kliniken.at0043-512-504-24000
Backup ContactHelmut Raab, MD
helmut.raab@tirol-kliniken.at0043-512-504-24000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026