High Intensity PreHab Before Major Abdominal Surgery

NCT05355909 | Recruiting DMC

• 1 other identifier: PreHab in abdominal Surgery
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation

Keywords

ventilatory anaerobic threshold, Prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

controll group

NO INTERVENTION

Standard of care without preoperative fitness program

Interventional group

EXPERIMENTAL

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

Procedure: Individualized high intensity preoperative fitness training

Interventions

Individualized high intensity preoperative fitness training PROCEDURE

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.

Interventional group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• BMI 18 - 35kg/m2
• Signed informed consent
• Elective abdominal surgery with moderate to high risk

You may not qualify if:

• Pregnancy of lactation
• Major trauma or massive haemorrhage with the last two weeks
• Contraindication for preoperative fitness training or ergometry
• Transplantation surgery

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Hospital

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Study Officials

• Helmut Raab, MD

  Medical University Innsbruck, Departement of Anaesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Gasteiger, MD, PD

CONTACT

0043-512-504-24000; lukas.gasteiger@tirol-kliniken.at

Helmut Raab, MD

CONTACT

0043-512-504-24000; helmut.raab@tirol-kliniken.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

AU (1)