PrehabilitationNCT05355909
High Intensity PreHab Before Major Abdominal Surgery
A study testing Individualized high intensity preoperative fitness training in people with Prehabilitation, run by Medical University Innsbruck at 1 site in Austria.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prehabilitation
- What is being tested?
- Individualized high intensity preoperative fitness training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- BMI 18 - 35kg/m2
- Signed informed consent
- Elective abdominal surgery with moderate to high risk
- Contraindication for preoperative fitness training or ergometry
- Transplantation surgery
Who cannot join
- Pregnancy of lactation
- Major trauma or massive haemorrhage with the last two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery
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.
Read more
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.
Read the 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.
- Conditions
- Prehabilitation
- Being tested
- Individualized high intensity preoperative fitness training
- Keywords
- ventilatory anaerobic threshold, Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized high intensity preoperative fitness trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Individualized high intensity preoperative fitness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, single blinded (patient-blinded) with two study groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helmut Raab, MD, Principal investigator, Medical University Innsbruck, Departement of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355909
- Sponsor's protocol ID
- PreHab in abdominal Surgery
- Status last verified
- Mar 2025
- First submitted
- 26 Apr 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05355909
- Acronym / sponsor ID
- PreHab in abdominal Surgery
- Conditions
- Prehabilitation
- Keywords
- ventilatory anaerobic threshold, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomised, single blinded (patient-blinded) with two study groups
| Arm | Type | Receives |
|---|---|---|
| controll group | No intervention | –Standard of care without preoperative fitness program |
| Interventional group | Experimental | Procedure: Individualized high intensity preoperative fitness trainingAfter randomisation the patients will obtain a two week personalised fitness program to improve the preoperative fitness |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA I-III
- BMI 18 - 35kg/m2
- Signed informed consent
- Elective abdominal surgery with moderate to high risk
- Contraindication for preoperative fitness training or ergometry
Key exclusion criteria (2 listed)
- Pregnancy of lactation
- Major trauma or massive haemorrhage with the last two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized high intensity preoperative fitness trainingThe 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. | Procedure or surgery | Interventional group |
Primary outcome
Preoperative fitness based on [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min]
Time frame: 2 weeks
(VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min] between inclusion and end of personalised training hervor surgery.
1 secondary outcome
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
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Raab, MD principal investigator
Medical University Innsbruck, Departement of Anaesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized high intensity preoperative fitness training in people with Prehabilitation, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative fitness based on [oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11 mL/kg/min] (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.