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High Intensity PreHab Before Major Abdominal Surgery

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Dec 31, 2026 to Jul 31, 2026
    • Eligibility criteria expanded, about 9 words
    • Study description shortened, about 9 words
    • Site details revised
  2. Notable Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026
    • Study description expanded, about 201 words
    v4
  3. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Jun 30, 2024 to Dec 31, 2024
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2022 to Aug 1, 2022
    • Study sites: 0 to 1
    • Secondary endpoint revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05355909
Lead Sponsor Medical University Innsbruck
Conditions
(from sponsor)
Prehabilitation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov