About this trial
In this prospective, randomized, controlled trial patients undergoing major gastrointestinal cancer surgery will be exercised (intervention group) 4 weeks before surgery with a high-intensity interval training (HIIT). They will also receive a specialized nutrition therapy and psychological support (multimodal prehabilitation). Aim of this study is to find out if the prehabilitation group is more resilient to postoperative complications when compared to the control group that will receive standard of care. Another goal is to unravel the underlying mechanisms that are stimulated by exercise like enhancing vascular function, improving immune system response, strengthen cellular tumor defense and optimizing neurological outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Candidate to elective major gastrointestinal cancer surgery (pelvic exenteration, cytoreductive surgery, oesophagectomy, transhiatal gastrectomy, hepatectomy, pancreatectomy, rectum resection)
High risk for surgical complications defined by presence of comorbid disease such as deconditioning, heart disease, diabetes, renal impairment or morbid obesity
Duke Activity Status Index score (DASI) <402
Schedule allowing for at least 4 weeks for intervention with multimodal prehabilitation prior to surgery / willingness to exercise
Disqualifiers
Non-elective surgery
Unstable cardiac or respiratory disease
Locomotor limitations precluding exercise training
Cognitive deterioration impeding adherence to the programme
Trial design
Parallel
Treatments tested in this trial
Multimodal Prehabilitation
Procedure/SurgeryMultimodal prehabilitation includes preoperative exercise (HIIT), nutritional optimization and psychological support
Treatment groups
Trial outcomes
Primary outcomes
Postoperative complications defined as Clavien-Dindo Classification grade III-V
Sponsors and contacts
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University Hospital of Cologne
Lead sponsor
Charity, University of Berlin
Collaborator
Johannes Gutenberg University Mainz
Collaborator
University Hospital Tuebingen
Collaborator
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