Preoperative Physical Exercise, Nutritional Support, and Psychological Intervention (Multimodal Prehabilitation) to Strengthen Patients' Overall Health and Reduce Postoperative Complications

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital of Cologne

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

Qualifiers

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

Treatments tested in this trial

  • Multimodal Prehabilitation

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital of Cologne

Lead sponsor

Charity, University of Berlin

Collaborator

Johannes Gutenberg University Mainz

Collaborator

University Hospital Tuebingen

Collaborator