Preoperative Physical Exercise, Nutritional Support, and Psychological Intervention (Multimodal Prehabilitation) to Strengthen Patients' Overall Health and Reduce Postoperative Complications
Germany400 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Non-elective surgery
* Unstable cardiac or respiratory disease
* Locomotor limitations precluding exercise training
* Cognitive deterioration impeding adherence to the programme
* Enrolment in other research studies affecting study endpoint
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative complications defined as Clavien-Dindo Classification grade III-V
Timeframe: During hospital stay until the day of discharge (assessed up to five days)