Clinical trial · Interventional
Preoperative Physical Exercise, Nutritional Support, and Psychological Intervention (Multimodal Prehabilitation) to Strengthen Patients' Overall Health and Reduce Postoperative Complications
Multimodal Prehabilitation Reduces Postoperative Complications in High Risk Patients Undergoing Major Gastrointestinal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Surgery | — | UNRESOLVED | — |
| Prehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Prehabilitation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- Multimodal Prehabilitation
- interventionNames
- Procedure: Multimodal Prehabilitation
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Standard of Care
Primary outcomes (1)
- measure
- Postoperative complications defined as Clavien-Dindo Classification grade III-V
- timeFrame
- During hospital stay until the day of discharge (assessed up to five days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available