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

NCT07389746 | Not Yet Recruiting DMC

• 2 other identifiers: SCHI1149/7-1DFG Project#: 558914691
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Surgery; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Postoperative complications defined as Clavien-Dindo Classification grade III-V

  During hospital stay until the day of discharge (assessed up to five days)

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Multimodal Prehabilitation

Procedure: Multimodal Prehabilitation

Control Group

NO INTERVENTION

Standard of Care

Interventions

Multimodal Prehabilitation PROCEDURE

Multimodal prehabilitation includes preoperative exercise (HIIT), nutritional optimization and psychological support

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: collaborator
• University Hospital of Cologne: lead
• Charity, University of Berlin: collaborator
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, 50931, Germany

Location

Central Study Contacts

Robert Schier, MD, PhD

CONTACT

0049-178-8210611; robert.schier@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)