Clinical trial · Interventional
Mechanistic Prehabilitation
Understanding How Exercise and Nutrition Enhance Preoperative Functional Capacity: a Mechanistic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulty in recruiting patients
Summary
Brief summary (as posted)
The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperinsulinemic euglycemic hyperaminoacid clamp | Device | — | UNRESOLVED |
| hyperinsulinemic euglycemic isoaminoacid clamp | Device | — | UNRESOLVED |
| Prehabilitation | Other | — | UNRESOLVED |
| whey protein supplementation | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prehabilitation
- description
- All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
- interventionNames
- Other: Prehabilitation
- Device: hyperinsulinemic euglycemic isoaminoacid clamp
- Device: hyperinsulinemic euglycemic hyperaminoacid clamp
- Dietary Supplement: whey protein supplementation
Primary outcomes (1)
- measure
- Protein Synthesis
- timeFrame
- up to 4 weeks before surgery
- description
- The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for elective colorectal surgery for cancer * 65 years and older Exclusion Criteria: * American Society of Anesthesiologists (ASA) health status class 4-5 * disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis) * endocrine disorders (diabetes or hemoglobin A1C\>6, hyper and hypothyrodisim) * steroid consumption * cardiac failure (New York Heart Association classes I-IV) * chronic obstructive pulmonary disease * renal failure (creatinine \> 115µmol/l) * hepatic failure (liver aminotranferases \>50% the normal range) * morbid obesity (BMI \>40) * anemia (hematocrit \< 30 %, haemoglobin \<100 g/L, albumin \< 25 g/L) * poor comprehension of English or French
References
Publications (1)
- BACKGROUNDLi C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9. PMID 23052535