Clinical trial · Interventional
Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty
Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study
NCT04715581CI-TRIAL-00092872recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive Cancer | — | UNRESOLVED | — |
| Nutrition Therapy | — | UNRESOLVED | — |
| Old Age; Debility | — | UNRESOLVED | — |
| Outcomes | — | UNRESOLVED | — |
| Preoperative Rehabilitation | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Postoperative exercise training | Behavioral | — | UNRESOLVED |
| Preoperative exercise training | Behavioral | — | UNRESOLVED |
| Preoperative nutritional optimization | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multicomponent prehabilitation group
- description
- Patients in the intervention group will receive nutritional optimization and exercise training before the surgery, exercise training after the surgery, and home-based rehabilitation after discharge.
- interventionNames
- Dietary Supplement: Preoperative nutritional optimization
- Behavioral: Preoperative exercise training
- Behavioral: Postoperative exercise training
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients in the control group will maintain normal diet and normal activity before surgery, normal activity after surgery, and normal activity after discharge.
Primary outcomes (2)
- measure
- A composite of delirium and non-delirium complications within 7 days after surgery (sub-study).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion criteria: 1. Age ≥65 years but \<90 years; 2. Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract; 3. Clinical Frailty Scale ≥5; 4. Provide written informed consent. Exclusion Criteria: 1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 2. Inability to communicate due to coma, profound dementia, or language barrier; 3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder; 4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease; 5. Severe heart dysfunction (left ventricular ejection fraction \<30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher; 6. Other reasons that are considered unsuitable for study participation.
References
Publications (40)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
- BACKGROUNDCollard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6. PMID 22881367
- BACKGROUNDSong X, Mitnitski A, Rockwood K. Prevalence and 10-year outcomes of frailty in older adults in relation to deficit accumulation. J Am Geriatr Soc. 2010 Apr;58(4):681-7. doi: 10.1111/j.1532-5415.2010.02764.x. Epub 2010 Mar 22. PMID 20345864
- BACKGROUNDMohile SG, Xian Y, Dale W, Fisher SG, Rodin M, Morrow GR, Neugut A, Hall W. Association of a cancer diagnosis with vulnerability and frailty in older Medicare beneficiaries. J Natl Cancer Inst. 2009 Sep 2;101(17):1206-15. doi: 10.1093/jnci/djp239. Epub 2009 Jul 28. PMID 19638506
- BACKGROUNDVerlaan S, Ligthart-Melis GC, Wijers SLJ, Cederholm T, Maier AB, de van der Schueren MAE. High Prevalence of Physical Frailty Among Community-Dwelling Malnourished Older Adults-A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2017 May 1;18(5):374-382. doi: 10.1016/j.jamda.2016.12.074. Epub 2017 Feb 24. PMID 28238676
- BACKGROUNDGuyonnet S, Rolland Y. Screening for Malnutrition in Older People. Clin Geriatr Med. 2015 Aug;31(3):429-37. doi: 10.1016/j.cger.2015.04.009. Epub 2015 May 13. PMID 26195101
- BACKGROUNDZhang DF, Su X, Meng ZT, Cui F, Li HL, Wang DX, Li XY. Preoperative severe hypoalbuminemia is associated with an increased risk of postoperative delirium in elderly patients: Results of a secondary analysis. J Crit Care. 2018 Apr;44:45-50. doi: 10.1016/j.jcrc.2017.09.182. Epub 2017 Sep 29.