NCT04715581 Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty
| NCT ID | NCT04715581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Old Age; Debility |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2021-11-25 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 Anesthesiol