Status:
RECRUITING
Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty
Lead Sponsor:
Peking University First Hospital
Conditions:
Old Age; Debility
Digestive Cancer
Eligibility:
All Genders
65-89 years
Phase:
NA
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 cance...
Detailed Description
Frailty is an age-related syndrome characterized with diminished physiological reserve that results in decreased homeostatic capacity and increased vulnerability to any stress from minor to major. App...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥65 years but \<90 years;
- 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;
- Clinical Frailty Scale ≥5;
- Provide written informed consent.
- Exclusion Criteria:
- Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- Inability to communicate due to coma, profound dementia, or language barrier;
- Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
- Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
- 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;
- Other reasons that are considered unsuitable for study participation.
Exclusion
Key Trial Info
Start Date :
November 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04715581
Start Date
November 25 2021
End Date
December 1 2028
Last Update
July 31 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034