Cancer Statistics, 2017.
Rebecca L Siegel, Kimberly D Miller, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/28055103Actively Recruiting
Phase Not Applicable
Age: 65Years - 89Years
All Genders
ID04715581
Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study
Led by Peking University First Hospital · Updated on 2025-07-31
540
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how a multicomponent prehabilitation program affects early and long-term results in elderly patients with frailty recovering from digestive cancer surgery. Frailty, common in adults 65 and older, especially those with digestive cancer, involves reduced physical reserve and increased vulnerability to stress, often worsened by malnutrition. This study aims to investigate how combining nutrition and exercise can improve recovery and outcomes for these patients. The study compares two groups: one receives nutritional optimization and exercise training before surgery, exercise training after surgery, and home-based rehabilitation after discharge; the other follows their normal diet and activity before and after surgery. Nutritional support includes oral supplements tailored to patients' needs, and exercise programs involve respiratory, aerobic, and muscle strength training supervised during hospital stay and followed up by phone post-discharge. Participants will be monitored for complications including delirium within 7 days after surgery, survival outcomes up to two years, and recovery markers such as time to oral intake and physical activity levels. Other assessments include length of hospital stay, quality of life, cognitive function, sleep quality, and physical performance. The study duration extends up to two years post-surgery to capture long-term effects and survival data.
CONDITIONS
Brief Title
Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty
Who Can Participate
Age: 65Years - 89Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 65 years or older but less than 90 years
- Scheduled for major digestive cancer surgery expected to last 2 hours or more
- Clinical Frailty Scale score of 5 or higher
- Able to provide written informed consent
You will not qualify if you...
- History of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
- Unable to communicate due to coma, severe dementia, or language barriers
- Unable to participate in preoperative rehabilitation due to paralysis, fracture, or movement disorders
- Unable to eat by mouth because of gastrointestinal or other diseases
- Severe heart dysfunction (ejection fraction below 30% or NYHA class IV), severe liver dysfunction (Child-Pugh class C), severe kidney dysfunction requiring dialysis before surgery, or ASA classification grade 4 or higher
- Other reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Preoperative Nutritional and Exercise Optimization
Duration - From hospital admission to one day prior to surgery
Participants receive nutritional supplementation and exercise training from hospital admission until one day before surgery to improve frailty and nutritional status.
Daily training sessions during hospital stay
Surgery and Immediate Post-operative Care
Duration - Surgery day and hospital stay duration
Participants undergo digestive cancer surgery and receive immediate post-operative care.
Hospital visits as per clinical care
Postoperative Exercise Training
Duration - During hospital stay and after discharge
Participants perform supervised muscle strength and aerobic exercises during hospital stay and continue home-based rehabilitation after discharge.
Regular supervised sessions in hospital and follow-up calls after discharge
Follow-up Monitoring
Duration - Up to 2 years after surgery
Participants are monitored for early and long-term outcomes including complications, functional recovery, and survival up to two years after surgery.
Periodic follow-up visits up to 2 years
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
D
Dong-Xin Wang, MD
H
Huai-Jin Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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