Functional Assessment in Liver Transplantation
This study is looking at how physical function and frailty (a state of being vulnerable to poor health outcomes) affect people with end-stage liver disease, both before and after a liver transplant. Researchers will use tests like grip strength, chair stands, and balance, which make up the Liver Frailty Index (LFI), to measure these changes. They will also look at how frailty is connected to outcomes for patients. The study aims to understand how frailty changes over time for people receiving a liver transplant or other treatments. You can join if you are an adult (18 or older) being treated for liver disease. The study plans to enroll 5000 participants.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 5000 participants.
- What's involved
- You will have geriatric assessments at each clinic visit before your transplant and for 12 months after, then annually. These assessments include cognitive tests, questionnaires, grip strength, chair stands, and balance tests. Some participants may also provide blood, urine, stool, or tissue samples during surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed annually after the first 12 months post-transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Functional Assessment in Liver Transplantation
At a glance
Conditions
Where it's being run
12 sites across 11 statesStudy leadership
- Jennifer C Lai, MD, MBA · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI).December 31, 2023
Grip strength: Performance-based. Measured in kilograms. This was measured in each subject's dominant hand using a hand dynamometer (Jamar Hydraulic hand dynamometer). We averaged three trials. Chair stands: Performance-based. Measured in number of chair stands per second. Number of chair stands completed in 30 seconds. Balance: Performance-based. Measured in seconds. Ability to balance in three positions (feet placed side to side, semitandem, and tandem) for 10 seconds each. Liver Frailty Index (LFI): (coefficient x grip) + (coefficient x chair stands) + (coefficient x balance) +6
- Examine the association between frailty and outcomes both before and after liver transplantation.December 31, 2023
Outcomes measured prior to transplant will include: waiting for transplant, died pre-transplant, deactivated too sick, deactivated for social reasons/inactive, deferred not a candidate, and transplanted. Outcomes that will be measured post transplant include: still alive, died post transplant, and re-transplanted. All measures will be acquired via patient interview or review of medical records.
- Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI.December 31, 2023
See outcome 1 for how LFI is measured.