Functional Assessment in Liver Transplantation

Recruiting

Brief Summary: This will be a prospective cohort study of patients with liver disease. Subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. Subjects will also answer questions regarding quality of life, personality, and/or cognitive function. Subjects will again undergo assessments at every clinic visit through 12 months after transplant. Then, they will be followed annually.

Detailed Description: Patients will be asked to perform the following study procedures:

1. Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires.

2. Measures of frailty and disability selected to capture the multi-dimensional aspects of frailty including functional status and physiologic reserve:

Fried Frailty Score: weakness (test of grip strength), exhaustion (patient interview), slowness (gait speed), low activity (patient interview) Short Physical Performance Battery: repeated chair stands, balance testing with feet together, 13-foot walk

3. Laboratory tests will all be obtained from the medical record: creatinine, total bilirubin, INR, sodium, albumin. All of these tests are necessary for listing for liver transplantation.

4. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients.

5. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
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.
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
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.

Secondary Outcome Measures

Name	Time	Method

Locations (12): Johns Hopkins
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Baltimore, Maryland, United States
University of Pittsburgh
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Pittsburgh, Pennsylvania, United States
Indiana University
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Indianapolis, Indiana, United States
Duke University Medical Center
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Durham, North Carolina, United States
University of California, San Francisco
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San Francisco, California, United States
University of Michigan
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Ann Arbor, Michigan, United States
Columbia University
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New York, New York, United States
Loma Linda University
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Loma Linda, California, United States
Northwestern University
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Chicago, Illinois, United States
University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States
Baylor Scott & White Health
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Dallas, Texas, United States
University of Washington
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Seattle, Washington, United States