Functional Assessment in Liver Transplantation

Study Overview
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Brief Summary
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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
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Patients will be asked to perform the following study procedures: Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires. 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 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. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Official Title
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Functional Assessment in Liver Transplant Candidates (FrAILT) Study

Conditions
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End Stage Liver Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥18 years old) Are seen for the treatment of liver disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI). | 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 | December 31, 2023 | 
| Examine the association between frailty and outcomes both before and after liver transplantation. | 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. | December 31, 2023 | 
| Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI. | See outcome 1 for how LFI is measured. | December 31, 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Liver, Liver Transplant, Frailty, end stage