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NCT Number: NCT03228290

Functional Assessment in Liver Transplantation

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.

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Key information

Conditions

End Stage Liver Disease Digestive System Diseases Fibrosis Frailty Hepatic Insufficiency Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥18 years old)
  • Are seen for the treatment of liver disease

Treatment and study plan

Primary outcomes

  1. Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI).

    Time frame: 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

  2. Examine the association between frailty and outcomes both before and after liver transplantation.

    Time frame: 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.

  3. Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI.

    Time frame: December 31, 2023

    See outcome 1 for how LFI is measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Fawzy Barry, BS

CONTACT

[email protected]

(415) 476-6119

Jennifer C Lai, MD, MBA

CONTACT

[email protected]

(415) 476-6422

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institute on Aging (NIA)

Registry information

Official study title

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

Acronym: FrAILT

Important dates

Study start
2011
Primary completion
2030
Study completion
2030
First posted
Jul 24, 2017
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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