CirrhosisFrAILTNCT03870568
Functional Assessment in Liver Transplantation
An observational study of Cirrhosis and End Stage Liver Disease, run by Baylor Research Institute at 1 site in United States.
Trial summary
In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, End Stage Liver Disease
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2015to 8 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrolled from Baylor University Medical Center.
Who may be able to join
- Adults (≥18 years old)
- Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority
- Are seen in the outpatient clinic setting
Who cannot join
- Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds, which is the first test that the participants complete upon enrollment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.
Read the detailed description
Subjects in this study will be asked questions regarding functional status and ability to do activities at home. Subjects will also be asked to complete several physical tests to assess functional status. For example, subjects will be asked to stand up from a chair several times, balance with their feet together, and walk down a hall as quickly as possible. Subjects will also be asked to perform a hand grip strength test.
Subjects will be assessed at baseline and at every clinic visit in the pre-transplant setting. Subjects will again be assessed at 3, 6, and 12 months post-transplant.
- Conditions
- Cirrhosis, End Stage Liver Disease
- Keywords
- frailty, liver transplantation, functional status
- Medical subject headings
- Fibrosis, End Stage Liver Disease, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation
Fried Frailty is calculated by combining into one score measurements of:
- Exhaustion: number of days patient felt exhaustion in the past 7 days
- Physical activity: has the subject performed any weight bearing activity in the past month? (Possible answers: yes or no).
- Grip strength test using dynamometer: Three measurements reported in kg.
- Walking speed in a 13-foot (4 meters) walk: Three measurements reported in seconds
- Unintentional Weight Loss: report if patient has lost 10 lbs or more in the last year.
- Minnesota Leisure Time Physical Activity Questionnaire (MNLTPA) calculated as a value of 1 for males with MNLTPA score less than 383 kcal/week and for females with a score less than 270 kcal/week.
Range of score is 0 to 5 with 0 being not frail and 5 being most frail
Measured: 5 years
Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation
The following measurements are used individually to assess liver frailty index:
Chair stands: The patient stands up from a sitting position without using his/her arms. The time (in seconds) the patient requires to complete the task is reported.
Balance testing: patients must stand up in side by side, semi tandem and tandem positions for 10 seconds each. If the subject can't hold position for 10 seconds, the number of seconds that the subject kept in position is reported. Scoring range is 1.0 to 7.0 with 1.0 to 3.0 being "robust" and 4.5 to 7.0 being "frail"
Measured: 5 years
Numbers Connection test measurements in 300 patients with end-stage liver disease
Patient connects numbers that are scattered at random on a piece of paper. Reported as time (in seconds) taken to connect the numbers.
Measured: 5 years
Work status
Possible answers: working, retired, on disability, other.
Measured: 5 years
Hospitalizations
Possible answers: yes or no. If yes, report #of nights and reason.
Measured: 5 years
Activities of daily living (ADLs)
Six questions about daily activities Scoring: A response of yes to any of the questions receives a value of 1. the ADL score is measured as the sum of the values of the 6 questions. A score of 0 correlates with "most dependent" and a score of 6 is "most independent."
Measured: At 1 year post transplantation
Instrumental Activities of Daily Living (IADLs)
Eight questions about daily activities:
Scoring: each question can be answered with a score of 0 or 1. The final iADL score is the sum of all values. The range of the score is 0 to 8 with 0 being most dependent and 8 being "most independent.'
Measured: At 1 year post transplantation
36 Item Short Form Survey Instrument (SF-36)
Patient will complete a 36 question questionnaire about quality of life at 1 year post transplantation.
Measured: At 1 year post transplantation
Secondary outcomes (1)
Correlation between frailty and outcomes both before and after liver transplantation.
The association between the subject's frailty score and their pre and post transplant outcomes will be assessed.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start6 Oct 2015
- Primary completion8 May 2024
- Study completion8 May 2024
Why it stopped: study transitioned from LIRB to CIRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Trotter, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870568
- Sponsor's protocol ID
- 015-243
- Acronym
- FrAILT
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2017
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment in Liver Transplantation
- ClinicalTrials.gov ID
- NCT03870568
- Acronym / sponsor ID
- FrAILT / 015-243
- Conditions
- Cirrhosis, End Stage Liver Disease
- Keywords
- frailty, liver transplantation, functional status
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study transitioned from LIRB to CIRB
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.
Detailed description
Subjects in this study will be asked questions regarding functional status and ability to do activities at home. Subjects will also be asked to complete several physical tests to assess functional status. For example, subjects will be asked to stand up from a chair several times, balance with their feet together, and walk down a hall as quickly as possible. Subjects will also be asked to perform a hand grip strength test.
Subjects will be assessed at baseline and at every clinic visit in the pre-transplant setting. Subjects will again be assessed at 3, 6, and 12 months post-transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled from Baylor University Medical Center.
Key inclusion criteria (3 listed)
- Adults (≥18 years old)
- Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority
- Are seen in the outpatient clinic setting
Key exclusion criteria (1 listed)
- Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds, which is the first test that the participants complete upon enrollment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation
Time frame: 5 years
Fried Frailty is calculated by combining into one score measurements of: * Exhaustion: number of days patient felt exhaustion in the past 7 days * Physical activity: has the subject performed any weight bearing activity in the past month? (Possible answers: yes or no). * Grip strength test using dynamometer: Three measurements reported in kg. * Walking speed in a 13-foot (4 meters) walk: Three measurements reported in seconds * Unintentional Weight Loss: report if patient has lost 10 lbs or more in the last year. * Minnesota Leisure Time Physical Activity Questionnaire (MNLTPA) calculated as a value of 1 for males with MNLTPA score less than 383 kcal/week and for females with a score less than 270 kcal/week. Range of score is 0 to 5 with 0 being not frail and 5 being most frail
Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation
Time frame: 5 years
The following measurements are used individually to assess liver frailty index: Chair stands: The patient stands up from a sitting position without using his/her arms. The time (in seconds) the patient requires to complete the task is reported. Balance testing: patients must stand up in side by side, semi tandem and tandem positions for 10 seconds each. If the subject can't hold position for 10 seconds, the number of seconds that the subject kept in position is reported. Scoring range is 1.0 to 7.0 with 1.0 to 3.0 being "robust" and 4.5 to 7.0 being "frail"
Numbers Connection test measurements in 300 patients with end-stage liver disease
Time frame: 5 years
Patient connects numbers that are scattered at random on a piece of paper. Reported as time (in seconds) taken to connect the numbers.
Work status
Time frame: 5 years
Possible answers: working, retired, on disability, other.
Hospitalizations
Time frame: 5 years
Possible answers: yes or no. If yes, report #of nights and reason.
Activities of daily living (ADLs)
Time frame: At 1 year post transplantation
Six questions about daily activities Scoring: A response of yes to any of the questions receives a value of 1. the ADL score is measured as the sum of the values of the 6 questions. A score of 0 correlates with "most dependent" and a score of 6 is "most independent."
Instrumental Activities of Daily Living (IADLs)
Time frame: At 1 year post transplantation
Eight questions about daily activities: Scoring: each question can be answered with a score of 0 or 1. The final iADL score is the sum of all values. The range of the score is 0 to 8 with 0 being most dependent and 8 being "most independent.'
36 Item Short Form Survey Instrument (SF-36)
Time frame: At 1 year post transplantation
Patient will complete a 36 question questionnaire about quality of life at 1 year post transplantation.
1 secondary outcome
Correlation between frailty and outcomes both before and after liver transplantation.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: study transitioned from LIRB to CIRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Trotter, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and End Stage Liver Disease, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study transitioned from LIRB to CIRB). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation (time frame: 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.