LIFT Intervention in Liver Transplant Candidates

April 23, 2026 updated by: Northwestern University

Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates

Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible.

In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy (PT) sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting.

The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.

The central hypothesis is that the LIFT intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic
  • English-speaking
  • Patients with access to a smart phone (with videoconference capabilities)
  • Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.

Exclusion Criteria:

  • Patients < 18 years of age
  • Patients who require outpatient physical therapy.
  • Patients without the ability to consent for themselves or through a medical power of attorney.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFT subgroup
Physical Therapy (PT) evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
Behavioral: "LIver FrailTy" intervention (LIFT)
Novel physical therapy intervention to decrease frailty in pre-transplant patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Frailty is described as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. This outcome is measured by the Liver frailty index [LFI]. LFI is composed of 3 performance-based tests (grip strength, chair stands, and balance). Patients are classified using established cutoffs (frail: LFI ≥ 4.5, pre-frail: LFI 3.3-4.4, robust: LFI ≤ 3.2). Higher LFI scores indicate a higher degree of frailty.
Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Patient-reported Physical Function
Time Frame: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)

Patient-reported physical quality of life was measured using a validated patient-reported outcome measure (Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS-PF]) completed in clinic.

Patient-reported physical function was measured using a validated patient-reported outcome measure: Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS-PF] Version 2.0 - Short Form 8c.

A higher PROMIS T-score represents more of the concept being measured. A score of 50 is the average for the United States general population with a standard deviation of 10. A Physical Function T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. Physical Function T-Scores range from 20.3 to 60.1.
Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Exercise Adherence Rate
Time Frame: 1 month and 3 months after Enrollment, throughout the follow-up period (mean follow-up time is 259 (±190) days)

Data continuously collected via TrueCoach smart phone application to document adherence to exercise regimen. If patients are unable to appropriately track adherence on the smart phone application, this data will be collected at weekly videoconference/telephone check-ins detailed below.

Exercise adherence rates are defined as the number of completed or attempted exercise days/total exercise days prescribed. Overall, patients were classified as adherent to the exercise regimen if their adherence rate was ≥ 75% and partially adherent if ≥ 50%. Patients were classified as non-adherent if their adherence rate was < 50%. The mean intervention rate was measured throughout the follow-up period (from enrollment to final assessment) - the mean follow-up time was 259 (±190) days.
1 month and 3 months after Enrollment, throughout the follow-up period (mean follow-up time is 259 (±190) days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes - Liver Related Complications
Time Frame: Throughout the follow-up period (mean follow-up time is 259 (±190) days)
Data collected from medical chart for liver related complications including but not limited to diagnosis of: ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome, infection.
Throughout the follow-up period (mean follow-up time is 259 (±190) days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Daniela Ladner, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00213159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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