LIFT Intervention in Liver Transplant Candidates

NCT04836923 | Unknown

• 1 other identifier: STU00213159
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators also aim to perform "Realistic Effort Action Planning" (REAP), which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention.

Conditions

Frailty; Cirrhosis; Liver Transplant

Outcome Measures

Primary Outcomes (6)

• Frailty

  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). There is no data to date describing the expected range of values. Higher LFI scores indicate a higher degree of frailty.

  Every month for up to 5 years

• Placement on liver transplant waitlist

  A clinical measure for the participant and where they are located on the liver transplant waiting list.

  Every month for up to 5 years

• Clinical Outcomes - waitlist / post-transplant mortality

  Measured if a patient dies while listed on the transplant waitlist or post-transplant.

  Every month for up to 5 years

• Clinical Outcomes - post transplant disposition

  Determined by location of patient after transplant (can be listed such as acute rehabilitation, subacute rehabilitation center, home, etc.)

  Every month for up to 5 years

• Clinical Outcomes - number and duration of hospitalizations

  Clinical measure for how many times a patient is hospitalized and how long those hospitalizations last.

  Every month for up to 5 years

• Clinical Outcomes - liver related complications

  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.

  Every month for up to 5 years

Secondary Outcomes (5)

• Endurance

  Every 3 months for up to 5 years

• Patient adherence

  Every week for up to 5 years

• Degree of hepatic encephalopathy

  Every 3 months for up to 5 years

• Patient-reported quality of life

  Every 3 months for up to 5 years

• Personality assessment

  Every month for up to 5 years

Study Arms (2)

LIFT subgroup

EXPERIMENTAL

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)

LIFT + REAP subgroup

EXPERIMENTAL

PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. We will also employ "Realistic Effort Action Planning" (REAP), a form of personality-informed motivational interviewing in a subset of patients to potentially enhance patient engagement and adherence to the home-exercise prescription.

Behavioral: "LIver FrailTy" intervention (LIFT); Behavioral: "Realistic Effort Action Planning" intervention (REAP)

Interventions

"LIver FrailTy" intervention (LIFT) BEHAVIORAL

Novel physical therapy intervention to decrease frailty in pre-transplant patients

LIFT + REAP subgroup; LIFT subgroup

"Realistic Effort Action Planning" intervention (REAP) BEHAVIORAL

This intervention is an interactive behavioral interviewing process to engage patients in their care

LIFT + REAP subgroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Thuluvath AJ, Polineni P, Morrissey S, Belfanti K, Nizamuddin M, Siddiqui O, Daud A, Simpson DC, Levitsky J, Flores AM, Duarte-Rojo A, Ladner DP. Home-based LIver FrailTy Intervention (LIFT) in Transplant Candidates: A Feasibility Study. Transplantation. 2025 Apr 1;109(4):e202-e212. doi: 10.1097/TP.0000000000005263. Epub 2024 Nov 6.

  PMID: 40131764 DERIVED

MeSH Terms

Conditions

Frailty; Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniela Ladner, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avesh Thuluvath, MD

CONTACT

3126940260; avesh.thuluvath@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery - Organ Transplantation

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: October 1, 2020
• Primary Completion: July 31, 2025
• Study Completion: September 1, 2025
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)