LIFT Intervention in Liver Transplant Candidates

NCT04836923 | Completed Results

• 1 other identifier: STU00213159
• Study Type: interventional
• Target: 81
• 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.

Conditions

Frailty; Cirrhosis; Liver Transplant

Outcome Measures

Primary Outcomes (3)

• 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). 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

  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

  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 Outcomes (1)

• Clinical Outcomes - Liver Related Complications

  Throughout the follow-up period (mean follow-up time is 259 (±190) days)

Study Arms (1)

LIFT subgroup

EXPERIMENTAL

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)

Interventions

"LIver FrailTy" intervention (LIFT) BEHAVIORAL

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

LIFT 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

Location

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

Limitations and Caveats

This study originally proposed another arm/intervention ("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. The study team did not have the resources, funding, or time during patient encounters to employ this intervention, and thus focused only on the LIFT intervention.

Results Point of Contact

• Title: Therese Banea
• Organization: Northwestern University

therese.banea@northwestern.edu

312-694-7993

Study Officials

• Daniela Ladner, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: October 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)