500 Participants Needed

LIFT + REAP for Frailty in Liver Transplant Candidates

AT
Overseen ByAvesh Thuluvath, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the LIFT + REAP treatment for frailty in liver transplant candidates?

Research suggests that addressing frailty in liver transplant candidates through structured exercise programs and multidisciplinary approaches can improve outcomes. Exercise training has been shown to be effective for patients with liver disease, and using standardized protocols to address frailty can enhance patient safety and transplant success.12345

Is the LIFT + REAP treatment safe for liver transplant candidates?

The available research does not provide specific safety data for the LIFT + REAP treatment, but it suggests that addressing frailty with structured exercise and nutrition programs is generally considered safe and beneficial for liver transplant candidates.12367

How is the LIFT treatment different from other treatments for frailty in liver transplant candidates?

The LIFT treatment is unique because it combines a structured exercise program with a multidisciplinary approach to address frailty in liver transplant candidates, focusing on improving physical fitness and overcoming barriers through new technology, unlike standard treatments that may not be as comprehensive.12358

Research Team

DL

Daniela P Ladner, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults with liver cirrhosis who are being considered for a liver transplant and have access to a smartphone. It includes those with cognitive impairments from hepatic encephalopathy, but excludes anyone needing outpatient physical therapy or unable to consent.

Inclusion Criteria

Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.
Patients with access to a smart phone (with videoconference capabilities)
I have liver cirrhosis and am being evaluated for a liver transplant.
See 1 more

Exclusion Criteria

I cannot give consent for myself and do not have a medical power of attorney.
I need physical therapy that can be done as an outpatient.
I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the LIFT intervention, which includes PT evaluation, an individualized home exercise prescription, daily text reminders, and weekly telephone check-ins. A subset will also receive REAP motivational interviewing.

Up to 5 years
Weekly telephone check-ins

Follow-up

Participants are monitored for frailty, clinical outcomes, and quality of life every month to every three months.

Up to 5 years
Monthly and quarterly assessments

Treatment Details

Interventions

  • LIver FrailTy Intervention (LIFT)
  • Realistic Effort Action Planning Intervention (REAP)
Trial OverviewThe study tests the 'LIver FrailTy' (LIFT) intervention, which involves a physical therapist's evaluation, personalized home exercises, exercise tracking via an app, daily text reminders, and phone check-ins. A subset will also receive motivational interviewing called REAP.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: LIFT subgroupExperimental Treatment1 Intervention
PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
Group II: LIFT + REAP subgroupExperimental Treatment2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Findings from Research

Frailty is a common issue in patients with end-stage liver disease, significantly affecting their vulnerability to health stressors and impacting outcomes in liver transplantation.
A multidisciplinary approach using standardized protocols to address malnutrition and physical debility is recommended to improve patient care and transplant outcomes, with resources and new technology being explored to support this strategy.
Frailty in liver transplantation: A comprehensive review.Liapakis, A., Morris, E., Emre, S.[2022]
A structured exercise training program (ETP) for liver transplant candidates showed a trend towards reduced 90-day readmission rates (17.9% vs 20%) and shorter hospital stays (14 days vs 17 days) compared to those who did not participate in the program.
While the ETP group had more infections post-surgery, there were no significant differences in overall postoperative complication rates between the ETP and non-ETP groups, suggesting that the exercise program may be beneficial without increasing major risks.
Exercise Training for Liver Transplant Candidates.Al-Judaibi, B., Alqalami, I., Sey, M., et al.[2020]
The Liver Frailty Index (LFI) is a strong predictor of waitlist mortality for liver transplant candidates, with an optimal cutoff of 4.4 for 3-month mortality and 4.2 for both 6 and 12-month mortality, based on a study of 1,405 patients.
Combining LFI with the Model for End Stage Liver Disease-sodium (MELDNa) significantly improves the prediction of waitlist mortality, increasing the area under the curve (AUC) from 0.73 to 0.79, indicating a more accurate assessment of risk.
Identifying an Optimal Liver Frailty Index Cutoff to Predict Waitlist Mortality in Liver Transplant Candidates.Kardashian, A., Ge, J., McCulloch, CE., et al.[2023]

References

Frailty in liver transplantation: A comprehensive review. [2022]
Exercise Training for Liver Transplant Candidates. [2020]
Identifying an Optimal Liver Frailty Index Cutoff to Predict Waitlist Mortality in Liver Transplant Candidates. [2023]
Brief PROMIS Assessment Screens for Frailty and Predicts Hospitalizations in Liver Transplant Candidates. [2023]
Gait Speed and Grip Strength Are Associated With Dropping Out of the Liver Transplant Waiting List. [2019]
Frailty as Tested by Gait Speed Is a Risk Factor for Liver Transplant Respiratory Complications. [2023]
Frailty predicts waitlist mortality in liver transplant candidates. [2023]
Use of a Mobile-Assisted Telehealth Regimen to Increase Exercise in Transplant Candidates: A Home-Based Prehabilitation Pilot and Feasibility Trial. [2023]