LIFT + REAP for Frailty in Liver Transplant Candidates

Overseen By Avesh Thuluvath, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Age < 18, Outpatient physical therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to strengthen and reduce frailty in individuals preparing for a liver transplant. The treatment, known as the Liver Frailty Intervention (LIFT), includes a personalized exercise plan, activity reminders, and regular check-ins with a support team. Some participants will also try an additional motivational approach called REAP to assess its impact on their results. Individuals with liver cirrhosis who are being evaluated for a transplant, speak English, and have access to a smartphone may be suitable candidates. The goal is to smooth the journey to a transplant and improve overall outcomes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance transplant preparation and recovery.

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 prior data suggests that the LIFT and REAP interventions are safe for liver transplant candidates?

Research has shown that the Liver Frailty (LIFT) program for individuals awaiting a liver transplant is likely safe. One study found that home-based programs like LIFT are feasible and can significantly improve frailty. Importantly, these programs had a low rate of adverse effects, with only about 9% of participants experiencing them.

Specific safety data for the LIFT + REAP program is limited. However, since it incorporates motivational interviewing into the LIFT program, similar safety levels are expected. This motivational component aims to enhance participation without adding physical risks.

Overall, evidence suggests that both programs are generally well-tolerated and could be a safe option for those considering participation in this type of clinical study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LIFT + REAP approach for frailty in liver transplant candidates because it combines physical therapy with personalized motivation strategies. Unlike standard care options that may focus solely on physical exercise, LIFT incorporates daily text reminders and weekly check-ins to keep patients engaged with their home exercise plans. The addition of REAP takes it a step further by using personality-informed motivational interviewing to boost patient adherence and engagement. This dual approach aims to not only improve physical health but also empower patients to stick with their exercise routines, potentially leading to better overall outcomes.

What evidence suggests that this trial's treatments could be effective for frailty in liver transplant candidates?

Research has shown that the Liver Frailty Intervention (LIFT), which participants in this trial may receive, can help improve frailty in people waiting for a liver transplant. Previous studies found that patients who followed a home-based exercise program designed for them experienced significant improvements in their frailty. These patients generally became more physically fit, which is important for a successful liver transplant.

Another treatment arm in this trial includes the LIFT + REAP combination, which adds a motivational component called "Realistic Effort Action Planning" (REAP) to encourage patients to maintain their exercise routines. This approach aims to increase patient engagement, potentially leading to even better results. Early findings suggest that both LIFT and LIFT + REAP show promise in improving physical fitness and reducing frailty in these patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniela P Ladner, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• LIver FrailTy Intervention (LIFT)
• Realistic Effort Action Planning Intervention (REAP)

Trial Overview The 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.

How Is the Trial Designed?

Group I: LIFT subgroup Experimental Treatment 1 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 subgroup Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A 14-week home-based exercise program for liver transplant candidates significantly improved physical fitness, as measured by the Liver Frailty Index (LFI) and the 6-minute walk test (6MWT), with LFI improving from 3.84 to 3.47 and 6MWT increasing by 41 meters.

The study demonstrated good feasibility with 68% of participants starting the intervention and achieving a 57% adherence rate, although maintaining the exercise routine proved challenging despite support from physical activity coaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Mobile-Assisted Telehealth Regimen to Increase Exercise in Transplant Candidates: A Home-Based Prehabilitation Pilot and Feasibility Trial. Duarte-Rojo, A., Bloomer, PM., Grubbs, RK., et al.[2023]

In a study of 107 liver transplant patients, slower gait speed was linked to a higher risk of aspiration and pulmonary infections, suggesting that frailty can predict serious respiratory complications after surgery.

Improving gait speed and overall frailty may be a modifiable risk factor that could enhance respiratory outcomes for liver transplant patients, as it was associated with shorter intubation times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty as Tested by Gait Speed Is a Risk Factor for Liver Transplant Respiratory Complications. Salim, TI., Nestlerode, LC., Lucatorto, EL., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying an Optimal Liver Frailty Index Cutoff to Predict Waitlist Mortality in Liver Transplant Candidates. Kardashian, A., Ge, J., McCulloch, CE., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty in liver transplantation: A comprehensive review. Liapakis, A., Morris, E., Emre, S.[2022]

In a study of 294 liver transplant candidates with a median age of 60, frailty was found to significantly predict mortality while on the transplant waitlist, with frail individuals having a higher risk of death or delisting due to illness (22% vs. 10% for non-frail).

Each 1-unit increase in the Fried Frailty score was associated with a 45% increased risk of waitlist mortality, highlighting the importance of assessing frailty in liver transplant candidates, regardless of their liver disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty predicts waitlist mortality in liver transplant candidates. Lai, JC., Feng, S., Terrault, NA., et al.[2023]

In a study of 81 liver transplant candidates, the Patient-Reported Outcomes Measurement Information System (PROMIS) survey effectively correlated with the Liver Frailty Index (LFI), indicating that patient-reported physical function can be a reliable indicator of frailty in patients with cirrhosis.

The findings suggest that using the PROMIS survey can help predict hospitalization rates in these patients, highlighting its potential as a quick screening tool for assessing frailty without the need for in-person assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief PROMIS Assessment Screens for Frailty and Predicts Hospitalizations in Liver Transplant Candidates. Thuluvath, AJ., Duarte-Rojo, A., Lai, JC., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Liver Transplant Candidates. Al-Judaibi, B., Alqalami, I., Sey, M., et al.[2020]

The 5-meter walk test (5MWT) and hand grip strength (HGS) are effective and simple measures of frailty in liver transplant patients, with significant differences observed between those who were dropped from the waiting list and those who remained or were transplanted.

Patients who were dropped from the waiting list exhibited significantly weaker hand grip strength (46.14 lb vs 59.6 lb) and slower walking speeds (0.92 m/s vs 1.03 m/s), suggesting that these frailty measures can help predict surgical risk and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait Speed and Grip Strength Are Associated With Dropping Out of the Liver Transplant Waiting List. Kulkarni, SS., Chen, H., Josbeno, DA., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04836923

LIFT Intervention in Liver Transplant Candidates Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40131764/

Home-based LIver FrailTy Intervention (LIFT) in Transplant ... This study shows that a home-based frailty intervention is feasible. The intervention led to significant improvement in frailty, ...

3. withpower.com withpower.com/trial/phase-frailty-9-2020-43a47

LIFT + REAP for Frailty in Liver Transplant Candidates Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04836923/lift-intervention-in-liver-transplant-candidates

LIFT Intervention in Liver Transplant Candidates In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant ...

5. allclinicaltrials.com allclinicaltrials.com/study/NCT04836923

LIFT Intervention in Liver Transplant Candidates - Clinical Trials Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9138922/

Frailty in liver transplantation: A comprehensive review - PMC Frailty is common among patients with end-stage liver disease (ESLD). One recent multicenter study found frailty to be present in 25% of outpatients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02367092

Exercise Intervention in Liver Transplant Patients This study aims to evaluate the effects of a home-based exercise intervention on outcomes in liver transplant candidates and recipients. This home-based ...