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LIFT + REAP for Frailty in Liver Transplant Candidates

N/A

Recruiting

Led By Daniela Ladner, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic

Be older than 18 years old

Must not have

Patients without the ability to consent for themselves or through a medical power of attorney.

Patients who require outpatient physical therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every week for up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new intervention to improve frailty in patients awaiting liver transplant. The intervention includes an evaluation by a physical therapist, an individualized home exercise prescription, and exercise tracking using a smart phone application. The investigators also aim to perform "Realistic Effort Action Planning" in a subset of patients to determine if this enhances the intervention.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on exercise and motivational interviewing interventions rather than medications or invasive procedures, side effects may include typical exercise-related issues such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have liver cirrhosis and am being evaluated for a liver transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot give consent for myself and do not have a medical power of attorney.

Select...

I need physical therapy that can be done as an outpatient.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every week for up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every week for up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every week for up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Outcomes - liver related complications

Clinical Outcomes - number and duration of hospitalizations

Clinical Outcomes - post transplant disposition

+3 more

Secondary study objectives

Hepatic Encephalopathy

Endurance

Patient adherence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met