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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every week for up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Outcomes - liver related complications

Clinical Outcomes - number and duration of hospitalizations

Clinical Outcomes - post transplant disposition

+3 more

Secondary outcome measures

Hepatic Encephalopathy

Endurance

Patient adherence

+2 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,481 Total Patients Enrolled

5 Trials studying Frailty

1,481 Patients Enrolled for Frailty

Daniela Ladner, MDPrincipal Investigator - Northwestern University

Northwestern Memorial Hospital

University Zurich (Medical School)

Stanford University Hospital (Residency)

Media Library

LIver FrailTy Intervention (LIFT) Clinical Trial Eligibility Overview. Trial Name: NCT04836923 — N/A

Frailty Research Study Groups: LIFT subgroup, LIFT + REAP subgroup

Frailty Clinical Trial 2023: LIver FrailTy Intervention (LIFT) Highlights & Side Effects. Trial Name: NCT04836923 — N/A

LIver FrailTy Intervention (LIFT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04836923 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the central purpose of this research initiative?

"The primary endpoint of this study, to be evaluated for up to 5 years at regular intervals, is post-transplant mortality. Secondary objectives include assessing hepatic encephalopathy with the List Sort Working Memory [LSWM], Flanker Inhibitory Control and Attention [FICA] and Pattern Comparison Processing Speed Test (PCPS) tests; endurance using 4-meter walk test; and personality assessment measured via Modified Midlife Development Inventory (MIDI). Specifically, LSWM examines participants' ability to repeat items in order from smallest to largest correctly; FICA evaluates patients' capacity for visual attention control over distractor arrows onto"

Answered by AI

How many people are partaking in this medical experiment?

"Affirmative. Clinicaltrials.gov data indicates that this medical experiment has been actively searching for subjects since October 1st 2020, with the last update being on April 6th 2021. 500 patients between one site are needed to complete the trial."

Answered by AI

Is this research endeavor currently accepting participants?

"According to the clinicaltrials.gov database, this research study is presently recruiting participants. The trial was initially made available on October 1st 2020 and further revised on April 6th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LIFT Intervention in Liver Transplant Candidates

Daniela Ladner 2020. "LIFT Intervention in Liver Transplant Candidates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04836923.

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