Clinical trial NCT04836923: LIFT Intervention in Liver Transplant Candidates
Official title: Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Cirrhosis
Liver Transplant
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

Detailed description: Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting.

The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. The investigators 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.

The central hypothesis is that the LIFT (+/- REAP) intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Frailty
timeFrame: Every month for up to 5 years
measure: Placement on liver transplant waitlist
timeFrame: Every month for up to 5 years
measure: Clinical Outcomes - waitlist / post-transplant mortality
timeFrame: Every month for up to 5 years
measure: Clinical Outcomes - post transplant disposition
timeFrame: Every month for up to 5 years
measure: Clinical Outcomes - number and duration of hospitalizations
timeFrame: Every month for up to 5 years
measure: Clinical Outcomes - liver related complications
timeFrame: Every month for up to 5 years
Secondary outcomes:
measure: Endurance
timeFrame: Every 3 months for up to 5 years
measure: Patient adherence
timeFrame: Every week for up to 5 years
measure: Degree of hepatic encephalopathy
timeFrame: Every 3 months for up to 5 years
measure: Patient-reported quality of life
timeFrame: Every 3 months for up to 5 years
measure: Personality assessment
timeFrame: Every month for up to 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Daniela Ladner, MD
role: PRINCIPAL_INVESTIGATOR
References: