This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical function and reducing frailty in adult Liver Transplant candidates. The intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.
The investigator will pilot-test a two-arm, randomized trial of a prehabilitation intervention in 38 pre-liver transplant patients with End Stage Liver Disease (ESLD). The investigator estimates an attrition rate of 20%, resulting n=30 participants; 10 participants in Arm 1 (control arm) and 20 participants in Arm 2 (intervention arm). To be eligible, patients must be waitlisted or "Penn-Ready" with a MELD-Na less than or equal to 25, English-speaking, able to safely participant in an exercise program, have a smartphone, and be identified as frail. The purpose of this trial is to develop and implement a program of medical optimization, physical activity, and nutrition recommendations specifically tailored to ESLD and designed to reduce frailty, improve physical function, and optimize pre- and post-transplant outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.
Medication reminders are sent to participants in Arm 2 on a daily basis.
Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Feasibility of the Intervention
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Time frame: 14 weeks
Acceptability of the Intervention
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.
Time frame: 14 weeks
Performance on the Short Physical Performance Battery (SPPB)
The SPPB is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines three areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. Static balance is measured in units of time (seconds) and patients are timed holding 3 different stances. Gait speed is measured in time (seconds) to walk 4 meters. Chair sits are measured as the time (seconds) it takes to get up and out of a chair 5 times without using one's arms to assist the exercise. Collectively, the three tests are used to generate a total score (0-12) that reflects a patient's frailty (score of 0) or lack of frailty (score of 12).
Time frame: 14 weeks
Grip strength
Grip strength will be measured using a digital hand dynamometer and the unit of measure is kilograms.
Time frame: 14 weeks
Grip strength level relative to BMI
Body Mass Index (BMI) will be calculated using height in inches and weight in pounds and reported as 'kg/m\^2'. Grip strength will be compared to BMI and a 'BMI-adjusted' grip strength level will be reported using established 'kilogram to BMI ratio' standards.
Time frame: 14 weeks
Body composition/BIA
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Bioelectrical impedance analysis will be completed using the Bodystat Quadscan 4000, which is a multi-frequency body composition analyzer. Body fat percentage (%) will be compared to lean body mass percentage and total body water percentage to assess sarcopenia and nutritional status.
Time frame: 14 weeks