NCT03584646

Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Diseases
• End Stage Liver Disease
• Frailty

Interventions

Type	Name	Description
DEVICE	Nokia GO Wearable StepTracker	All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.
OTHER	Medication Reminder	Medication reminders are sent to participants in Arm 2 on a daily basis.
OTHER	Weekly Check-in appointment with study team or provider	Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.

Timeline

• Start date: 2018-02-28
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2018-07-12
• Last updated: 2023-01-11

Locations

1 site across 1 country: United States