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



Status:Active, not recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - 95
Updated:2/7/2019
Start Date:February 28, 2018
End Date:September 2019

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

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.

Inclusion Criteria:

1. Participants must be wait-listed, in transplant evaluation, or "Penn Ready" with a
MELD-Na score less than or equal to 25;

2. Patients must be English speaking and own/use a smartphone and cognitively able to
consent;

3. Patient and physician feel that individual can safely participate in an exercise
program;

4. Meeting at least one 'at risk' criterion for impaired physical performance, frailty,
or malnutrition (by SPPB, abPG-SG, dynamometer measured grip strength), or physical
deconditioning as determined by physical therapist, or treating clinician.

Exclusion Criteria:

1. The patient is unable to provide informed consent;

2. The patient has been hospitalized within the last 30 days;

3. A score of 0-3 points on the SPPB assessment indicating inability to participate in a
physical activity program or a score of 12 in the absence of frailty or malnutrition
(indicating low risk for poor physical or performance or malnutrition);

4. The patient is at risk for falling as defined by clinician assessment results or if
the patient states that he/she has a history of falling (record of a fall(s) in the
past 30 days);

5. The patient is already enrolled in a financial incentive-based exercise program using
a wearable device;

6. Any other medical conditions that would prohibit participation in a physical activity
program as determined by transplant clinicians or severe vision, hearing, or mobility
impairment precluding participation.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Marina Serper, MD, MS
Phone: 215-360-0913
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mi
from
Philadelphia, PA
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