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

Completed · Not applicable

Conditions studied: Liver Diseases, End Stage Liver Disease, Frailty

In brief

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.

Key facts

Study ID

NCT03584646

Run by

University of Pennsylvania

People needed

30

Starts

2018-02-28

Expected to finish

2022-10-01

Last updated by the study team

2023-01-11

Who can join

Age: 21 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be wait-listed, in transplant evaluation, or "Penn Ready" with a MELD-Na score less than or equal to 25;
• Patients must be English speaking and own/use a smartphone and cognitively able to consent;
• Patient and physician feel that individual can safely participate in an exercise program;
• 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.

You may not qualify if…

• The patient is unable to provide informed consent;
• The patient has been hospitalized within the last 30 days;
• 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);
• 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);
• The patient is already enrolled in a financial incentive-based exercise program using a wearable device;
• 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.

Where it is running

• Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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