Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03584646
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.
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Notify Me21 year–95 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 14 weeks
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Time frame: 14 weeks
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.
Time frame: 14 weeks
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 will be measured using a digital hand dynamometer and the unit of measure is kilograms.
Time frame: 14 weeks
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
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: 12 months
A medical record review will be conducted at the end of the study to review clinical outcomes, liver transplant listing date and occurrence will be assessed.
Time frame: 12 months
A medical record review will be conducted at the end of the study to review clinical outcomes, date and occurrence liver transplantation will be assessed.
Time frame: 12 months
A medical record review will be conducted at the end of the study to review clinical outcomes, occurrence and/or date of death will be assessed.
Time frame: 12 months
A medical record review will be conducted at the end of the study to review clinical outcomes, number of admissions/hospitalizations will be assessed.
Time frame: 12 months
A medical record review will be conducted at the end of the study to review clinical outcomes, occurrence and date of removal from the liver transplant list will be assessed.
University of Pennsylvania
Other
Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
Acronym: PRIMER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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