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

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ClinicalTrials.gov Identifier: NCT03584646
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Marina Serper, MD, MS, University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Diseases End Stage Liver Disease Frailty Device: Nokia GO Wearable StepTracker Other: Medication Reminder Other: Weekly Check-in appointment with study team or provider Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigator will conduct a patient-randomized, two-arm pilot study of 38 participants with a predicted attrition rate of 20% resulting in 30 total participants; n=10 in Arm 1 and n=20 in Arm 2. Arm 1 will serve as the control arm and Arm 2 will serve as the intervention arm.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 - Control Arm
Usual care, nutrition and exercise counseling at baseline, use of the Nokia GO wearable step tracker device and end-of-study assessment at the end of the 14-week study period. Participants will receive the Nokia GO wearable step tracker to monitor daily step counts, but they will not be provided with personalized walking goals or automated feedback on goal attainment via text message.
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.

Experimental: Arm 2 - Intervention arm
Physical activity program supported by financial incentives for meeting walking goals and participating in weekly check-in appointments with study team members via telephone calls. Participants in the intervention arm will also receive twice-daily medication reminders via bidirectional text messages to promote medication adherence. Participants in Arm 2 will also receive personalized nutrition and exercise counseling, daily feedback on step counts via the Nokia GO wearable step tracker and their smartphones, and an end-of-study assessment.
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.




Primary Outcome Measures :
  1. Feasibility of the Intervention [ Time Frame: 14 weeks ]
    Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.

  2. Acceptability of the Intervention [ Time Frame: 14 weeks ]
    Acceptability will be measured using a patient satisfaction questionnaire upon study completion.


Secondary Outcome Measures :
  1. Performance on the Short Physical Performance Battery (SPPB) [ 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).

  2. Grip strength [ Time Frame: 14 weeks ]
    Grip strength will be measured using a digital hand dynamometer and the unit of measure is kilograms.

  3. Grip strength level relative to BMI [ 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.

  4. Body composition/BIA [ 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.


Other Outcome Measures:
  1. Clinical Outcomes from Medical Record Review - Liver Transplant listing [ 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.

  2. Clinical Outcomes from Medical Record Review - Liver Transplantation [ 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.

  3. Clinical Outcomes from Medical Record Review - Death [ 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.

  4. Clinical Outcomes from Medical Record Review - Hospitalization [ 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.

  5. Clinical Outcomes from Medical Record Review - Removal from Liver Transplant List [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584646


Locations
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United States, Pennsylvania
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: Marina Serper, MD, MS, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03584646     History of Changes
Other Study ID Numbers: 828669
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marina Serper, MD, MS, University of Pennsylvania:
liver transplantation
malnutrition
exercise
prehabilitation
nutrition
sarcopenia

Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Frailty
Digestive System Diseases
Pathologic Processes
Liver Failure
Hepatic Insufficiency