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

Primary Purpose

Liver Diseases, End Stage Liver Disease, Frailty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nokia GO Wearable StepTracker
Medication Reminder
Weekly Check-in appointment with study team or provider
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases focused on measuring liver transplantation, malnutrition, exercise, prehabilitation, nutrition, sarcopenia

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Perelman Center for Advanced Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1 - Control Arm

Arm 2 - Intervention arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of the Intervention
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Acceptability of the Intervention
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.

Secondary Outcome Measures

Performance on the Short Physical Performance Battery (SPPB)
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).
Grip strength
Grip strength will be measured using a digital hand dynamometer and the unit of measure is kilograms.
Grip strength level relative to BMI
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.
Body composition/BIA
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.

Full Information

First Posted
February 1, 2018
Last Updated
January 10, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03584646
Brief Title
Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
Acronym
PRIMER
Official Title
Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, End Stage Liver Disease, Frailty
Keywords
liver transplantation, malnutrition, exercise, prehabilitation, nutrition, sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Control Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2 - Intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nokia GO Wearable StepTracker
Intervention Description
All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.
Intervention Type
Other
Intervention Name(s)
Medication Reminder
Intervention Description
Medication reminders are sent to participants in Arm 2 on a daily basis.
Intervention Type
Other
Intervention Name(s)
Weekly Check-in appointment with study team or provider
Intervention Description
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 Measure Information:
Title
Feasibility of the Intervention
Description
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Time Frame
14 weeks
Title
Acceptability of the Intervention
Description
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Performance on the Short Physical Performance Battery (SPPB)
Description
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
Title
Grip strength
Description
Grip strength will be measured using a digital hand dynamometer and the unit of measure is kilograms.
Time Frame
14 weeks
Title
Grip strength level relative to BMI
Description
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
Title
Body composition/BIA
Description
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
14 weeks
Other Pre-specified Outcome Measures:
Title
Clinical Outcomes from Medical Record Review - Liver Transplant listing
Description
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
Title
Clinical Outcomes from Medical Record Review - Liver Transplantation
Description
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
Title
Clinical Outcomes from Medical Record Review - Death
Description
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
Title
Clinical Outcomes from Medical Record Review - Hospitalization
Description
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
Title
Clinical Outcomes from Medical Record Review - Removal from Liver Transplant List
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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