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

NCT03584646 | Completed

• 1 other identifier: 828669
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Diseases; End Stage Liver Disease; Frailty

Keywords

liver transplantation; malnutrition; exercise; prehabilitation; nutrition; sarcopenia

Outcome Measures

Primary Outcomes (2)

• Feasibility of the Intervention

  Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.

  14 weeks

• Acceptability of the Intervention

  Acceptability will be measured using a patient satisfaction questionnaire upon study completion.

  14 weeks

Secondary Outcomes (4)

• Performance on the Short Physical Performance Battery (SPPB)

  14 weeks

• Grip strength

  14 weeks

• Grip strength level relative to BMI

  14 weeks

• Body composition/BIA

  14 weeks

Other Outcomes (5)

• Clinical Outcomes from Medical Record Review - Liver Transplant listing

  12 months

• Clinical Outcomes from Medical Record Review - Liver Transplantation

  12 months

• Clinical Outcomes from Medical Record Review - Death

  12 months

Study Arms (2)

Arm 1 - Control Arm

EXPERIMENTAL

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

Arm 2 - Intervention arm

EXPERIMENTAL

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; Other: Medication Reminder; Other: Weekly Check-in appointment with study team or provider

Interventions

Nokia GO Wearable StepTracker DEVICE

All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.

Arm 1 - Control Arm; Arm 2 - Intervention arm

Medication Reminder OTHER

Medication reminders are sent to participants in Arm 2 on a daily basis.

Arm 2 - Intervention arm

Weekly Check-in appointment with study team or provider OTHER

Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.

Arm 2 - Intervention arm

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Liver Diseases; End Stage Liver Disease; Frailty; Malnutrition; Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: July 12, 2018
• Study Start: February 28, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)