Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients

April 8, 2026 updated by: Samsung Medical Center

Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients: Randomized Controlled Trials

This randomized controlled study aims to evaluate the effectiveness of a digital rehabilitation exercise platform in patients undergoing living donor liver transplantation. A total of 36 adult patients who require ongoing rehabilitation after living donor liver transplantation will be recruited and randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group will receive a personalized exercise program delivered through a digital rehabilitation platform in addition to standard exercise education, whereas the control group will receive standard exercise education only. Physical function, body composition, quality of life, and physical activity will be assessed before surgery, at discharge, at 1 month after discharge, and at 3 months after discharge to determine whether the digital rehabilitation platform improves recovery-related outcomes during the post-transplant period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing living donor liver transplantation who require continuous rehabilitation treatment
  • Adults aged 20 to 65 years
  • Able to independently operate digital devices such as a smartphone or tablet PC
  • Able to perform exercises and review feedback using the digital rehabilitation platform
  • No significant impairment in hearing, vision, or cognitive function that would interfere with understanding audio and visual instructions provided by the platform

Exclusion Criteria:

  • Patients with an inadequate level of consciousness or cognitive impairment making cooperation with the rehabilitation exercise program difficult
  • Patients who have difficulty using digital devices or cannot independently use digital-based services
  • Patients with severe limitations in muscle strength or range of motion, or amputation-related disability, making the exercise program difficult to perform
  • Patients who require restriction of movement necessary for the rehabilitation exercise program due to fracture or musculoskeletal instability
  • Patients with pain during upper or lower extremity movement and biomechanical instability that makes participation difficult
  • Patients with visual or hearing impairment that interferes with cooperation in the rehabilitation exercise program
  • Patients who develop medical complications or transplant rejection during study participation
  • Patients unable to perform physical activity because of abdominal pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital Rehabilitation Platform Group
Participants in this group will receive a personalized exercise program using a digital rehabilitation platform in addition to standard exercise education. During hospitalization, participants will perform platform-based exercise sessions with research staff, and after discharge they will continue self-exercise and self-management using the platform. Exercise content may be adjusted according to assessment results and participant condition.
Behavioral: Digital Rehabilitation Platform
A personalized digital rehabilitation exercise program for patients undergoing living donor liver transplantation. The program includes exercise guidance during hospitalization and continued home-based self-exercise and self-management after discharge through a digital rehabilitation platform.
Active Comparator: Standard Exercise Education Group
Participants in this group will receive standard exercise education according to usual rehabilitation care procedures during hospitalization and will continue self-exercise and self-management after discharge based on the education and materials provided.
Behavioral: Standard Exercise Education
Usual rehabilitation exercise education provided during hospitalization for patients undergoing living donor liver transplantation, with instructions for continued self-exercise and self-management after discharge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-Minute Walk Distance in meters
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge
Six-minute walk distance will be measured using the 6-Minute Walk Test to assess functional exercise capacity and physical endurance in patients undergoing living donor liver transplantation. The reported value will be the total distance walked in meters.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medical Research Council Sum Score
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Overall muscle strength will be assessed using the Medical Research Council Sum Score. The reported value will be the total MRC Sum Score.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Grip Strength in kilograms
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Muscle strength will be assessed using handgrip dynamometry. The reported value will be grip strength in kilograms.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Short Physical Performance Battery total score
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge
Lower extremity physical performance will be assessed using the Short Physical Performance Battery. The reported value will be the total SPPB score.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge
Functional Ambulation Categories score
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Walking independence will be assessed using the Functional Ambulation Categories scale. The reported value will be the FAC score.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Skeletal Muscle Mass measured by bioelectrical impedance analysis
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Body composition will be assessed using bioelectrical impedance analysis. The reported value will be skeletal muscle mass.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
EQ-5D index score
Time Frame: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Health-related quality of life will be assessed using the EQ-5D questionnaire. The reported value will be the EQ-5D index score.
Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
Average daily step count measured by Fitbit Charge 5
Time Frame: 1 month after discharge and 3 months after discharge.
Physical activity will be assessed using Fitbit Charge 5. The reported value will be average daily step count.discharge.
1 month after discharge and 3 months after discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-01-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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