- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530913
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
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- 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
-
-
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Seoul, South Korea
- Samsung Medical Center
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
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.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge
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Secondary Outcome Measures
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.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
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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.
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Muscle strength will be assessed using handgrip dynamometry.
The reported value will be grip strength in kilograms.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
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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
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Lower extremity physical performance will be assessed using the Short Physical Performance Battery.
The reported value will be the total SPPB score.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge
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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.
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Walking independence will be assessed using the Functional Ambulation Categories scale.
The reported value will be the FAC score.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
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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.
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Body composition will be assessed using bioelectrical impedance analysis.
The reported value will be skeletal muscle mass.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
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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.
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Health-related quality of life will be assessed using the EQ-5D questionnaire.
The reported value will be the EQ-5D index score.
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Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.
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Average daily step count measured by Fitbit Charge 5
Time Frame: 1 month after discharge and 3 months after discharge.
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Physical activity will be assessed using Fitbit Charge 5.
The reported value will be average daily step count.discharge.
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1 month after discharge and 3 months after discharge.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 26, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 31, 2026
First Submitted That Met QC Criteria
April 8, 2026
First Posted (Actual)
April 15, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID 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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