Liver TransplantationNCT07530913
Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients
A study testing Digital Rehabilitation Platform and Standard Exercise Education in people with Liver Transplantation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Digital Rehabilitation Platform and Standard Exercise Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Liver Transplantation
- Being tested
- Digital Rehabilitation Platform, Standard Exercise Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Rehabilitation PlatformBehavioural
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.
Standard Exercise EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Rehabilitation Platform Group | Experimental | 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. Receives: Behavioral: Digital Rehabilitation Platform |
| Standard Exercise Education Group | Active comparator | 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. Receives: Behavioral: Standard Exercise Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Distance in meters
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.
Measured: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge
Secondary outcomes (7)
Medical Research Council Sum Score
Overall muscle strength will be assessed using the Medical Research Council Sum Score. The reported value will be the total MRC Sum Score.
Measured: 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
Muscle strength will be assessed using handgrip dynamometry. The reported value will be grip strength in kilograms.
Measured: 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
Lower extremity physical performance will be assessed using the Short Physical Performance Battery. The reported value will be the total SPPB score.
Measured: 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
Walking independence will be assessed using the Functional Ambulation Categories scale. The reported value will be the FAC score.
Measured: 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
Body composition will be assessed using bioelectrical impedance analysis. The reported value will be skeletal muscle mass.
Measured: 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
Health-related quality of life will be assessed using the EQ-5D questionnaire. The reported value will be the EQ-5D index score.
Measured: 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
Physical activity will be assessed using Fitbit Charge 5. The reported value will be average daily step count.discharge.
Measured: 1 month after discharge and 3 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start26 Mar 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530913
- Sponsor's protocol ID
- 2026-01-020
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients: Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT07530913
- Acronym / sponsor ID
- 2026-01-020
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Rehabilitation Platform Group | Experimental | Behavioral: Digital Rehabilitation PlatformParticipants 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. |
| Standard Exercise Education Group | Active comparator | Behavioral: Standard Exercise EducationParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Rehabilitation PlatformA 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. | Behavioural | Digital Rehabilitation Platform Group |
| Standard Exercise EducationUsual rehabilitation exercise education provided during hospitalization for patients undergoing living donor liver transplantation, with instructions for continued self-exercise and self-management after discharge. | Behavioural | Standard Exercise Education Group |
Primary outcome
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.
7 secondary outcomes
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.
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.
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
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.
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.
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.
Average daily step count measured by Fitbit Charge 5
Time frame: 1 month after discharge and 3 months after discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Rehabilitation Platform and Standard Exercise Education in people with Liver Transplantation, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.