NCT07530913

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 26, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

March 31, 2026

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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

    Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge.

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Standard Exercise Education

Interventions

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.

Standard Exercise Education Group

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.

Digital Rehabilitation Platform Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 15, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations