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Enrolling by Invitation

NCT Number: NCT07530913

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

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.

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Key information

Conditions

Liver Transplantation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Rehabilitation Platform

Behavioral

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 Education

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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