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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (7)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Samsung Medical Center — Seoul

Identifiers

NCT: NCT07530913 · 2026-01-020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗