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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• 6-Minute Walk Distance in meters [Срок оценки: Baseline (preoperative admission), on the day of hospital discharge from the index transplantation admission, 1 month after discharge, and 3 months after discharge]

Вторичные конечные точки (7)

• Medical Research Council Sum Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 1 month after discharge and 3 months after discharge.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07530913 · 2026-01-020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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