Liver Transplantation
Conditions
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.
Interventions
BEHAVIORALDigital 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.
BEHAVIORALStandard 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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Distance 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Overall muscle strength will be assessed using the Medical Research Council Sum Score. The reported value will be the total MRC Sum Score. |
| 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. | Muscle strength will be assessed using handgrip dynamometry. The reported value will be grip strength in kilograms. |
| 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 | Lower extremity physical performance will be assessed using the Short Physical Performance Battery. The reported value will be the total SPPB score. |
| 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. | Walking independence will be assessed using the Functional Ambulation Categories scale. The reported value will be the FAC score. |
| 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. | Body composition will be assessed using bioelectrical impedance analysis. The reported value will be skeletal muscle mass. |
| EQ-5D index score | 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. |
| Average daily step count measured by Fitbit Charge 5 | 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. |
Countries
South Korea
Outcome results
None listed