Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients: Randomized Controlled Trials
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Samsung Medical Center
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 6-Minute Walk Distance in meters
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Digital Rehabilitation Platform Group
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.
Intervention: Digital Rehabilitation Platform (Behavioral)
Standard Exercise Education Group
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.
Intervention: Standard Exercise Education (Behavioral)
Outcomes
Primary Outcomes
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
- 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.)
- 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.)
- Average daily step count measured by Fitbit Charge 5(1 month after discharge and 3 months after discharge.)