- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425314
Effects of The Telerehabilitation-Based Exercise Program in Liver Transplant Patients
Effects of The Telerehabilitation-Based Exercise Program On Muscle Strength, Exercise Capacity and Fatigue Levels in Liver Transplant Patients
This randomized controlled study aims to evaluate the effects of a telerehabilitation-based exercise program on muscle strength, exercise capacity, fatigue level, and cognitive status in adult liver transplant recipients. Liver transplantation is a major surgical procedure, and patients may experience reduced physical capacity, muscle weakness, and fatigue during recovery. Exercise-based rehabilitation may help improve these outcomes, but access to in-person rehabilitation programs may be limited after discharge.
Participants will be randomly assigned to either a control group receiving routine post-transplant care or an intervention group participating in a supervised telerehabilitation exercise program. The intervention consists of a 12-week program conducted twice weekly via video communication with a physiotherapist. Outcomes will be assessed at baseline and after completion of the program.
The study seeks to determine whether a structured, remotely supervised exercise program can improve functional recovery and reduce fatigue in liver transplant patients, potentially offering an accessible rehabilitation option after hospital discharge.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Malatya, Turkey (Türkiye), 4400
- Inonu University Turgut Ozal Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult liver transplant recipients aged 18 years or older
- Medically stable and cleared for participation in an exercise program
- Able to communicate and cooperate with the researcher
- Literate and able to understand instructions
- No orthopedic or neurological condition that would limit exercise participation
- Approximately one month post-discharge following liver transplantation
- Willing to participate and provide informed consent
Exclusion Criteria:
- Presence of medical conditions that contraindicate exercise participation
- Severe cardiovascular, respiratory, neurological, or musculoskeletal disorders that could interfere with the exercise program
- Cognitive impairment preventing understanding of instructions or participation in assessments
- Postoperative complications requiring activity restriction
- Participation in another structured exercise or rehabilitation program during the study period
- Refusal or inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Telerehabilitation Exercise Group
Participants assigned to this arm received a structured telerehabilitation-based exercise program in addition to routine post-transplant care.
The program was conducted for 12 weeks, twice weekly, via real-time video communication with a physiotherapist.
Sessions included warm-up exercises, posture and breathing exercises, isometric strengthening exercises, functional movements such as sit-to-stand, walking training, and cool-down stretching.
Exercise intensity was maintained at a moderate level and progressed gradually throughout the program.
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Participants in this group received a structured telerehabilitation-based exercise program delivered under real-time supervision by a physiotherapist.
The intervention lasted 12 weeks and was conducted twice weekly via video communication.
Each session lasted approximately 30-45 minutes and included warm-up exercises, posture and breathing exercises, isometric strengthening exercises for upper and lower extremities, functional exercises such as sit-to-stand, and walking training, followed by cool-down and stretching.
Exercise intensity was maintained at a moderate level based on perceived exertion, and progression was applied throughout the program by increasing repetitions and duration to ensure adaptation and safety.
Participants were initially instructed face-to-face before discharge and then continued the program remotely after discharge.
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No Intervention: Control Group
Participants assigned to this arm continued their routine daily activities and received standard post-transplant care without participating in a structured or supervised exercise or rehabilitation program during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test (6MWT) Distance
Time Frame: Baseline (pre-intervention) and end of the 12-week intervention period
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Change in functional exercise capacity measured by the distance (meters) walked during the 6-minute walk test.
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Baseline (pre-intervention) and end of the 12-week intervention period
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Fatigue Severity Scale
Time Frame: Baseline (pre-intervention) and end of the 12-week intervention period
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Change in fatigue severity measured using the Fatigue Severity Scale (FSS).
Total scores range from 9 to 63, with higher scores indicating greater fatigue severity.
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Baseline (pre-intervention) and end of the 12-week intervention period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Peripheral Oxygen Saturation (SpO₂)
Time Frame: Baseline and end of 12 weeks
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Change in oxygen saturation measured by pulse oximeter.
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Baseline and end of 12 weeks
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Heart Rate
Time Frame: Baseline and end of 12 weeks
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Change in heart rate measured using a pulse oximeter device.
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Baseline and end of 12 weeks
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Montreal Cognitive Assessment (MoCA) Score
Time Frame: Baseline and end of 12 weeks
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Change in cognitive function assessed using the Montreal Cognitive Assessment (MoCA).
Total scores range from 0 to 30, with higher scores indicating better cognitive function.
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Baseline and end of 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ilker DEMİR, PhD, Inonu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/113 (Other Identifier: Hasan Kalyoncu Universty)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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