- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694245
Physical and Cognitive Outcomes After Post-Transplant Physiotherapy in Liver Transplant Recipients
Evaluation of Physical and Cognitive Outcomes in Liver Transplant Recipients Who Participated in a Post-Transplant Physiotherapy Program
Liver transplantation is the most effective treatment for end-stage liver disease. However, many recipients continue to experience problems such as reduced physical function, impaired balance, fatigue, and cognitive difficulties even after successful transplantation. Although physiotherapy is commonly provided during the early postoperative period, its long-term benefits are not well understood.
This observational cross-sectional study evaluated the long-term physical and cognitive outcomes of adult liver transplant recipients approximately one year after transplantation. A total of 106 participants were included and divided into two groups according to whether they had participated in a routine post-transplant physiotherapy and rehabilitation program. Physical performance, balance, functional exercise capacity, cognitive function, and fatigue were assessed using standardized clinical outcome measures.
The study aimed to determine whether participation in a routine physiotherapy program was associated with better long-term functional outcomes after liver transplantation. The findings may help improve long-term rehabilitation strategies and support the integration of physiotherapy into routine multidisciplinary follow-up care for liver transplant recipients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Detailed Description
Liver transplantation is the standard treatment for end-stage liver disease and has substantially improved long-term survival. As survival has increased, greater attention has been directed toward long-term functional recovery, including the restoration of physical performance, cognitive function, and independence in daily living. Despite successful transplantation, many recipients continue to experience persistent impairments such as reduced mobility, balance deficits, fatigue, and cognitive dysfunction, which may negatively affect quality of life and long-term health outcomes.
Physiotherapy and rehabilitation are widely recommended during the postoperative period to promote recovery and prevent complications. Although previous studies have demonstrated the short-term benefits of rehabilitation after liver transplantation, evidence regarding its long-term effects remains limited. In particular, few studies have evaluated whether improvements achieved during the early postoperative period are maintained approximately one year after transplantation.
This observational cross-sectional study was conducted to evaluate the long-term physical and cognitive outcomes of liver transplant recipients who had participated in a routine post-transplant physiotherapy program compared with recipients who had not received postoperative physiotherapy. The study assessed functional mobility, balance, functional exercise capacity, cognitive performance, and fatigue using standardized clinical assessment tools.
The findings of this study are expected to provide further evidence regarding the long-term contribution of routine physiotherapy to functional recovery after liver transplantation and to support the development of multidisciplinary rehabilitation strategies for transplant recipients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44280
- Liver Transplant Institute Hospital, Turgut Özal Medical Center, İnönü University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult liver transplant recipients aged 18 years or older.
- At least 1 year since liver transplantation.
- Spontaneous breathing.
- Hemodynamically stable.
- Able to read and write.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- History of a neurological disorder.
- Presence of a neuropsychiatric disorder.
- Orthopedic or rheumatologic conditions that could interfere with the assessments.
- Advanced cardiopulmonary disease.
- Visual or hearing impairment that prevented completion of the assessments. Refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Routine Physiotherapy Group
Adult liver transplant recipients who completed the routine post-transplant physiotherapy and rehabilitation program.
Participants were assessed approximately one year after liver transplantation.
|
Participation in the routine postoperative physiotherapy and rehabilitation program provided after liver transplantation as part of standard clinical care.
The program included breathing exercises, progressive mobilization, muscle strengthening, balance training, gait training, and functional exercises.
Participants were not assigned to this intervention by the study protocol; the intervention had been completed before enrollment in this observational study.
|
|
Control Group
Adult liver transplant recipients who did not participate in any postoperative physiotherapy or rehabilitation program and were evaluated approximately one year after transplantation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Mobility
Time Frame: Approximately 1 year after liver transplantation
|
Functional mobility assessed using the Timed Up and Go (TUG) Test.
The outcome is recorded as the time required to complete the test, measured in seconds (minimum possible value: 0 seconds; no predefined maximum value).
Lower completion times indicate better functional mobility.
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Approximately 1 year after liver transplantation
|
|
Static Balance
Time Frame: Approximately 1 year after liver transplantation
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Static balance assessed using the Single-Leg Stance Test.
Participants were instructed to stand on their dominant leg for as long as possible while maintaining balance.
The duration of single-leg stance was recorded in seconds (minimum possible value: 0 seconds; no predefined maximum value), and the best performance was used for analysis.
Longer standing times indicate better static balance.
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Approximately 1 year after liver transplantation
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Cognitive Function
Time Frame: Approximately 1 year after liver transplantation
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Cognitive function assessed using the Montreal Cognitive Assessment (MoCA).
Scores range from 0 to 30, with higher scores indicating better cognitive performance.
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Approximately 1 year after liver transplantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Exercise Capacity
Time Frame: Approximately 1 year after liver transplantation
|
Functional exercise capacity assessed using the Six-Minute Walk Test (6MWT).
Walking distance was measured in meters (minimum possible value: 0 meters; no predefined maximum value).
Greater walking distances indicate better functional exercise capacity.
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Approximately 1 year after liver transplantation
|
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Fatigue Severity
Time Frame: Approximately 1 year after liver transplantation
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Fatigue severity assessed using the Fatigue Severity Scale (FSS).
Total scores range from 9 to 63, with higher scores indicating greater fatigue severity.
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Approximately 1 year after liver transplantation
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Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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