Liver Transplantation (LT)NCT07694245
Physical and Cognitive Outcomes After Post-Transplant Physiotherapy in Liver Transplant Recipients
An observational study of Liver Transplantation (LT) and End-Stage Liver Disease, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation (LT), End-Stage Liver Disease
- What is being tested?
- Routine Post-Transplant Physiotherapy
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Oct 2024to 15 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult liver transplant recipients who underwent liver transplantation at Turgut Özal Medical Center, İnönü University, and were evaluated approximately one year after transplantation. Participants were classified according to whether they had participated in a routine post-transplant physiotherapy and rehabilitation program.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Liver Transplant Institute Hospital, Turgut Özal Medical Center, İnönü University
Malatya, 44280
About this study
Official title: 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.
Read the 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.
- Being tested
- Routine Post-Transplant Physiotherapy
- Keywords
- Liver transplantation, Physiotherapy, Rehabilitation, Functional mobility, Cognitive function, Fatigue
- Medical subject headings
- End Stage Liver Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Post-Transplant PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine Post-Transplant Physiotherapy | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Mobility
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.
Measured: Approximately 1 year after liver transplantation
Static Balance
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.
Measured: Approximately 1 year after liver transplantation
Cognitive Function
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Approximately 1 year after liver transplantation
Secondary outcomes (2)
Functional Exercise Capacity
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.
Measured: Approximately 1 year after liver transplantation
Fatigue Severity
Fatigue severity assessed using the Fatigue Severity Scale (FSS). Total scores range from 9 to 63, with higher scores indicating greater fatigue severity.
Measured: Approximately 1 year after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start27 Oct 2024
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplantation (LT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker DEMİR, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694245
- Sponsor's protocol ID
- 2024/116
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical and Cognitive Outcomes in Liver Transplant Recipients Who Participated in a Post-Transplant Physiotherapy Program
- ClinicalTrials.gov ID
- NCT07694245
- Acronym / sponsor ID
- 2024/116
- Keywords
- Liver transplantation, Physiotherapy, Rehabilitation, Functional mobility, Cognitive function, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Physiotherapy Group | – | Other: Routine Post-Transplant PhysiotherapyAdult liver transplant recipients who completed the routine post-transplant physiotherapy and rehabilitation program. Participants were assessed approximately one year after liver transplantation. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult liver transplant recipients who underwent liver transplantation at Turgut Özal Medical Center, İnönü University, and were evaluated approximately one year after transplantation. Participants were classified according to whether they had participated in a routine post-transplant physiotherapy and rehabilitation program.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Post-Transplant PhysiotherapyParticipation 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. | Other | Routine Physiotherapy Group |
Primary outcome
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.
Static Balance
Time frame: Approximately 1 year after liver transplantation
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.
Cognitive Function
Time frame: Approximately 1 year after liver transplantation
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.
2 secondary outcomes
Functional Exercise Capacity
Time frame: Approximately 1 year after liver transplantation
Fatigue Severity
Time frame: Approximately 1 year after liver transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation (LT) and End-Stage Liver Disease, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Mobility (time frame: Approximately 1 year after liver transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.