NCT07694245

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 3, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Liver transplantationPhysiotherapyRehabilitationFunctional mobilityCognitive functionFatigue

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Approximately 1 year after liver transplantation

Secondary Outcomes (2)

  • Functional Exercise Capacity

    Approximately 1 year after liver transplantation

  • Fatigue Severity

    Approximately 1 year after liver transplantation

Study Arms (2)

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.

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.

Interventions

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.

Routine Physiotherapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Transplant Institute Hospital, Turgut Özal Medical Center, İnönü University

Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

End Stage Liver DiseaseFatigue

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

October 27, 2024

Primary Completion

June 15, 2026

Study Completion

June 15, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations