Multidimensional Frailty Assessment and Post-Transplant Outcomes in Liver Transplant Candidates

NCT07414095 | Recruiting

• 1 other identifier: 2537
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate frailty, nutrition, sarcopenia, and psychological health in people waiting for a liver transplant. The purpose is to understand how these factors affect outcomes before and after transplantation. By identifying patients at higher risk early, the study aims to support the development of better care programs in the future. Participants will complete simple tests of physical strength, walking speed, and daily activity levels. Their nutrition and psychological well-being will also be assessed. The study will then look at how these results relate to medical scores used in liver disease and to outcomes after transplant, such as hospital stay, complications, or survival. Adults aged 18-65 years who are on the liver transplant waiting list and can understand Turkish are eligible to join.

Conditions

End-Stage Liver Disease; Liver Transplantation; Cirrhosis

Keywords

Liver Transplant Candidates; Frailty; Sarcopenia; Malnutrition; Psychosocial Health

Outcome Measures

Primary Outcomes (4)

• Liver Frailty Index (LFI)

  Frailty will be assessed using the Liver Frailty Index (LFI), which is calculated from three standardized physical performance tests: grip strength (kg, average of three trials), chair stands (seconds to complete five repetitions), and balance test (seconds, up to 10 seconds in three positions). LFI score will be calculated according to the standard LFI formula. Frailty severity will be categorized as: ≥4.5: Severe frailty 3.2-4.4: Moderate frailty \<3.2: Not frail Unit of Measure: LFI score (continuous) Direction: Higher scores indicate greater frailty (worse outcome).

  At hospital admission when liver transplantation is confirmed.

• 6-Minute Walk Test (6MWT) Distance

  The 6-minute walk test (6MWT) will be conducted according to European Respiratory Society and American Thoracic Society guidelines along a 30-meter corridor. Participants will be instructed to walk as far as possible in six minutes. Distance walked will be recorded in meters and rounded to the nearest meter. Oxygen saturation, heart rate, blood pressure, and fatigue (Modified Borg Scale) will be recorded before and after the test, with continuous SpO₂ and heart rate monitoring during the walk. Frailty classification will be based on the following thresholds: \<250 m (severe frailty), 250-350 m (moderate frailty), \>350 m (not frail). Unit of Measure: Meters (continuous) Direction: Higher walking distance indicates lower frailty (better outcome).

  At hospital admission when liver transplantation is confirmed.

• Karnofsky Performance Status (KPS)

  The Karnofsky Performance Status (KPS) is a subjective measure of frailty, originally developed for oncology and subsequently applied in cirrhosis. The scale ranges from 0% (death) to 100% (normal; no complaints; no evidence of disease), scored in 10-point increments. Applicable to both hospitalized and ambulatory patients. Frailty classification will be based on the following thresholds: 0-40% = Severe frailty 50-70% = Moderate frailty ≥80% = Not frail Unit of Measure: Percentage (%) Direction: Higher KPS score indicates lower frailty (better outcome).

  At hospital admission when liver transplantation is confirmed.

• Activities of Daily Living (ADL)

  The Activities of Daily Living (ADL) scale is a subjective measure of frailty, developed to assess functional status in aging populations. It evaluates six functions: bathing, dressing, toileting, continence, transferring, and feeding. The scale is self-reported and scored from 0 (dependent) to 6 (independent). Frailty classification will be based on the following thresholds: ≥2 difficulties (severe frailty), 1 difficulty (moderate frailty), and 0 difficulties (not frail). Unit of Measure: Score (0-6) Direction: Higher scores indicate lower frailty (better outcome).

  At hospital admission when liver transplantation is confirmed.

Secondary Outcomes (15)

• Nutritional Risk Index (NRI)

  At hospital admission when liver transplantation is confirmed.

• Phase Angle Measured by Bioelectrical Impedance Analysis (BIA)

  At hospital admission when liver transplantation is confirmed.

• Sarcopenia Diagnosis According to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) Criteria

  At hospital admission when liver transplantation is confirmed.

• Handgrip Strength (HGS)

  At hospital admission when liver transplantation is confirmed.

• Skeletal Muscle Index (SMI)

  At hospital admission when liver transplantation is confirmed.

Study Arms (1)

Adult Liver Transplant Candidates

This cohort includes adult patients (aged 18-65 years) who are on the liver transplant waiting list and able to understand Turkish. Participants will undergo assessments of frailty, sarcopenia, malnutrition, and psychosocial health. No therapeutic intervention will be applied; this is an observational study. Clinical outcomes after transplantation, such as length of ICU stay, hospital discharge time, complications, and survival, will be recorded prospectively.

Other: Comprehensive Observational Assessment in Liver Transplant Candidates

Interventions

Comprehensive Observational Assessment in Liver Transplant Candidates OTHER

This study involves a comprehensive, multidimensional assessment of liver transplant candidates focusing on frailty, sarcopenia, malnutrition, and psychosocial status. Frailty will be measured using the Liver Frailty Index (LFI), 6-Minute Walk Test (6MWT), Karnofsky Performance Status (KPS), and Activities of Daily Living (ADL). Sarcopenia will be evaluated through handgrip strength, Appendicular Skeletal Muscle Mass (ASM)/Skeletal Muscle Index (SMI), and 4-meter gait speed. Malnutrition will be assessed using the Nutritional Risk Index (NRI) and phase angle derived from bioelectrical impedance analysis. Psychosocial status will be measured with the Hospital Anxiety and Depression Scale (HADS). Clinical parameters (MELD-Na, Child-Pugh, CKI-OKN) will be recorded. Post-transplant adverse outcomes including prolonged hospital and ICU stay, postoperative complications, early mortality, and duration of mechanical ventilation will be monitored up to 30 days after surgery.

Adult Liver Transplant Candidates

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients listed as liver transplant candidates at a private hospital in Izmir, Turkey.

You may qualify if:

• Being listed as a liver transplant candidate
• Age between 18 and 65 years
• Ability to understand the Turkish language

You may not qualify if:

• Presence of orthopedic and/or neurological problems severe enough to prevent completion of assessment tools
• Inability to understand verbal commands
• Being a recipient of multiple organ transplants
• Presence of serious active extrahepatic malignancy

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Izmir University of Economics Medical Point Hospital: collaborator

Study Sites (1)

Izmir University of Economics Medical Point Hospital

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease; Fibrosis; Frailty; Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Assistant Professor

CONTACT

14046; ayse.vatansever@bakircay.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 17, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TU (1)