About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being listed as a liver transplant candidate
Age between 18 and 65 years
Ability to understand the Turkish language
Disqualifiers
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
Trial population
The study population consists of patients listed as liver transplant candidates at a private hospital in Izmir, Turkey.
Trial design
Cohort
Prospective
Treatments tested in this trial
Comprehensive Observational Assessment in Liver Transplant Candidates
Other interventionThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
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).
Secondary outcomes
Nutritional Risk Index (NRI)
Nutritional status will be assessed using the Nutritional Risk Index (NRI). The NRI score will be calculated using serum albumin level (g/dL), current body weight (kg), and usual body weight (kg) according to the following formula: NRI = (15.19 × serum albumin \[g/dL\]) + (41.7 × current weight / usual weight) Nutritional status will be categorized as follows: NRI ≥ 100: No malnutrition 97.5 ≤ NRI \< 100: Mild malnutrition 83.5 ≤ NRI \< 97.5: Moderate malnutrition NRI \< 83.5: Severe malnutrition Unit of Measure: NRI score Direction: Higher NRI values indicate better nutritional status.
Phase Angle Measured by Bioelectrical Impedance Analysis (BIA)
Phase angle will be measured using bioelectrical impedance analysis (BIA) as an indicator of cellular integrity and nutritional status. Measurements will be performed according to standard BIA procedures at the time of hospital admission. Phase angle values will be categorized according to predefined study criteria as follows: \<4.4 degrees: Abnormal 4.4-5.4 degrees: Borderline ≥5.4 degrees: Normal Unit of Measure: Degrees Direction: Higher phase angle values indicate better cellular health and nutritional status.
Sarcopenia Diagnosis According to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) Criteria
Sarcopenia will be assessed according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. Evaluation will include assessment of muscle strength, muscle mass, and physical performance using standardized measurement procedures at hospital admission. Sarcopenia will be classified as: Probable sarcopenia: Low muscle strength Sarcopenia: Low muscle strength and low muscle mass Severe sarcopenia: Low muscle strength, low muscle mass, and low physical performance Unit of Measure: Categorical classification (probable sarcopenia, sarcopenia, severe sarcopenia) Direction: Lower sarcopenia severity indicates better muscle status.
Handgrip Strength (HGS)
Handgrip strength will be measured using a hand dynamometer in the dominant hand following a standardized protocol (patient seated, elbow at 90 degrees, three trials, best value recorded). Low muscle strength will be defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria as \<27 kg for men and \<16 kg for women. Unit of Measure: Kilograms (kg) Direction: Higher handgrip strength indicates better muscle strength and physical status.
Sponsors and contacts
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Izmir Bakircay University
Lead sponsor
Izmir University of Economics Medical Point Hospital
Collaborator