Investigation of the Relationship Between Frailty, Sarcopenia, Malnutrition, and Psychosocial Parameters and Post-Transplant Outcomes in Liver Transplant Candidates
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Izmir Bakircay University
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Liver Frailty Index (LFI)
概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being listed as a liver transplant candidate
- •Age between 18 and 65 years
- •Ability to understand the Turkish language
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Comprehensive Observational Assessment in Liver Transplant Candidates (Other)
结局指标
主要结局
Liver Frailty Index (LFI)
时间窗: At hospital admission when liver transplantation is confirmed.
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
时间窗: At hospital admission when liver transplantation is confirmed.
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)
时间窗: At hospital admission when liver transplantation is confirmed.
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)
时间窗: At hospital admission when liver transplantation is confirmed.
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).
次要结局
- 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.)
- Gait Speed (4-meter walk test)(At hospital admission when liver transplantation is confirmed.)
- Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(At hospital admission when liver transplantation is confirmed.)
- Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(At hospital admission when liver transplantation is confirmed.)
- Hospital Anxiety and Depression Scale - Total Score (HADS Total)(At hospital admission when liver transplantation is confirmed.)
- Charlson Comorbidity Index - Orthotopic Liver Transplant (CCI-OLT)(At hospital admission when liver transplantation is confirmed.)
- Intensive Care Unit (ICU) Length of Stay(From the day of liver transplantation until ICU discharge (within 30 days post-transplant).)
- Hospital Length of Stay(From the day of liver transplantation until hospital discharge (within 30 days post-transplant).)
- Postoperative Mechanical Ventilation Duration(From the day of liver transplantation until extubation or 30 days post-transplant, whichever occurs first.)
- Early Postoperative Complications (within 30 days)(Within 30 days after liver transplantation.)
- 30-Day Mortality(Within 30 days after liver transplantation.)
研究者
AYŞE KAYALI VATANSEVER
Assistant Professor, PhD
Izmir Bakircay University