Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of a Multifactorial Intervention (Home Exercise, Branched-chain Aminoacids and Probiotic)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Substudy I: Mortality during hospitalization and follow-up
研究概览
简要总结
This study evaluate Frailty syndrome (FS) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. Identifying, treating and preventing FS can improve the prognosis and quality of life of these patients and reduce health costs.
详细描述
Substudy I. The phase angle (PA) determined by electrical bioimpedance is an index of FS with prognostic value in outpatients with cirrhosis, but its usefulness in hospitalized patients has not been studied. Objective: To analyze the prognostic value of PA in hospitalized patients with cirrhosis. Patients and Methods: 100 hospitalized patients with cirrhosis will be consecutively included and PA will be determined by bioimpedance at admission. The correlation between PA and liver function and frailty markers, and the evolution during hospitalization, as well as the incidence of falls, hospitalizations and mortality during follow-up will be analyzed. Substudy II. Given the multidimensional nature of the FS, we propose a multifactorial non-pharmacological intervention based on evidence from previous studies that could be implemented in daily clinical practice. Objective: To evaluate if a multifactorial intervention can improve the FS and decrease the related events (hospitalizations, falls and mortality) in patients with cirrhosis. Patients and Methods: 150 outpatients with cirrhosis will be included and evaluated using the Liver Frailty Index. Frail and pre-frail patients will be randomized into two groups: one group that will receive a multifactorial intervention, consisting of exercise at home, branched-chain amino acids and multispecies probiotic for one year, and one control group. The evolution of the Liver Frailty Index and other parameters (muscle and cognitive function, bioimpedance, risk of falls, quality of life) and biomarkers (miostatin, immune response, microbiota) of FS, and the incidence of hospitalizations, falls and mortality in both groups will be prospectively analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Aged >18 years old, with cirrhosis diagnosed by clinical, analytical and ultrasound criteria or liver biopsy
- •Conscious and oriented in time and space and able to understand and follow the indications of the study.
排除标准
- •Liver cirrhosis with poor prognosis (MELD [Model for End Stage Liver Disease]> 25)
- •Hepatocellular carcinoma or other active neoplastic disease
- •Expected survival <6 months
- •Acute and/or chronic hepatic encephalopathy
- •Neurological disorder that hinders the performance of the tests
- •Active alcoholism in the previous 3 months
- •Severe comorbidities
- •Hospitalization in the previous month
- •Contraindications to exercise or probiotic treatment (immunosuppression)
- •Refusal to sign informed consent.
研究组 & 干预措施
Control group
Frail and pre-frail patients will be followed but will not receive any specific intervention.
干预措施: No specific intervention. (Combination Product)
Multifactorial intervention
Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months.
干预措施: Home exercise program for 12 months. (Combination Product)
Multifactorial intervention
Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months.
干预措施: Multispecies probiotic: Vivomixx® (Combination Product)
Multifactorial intervention
Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months.
干预措施: Branched-chain amino acids (BCAA) (Combination Product)
结局指标
主要结局
Substudy I: Mortality during hospitalization and follow-up
时间窗: One year
At the time of admission, during hospitalization and in one hundred outpatients visits every 3 months until 12 months of follow-up
Substudy II: Evolution of the Liver Frailty Index.
时间窗: One year
At the beginning and every 3 months in one hundred fifty outpatient visits until the end of the study at 12 months
次要结局
- Degree of sarcopenia(One year)
- Phase angle (PA)(One year)
- Biomarkers of frailty(One year)
- Fall risk tests(One year)
- Fecal microbiota(One year)
- Degree Quality of life(One year)
- Cognitive function(One year)
- Degree of Quality of life(One year)