Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention
- Conditions
- Cirrhosis of the LiverSarcopeniaFrailty Syndrome
- Interventions
- Combination Product: Home exercise program for 12 months.Combination Product: No specific intervention.Combination Product: Branched-chain amino acids (BCAA)
- Registration Number
- NCT04243148
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multifactorial intervention Home exercise program for 12 months. Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months. Multifactorial intervention Branched-chain amino acids (BCAA) Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months. Control group No specific intervention. Frail and pre-frail patients will be followed but will not receive any specific intervention.
- Primary Outcome Measures
Name Time Method Substudy I: Mortality during hospitalization and follow-up 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. One year At the beginning and every 3 months in one hundred fifty outpatient visits until the end of the study at 12 months
- Secondary Outcome Measures
Name Time Method Degree of sarcopenia One year Grip strength assessed by a dynamometer (KERN MAP 80K1, Akern). The results will be adjusted by age and gender
Phase angle (PA) One year By bioimpedance (BIA 101 with Bodygram Pro software, Akern) at admission, hospital discharge and every 3 months.
Biomarkers of frailty One year At baseline and at 12 months.We will quantify by specific ELISA kits and multiplex assays biomarkers
Fall risk tests One year Walking speed (41) and Timed Up \& Go: time in seconds that the patient uses to get up from a chair, walk 3 meters and sit back without support. Times greater than 9 seconds to travel the distance is considered a risk of falls
Degree of Quality of life One year SF-36 questionnaire
- Scores above 50 will be better and below 50 points will be worse.Fecal microbiota One year At baseline, 6 and 12 months.For the extraction of genomic DNA from stool samples, a previous protocol according to the International consortium (IHMS: http://www.microbiome-standards.org/) will be used.
Degree Quality of life One year Depression and anxiety scale (HADS): Scores higher than 11 are probably cases in each of the subscales
Cognitive function One year Psychometric Hepatic Encephalopathy Score (PHES). Scores \<-4 points is considered as a cognitiva impairment
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain