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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifactorial intervention | Experimental | Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months. |
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| Control group | Experimental | Frail and pre-frail patients will be followed but will not receive any specific intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home exercise program for 12 months. | Combination Product | Physical exercise at home: At the beginning of the study, group sessions will be conducted with 5 patients of 1-hour duration, where they will be taught the individualized program according to their physical condition and they will be given the necessary material (pedaling, dumbbells and elastic bands) and paper support on the program, also using the Vivifrail method through infographics. The group session will be repeated every 3 months to check the compliance of the program by reviewing daily activity, evaluate possible problems and review the exercises. The program will consist of aerobic and anaerobic exercise by pedaling (cardiovascular resistance) and resistance exercises with dumbbells and elastic bands (muscular strength), flexibility training by stretching, and coordination and balance exercises. Patients will perform 3 sessions per week of 20-30 min. increasing progressively according to tolerance up to 45-60 min. each. |
| Measure | Description | Time Frame |
|---|---|---|
| Substudy I: Mortality during hospitalization and follow-up | At the time of admission, during hospitalization and in one hundred outpatients visits every 3 months until 12 months of follow-up | One year |
| Substudy II: Evolution of the Liver Frailty Index. | At the beginning and every 3 months in one hundred fifty outpatient visits until the end of the study at 12 months | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Phase angle (PA) | By bioimpedance (BIA 101 with Bodygram Pro software, Akern) at admission, hospital discharge and every 3 months. | One year |
| Degree of sarcopenia | Grip strength assessed by a dynamometer (KERN MAP 80K1, Akern). The results will be adjusted by age and gender |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Germán Soriano, PhD | Hospital Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41174950 | Derived | Vega-Abellaneda S, Roman E, Soler Z, Ortiz MA, Rossi G, Biagini L, Sanchez E, Pons-Tarin M, Laghi L, Mengucci C, Kaur N, Poca M, Cuyas B, Serrano-Gomez G, Alvarado E, Manichanh C, Soriano G. A Metagenomics Approach to Frailty in Patients With Cirrhosis Undergoing a Multifactorial Intervention. Liver Int. 2025 Dec;45(12):e70418. doi: 10.1111/liv.70418. | |
| 38701490 |
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| Multispecies probiotic: Vivomixx® | Combination Product | Multispecies probiotic: Vivomixx® is a probiotic mixture of 8 bacterial strains: Streptococcus thermophilus DSM 24731® / NCIMB 30438, Bifidobacterium breve DSM 24732® / NCIMB 30441, Bifidobacterium longum DSM 24736® / NCIMB 30435*, Bifidobacterium infantis DSM 24737® / NCIMB 30436*, Lactobacillus acidophilus DSM 24735® / NCIMB 30442, Lactobacillus plantarum DSM 24730® / NCIMB 30437, Lactobacillus paracasei DSM 24733® / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM 24734® / NCIMB 30440** * Re-classified as B. lactis ** Re-classified as L. helveticus The active agent will be supplied as an envelope of 4.4 g with a dose of 450x109 million live bacteria per envelope with maltose and silicon dioxide as excipients, administered 2 times/day throughout the study. |
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| Branched-chain amino acids (BCAA) | Combination Product | Branched-chain amino acids (BCAA): In addition to the exercise program and the probiotic, patients in the intervention group will receive BCAA supplements (powder in 8:1:1 ratio in favor of L-leucine) 10 g 30-60 min. before the exercise session throughout the study, in order to enhance the effect of exercise on muscle mass and improve cognitive function. We have chosen this dose based on the literature data and the satisfactory results obtained with this dose in our previous study. BCAA supplements will be supplied by the Pharmacy Service of our center. |
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| No specific intervention. | Combination Product | Follow up as a clinical practice |
|
| One year |
| Biomarkers of frailty | At baseline and at 12 months.We will quantify by specific ELISA kits and multiplex assays biomarkers | One year |
| Fall risk tests | 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 | One year |
| Cognitive function | Psychometric Hepatic Encephalopathy Score (PHES). Scores <-4 points is considered as a cognitiva impairment | One year |
| Degree of Quality of life | SF-36 questionnaire - Scores above 50 will be better and below 50 points will be worse. | One year |
| Fecal microbiota | 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. | One year |
| Degree Quality of life | Depression and anxiety scale (HADS): Scores higher than 11 are probably cases in each of the subscales | One year |
| Roman E, Kaur N, Sanchez E, Poca M, Padros J, Nadal MJ, Cuyas B, Alvarado E, Vidal S, Ortiz MA, Hernandez E, Santesmases R, Urgell E, Juanes E, Ferrero-Gregori A, Escorsell A, Guarner C, Soriano G. Home exercise, branched-chain amino acids, and probiotics improve frailty in cirrhosis: A randomized clinical trial. Hepatol Commun. 2024 May 3;8(5):e0443. doi: 10.1097/HC9.0000000000000443. eCollection 2024 May 1. |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D055948 | Sarcopenia |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000597 | Amino Acids, Branched-Chain |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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