Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention

NCT04243148 | Completed DMC

• 1 other identifier: IIBSP-FRA-2019-36
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis of the Liver; Sarcopenia; Frailty Syndrome

Keywords

Falls; Hospitalizations; Mortality; Phase angle; Body Composition

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Phase angle (PA)

  One year

• Degree of sarcopenia

  One year

• Biomarkers of frailty

  One year

• Fall risk tests

  One year

• Cognitive function

  One year

Study Arms (2)

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.

Combination Product: Home exercise program for 12 months.; Combination Product: Multispecies probiotic: Vivomixx®; Combination Product: Branched-chain amino acids (BCAA)

Control group

EXPERIMENTAL

Frail and pre-frail patients will be followed but will not receive any specific intervention.

Combination Product: No specific intervention.

Interventions

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.

Multifactorial intervention

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.

Multifactorial intervention

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.

Multifactorial intervention

No specific intervention. COMBINATION_PRODUCT

Follow up as a clinical practice

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (2)

• 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.

  PMID: 41174950 DERIVED

• 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.

  PMID: 38701490 DERIVED

MeSH Terms

Conditions

Fibrosis; Sarcopenia; Frailty

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Germán Soriano, PhD

  Hospital Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 28, 2020
• Study Start: May 13, 2020
• Primary Completion: June 30, 2022
• Study Completion: May 30, 2023
• Last Updated: February 29, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)