Clinical trial

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)

Name

IIBSP-FRA-2019-36

Description

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.

Trial arms

Trial start

2020-05-13

Estimated PCD

2022-06-30

Trial end

2023-05-30

Status

Completed

Treatment

Home exercise program for 12 months.

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.

Arms:

Multifactorial intervention

Multispecies probiotic: Vivomixx®

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.

Arms:

Multifactorial intervention

Branched-chain amino acids (BCAA)

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.

Arms:

Multifactorial intervention

No specific intervention.

Follow up as a clinical practice

Arms:

Control group

Size

Primary endpoint

Substudy I: Mortality during hospitalization and follow-up

One year

Substudy II: Evolution of the Liver Frailty Index.

One year

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

Updated at

2024-02-29

1 organization

4 products

3 indications

Organization

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

Product

Home exercise program

Indication

Cirrhosis

Indication