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

NACompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

May 13, 2020

Primary Completion Date

June 30, 2022

Study Completion Date

May 30, 2023

Conditions
Cirrhosis of the LiverSarcopeniaFrailty Syndrome
Interventions
COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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."

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

No specific intervention.

Follow up as a clinical practice

Trial Locations (1)

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

All Listed Sponsors
lead

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

OTHER

NCT04243148 - Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention | Biotech Hunter | Biotech Hunter