The efficacy of adding branched-chain amino acid supplement with home-based exercise for treatment of sarcopenia in cirrhotic patients

Phase 3

• Conditions: sarcopenia in cirrhotic patients; sarcopenia, cirrhosis, exercise, branched-chain amino acide, BCAA, CPET, skeletal muscle index, SMI

• Registration Number: TCTR20230713008
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-13
• Study Completion: 2024-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Any cause cirrhotic patient with CTP atleast 7
Sarcopenia by Computer Tomography scan

Exclusion Criteria

Severe comorbid disease: ESRD,uncontrol DM,COPD,CHF,ACS,cancer
HIV infection, AIDS
Liver or kidney transplant
HCC beyond Milan Criteria
History of TIPS
Uncontrol ascites, EV, GV, Jaundice
Hepatic encephalopathy
Current alcohol drinking
Hospitalization due to severe bacterial infection
Receive BCAA within 6 months
Severe orthopedic problems limiting possibility to exercise
Pregnancy
Patient refuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sarcopenia improvement 12 weeks Skeletal Muscle Index (SMI)

Secondary Outcome Measures

Name	Time	Method
aerobic muscle function 12 weeks Cardio Pulmonary Exercise Test, 6-Minute Walk Test,frailty 12 weeks liver frailty index,severity of cirrhosis 12 weeks Model for End stage Liver Disease,Child Turcotte Pugh score,quality of life 12 weeks Thai SF-36 questionaire