Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Dietary Supplement: Leucine supplements

• Registration Number: NCT01060813
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2011-09
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• compensated liver cirrhosis.

Exclusion Criteria

• hepatocellular carcinoma,
• active alcoholism (less than 1 year),
• decompensated cirrhosis,
• variceal bleeding less than 3 months,
• contraindication for exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + Leucine	Leucine supplements	Patients will receive leucine 10 g/d po + exercise for 3 months
Leucine without exercise	Leucine supplements	patients will receive leucine 10 g/d po

Primary Outcome Measures

Name	Time	Method
glutamine synthetase activity	three months

Secondary Outcome Measures

Name	Time	Method
quality of life	three months

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain