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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise + Leucine

Patients will receive leucine 10 g/d po + exercise for 3 months

Group Type ACTIVE_COMPARATOR

Leucine supplements

Intervention Type DIETARY_SUPPLEMENT

leucine supplements

Leucine without exercise

patients will receive leucine 10 g/d po

Group Type ACTIVE_COMPARATOR

Leucine supplements

Intervention Type DIETARY_SUPPLEMENT

leucine supplements

Interventions

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Leucine supplements

leucine supplements

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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No other names

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No