Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis

Study Overview
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Brief Summary
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The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.

Detailed Description
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Exercise group: will do a physiotherapist supervised exercise programme 1 hour three times per week during three months and relaxation after exercise. Control group: only relaxation 1 hour three times per week during three months. Assessment: clinical and laboratory examinations performed at baseline and at the end of the study. The investigators will analyze the changes in muscle mass by anthropometric measurements and advanced techniques (CT scan, densitometry), effort tolerance (stress test), quality of life (sF-36), glutamine synthetase activity in blood, oxidative damage and inflammatory response. The investigators will analyze the survival and complications of cirrhosis during the study and follow-up.

Conditions
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Cirrhosis

Intervention / Treatment
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* Other: Exercise + relaxation
* Other: Relaxation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise, relaxation<br>Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months | Other: Exercise + relaxation<br>* Exercise + relaxation<br>|
| Other: Relaxation<br>Relaxation without exercise Patients will receive only relaxation for 3 months | Other: Relaxation<br>* Relaxation without exercise Patients will receive only relaxation for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in muscle mass |  | Basal and three months | 
| Change in Effort tolerance |  | Basal and three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Exercise, Relaxation, Muscle mass, Effort tolerance