Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol)

Study Overview
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Brief Summary
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This study evaluates the effects of a structured exercise (The LFN-exercise protocol) program plus diet, on cerebral hemodynamics (cerebral blood flow) and hepatic hemodynamics (portal pressure), as well as on nutritional status (body composition and nutritional markers) in order to facilitate the prescription of exercise in patients with cirrhosis.

Official Title
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Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)

Conditions
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Cirrhosis, Portal Hypertension, Exercise

Intervention / Treatment
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* Other: Exercise
* Other: nutritional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine <1.5 mg/dL; able to attend the appointed visits and willing to participate in the study. Exclusion Criteria: Presence of high-risk varices in upper endoscopy (red marks, large varices or gastric varices); concomitant cardiopulmonary diseases; decompensated Type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopaedic or osteomuscular limitations; any type of cancer, primary sclerosing cholangitis and Inflammatory bowel disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Personalized nutritional therapy | Other: nutritional therapy<br>* individualised nutritional intervention<br>|
| Experimental: Exercise<br>Aerobic exercise + Personalized nutritional therapy | Other: Exercise<br>* aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Cerebral hemodynamics | improvement in transcranial Doppler ultrasound | 12 weeks | 
| Improvement in neurocognitive status-1 | improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score) | 12 weeks | 
| Improvement in neurocognitive status-2 | improvement in neuropsychometric tests (CFF; critical flicker frequency) | 12 weeks | 
| Changes in hepatic hemodynamics | Improvement in HVPG (HVPG; hepatic venous pressure gradient) | 12 weeks | 
| Improvement in body composition | improvement in body composition (BIA; Bioelectrical impedance analysis) | 12 weeks | 
| Improvement in nutritional status | improvement in blood markers of nutritional status (measured in serum/RNA expression) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | improvement in 6MWT (6MWT; Six-minute walk test) | 12 weeks | 
| Physical activity | improvement in Physical activity Questionnaires | 12 weeks | 
| Physical activity tolerance | improvement in CPET (CPET; Cardiopulmonary exercise test) | 12 weeks | 
| Oxidative stress | improvement in markers of systemic oxidative stress | 12 weeks |