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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cirrhosis Portal Hypertension Exercise

Interventions

ExerciseOTHER

aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.

nutritional therapyOTHER

individualised nutritional intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Improvement in Cerebral hemodynamics

improvement in transcranial Doppler ultrasound

Time frame: 12 weeks

Improvement in neurocognitive status-1

improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)

Time frame: 12 weeks

Improvement in neurocognitive status-2

improvement in neuropsychometric tests (CFF; critical flicker frequency)

Time frame: 12 weeks

Changes in hepatic hemodynamics

Improvement in HVPG (HVPG; hepatic venous pressure gradient)

Time frame: 12 weeks

Improvement in body composition

improvement in body composition (BIA; Bioelectrical impedance analysis)

Time frame: 12 weeks

Improvement in nutritional status

improvement in blood markers of nutritional status (measured in serum/RNA expression)

Time frame: 12 weeks

Secondary Outcomes

Physical fitness

improvement in 6MWT (6MWT; Six-minute walk test)

Time frame: 12 weeks

Physical activity

improvement in Physical activity Questionnaires

Time frame: 12 weeks

Physical activity tolerance

Data from ClinicalTrials.gov

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