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Clinical Trials/NCT03932552
NCT03932552
Completed
Not Applicable

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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran0 sites28 target enrollmentFebruary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cirrhosis
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Enrollment
28
Primary Endpoint
Improvement in neurocognitive status-1
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2016
End Date
January 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Responsible Party
Sponsor

Eligibility Criteria

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 neurocognitive status-1

Time Frame: 12 weeks

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

Improvement in nutritional status

Time Frame: 12 weeks

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

Improvement in Cerebral hemodynamics

Time Frame: 12 weeks

improvement in transcranial Doppler ultrasound

Improvement in neurocognitive status-2

Time Frame: 12 weeks

improvement in neuropsychometric tests (CFF; critical flicker frequency)

Changes in hepatic hemodynamics

Time Frame: 12 weeks

Improvement in HVPG (HVPG; hepatic venous pressure gradient)

Improvement in body composition

Time Frame: 12 weeks

improvement in body composition (BIA; Bioelectrical impedance analysis)

Secondary Outcomes

  • Physical activity(12 weeks)
  • Physical fitness(12 weeks)
  • Physical activity tolerance(12 weeks)
  • Oxidative stress(12 weeks)

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