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Completed

NCT Number: NCT03932552

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

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.

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Key information

Conditions

Cirrhosis Behavior Digestive System Diseases Exercise Fibrosis Hypertension, Portal Liver Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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

Nutritional therapy

Other

individualised nutritional intervention

Primary outcomes

  1. Improvement in Cerebral hemodynamics

    Time frame: 12 weeks

    improvement in transcranial Doppler ultrasound

  2. Improvement in neurocognitive status-1

    Time frame: 12 weeks

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

  3. Improvement in neurocognitive status-2

    Time frame: 12 weeks

    improvement in neuropsychometric tests (CFF; critical flicker frequency)

  4. Changes in hepatic hemodynamics

    Time frame: 12 weeks

    Improvement in HVPG (HVPG; hepatic venous pressure gradient)

  5. Improvement in body composition

    Time frame: 12 weeks

    improvement in body composition (BIA; Bioelectrical impedance analysis)

  6. Improvement in nutritional status

    Time frame: 12 weeks

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

Secondary outcomes

  1. Physical fitness

    Time frame: 12 weeks

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

  2. Physical activity

    Time frame: 12 weeks

    improvement in Physical activity Questionnaires

  3. Physical activity tolerance

    Time frame: 12 weeks

    improvement in CPET (CPET; Cardiopulmonary exercise test)

  4. Oxidative stress

    Time frame: 12 weeks

    improvement in markers of systemic oxidative stress

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Acronym: LFN-EP

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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