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

Primary Purpose

Cirrhosis, Portal Hypertension, Exercise

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
nutritional therapy
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Exercise

    Arm Description

    Personalized nutritional therapy

    Aerobic exercise + Personalized nutritional therapy

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Physical fitness
    improvement in 6MWT (6MWT; Six-minute walk test)
    Physical activity
    improvement in Physical activity Questionnaires
    Physical activity tolerance
    improvement in CPET (CPET; Cardiopulmonary exercise test)
    Oxidative stress
    improvement in markers of systemic oxidative stress

    Full Information

    First Posted
    March 12, 2019
    Last Updated
    August 31, 2022
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Collaborators
    Universidad Nacional Autonoma de Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03932552
    Brief Title
    Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol)
    Acronym
    LFN-EP
    Official Title
    Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    January 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Collaborators
    Universidad Nacional Autonoma de Mexico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cirrhosis, Portal Hypertension, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Personalized nutritional therapy
    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    Aerobic exercise + Personalized nutritional therapy
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.
    Intervention Type
    Other
    Intervention Name(s)
    nutritional therapy
    Intervention Description
    individualised nutritional intervention
    Primary Outcome Measure Information:
    Title
    Improvement in Cerebral hemodynamics
    Description
    improvement in transcranial Doppler ultrasound
    Time Frame
    12 weeks
    Title
    Improvement in neurocognitive status-1
    Description
    improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
    Time Frame
    12 weeks
    Title
    Improvement in neurocognitive status-2
    Description
    improvement in neuropsychometric tests (CFF; critical flicker frequency)
    Time Frame
    12 weeks
    Title
    Changes in hepatic hemodynamics
    Description
    Improvement in HVPG (HVPG; hepatic venous pressure gradient)
    Time Frame
    12 weeks
    Title
    Improvement in body composition
    Description
    improvement in body composition (BIA; Bioelectrical impedance analysis)
    Time Frame
    12 weeks
    Title
    Improvement in nutritional status
    Description
    improvement in blood markers of nutritional status (measured in serum/RNA expression)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Physical fitness
    Description
    improvement in 6MWT (6MWT; Six-minute walk test)
    Time Frame
    12 weeks
    Title
    Physical activity
    Description
    improvement in Physical activity Questionnaires
    Time Frame
    12 weeks
    Title
    Physical activity tolerance
    Description
    improvement in CPET (CPET; Cardiopulmonary exercise test)
    Time Frame
    12 weeks
    Title
    Oxidative stress
    Description
    improvement in markers of systemic oxidative stress
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ricardo U Macías-Rodríguez, M.D., PhD
    Organizational Affiliation
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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