NCT03932552

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 1, 2022

Status Verified

March 1, 2019

Enrollment Period

3.9 years

First QC Date

March 12, 2019

Last Update Submit

August 31, 2022

Conditions

CirrhosisPortal HypertensionExercise

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • Physical fitness

    12 weeks

  • Physical activity

    12 weeks

  • Physical activity tolerance

    12 weeks

  • Oxidative stress

    12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Personalized nutritional therapy

Other: nutritional therapy

Exercise

EXPERIMENTAL

Aerobic exercise + Personalized nutritional therapy

Other: Exercise

Interventions

ExerciseOTHER

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

Exercise
nutritional therapyOTHER

individualised nutritional intervention

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Macias-Rodriguez RU, Ruiz-Margain A, Roman-Calleja B, Cantu-Brito C, Flores-Silva F, Gabutti-Thomas A, Aguilar-Najera O, Cruz-Contreras M, Weber-Sangri L, Rios-Torres S, Delgadillo AT, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D. Effect of a monitored exercise protocol in cerebral and hepatic hemodynamics in patients with cirrhosis and portal hypertension. Dig Liver Dis. 2024 May;56(5):827-835. doi: 10.1016/j.dld.2023.11.011. Epub 2023 Nov 25.

    PMID: 38008698DERIVED

MeSH Terms

Conditions

FibrosisHypertension, PortalMotor Activity

Interventions

ExerciseNutrition Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeutics

Study Officials

  • Ricardo U Macías-Rodríguez, M.D., PhD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

April 30, 2019

Study Start

February 1, 2016

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

September 1, 2022

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share