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

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

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 Overview

• Status: Completed
• Conditions: Exercise; Cirrhosis; Portal Hypertension
• Intervention / Treatment: Other: nutritional therapy; Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Personalized nutritional therapy	Other: nutritional therapy; individualised nutritional intervention
Experimental: Exercise; Aerobic exercise + Personalized nutritional therapy	Other: Exercise; aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical fitness	improvement in 6MWT (6MWT; Six-minute walk test)	12 weeks
Physical activity	improvement in Physical activity Questionnaires	12 weeks
Physical activity tolerance	improvement in CPET (CPET; Cardiopulmonary exercise test)	12 weeks
Oxidative stress	improvement in markers of systemic oxidative stress	12 weeks

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Universidad Nacional Autonoma de Mexico
• Investigators: Study Director: Ricardo U Macías-Rodríguez, M.D., PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: MICTLAN-EXERCISE 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No