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

Exercise Clinical Trial

— LFN-EP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932552
• Other study ID #: MICTLAN-EXERCISE 1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Exercise
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Other:
• Exercise
aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.
• nutritional therapy
individualised nutritional intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Universidad Nacional Autonoma de Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Cerebral hemodynamics	improvement in transcranial Doppler ultrasound	12 weeks
Primary	Improvement in neurocognitive status-1	improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)	12 weeks
Primary	Improvement in neurocognitive status-2	improvement in neuropsychometric tests (CFF; critical flicker frequency)	12 weeks
Primary	Changes in hepatic hemodynamics	Improvement in HVPG (HVPG; hepatic venous pressure gradient)	12 weeks
Primary	Improvement in body composition	improvement in body composition (BIA; Bioelectrical impedance analysis)	12 weeks
Primary	Improvement in nutritional status	improvement in blood markers of nutritional status (measured in serum/RNA expression)	12 weeks
Secondary	Physical fitness	improvement in 6MWT (6MWT; Six-minute walk test)	12 weeks
Secondary	Physical activity	improvement in Physical activity Questionnaires	12 weeks
Secondary	Physical activity tolerance	improvement in CPET (CPET; Cardiopulmonary exercise test)	12 weeks
Secondary	Oxidative stress	improvement in markers of systemic oxidative stress	12 weeks