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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03932552

Acronym

LFN-EP

Enrollment

Registered

2019-04-30

Start date

2016-02-01

Completion date

2020-01-31

Last updated

2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Portal Hypertension, Exercise

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.

Interventions

OTHERExercise

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

OTHERnutritional therapy

individualised nutritional intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Improvement in nutritional status	12 weeks	improvement in blood markers of nutritional status (measured in serum/RNA expression)
Improvement in neurocognitive status-1	12 weeks	improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
Improvement in neurocognitive status-2	12 weeks	improvement in neuropsychometric tests (CFF; critical flicker frequency)
Changes in hepatic hemodynamics	12 weeks	Improvement in HVPG (HVPG; hepatic venous pressure gradient)
Improvement in body composition	12 weeks	improvement in body composition (BIA; Bioelectrical impedance analysis)
Improvement in Cerebral hemodynamics	12 weeks	improvement in transcranial Doppler ultrasound

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026