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

Not Applicable

Completed

• Conditions: Cirrhosis; Portal Hypertension; Exercise
• Interventions: Other: Exercise; Other: nutritional therapy

• Registration Number: NCT03932552
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-30
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Aerobic exercise + Personalized nutritional therapy
Control	nutritional therapy	Personalized nutritional therapy

Primary Outcome Measures

Name	Time	Method
Improvement in neurocognitive status-1	12 weeks	improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
Improvement in nutritional status	12 weeks	improvement in blood markers of nutritional status (measured in serum/RNA expression)
Improvement in Cerebral hemodynamics	12 weeks	improvement in transcranial Doppler ultrasound
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)

Secondary Outcome Measures

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