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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Portal Hypertension; Cirrhosis; Exercise

Treatments: Other: Exercise; Other: nutritional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03932552

MICTLAN-EXERCISE 1

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Control

Active Comparator group

Description:

Personalized nutritional therapy

Treatment:

Other: nutritional therapy

Exercise

Experimental group

Description:

Aerobic exercise + Personalized nutritional therapy

Treatment:

Other: Exercise