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

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03932552
• Collaborator: Universidad Nacional Autonoma de Mexico (Other)
• Enrollment: 28
• Arms: 2
• Anticipated Duration (Months): 42.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis; Portal Hypertension; Exercise	Other: Exercise; Other: nutritional therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Aug 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Improvement in Cerebral hemodynamics [12 weeks]

   improvement in transcranial Doppler ultrasound

2. Improvement in neurocognitive status-1 [12 weeks]

   improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)

3. Improvement in neurocognitive status-2 [12 weeks]

   improvement in neuropsychometric tests (CFF; critical flicker frequency)

4. Changes in hepatic hemodynamics [12 weeks]

   Improvement in HVPG (HVPG; hepatic venous pressure gradient)

5. Improvement in body composition [12 weeks]

   improvement in body composition (BIA; Bioelectrical impedance analysis)

6. Improvement in nutritional status [12 weeks]

   improvement in blood markers of nutritional status (measured in serum/RNA expression)

Secondary Outcome Measures

1. Physical fitness [12 weeks]

   improvement in 6MWT (6MWT; Six-minute walk test)

2. Physical activity [12 weeks]

   improvement in Physical activity Questionnaires

3. Physical activity tolerance [12 weeks]

   improvement in CPET (CPET; Cardiopulmonary exercise test)

4. Oxidative stress [12 weeks]

   improvement in markers of systemic oxidative stress

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• ClinicalTrials.gov Identifier: NCT03932552
• Other Study ID Numbers: MICTLAN-EXERCISE 1
• First Posted: Apr 30, 2019
• Last Update Posted: Aug 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Hypertension, Portal; Fibrosis

Study Results

No Results Posted as of Aug 7, 2019