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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03932552

Recruitment Status Active, not recruiting

First Posted April 30, 2019

Last update posted August 7, 2019

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:Cirrhosis
    Portal Hypertension
    Exercise
  • Intervention/Treatment: Other: Exercise
    Other: nutritional therapy
  • Phase: N/A
Detailed Description

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: February 2016
  • Estimated Primary Completion Date: December 2018
  • Actual Study Completion Date: August 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Exercise
Aerobic exercise + Personalized nutritional therapy
Other: Exercise
aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.
Active Comparator: Control
Personalized nutritional therapy
Other: nutritional therapy
individualised nutritional intervention
Outcome Measures
  • Primary Outcome Measures: 1. Improvement in Cerebral hemodynamics [ Time Frame: 12 weeks ]
    improvement in transcranial Doppler ultrasound
  • 2. Improvement in neurocognitive status-1 [ Time Frame: 12 weeks ]
    improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
  • 3. Improvement in neurocognitive status-2 [ Time Frame: 12 weeks ]
    improvement in neuropsychometric tests (CFF; critical flicker frequency)
  • 4. Changes in hepatic hemodynamics [ Time Frame: 12 weeks ]
    Improvement in HVPG (HVPG; hepatic venous pressure gradient)
  • 5. Improvement in body composition [ Time Frame: 12 weeks ]
    improvement in body composition (BIA; Bioelectrical impedance analysis)
  • 6. Improvement in nutritional status [ Time Frame: 12 weeks ]
    improvement in blood markers of nutritional status (measured in serum/RNA expression)
  • Secondary Outcome Measures: 1. Physical fitness [ Time Frame: 12 weeks ]
    improvement in 6MWT (6MWT; Six-minute walk test)
  • 2. Physical activity [ Time Frame: 12 weeks ]
    improvement in Physical activity Questionnaires
  • 3. Physical activity tolerance [ Time Frame: 12 weeks ]
    improvement in CPET (CPET; Cardiopulmonary exercise test)
  • 4. Oxidative stress [ Time Frame: 12 weeks ]
    improvement in markers of systemic oxidative stress
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts
Locations
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

More Information
  • Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • ClinicalTrials.gov Identifier: NCT03932552 History of Changes
  • Other Study ID Numbers: MICTLAN-EXERCISE 1
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: August 7, 2019
  • Last Verified: March 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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: Hypertension, Portal
    Fibrosis
    Liver Cirrhosis