CirrhosisLFN-EPNCT03932552
Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol)
A study testing Exercise and nutritional therapy in people with Cirrhosis and Portal Hypertension, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Portal Hypertension, Exercise
- What is being tested?
- Exercise and nutritional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)
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.
- Conditions
- Cirrhosis, Portal Hypertension, Exercise
- Being tested
- Exercise, nutritional therapy
- Medical subject headings
- Fibrosis, Hypertension, Portal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.
nutritional therapyOther
individualised nutritional intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Personalized nutritional therapy Receives: Other: nutritional therapy |
| Exercise | Experimental | Aerobic exercise + Personalized nutritional therapy Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Cerebral hemodynamics
improvement in transcranial Doppler ultrasound
Measured: 12 weeks
Improvement in neurocognitive status-1
improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
Measured: 12 weeks
Improvement in neurocognitive status-2
improvement in neuropsychometric tests (CFF; critical flicker frequency)
Measured: 12 weeks
Changes in hepatic hemodynamics
Improvement in HVPG (HVPG; hepatic venous pressure gradient)
Measured: 12 weeks
Improvement in body composition
improvement in body composition (BIA; Bioelectrical impedance analysis)
Measured: 12 weeks
Improvement in nutritional status
improvement in blood markers of nutritional status (measured in serum/RNA expression)
Measured: 12 weeks
Secondary outcomes (4)
Physical fitness
improvement in 6MWT (6MWT; Six-minute walk test)
Measured: 12 weeks
Physical activity
improvement in Physical activity Questionnaires
Measured: 12 weeks
Physical activity tolerance
improvement in CPET (CPET; Cardiopulmonary exercise test)
Measured: 12 weeks
Oxidative stress
improvement in markers of systemic oxidative stress
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Feb 2016
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Responsible party
- Sponsor
- Investigators
- Ricardo U Macías-Rodríguez, M.D., PhD, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932552
- Sponsor's protocol ID
- MICTLAN-EXERCISE 1
- Acronym
- LFN-EP
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macias-Rodriguez RU, Ruiz-Margain A, Roman-Calleja B, Cantu-Brito C, Flores-Silva F, Gabutti-Thomas A, Aguilar-Najera O, Cruz-Contreras M, Weber-Sangri L, Rios-Torres S, Delgadillo AT, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D. Effect of a monitored exercise protocol in cerebral and hepatic hemodynamics in patients with cirrhosis and portal hypertension. Dig Liver Dis. 2024 May;56(5):827-835. doi: 10.1016/j.dld.2023.11.011. Epub 2023 Nov 25.
PubMed 38008698
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)
- ClinicalTrials.gov ID
- NCT03932552
- Acronym / sponsor ID
- LFN-EP / MICTLAN-EXERCISE 1
- Conditions
- Cirrhosis, Portal Hypertension, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: nutritional therapyPersonalized nutritional therapy |
| Exercise | Experimental | Other: ExerciseAerobic exercise + Personalized nutritional therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exerciseaerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity. | Other | Exercise |
| nutritional therapyindividualised nutritional intervention | Other | Control |
Primary outcome
Improvement in Cerebral hemodynamics
Time frame: 12 weeks
improvement in transcranial Doppler ultrasound
Improvement in neurocognitive status-1
Time frame: 12 weeks
improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
Improvement in neurocognitive status-2
Time frame: 12 weeks
improvement in neuropsychometric tests (CFF; critical flicker frequency)
Changes in hepatic hemodynamics
Time frame: 12 weeks
Improvement in HVPG (HVPG; hepatic venous pressure gradient)
Improvement in body composition
Time frame: 12 weeks
improvement in body composition (BIA; Bioelectrical impedance analysis)
Improvement in nutritional status
Time frame: 12 weeks
improvement in blood markers of nutritional status (measured in serum/RNA expression)
4 secondary outcomes
Physical fitness
Time frame: 12 weeks
Physical activity
Time frame: 12 weeks
Physical activity tolerance
Time frame: 12 weeks
Oxidative stress
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 38008698Macias-Rodriguez RU, Ruiz-Margain A, Roman-Calleja B, Cantu-Brito C, Flores-Silva F, Gabutti-Thomas A, Aguilar-Najera O, Cruz-Contreras M, Weber-Sangri L, Rios-Torres S, Delgadillo AT, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D. Effect of a monitored exercise protocol in cerebral and hepatic hemodynamics in patients with cirrhosis and portal hypertension. Dig Liver Dis. 2024 May;56(5):827-835. doi: 10.1016/j.dld.2023.11.011. Epub 2023 Nov 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo U Macías-Rodríguez, M.D., PhD study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and nutritional therapy in people with Cirrhosis and Portal Hypertension, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Cerebral hemodynamics (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.