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出境医 / 临床实验 / Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol) (LFN-EP)
Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol) (LFN-EP)
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 | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| 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 1, 2016 |
| Actual Primary Completion Date : | December 31, 2018 |
| Estimated Study Completion Date : | August 31, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Control
Personalized nutritional therapy
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Other: nutritional therapy
individualised nutritional intervention
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Experimental: Exercise
Aerobic exercise + Personalized nutritional therapy
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Other: Exercise
aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.
|
Outcome Measures
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- Physical fitness [ Time Frame: 12 weeks ]improvement in 6MWT (6MWT; Six-minute walk test)
- Physical activity [ Time Frame: 12 weeks ]improvement in Physical activity Questionnaires
- Physical activity tolerance [ Time Frame: 12 weeks ]improvement in CPET (CPET; Cardiopulmonary exercise test)
- Oxidative stress [ Time Frame: 12 weeks ]improvement in markers of systemic oxidative stress
Eligibility Criteria
| Ages Eligible for Study: | 18 Years 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
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 |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 12, 2019 | ||||
| First Posted Date ICMJE | April 30, 2019 | ||||
| Last Update Posted Date | August 7, 2019 | ||||
| Actual Study Start Date ICMJE | February 1, 2016 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol) | ||||
| Official Title ICMJE | Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study) | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Actual Enrollment ICMJE |
28 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | August 31, 2019 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03932552 | ||||
| Other Study ID Numbers ICMJE | MICTLAN-EXERCISE 1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
| Study Sponsor ICMJE | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
| Collaborators ICMJE | Universidad Nacional Autonoma de Mexico | ||||
| Investigators ICMJE |
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| PRS Account | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
| Verification Date | March 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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