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Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517738
First Posted: August 17, 2007
Last Update Posted: October 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Instituto Nacional de Cardiologia Ignacio Chavez
Information provided by (Responsible Party):
Andres Duarte-Rojo, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  Purpose
Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.

Condition Intervention Phase
Cirrhosis Other: Physical training Other: Diet intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension

Resource links provided by NLM:


Further study details as provided by Andres Duarte-Rojo, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Improvement in QOL questionnaires [ Time Frame: 3 months ]
    QOL will be measured by means of SF-36 and CLDQ

  • Lack of deterioration in portal hypertension [ Time Frame: 3 months ]
    This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization


Secondary Outcome Measures:
  • Improvement in cognitive status [ Time Frame: 3 months ]
    This outcome will be evaluated with neuropsychological tests: psychometric hepatic encephalpathy score (PHES) and the critical flicker frequency test (CFF)

  • No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices [ Time Frame: 3 months ]
    History taking, hemoglobin measurement, and endoscopy for a detailed description regarding number and size of esophageal varices

  • Improved ammonia metabolism and decrease in oxidative stress [ Time Frame: 3 months ]
    Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein

  • Improvement in physical capacity and exercise tolerance [ Time Frame: 3 months ]
    Metabolic equivalents (METs) achieved in the treadmill test


Enrollment: 29
Study Start Date: February 2007
Study Completion Date: May 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical training - No encephalopathy
Patients randomized to the physical training program and diet intervention
Other: Physical training
A program of exercising under strict surveillance, with endurance and coordination maneuvers
Other Names:
  • Exercise
  • Muscle ammonia metabolism
Other: Diet intervention
Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
Other Names:
  • Nutritional therapy
  • Diet
Active Comparator: Control - No encephalopathy
Patients not allocated to exercise program, but undergoing diet intervention
Other: Diet intervention
Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
Other Names:
  • Nutritional therapy
  • Diet
Experimental: Physical training - Early encephalopathy
Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program
Other: Physical training
A program of exercising under strict surveillance, with endurance and coordination maneuvers
Other Names:
  • Exercise
  • Muscle ammonia metabolism
Other: Diet intervention
Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
Other Names:
  • Nutritional therapy
  • Diet
Active Comparator: Control - Early encephalopathy
Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention
Other: Diet intervention
Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
Other Names:
  • Nutritional therapy
  • Diet

Detailed Description:
Patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (QOL), as it has been shown with the use of questionnaires such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The deterioration in QOL is progressively accentuated as liver failure advances. There is a positive association between the level of physical activity and the sense of QOL, and physical training programs have proved to be useful in improving QOL in cardiovascular and pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a physical training program may improve QOL and hepatic encephalopathy in patients with cirrhosis and portal hypertension. Data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-proven or clinically evident cirrhosis
  • Able to perform exercise

Exclusion Criteria:

  • Overt hepatic encephalopathy grades 3 or 4
  • Cardiovascular complications (pulmonary hypertension, heart failure)
  • Diabetes mellitus and microangiopathic complications, or under treatment with insulin
  • Renal failure
  • Portal hypertension with high risk for variceal bleeding
  • Hepatocellular carcinoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517738


Locations
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico, DF, Mexico, 14000
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, DF, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
Study Chair: Sergio Ponce de Leon-Rosales, M.D. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran / Universidad Nacional Autonoma de Mexico
Study Chair: Florencia Vargas-Voráckova, MD Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán/ Universidad Nacional Autónoma de México
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andres Duarte-Rojo, MD, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00517738     History of Changes
Other Study ID Numbers: CIIBH-Ref.1639/GAS 166-09/11-1
First Submitted: August 16, 2007
First Posted: August 17, 2007
Last Update Posted: October 8, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases