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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Instituto Nacional de Cardiologia Ignacio Chavez
Information provided by:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00517738
First received: August 16, 2007
Last updated: July 6, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Improvement in QOL questionnaires [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    QOL will be measured by means of SF-36 and CLDQ

  • Lack of deterioration in portal hypertension [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Metabolic equivalents (METs) achieved in the treadmill test


Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (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:
  • Physical training
  • 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:
  • Physical training
  • 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517738

Contacts
Contact: Andres Duarte-Rojo, M.D., M.Sc. 52 (55) 5487 0900 ext 2706 aduarter@hotmail.com
Contact: Aldo Torre-Delgadillo, M.D., M.Sc. 52 (55) 5487 0900 ext 2711 detoal@yahoo.com

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico, DF, Mexico, 14000
Contact: Aldo Torre-Delgadillo, M.D., M.Sc.    52 55 5573 3418    detoal@yahoo.com   
Contact: Andres Duarte-Rojo, M.D., M.Sc.    52 55 5573 3418    aduarter76@yahoo.com.mx   
Sub-Investigator: Andres Duarte-Rojo, M.D., M.Sc.         
Principal Investigator: Aldo Torre-Delgadillo, M.D., M.Sc.         
Sub-Investigator: Ricardo Macías-Rodríguez, M.D.         
Instituto Nacional de Cardiologia Ignacio Chavez Active, not recruiting
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

No publications provided

Responsible Party: Sergio Ponce-de Leon, Subdirector de Servicios Paramedicos, 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
Study First Received: August 16, 2007
Last Updated: July 6, 2011
Health Authority: Mexico: National Council of Science and Technology

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

ClinicalTrials.gov processed this record on April 17, 2014