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Completed

NCT Number: NCT00517738

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

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical training

Other

A program of exercising under strict surveillance, with endurance and coordination maneuvers

Other names: Exercise, Muscle ammonia metabolism

Diet intervention

Other

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

Primary outcomes

  1. Improvement in QOL questionnaires

    Time frame: 3 months

    QOL will be measured by means of SF-36 and CLDQ

  2. 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 outcomes

  1. 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)

  2. 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

  3. 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

  4. Improvement in physical capacity and exercise tolerance

    Time frame: 3 months

    Metabolic equivalents (METs) achieved in the treadmill test

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

Registry information

Official study title

Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2007
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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