Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis
- Conditions
- Cirrhosis
- Interventions
- Other: Physical trainingOther: Diet intervention
- Registration Number
- NCT00517738
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Biopsy-proven or clinically evident cirrhosis
- Able to perform exercise
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical training - Early encephalopathy Diet intervention Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program Control - Early encephalopathy Diet intervention Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention Control - No encephalopathy Diet intervention Patients not allocated to exercise program, but undergoing diet intervention Physical training - No encephalopathy Physical training Patients randomized to the physical training program and diet intervention Physical training - No encephalopathy Diet intervention Patients randomized to the physical training program and diet intervention Physical training - Early encephalopathy Physical training Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program
- Primary Outcome Measures
Name Time Method Improvement in QOL questionnaires 3 months QOL will be measured by means of SF-36 and CLDQ
Lack of deterioration in portal hypertension 3 months This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization
- Secondary Outcome Measures
Name Time Method No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices 3 months History taking, hemoglobin measurement, and endoscopy for a detailed description regarding number and size of esophageal varices
Improvement in physical capacity and exercise tolerance 3 months Metabolic equivalents (METs) achieved in the treadmill test
Improvement in cognitive status 3 months This outcome will be evaluated with neuropsychological tests: psychometric hepatic encephalpathy score (PHES) and the critical flicker frequency test (CFF)
Improved ammonia metabolism and decrease in oxidative stress 3 months Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein
Trial Locations
- Locations (2)
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽Mexico, DF, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico, DF, Mexico