Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cirrhosis
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Lack of deterioration in portal hypertension
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Andres Duarte-Rojo
MD, PhD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Eligibility 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
Outcomes
Primary Outcomes
Lack of deterioration in portal hypertension
Time Frame: 3 months
This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization
Improvement in QOL questionnaires
Time Frame: 3 months
QOL will be measured by means of SF-36 and CLDQ
Secondary Outcomes
- No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices(3 months)
- Improvement in physical capacity and exercise tolerance(3 months)
- Improvement in cognitive status(3 months)
- Improved ammonia metabolism and decrease in oxidative stress(3 months)