Cirrhosis
Conditions
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.
Interventions
OTHERPhysical training
A program of exercising under strict surveillance, with endurance and coordination maneuvers
OTHERDiet 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
Sponsors
Instituto Nacional de Cardiologia Ignacio Chavez
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Improved ammonia metabolism and decrease in oxidative stress | 3 months | Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein |
| Improvement in physical capacity and exercise tolerance | 3 months | Metabolic equivalents (METs) achieved in the treadmill test |
Countries
Mexico
Outcome results
None listed