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| Name | Class |
|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical training - No encephalopathy | Experimental | Patients randomized to the physical training program and diet intervention |
|
| Control - No encephalopathy | Active Comparator | Patients not allocated to exercise program, but undergoing diet intervention |
|
| Physical training - Early encephalopathy | Experimental | Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program |
|
| Control - Early encephalopathy | Active Comparator | Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical training | Other | A program of exercising under strict surveillance, with endurance and coordination maneuvers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in QOL questionnaires | QOL will be measured by means of SF-36 and CLDQ | 3 months |
| Lack of deterioration in portal hypertension | This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in cognitive status | This outcome will be evaluated with neuropsychological tests: psychometric hepatic encephalpathy score (PHES) and the critical flicker frequency test (CFF) | 3 months |
| No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez | Mexico City | Mexico City | 14000 | Mexico | ||
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27415618 | Derived | Macias-Rodriguez RU, Ilarraza-Lomeli H, Ruiz-Margain A, Ponce-de-Leon-Rosales S, Vargas-Vorackova F, Garcia-Flores O, Torre A, Duarte-Rojo A. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial. Clin Transl Gastroenterol. 2016 Jul 14;7(7):e180. doi: 10.1038/ctg.2016.38. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D044623 | Nutrition Therapy |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| 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 |
|
|
History taking, hemoglobin measurement, and endoscopy for a detailed description regarding number and size of esophageal varices |
| 3 months |
| Improved ammonia metabolism and decrease in oxidative stress | Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein | 3 months |
| Improvement in physical capacity and exercise tolerance | Metabolic equivalents (METs) achieved in the treadmill test | 3 months |
| Mexico City |
| Mexico City |
| 14000 |
| Mexico |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |