Clinical trial NCT00517738: Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis
Official title: Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cirrhosis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Cardiologia Ignacio Chavez
First posted: 2007-08-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Improvement in QOL questionnaires
timeFrame: 3 months
measure: Lack of deterioration in portal hypertension
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in cognitive status
timeFrame: 3 months
measure: No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices
timeFrame: 3 months
measure: Improved ammonia metabolism and decrease in oxidative stress
timeFrame: 3 months
measure: Improvement in physical capacity and exercise tolerance
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
state: DF
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran / Universidad Nacional Autonoma de Mexico
name: Sergio Ponce de Leon-Rosales, M.D.
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán/ Universidad Nacional Autónoma de México
name: Florencia Vargas-Voráckova, MD
role: STUDY_CHAIR
References:
citation: 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.