NCT00517738

Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis

Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
OTHER	Physical training	A program of exercising under strict surveillance, with endurance and coordination maneuvers
OTHER	Diet 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

Timeline

• Start date: 2007-02-01
• Primary completion: 2014-01-01
• Completion: 2014-05-01
• First posted: 2007-08-17
• Last updated: 2015-10-08

Locations

2 sites across 1 country: Mexico