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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 2

Conditions: Cirrhosis

Treatments: Other: Diet intervention; Other: Physical training

Study type: Interventional

Funder types: Other

Identifiers

NCT00517738

CIIBH-Ref.1639/GAS 166-09/11-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 4 patient groups

Physical training - No encephalopathy

Experimental group

Description:

Patients randomized to the physical training program and diet intervention

Treatment:

Other: Physical training

Other: Diet intervention

Control - No encephalopathy

Active Comparator group

Description:

Patients not allocated to exercise program, but undergoing diet intervention

Treatment:

Other: Diet intervention

Physical training - Early encephalopathy

Experimental group

Description:

Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program

Treatment:

Other: Physical training

Other: Diet intervention

Control - Early encephalopathy

Active Comparator group

Description:

Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention

Treatment:

Other: Diet intervention