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

Phase 2

Completed

• Conditions: Cirrhosis
• Interventions: Other: Physical training; Other: Diet intervention

• Registration Number: NCT00517738
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-17
• Primary Completion: 2014-01
• Study Completion: 2014-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical training - Early encephalopathy	Diet intervention	Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program
Control - Early encephalopathy	Diet intervention	Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention
Control - No encephalopathy	Diet intervention	Patients not allocated to exercise program, but undergoing diet intervention
Physical training - No encephalopathy	Physical training	Patients randomized to the physical training program and diet intervention
Physical training - No encephalopathy	Diet intervention	Patients randomized to the physical training program and diet intervention
Physical training - Early encephalopathy	Physical training	Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Improvement in physical capacity and exercise tolerance	3 months	Metabolic equivalents (METs) achieved in the treadmill test
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)
Improved ammonia metabolism and decrease in oxidative stress	3 months	Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein

Trial Locations

Locations (2)

Instituto Nacional de Cardiologia Ignacio Chavez; 🇲🇽 Mexico, DF, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico, DF, Mexico