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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517738
• Other study ID #: CIIBH-Ref.1639/GAS 166-09/11-1
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: October 7, 2015
• Start date: February 2007
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Other:
• Physical training
A program of exercising under strict surveillance, with endurance and coordination maneuvers
• 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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico	DF
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	DF

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in QOL questionnaires	QOL will be measured by means of SF-36 and CLDQ	3 months	No
Primary	Lack of deterioration in portal hypertension	This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization	3 months	Yes
Secondary	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
Secondary	No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices	History taking, hemoglobin measurement, and endoscopy for a detailed description regarding number and size of esophageal varices	3 months	Yes
Secondary	Improved ammonia metabolism and decrease in oxidative stress	Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein	3 months	No
Secondary	Improvement in physical capacity and exercise tolerance	Metabolic equivalents (METs) achieved in the treadmill test	3 months	No