Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517738
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2007-08-16
Brief Title:
Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
Official Title:
Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None