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Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis

This study is not yet open for participant recruitment.
Verified September 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
German Soriano, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01447537
First received: September 28, 2011
Last updated: October 5, 2011
Last verified: September 2011
History of Changes
  Purpose

The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.


Condition Intervention
Cirrhosis
 Other: Exercise + relaxation
Other: Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Increase in muscle mass [ Time Frame: Basal and three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Effort tolerance [ Time Frame: Basal and three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2011
Arms Assigned Interventions
Active Comparator: Exercise, relaxation
Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months
 Other: Exercise + relaxation
Exercise + relaxation
Relaxation
Relaxation without exercise Patients will receive only relaxation for 3 months
 Other: Relaxation
Relaxation without exercise Patients will receive only relaxation for 3 months

Detailed Description:

Exercise group: will do a physiotherapist supervised exercise programme 1 hour three times per week during three months and relaxation after exercise. Control group: only relaxation 1 hour three times per week during three months.

Assessment: clinical and laboratory examinations performed at baseline and at the end of the study. The investigators will analyze the changes in muscle mass by anthropometric measurements and advanced techniques (CT scan, densitometry), effort tolerance (stress test), quality of life (sF-36), glutamine synthetase activity in blood, oxidative damage and inflammatory response. The investigators will analyze the survival and complications of cirrhosis during the study and follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Compensated liver cirrhosis

Exclusion Criteria:

  • hepatocellular carcinoma
  • active alcoholism (less than 1 year)
  • decompensated cirrhosis
  • variceal bleeding less than 3 months.
  • contraindication for exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447537

Contacts
Contact: German Soriano MD PhD +34935565920 gsoriano@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: German Soriano MD PhD     +34935565920     gsoriano@santpau.cat    
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: German Soriano MD PhD Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: German Soriano, Dr. German Soriano Pastor Principal Investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01447537     History of Changes
Other Study ID Numbers: IIBSP-PEF-2010-50
Study First Received: September 28, 2011
Last Updated: October 5, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Cirrhosis
Exercise
Relaxation
Muscle mass
Effort tolerance

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013