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

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Other: Relaxation; Other: Exercise + relaxation

• Registration Number: NCT01447537
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation	Relaxation	Relaxation without exercise Patients will receive only relaxation for 3 months
Exercise, relaxation	Exercise + relaxation	Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months

Primary Outcome Measures

Name	Time	Method
Increase in muscle mass	Basal and three months
Change in Effort tolerance	Basal and three months

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain