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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Cirrhosis

Treatments: Other: Exercise + relaxation; Other: Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT01447537

IIBSP-PEF-2010-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Exercise, relaxation

Active Comparator group

Description:

Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months

Treatment:

Other: Exercise + relaxation

Relaxation

Other group

Description:

Relaxation without exercise Patients will receive only relaxation for 3 months

Treatment:

Other: Relaxation