Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01447537
Enrollment
30
Registered
2011-10-06
Start date
2011-09-30
Completion date
2012-06-30
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

Cirrhosis, Exercise, Relaxation, Muscle mass, Effort tolerance

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.

Interventions

OTHERExercise + relaxation

Exercise + relaxation

OTHERRelaxation

Relaxation without exercise Patients will receive only relaxation for 3 months

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Increase in muscle massBasal and three months
Change in Effort toleranceBasal and three months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026