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

NCT ID: NCT01447537

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Cirrhosis

Keywords

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Cirrhosis Exercise Relaxation Muscle mass Effort tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise, relaxation

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

Group Type ACTIVE_COMPARATOR

Exercise + relaxation

Intervention Type OTHER

Exercise + relaxation

Relaxation

Relaxation without exercise Patients will receive only relaxation for 3 months

Group Type OTHER

Relaxation

Intervention Type OTHER

Relaxation without exercise Patients will receive only relaxation for 3 months

Interventions

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Exercise + relaxation

Exercise + relaxation

Intervention Type OTHER

Relaxation

Relaxation without exercise Patients will receive only relaxation for 3 months

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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German Soriano

Dr. German Soriano Pastor Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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German Soriano MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Roman E, Garcia-Galceran C, Torrades T, Herrera S, Marin A, Donate M, Alvarado-Tapias E, Malouf J, Nacher L, Serra-Grima R, Guarner C, Cordoba J, Soriano G. Effects of an Exercise Programme on Functional Capacity, Body Composition and Risk of Falls in Patients with Cirrhosis: A Randomized Clinical Trial. PLoS One. 2016 Mar 24;11(3):e0151652. doi: 10.1371/journal.pone.0151652. eCollection 2016.

Reference Type DERIVED
PMID: 27011355 (View on PubMed)

Other Identifiers

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IIBSP-PEF-2010-50

Identifier Type: -

Identifier Source: org_study_id