Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 14, 2015
December 1, 2015
9 months
September 28, 2011
December 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Increase in muscle mass
Basal and three months
Change in Effort tolerance
Basal and three months
Study Arms (2)
Exercise, relaxation
ACTIVE COMPARATORActive comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months
Relaxation
OTHERRelaxation without exercise Patients will receive only relaxation for 3 months
Interventions
Relaxation without exercise Patients will receive only relaxation for 3 months
Eligibility Criteria
You may qualify if:
- Compensated liver cirrhosis
You may not qualify if:
- hepatocellular carcinoma
- active alcoholism (less than 1 year)
- decompensated cirrhosis
- variceal bleeding less than 3 months.
- contraindication for exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Related Publications (1)
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.
PMID: 27011355DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
German Soriano MD PhD
Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. German Soriano Pastor Principal Investigator
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 6, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
December 14, 2015
Record last verified: 2015-12