Back to resultsMechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise + relaxation
Relaxation
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis focused on measuring Cirrhosis, Exercise, Relaxation, Muscle mass, Effort tolerance
Eligibility Criteria
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
Sites / Locations
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Exercise, relaxation
Relaxation
Arm Description
Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months
Relaxation without exercise Patients will receive only relaxation for 3 months
Outcomes
Primary Outcome Measures
Increase in muscle mass
Change in Effort tolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT01447537
First Posted
September 28, 2011
Last Updated
December 11, 2015
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT01447537
Brief Title
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Cirrhosis, Exercise, Relaxation, Muscle mass, Effort tolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise, relaxation
Arm Type
Active Comparator
Arm Description
Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months
Arm Title
Relaxation
Arm Type
Other
Arm Description
Relaxation without exercise Patients will receive only relaxation for 3 months
Intervention Type
Other
Intervention Name(s)
Exercise + relaxation
Intervention Description
Exercise + relaxation
Intervention Type
Other
Intervention Name(s)
Relaxation
Intervention Description
Relaxation without exercise Patients will receive only relaxation for 3 months
Primary Outcome Measure Information:
Title
Increase in muscle mass
Time Frame
Basal and three months
Title
Change in Effort tolerance
Time Frame
Basal and three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
German Soriano MD PhD
Organizational Affiliation
Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27011355
Citation
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.
Results Reference
derived
Learn more about this trial
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
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