CirrhosisPhase 2NCT00517738
Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis
A Phase 2 study testing Physical training and Diet intervention in people with Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
Trial summary
Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Physical training and Diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesMexico
- Study dates
- Feb 2007to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven or clinically evident cirrhosis
- Able to perform exercise
Who cannot join
- Overt hepatic encephalopathy grades 3 or 4
- Cardiovascular complications (pulmonary hypertension, heart failure)
- Diabetes mellitus and microangiopathic complications, or under treatment with insulin
- Renal failure
- Portal hypertension with high risk for variceal bleeding
- Hepatocellular carcinoma
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, Mexico City, 14000
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
About this study
Official title: Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension
Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.
Read the detailed description
Patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (QOL), as it has been shown with the use of questionnaires such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The deterioration in QOL is progressively accentuated as liver failure advances. There is a positive association between the level of physical activity and the sense of QOL, and physical training programs have proved to be useful in improving QOL in cardiovascular and pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a physical training program may improve QOL and hepatic encephalopathy in patients with cirrhosis and portal hypertension. Data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.
- Conditions
- Cirrhosis
- Being tested
- Physical training, Diet intervention
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Also called Exercise, Muscle ammonia metabolism
A program of exercising under strict surveillance, with endurance and coordination maneuvers
Diet interventionOther
Also called Nutritional therapy, Diet
Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema
| Study group | Role | What they receive |
|---|---|---|
| Physical training - No encephalopathy | Experimental | Patients randomized to the physical training program and diet intervention Receives: Other: Physical training; Other: Diet intervention |
| Control - No encephalopathy | Active comparator | Patients not allocated to exercise program, but undergoing diet intervention Receives: Other: Diet intervention |
| Physical training - Early encephalopathy | Experimental | Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program Receives: Other: Physical training; Other: Diet intervention |
| Control - Early encephalopathy | Active comparator | Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention Receives: Other: Diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in QOL questionnaires
QOL will be measured by means of SF-36 and CLDQ
Measured: 3 months
Lack of deterioration in portal hypertension
This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization
Measured: 3 months
Secondary outcomes (4)
Improvement in cognitive status
This outcome will be evaluated with neuropsychological tests: psychometric hepatic encephalpathy score (PHES) and the critical flicker frequency test (CFF)
Measured: 3 months
No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices
History taking, hemoglobin measurement, and endoscopy for a detailed description regarding number and size of esophageal varices
Measured: 3 months
Improved ammonia metabolism and decrease in oxidative stress
Ammonia, glutamine, glutamate, and glutamine synthetase determinations, as well as oxidative carbonylation of protein
Measured: 3 months
Improvement in physical capacity and exercise tolerance
Metabolic equivalents (METs) achieved in the treadmill test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez
- Responsible party
- Principal investigator, Andres Duarte-Rojo, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Sergio Ponce de Leon-Rosales, M.D., Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran / Universidad Nacional Autonoma de MexicoFlorencia Vargas-Voráckova, MD, Study chair, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán/ Universidad Nacional Autónoma de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517738
- Sponsor's protocol ID
- CIIBH-Ref.1639/GAS 166-09/11-1
- Status last verified
- Oct 2015
- First submitted
- 16 Aug 2007
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Macias-Rodriguez RU, Ilarraza-Lomeli H, Ruiz-Margain A, Ponce-de-Leon-Rosales S, Vargas-Vorackova F, Garcia-Flores O, Torre A, Duarte-Rojo A. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial. Clin Transl Gastroenterol. 2016 Jul 14;7(7):e180. doi: 10.1038/ctg.2016.38.
PubMed 27415618
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension
- ClinicalTrials.gov ID
- NCT00517738
- Acronym / sponsor ID
- CIIBH-Ref.1639/GAS 166-09/11-1
- Conditions
- Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia Ignacio Chavez
- Study start
- Feb 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.
Detailed description
Patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (QOL), as it has been shown with the use of questionnaires such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The deterioration in QOL is progressively accentuated as liver failure advances. There is a positive association between the level of physical activity and the sense of QOL, and physical training programs have proved to be useful in improving QOL in cardiovascular and pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a physical training program may improve QOL and hepatic encephalopathy in patients with cirrhosis and portal hypertension. Data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical training - No encephalopathy | Experimental | Other: Physical training, Other: Diet interventionPatients randomized to the physical training program and diet intervention |
| Control - No encephalopathy | Active comparator | Other: Diet interventionPatients not allocated to exercise program, but undergoing diet intervention |
| Physical training - Early encephalopathy | Experimental | Other: Physical training, Other: Diet interventionPatients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program |
| Control - Early encephalopathy | Active comparator | Other: Diet interventionPatients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy-proven or clinically evident cirrhosis
- Able to perform exercise
Key exclusion criteria (6 listed)
- Overt hepatic encephalopathy grades 3 or 4
- Cardiovascular complications (pulmonary hypertension, heart failure)
- Diabetes mellitus and microangiopathic complications, or under treatment with insulin
- Renal failure
- Portal hypertension with high risk for variceal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingAlso: Exercise, Muscle ammonia metabolismA program of exercising under strict surveillance, with endurance and coordination maneuvers | Other | Physical training - Early encephalopathy, Physical training - No encephalopathy |
| Diet interventionAlso: Nutritional therapy, DietEnergy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema | Other | Control - Early encephalopathy, Control - No encephalopathy, Physical training - Early encephalopathy, Physical training - No encephalopathy |
Primary outcome
Improvement in QOL questionnaires
Time frame: 3 months
QOL will be measured by means of SF-36 and CLDQ
Lack of deterioration in portal hypertension
Time frame: 3 months
This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization
4 secondary outcomes
Improvement in cognitive status
Time frame: 3 months
No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices
Time frame: 3 months
Improved ammonia metabolism and decrease in oxidative stress
Time frame: 3 months
Improvement in physical capacity and exercise tolerance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Derived from this study: PubMed 27415618Macias-Rodriguez RU, Ilarraza-Lomeli H, Ruiz-Margain A, Ponce-de-Leon-Rosales S, Vargas-Vorackova F, Garcia-Flores O, Torre A, Duarte-Rojo A. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial. Clin Transl Gastroenterol. 2016 Jul 14;7(7):e180. doi: 10.1038/ctg.2016.38.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Ponce de Leon-Rosales, M.D. study chair
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran / Universidad Nacional Autonoma de Mexico
Florencia Vargas-Voráckova, MD study chair
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán/ Universidad Nacional Autónoma de México
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical training and Diet intervention in people with Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in QOL questionnaires (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00517738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.