End-stage Liver Disease (ESLD)NCT02776553
A Physical Activity Program in End-state Liver Disease
A study testing Nutritional consultation, Physical training program and Behavioral modification therapy in people with End-stage Liver Disease (ESLD) and Liver Transplant, run by University of Arkansas at 1 site in United States.
Trial summary
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia
- What is being tested?
- Nutritional consultation, Physical training program and Behavioral modification therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 70.
- Cirrhosis, any cause, defined as:
- Biopsy-proven.
- Two or more of the following: albumin <3.5 g/dL, International Normalized Ration (INR) >1.3, radiologic or endoscopic evidence of portal hypertension.
- Creatinine <2.0 mg/dL.
- Physiologic Model for End Stage Liver Disease (MELD) ≥10.
- Decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice.
- Potential transplant candidate as per UAMS criteria
Who cannot join
- Large gastric or esophageal varices with contraindication to use beta-blockers.
- Persistent hepatic encephalopathy grades 2-4.
- Prior diagnosis of hepatocellular carcinoma, or hepatic hydrothorax (with prior repeated thoracocentesis).
- Cirrhotic cardiomyopathy or congestive heart failure, pulmonary vascular complications, known active coronary artery disease, syncope, and cardiac dysrhythmias.
- Physical impediment to perform a cardiorespiratory fitness test.
- Use of implantable defibrillator or a pacemaker.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness, Cirrhosis, Portal Hypertension
- Being tested
- Nutritional consultation, Physical training program, Behavioral modification therapy
- Medical subject headings
- End Stage Liver Disease, Sarcopenia, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional consultationOther
Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training programBehavioural
Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapyBehavioural
The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
| Study group | Role | What they receive |
|---|---|---|
| Active (physical training program) | Experimental | physical activity + behavioral therapy + nutritional intervention Receives: Other: Nutritional consultation; Behavioral: Physical training program; Behavioral: Behavioral modification therapy |
| Control | Active comparator | nutritional intervention Receives: Other: Nutritional consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fitness - VO2
Peak VO2 will be obtained from cardiorespiratory stress test
Measured: Change from Baseline to 12 weeks after baseline
Physical Fitness - Distance Walked
Total distance walked during 6-minute walk test
Measured: Change from Baseline to 12 weeks after baseline
Sarcopenia
Total thigh muscle volume (cm^3), as determined by CT-scan.
Measured: Change from Baseline to 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-stage Liver Disease (ESLD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andres Duarte-Rojo, MD, Principal investigator, University of Arkansas Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776553
- Sponsor's protocol ID
- 203659
- Status last verified
- Aug 2020
- First submitted
- 13 May 2016
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
- ClinicalTrials.gov ID
- NCT02776553
- Acronym / sponsor ID
- 203659
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness, Cirrhosis, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active (physical training program) | Experimental | Other: Nutritional consultation, Behavioral: Physical training program, Behavioral: Behavioral modification therapyphysical activity + behavioral therapy + nutritional intervention |
| Control | Active comparator | Other: Nutritional consultationnutritional intervention |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 40 to 70.
- Cirrhosis, any cause, defined as:
- Creatinine <2.0 mg/dL.
- Physiologic Model for End Stage Liver Disease (MELD) ≥10.
- Decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice.
Key exclusion criteria (6 listed)
- Large gastric or esophageal varices with contraindication to use beta-blockers.
- Persistent hepatic encephalopathy grades 2-4.
- Prior diagnosis of hepatocellular carcinoma, or hepatic hydrothorax (with prior repeated thoracocentesis).
- Cirrhotic cardiomyopathy or congestive heart failure, pulmonary vascular complications, known active coronary artery disease, syncope, and cardiac dysrhythmias.
- Physical impediment to perform a cardiorespiratory fitness test.
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 |
|---|---|---|
| Nutritional consultationDietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids | Other | Active (physical training program), Control |
| Physical training programPhysical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline. | Behavioural | Active (physical training program) |
| Behavioral modification therapyThe behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits. | Behavioural | Active (physical training program) |
Primary outcome
Physical Fitness - VO2
Time frame: Change from Baseline to 12 weeks after baseline
Peak VO2 will be obtained from cardiorespiratory stress test
Physical Fitness - Distance Walked
Time frame: Change from Baseline to 12 weeks after baseline
Total distance walked during 6-minute walk test
Sarcopenia
Time frame: Change from Baseline to 12 weeks after baseline
Total thigh muscle volume (cm^3), as determined by CT-scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andres Duarte-Rojo, MD principal investigator
University of Arkansas Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional consultation, Physical training program and Behavioral modification therapy in people with End-stage Liver Disease (ESLD) and Liver Transplant, run by University of Arkansas at 1 site in United States.
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 8 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Fitness - VO2 (time frame: Change from Baseline to 12 weeks after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.