CompletedNot Applicable

A Physical Activity Program in End-state Liver Disease

United States20 participantsStarted 2016-06

Plain-language 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. 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.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physical Fitness - VO2

Timeframe: Change from Baseline to 12 weeks after baseline

Physical Fitness - Distance Walked

Timeframe: Change from Baseline to 12 weeks after baseline

Sarcopenia

Timeframe: Change from Baseline to 12 weeks after baseline

Trial details

NCT IDNCT02776553

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05

Results submitted2020-06-23

View on ClinicalTrials.gov More End-stage Liver Disease (ESLD) trials

Plain-language summary

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.