A Physical Activity Program in End-state Liver Disease
Completed · Not applicable
Conditions studied: End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness, Cirrhosis, Portal Hypertension
In brief
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.
Key facts
- Study ID
- NCT02776553
- Run by
- University of Arkansas
- People needed
- 20
- Starts
- 2016-06-01
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2020-08-06
Who can join
Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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