A Physical Activity Program in End-state Liver Disease
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 5/18/2018 |
| Start Date: | June 2016 |
| End Date: | May 2020 |
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.
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.
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.
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Andres Duarte-Rojo, MD
Phone: 501-686-5175
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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