A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arkansas
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Sarcopenia
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 40 to
- •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) ≥
- •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-
- •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.
Outcomes
Primary Outcomes
Sarcopenia
Time Frame: Change from Baseline to 12 weeks after baseline
Total thigh muscle volume (cm\^3), as determined by CT-scan.
Physical Fitness - Distance Walked
Time Frame: Change from Baseline to 12 weeks after baseline
Total distance walked during 6-minute walk test
Physical Fitness - VO2
Time Frame: Change from Baseline to 12 weeks after baseline
Peak VO2 will be obtained from cardiorespiratory stress test
Secondary Outcomes
No secondary outcomes reported