N/A
N=17
A Physical Activity Program in End-state Liver Disease
End-stage Liver Disease (ESLD) · Liver Transplant · Sarcopenia · Poor Physical Fitness · Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT02776553 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Physical Fitness - VO2 — -1; -3 mL oxygen/kg/min — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutritional consultation (Other); Physical training program (Behavioral); Behavioral modification therapy (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Fitness - VO2 |
-1; -3 | 0.49 |
| PRIMARY Physical Fitness - Distance Walked |
59.2; -91.4 | 0.03 sig |
| PRIMARY Sarcopenia |
-124; -373 | 0.37 |
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.
Eligibility Criteria
Inclusion Criteria
- Age 40 to 70.
- Cirrhosis, any cause, defined as:
- Biopsy-proven.
- Two or more of the following: albumin 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.
Data sourced from ClinicalTrials.gov (NCT02776553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.