A Physical Activity Program in End-state Liver Disease

Not Applicable

Completed

Conditions: Liver Transplant
Sarcopenia
End-stage Liver Disease (ESLD)
Poor Physical Fitness
Cirrhosis
Portal Hypertension

Interventions: Other: Nutritional consultation
Behavioral: Physical training program
Behavioral: Behavioral modification therapy

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control	Nutritional consultation	nutritional intervention
Active (physical training program)	Nutritional consultation	physical activity + behavioral therapy + nutritional intervention
Active (physical training program)	Behavioral modification therapy	physical activity + behavioral therapy + nutritional intervention
Active (physical training program)	Physical training program	physical activity + behavioral therapy + nutritional intervention

Primary Outcome Measures

Name	Time	Method
Sarcopenia	Change from Baseline to 12 weeks after baseline	Total thigh muscle volume (cm\^3), as determined by CT-scan.
Physical Fitness - Distance Walked	Change from Baseline to 12 weeks after baseline	Total distance walked during 6-minute walk test
Physical Fitness - VO2	Change from Baseline to 12 weeks after baseline	Peak VO2 will be obtained from cardiorespiratory stress test