A Physical Activity Program in End-state Liver Disease

University of Arkansas20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End-stage Liver Disease (ESLD)Liver Transplant Sarcopenia Poor Physical Fitness Cirrhosis

Interventions

Nutritional consultationOTHER

Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids

Physical training programBEHAVIORAL

Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.

Behavioral modification therapyBEHAVIORAL

The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Physical Fitness - VO2

Peak VO2 will be obtained from cardiorespiratory stress test

Time frame: Change from Baseline to 12 weeks after baseline

Physical Fitness - Distance Walked

Total distance walked during 6-minute walk test

Time frame: Change from Baseline to 12 weeks after baseline

Sarcopenia

Total thigh muscle volume (cm\^3), as determined by CT-scan.

Time frame: Change from Baseline to 12 weeks after baseline

A Physical Activity Program in End-state Liver Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes