A Physical Activity Program in End-state Liver Disease

University of Arkansas

Status: Completed

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

Treatments: Other: Nutritional consultation; Behavioral: Behavioral modification therapy; Behavioral: Physical training program

Study type: Interventional

Funder types: Other

Identifiers

NCT02776553

203659

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Active (physical training program)

Experimental group

Description:

physical activity + behavioral therapy + nutritional intervention

Treatment:

Behavioral: Behavioral modification therapy

Other: Nutritional consultation

Behavioral: Physical training program

Control

Active Comparator group

Description:

nutritional intervention

Treatment:

Other: Nutritional consultation