A Physical Activity Program in End-state Liver Disease

A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile

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 Overview

• Status: Completed
• Conditions: Cirrhosis; Sarcopenia; Portal Hypertension; Liver Transplant; End-stage Liver Disease (ESLD); Poor Physical Fitness
• Intervention / Treatment: Other: Nutritional consultation; Behavioral: Physical training program; Behavioral: Behavioral modification therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active (physical training program); physical activity + behavioral therapy + nutritional intervention	Other: Nutritional consultation; 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; Behavioral: Physical training program; 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: Behavioral modification therapy; 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.
Active Comparator: Control; nutritional intervention	Other: Nutritional consultation; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Andres Duarte-Rojo, MD, University of Arkansas Medical Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Liver Diseases; End Stage Liver Disease; Sarcopenia; Hypertension, Portal
• Other Study ID Numbers: 203659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No