A Physical Activity Program in End-state Liver Disease

NCT ID: NCT02776553

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active (physical training program)

physical activity + behavioral therapy + nutritional intervention

Group Type: EXPERIMENTAL

Nutritional consultation

Intervention Type: OTHER

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 program

Intervention Type: BEHAVIORAL

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 therapy

Intervention Type: BEHAVIORAL

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.

Control

nutritional intervention

Group Type: ACTIVE_COMPARATOR

Nutritional consultation

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andres Duarte-Rojo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas Medical Sciences

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

203659

Identifier Type: -

Identifier Source: org_study_id