A Physical Activity Program in End-state Liver Disease

NCT02776553 | Completed Results

• 1 other identifier: 203659
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Active (physical training program)

EXPERIMENTAL

physical activity + behavioral therapy + nutritional intervention

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

Control

ACTIVE COMPARATOR

nutritional intervention

Other: Nutritional consultation

Interventions

Nutritional consultation 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

Active (physical training program); Control

Physical training program 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.

Active (physical training program)

Behavioral modification therapy 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.

Active (physical training program)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Sarcopenia; Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Arny A. Ferrando, Ph.D.
• Organization: University of Arkansas for Medical Sciences

aferrando@uams.edu

501-526-5711

Study Officials

• Andres Duarte-Rojo, MD

  University of Arkansas Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 18, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)