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Completed

NCT Number: NCT02776553

A Physical Activity Program in End-state Liver Disease

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.

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Key information

Conditions

End-stage Liver Disease (ESLD) Atrophy Cirrhosis Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Hypertension, Portal Liver Diseases Liver Failure Liver Transplant Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Poor Physical Fitness Portal Hypertension Sarcopenia Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Physical Fitness - VO2

    Time frame: Change from Baseline to 12 weeks after baseline

    Peak VO2 will be obtained from cardiorespiratory stress test

  2. Physical Fitness - Distance Walked

    Time frame: Change from Baseline to 12 weeks after baseline

    Total distance walked during 6-minute walk test

  3. Sarcopenia

    Time frame: Change from Baseline to 12 weeks after baseline

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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 18, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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