Back to resultsA Physical Activity Program in End-state Liver Disease
Primary Purpose
End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional consultation
Physical training program
Behavioral modification therapy
Sponsored by
About this trial
This is an interventional treatment trial for End-stage Liver Disease (ESLD)
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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active (physical training program)
Control
Arm Description
physical activity + behavioral therapy + nutritional intervention
nutritional intervention
Outcomes
Primary Outcome Measures
Physical Fitness - VO2
Peak VO2 will be obtained from cardiorespiratory stress test
Physical Fitness - Distance Walked
Total distance walked during 6-minute walk test
Sarcopenia
Total thigh muscle volume (cm^3), as determined by CT-scan.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02776553
Brief Title
A Physical Activity Program in End-state Liver Disease
Official Title
A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness, Cirrhosis, Portal Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active (physical training program)
Arm Type
Experimental
Arm Description
physical activity + behavioral therapy + nutritional intervention
Arm Title
Control
Arm Type
Active Comparator
Arm Description
nutritional intervention
Intervention Type
Other
Intervention Name(s)
Nutritional consultation
Intervention Description
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
Behavioral
Intervention Name(s)
Physical training program
Intervention Description
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
Intervention Name(s)
Behavioral modification therapy
Intervention Description
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 Outcome Measure Information:
Title
Physical Fitness - VO2
Description
Peak VO2 will be obtained from cardiorespiratory stress test
Time Frame
Change from Baseline to 12 weeks after baseline
Title
Physical Fitness - Distance Walked
Description
Total distance walked during 6-minute walk test
Time Frame
Change from Baseline to 12 weeks after baseline
Title
Sarcopenia
Description
Total thigh muscle volume (cm^3), as determined by CT-scan.
Time Frame
Change from Baseline to 12 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Duarte-Rojo, MD
Organizational Affiliation
University of Arkansas Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Physical Activity Program in End-state Liver Disease
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