A Physical Activity Program in End-state Liver Disease

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776553
• Other study ID #: 203659
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: August 2020
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• End Stage Liver Disease
• End-stage Liver Disease (ESLD)
• Hypertension, Portal
• Liver Diseases
• Liver Transplant
• Poor Physical Fitness
• Portal Hypertension
• Sarcopenia

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 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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

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