Phase
Condition
Scar Tissue
Liver Disease
Liver Disorders
Treatment
Enhanced Usual Care
Investigator recommended exercise
Lactulose
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinical diagnosis of cirrhosis based on histology and/or imaging specified in theprotocol.
Evidence of portal hypertension - must meet at least one of the following criteria:
Ascites (present or within past 2 years)
Varices (seen by Esophagogastroduodenoscopy or by Ultrasound(US) orcross-sectional imaging)
Fibroscan Liver stiffness measurement (LSM) >25 kilopascals (kPa) (if no otherfactors present)
Magnetic resonance elastography (MRE) LSM > 5 kPa (if no other factors present)
Acoustic radiation force impulse LSM > 17kpa (if no other factors present)
Hepatic vein pressure gradient > 10 millimetres of mercury (mmHg)
Portal hypertensive gastropathy seen on Esophagogastroduodenoscopy
Platelet count < 80/ units per liter (uL)
Recanalized umbilical vein (by US or cross-sectional imaging)
Access to Wireless Fidelity (Wi-Fi) at home
Owns or access to a smartphone, tablet or computer
English or Spanish speaking
Willing to participate in exercise program
Exclusion
Exclusion Criteria:
Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days total oflactulose
Took lactulose for non - HE reasons for >28 days total in last 6 months
Took Rifaximin for > 28 days total in last 6 months
Model for End Stage Liver Disease (MELD) > 25 (Exception: MELD > 25 with clinicallystable End-Stage Renal Disease (ESRD) for whom the bilirubin is < 5 g/dL)
Barcelona Clinic Liver Cancer (BCLC) > C Hepatocellular Carcinoma (HCC)
Currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib
Greater than (>) 3 paracentesis/month in last 2 months
Active Metastatic solid malignancy or acute leukemia within last 3 years
Severe cognitive, vision, or hearing impairment (without use of corrective lenses orhearing assist devices) or psychiatric illness precluding study participation
Currently participates in Tai-Chi or performs >150 min/week vigorous physicalactivity
Currently receiving lower body physical and/or occupational therapy
Living in an assisted living facility
Hemoglobin A1C > 12 (within past 12 months)
Requires a low galactose diet
Deemed unsuitable by the study investigator
Inclusion Criteria for the Caregivers of the participants:
Adult > 18 years of age
Informal caregiver of a participant enrolled in LIVE-SMART
English speaking
Exclusion Criteria for the Caregivers of the participants:
- Non-English speaking
Study Design
Study Description
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Baylor Scott & White Research Institute (BSW)
Dallas, Texas 75246
United StatesActive - Recruiting
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