Phase
Condition
Scar Tissue
Liver Disease
Liver Disorders
Treatment
Lactulose
Enhanced Usual Care
Investigator recommended exercise
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 StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Baylor Scott & White Research Institute (BSW)
Dallas, Texas 75246
United StatesSite Not Available
Baylor Scott & White Research Institute (BSW)
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.