LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
Cirrhosis, Liver, Portal Hypertension
About this trial
This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Exercise program, Lactulose, Tai-Chi, Fall prevention, Dietary Protein
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of cirrhosis based on histology and/or imaging specified in the protocol. 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 or cross-sectional imaging) Fibroscan Liver stiffness measurement (LSM) >25 kilopascals (kPa) (if no other factors 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) 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 Criteria: Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days of lactulose Took lactulose for non - HE reasons for >28 days in last 6 months Model for End Stage Liver Disease (MELD) > 25 (Exception: MELD > 25 with clinically stable 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 or hearing assist devices) or psychiatric illness precluding study participation Currently participates in Tai-Chi or performs >150 min/week vigorous physical activity Currently receiving physical 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
Sites / Locations
- University of MichiganRecruiting
- University of PennsylvaniaRecruiting
- Baylor Scott & White Research Institute (BSW)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Experimental
Enhanced usual care group
Treatment (Lactulose) group plus enhanced usual care
Enhanced usual care group followed by investigator recommended exercise
Treatment (Lactulose) plus enhanced usual care then TeleTai-Chi exercise classes
Enhanced usual care group followed by Tele-Tai Chi exercise classes
Treatment (Lactulose) plus enhanced usual care then recommended exercise
Participants will be in stage 1 for approximately 12 weeks and then be re-evaluated. Participation will end the study if not qualified for 2nd stage.
Participants will be in stage 1 for approximately 12 weeks and then be re-evaluated. Participation will end the study if not qualified for 2nd stage.
This is considered stage 2 for 12 weeks (for eligible re-randomized participants).
This is considered stage 2 for 12 weeks (for eligible re-randomized participants)
This is considered stage 2 for 12 weeks (for eligible re-randomized participants)
This is considered stage 2 for 12 weeks (for eligible re-randomized participants)