LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death.

Participants that are enrolled will be randomized to stage one of this project for approximately 12 weeks. After completing stage one, participants will be re-evaluated and if eligible will be re-randomized to stage 2 of the project that will last approximately 12 more weeks.

The study hypothesizes that sequential lactulose/TeleTai-Chi will reduce falls, incident overt HE, death and physical frailty and will improve cognitive function, and Health Related Quality of Life (HRQOL) over 24 weeks compared to other treatment combinations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Lactulose

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)

• 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