LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

Launched by UNIVERSITY OF MICHIGAN · Mar 20, 2023

Keywords

ClinConnect Summary

The LiveSMART Trial is a clinical study aimed at preventing falls in patients with cirrhosis, a serious liver condition. Researchers want to see if a combination of lactulose (a medication) and virtual Tai-Chi exercises can help reduce harmful falls, improve mental function, and enhance overall quality of life for participants over 24 weeks. Eligible participants are adults aged 65 to 74 who have been diagnosed with cirrhosis and show signs of portal hypertension, such as fluid in the abdomen or swollen veins. They should also have access to Wi-Fi and a smartphone or computer.

Participants in the study will first engage in an initial 12-week phase and then be re-randomized for another 12 weeks. Throughout the trial, they will be monitored for their health and any changes in their condition. This study is an opportunity for those who qualify to potentially improve their health while contributing to valuable research that could benefit others facing similar challenges in the future.

Gender

ALL

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(US) 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)
• • 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 Criteria:
• • Overt hepatic encephalopathy (HE) within 6 months, requiring \>28 days total of lactulose
• • 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 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 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