LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis
2 other identifiers
interventional
230
1 country
3
Brief 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 or liver transplant over 24 weeks. 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-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. As detailed below, an observational component that enrolls caregivers of the trial participants is being conducted. Upon completion, Participants listed in the record here only include trial participants; and the observational component was moved to a new registration for clarity, NCT07140120.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
June 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2025
CompletedSeptember 10, 2025
September 1, 2025
1.7 years
March 20, 2023
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients experiencing a hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, liver transplant, and death/transplant
Composite outcome is defined as any of the following: • Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring medical intervention including: Hospitalization or overnight observation in the Emergency Room (ER); surgery, transfusion, stitches * Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level * Include falls that result in minor injuries that are addressed with first aid (e.g., ice, bandage) * Incident Overt HE: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator * Death: Mortality with any cause * Liver transplant: Replacement of a diseased liver with the healthy liver from another person because of acute-on-chronic liver failure (using the EASL-CLIF-C definition consisting of an acute increase in the bilirubin and/or INR, acute kidney injury, overt HE, hypertension, and hypoxia).
Baseline to 24 weeks (following stage 2)
Secondary Outcomes (17)
Injurious Falls
Baseline to 24 weeks (following stage 2)
Non-Injurious Falls
Baseline to 24 weeks (following stage 2)
Incident Overt hepatic encephalopathy (HE)
Baseline to 24 weeks (following stage 2)
Death/transplant
Baseline to 24 weeks (following stage 2)
Incident of Liver Transplant
Baseline to 24 weeks (following stage 2)
- +12 more secondary outcomes
Study Arms (4)
Enhanced Usual Care group followed by investigator recommended exercise
ACTIVE COMPARATOREnhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Investigator-Recommended Exercise at Stage 2
Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes
EXPERIMENTALLactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then TeleTai-Chi exercise classes at Stage 2
Enhanced Usual Care group followed by Tele-Tai Chi exercise classes
EXPERIMENTALEnhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Tele-Tai Chi exercise classes at Stage 2
Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise
EXPERIMENTALLactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then Investigator-Recommended Exercise at Stage 2
Interventions
Patients will be provided and counseled on two methods which will enhance care. The first is a handout on nutrition recommendations and protein supplementation. This will include the recommendation of both high protein snacks during the daytime (e.g., protein bars) and a high-protein night-time snack (e.g., peanut butter and crackers). The second will be to counsel participants on falls prevention methods that can be enacted in day-to-day life. All participants will be provided with a standard hand-out of Centers for Disease Control and Prevention (CDC)-endorsed fall-risk reduction measures.
Patients will be prescribed lactulose and will also receive enhanced usual care. Lactulose will be taken on a specific schedule based on the average number of bowel movements on average per day. It will be started at 15 milliliter (mL) dose and will be instructed to slowly increase the lactulose dose over the course of the first week of Stage 1 participation. The prescribed maximum dose will be 30 mL (20g) twice daily. The dose will slowly increase toward the maximum or until participants reach 2-3 soft bowel movements daily. Participants that receive Lactulose during stage 1 will continue this in stage 2.
Participants randomized to enhanced usual care will be reminded of standard fall precautions outlined in the Fall Prevention Primer that were provided in Stage 1 and will receive exercise recommendations.
TeleTai-Chi will be taught remotely via live Zoom classes of up to 15 patients by a certified TeleTai-Chi instructor three times per week (for approximately 12 weeks). Classes will be conducted via a HIPAA-compliant Zoom server through the University of Michigan. Participants will be instructed to use Zoom by smartphone, tablet, or computer. High-Definition Multimedia Interface (HDMI) cables and other device specific equipment to connect devices to televisions will be provided.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor Scott & White Research Institute (BSW)
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elliott Tapper, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Marina Serper, MD, MS
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Internal Medicine
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 3, 2023
Study Start
June 13, 2023
Primary Completion
March 7, 2025
Study Completion
March 7, 2025
Last Updated
September 10, 2025
Record last verified: 2025-09