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NCT05794555CompletedPhase 3

LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
233 (actual)
First submitted
20 Mar 2023
Start date
13 Jun 2023
Primary completion date
7 Mar 2025
Lead sponsor
University of Michigan
NCT number
NCT05794555

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 233
  • From 13 Jun 2023 to the primary completion date, 7 Mar 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib
  • Currently receiving lower body physical and/or occupational therapy

Other illness

  • Barcelona Clinic Liver Cancer (BCLC) \> C Hepatocellular Carcinoma (HCC)
  • 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

Lab values

  • 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)
  • Hemoglobin A1C \> 12 (within past 12 months)

Other

  • 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
  • Greater than (\>) 3 paracentesis/month in last 2 months
  • Currently participates in Tai-Chi or performs \>150 min/week vigorous physical activity
  • Living in an assisted living facility
  • Requires a low galactose diet
  • Deemed unsuitable by the study investigator
  • \- Non-English speaking

Who the study is looking for

  • 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
  • Adult \> 18 years of age
  • Informal caregiver of a participant enrolled in LIVE-SMART
  • English speaking

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status		Ann ArborUnited StatesUnknown status
Baylor Scott & White Research Institute (BSW)
Coordinator of this site? Confirm its status		DallasUnited StatesUnknown status
University of Pennsylvania
Coordinator of this site? Confirm its status		PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.