LiveSMART Trial to Prevent Falls in Patients with Cirrhosis

Last updated: October 18, 2024
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

3

Condition

Scar Tissue

Liver Disease

Liver Disorders

Treatment

Enhanced Usual Care

Investigator recommended exercise

Lactulose

Clinical Study ID

NCT05794555
HUM00225275
CER-2021C3-24907
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of cirrhosis based on histology and/or imaging specified in theprotocol.

  • 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) orcross-sectional imaging)

  • Fibroscan Liver stiffness measurement (LSM) >25 kilopascals (kPa) (if no otherfactors 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

Exclusion Criteria:

  • Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days total oflactulose

  • 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 clinicallystable 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 orhearing assist devices) or psychiatric illness precluding study participation

  • Currently participates in Tai-Chi or performs >150 min/week vigorous physicalactivity

  • 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

Study Design

Total Participants: 430
Treatment Group(s): 4
Primary Treatment: Enhanced Usual Care
Phase: 3
Study Start date:
June 13, 2023
Estimated Completion Date:
September 30, 2025

Study Description

The Clinicaltrials.gov registration record was updated as requested by Patient-Centered Outcomes Research Institute (PCORI) based on protocol amendment version 3.0 after approval by the Institutional Review Board. These changes included: the additional aim for a supplemental observational study to assess social determinants of health, financial burdens, etc., and includes recruitment of the caregivers for this supplemental study along with the trial participants, as well as updated outcomes for the trial. The caregivers that are enrolled are not in the clinical trial. Because all of the outcome measures in the supplemental study are other outcome measures (neither primary nor secondary to the trial) these are not included in this registration.

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute (BSW)

    Dallas, Texas 75246
    United States

    Active - Recruiting

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