COMPLETED

LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

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Conditions

Cirrhosis, LiverPortal HypertensionExercise programLactuloseTai-ChiFall preventionDietary Protein

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-13
Study Completion:2025-03-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05794555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of cirrhosis based on histology and/or imaging specified in the protocol.
  2. * Evidence of portal hypertension - must meet at least one of the following criteria:
  3. * Ascites (present or within past 2 years)
  4. * Varices (seen by Esophagogastroduodenoscopy or by Ultrasound(US) or cross-sectional imaging)
  5. * Fibroscan Liver stiffness measurement (LSM) \>25 kilopascals (kPa) (if no other factors present)
  6. * Magnetic resonance elastography (MRE) LSM \> 5 kPa (if no other factors present)
  7. * Acoustic radiation force impulse LSM \> 17kpa (if no other factors present)
  8. * Hepatic vein pressure gradient \> 10 millimetres of mercury (mmHg)
  9. * Portal hypertensive gastropathy seen on Esophagogastroduodenoscopy
  10. * Platelet count \< 80/ units per liter (uL)
  11. * Recanalized umbilical vein (by US or cross-sectional imaging)
  12. * Access to Wireless Fidelity (Wi-Fi) at home
  13. * Owns or access to a smartphone, tablet or computer
  14. * English or Spanish speaking
  15. * Willing to participate in exercise program
  1. * Overt hepatic encephalopathy (HE) within 6 months, requiring \>28 days total of lactulose
  2. * Took lactulose for non - HE reasons for \>28 days total in last 6 months
  3. * Took Rifaximin for \> 28 days total in last 6 months
  4. * 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)
  5. * Barcelona Clinic Liver Cancer (BCLC) \> C Hepatocellular Carcinoma (HCC)
  6. * Currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib
  7. * Greater than (\>) 3 paracentesis/month in last 2 months
  8. * Active Metastatic solid malignancy or acute leukemia within last 3 years
  9. * Severe cognitive, vision, or hearing impairment (without use of corrective lenses or hearing assist devices) or psychiatric illness precluding study participation
  10. * Currently participates in Tai-Chi or performs \>150 min/week vigorous physical activity
  11. * Currently receiving lower body physical and/or occupational therapy
  12. * Living in an assisted living facility
  13. * Hemoglobin A1C \> 12 (within past 12 months)
  14. * Requires a low galactose diet
  15. * Deemed unsuitable by the study investigator
  16. * Adult \> 18 years of age
  17. * Informal caregiver of a participant enrolled in LIVE-SMART
  18. * English speaking

Contacts and Locations

Principal Investigator

Elliott Tapper, MD
PRINCIPAL_INVESTIGATOR
University of Michigan
Marina Serper, MD, MS
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Michigan

  • Elliott Tapper, MD, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Marina Serper, MD, MS, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-13
Study Completion Date2025-03-07

Study Record Updates

Study Start Date2023-06-13
Study Completion Date2025-03-07

Terms related to this study

Keywords Provided by Researchers

  • Exercise program
  • Lactulose
  • Tai-Chi
  • Fall prevention
  • Dietary Protein

Additional Relevant MeSH Terms

  • Cirrhosis, Liver
  • Portal Hypertension