LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Portal Hypertension; Cirrhosis, Liver

Treatments: Drug: Lactulose; Behavioral: Enhanced Usual Care; Behavioral: TeleTai-Chi (virtual); Behavioral: Investigator recommended exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05794555

HUM00225275

CER-2021C3-24907 (Other Identifier)

Details and patient eligibility

About

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.

Full 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. After further discussion with PCORI, these changes were removed from this record and used to create a separate record for the supplemental study focused on caregivers (NCT07140120).

The caregivers that are enrolled are not in the clinical trial. All clinical trial information is provided in this record, but upon completion of enrollment and consideration of transparent results reporting, it was decided to move all the items related to the observational supplemental study to its own record.

To improve clarity in the record, the two arms representing stage 1 of the project were incorporated into the remaining four representing stage 2, so the remaining arms now represent both stage 1 and stage 2.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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230 participants in 4 patient groups

Enhanced Usual Care group followed by investigator recommended exercise

Active Comparator group

Description:

Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Investigator-Recommended Exercise at Stage 2

Treatment:

Behavioral: Investigator recommended exercise

Behavioral: Enhanced Usual Care

Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes

Experimental group

Description:

Lactulose 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

Treatment:

Behavioral: TeleTai-Chi (virtual)

Behavioral: Enhanced Usual Care

Drug: Lactulose

Enhanced Usual Care group followed by Tele-Tai Chi exercise classes

Experimental group

Description:

Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Tele-Tai Chi exercise classes at Stage 2

Treatment:

Behavioral: TeleTai-Chi (virtual)

Behavioral: Enhanced Usual Care

Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise

Experimental group

Description:

Lactulose 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

Treatment:

Behavioral: Investigator recommended exercise

Behavioral: Enhanced Usual Care

Drug: Lactulose