LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

NCT ID: NCT05794555

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2025-03-07

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.

Detailed 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.

Conditions

Cirrhosis, Liver; Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced Usual Care group followed by investigator recommended exercise

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

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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.

Investigator recommended exercise

Intervention Type: BEHAVIORAL

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.

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

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

Group Type: EXPERIMENTAL

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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.

Lactulose

Intervention Type: DRUG

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.

TeleTai-Chi (virtual)

Intervention Type: BEHAVIORAL

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.

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

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

Group Type: EXPERIMENTAL

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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.

TeleTai-Chi (virtual)

Intervention Type: BEHAVIORAL

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.

Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise

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

Group Type: EXPERIMENTAL

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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.

Lactulose

Intervention Type: DRUG

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.

Investigator recommended exercise

Intervention Type: BEHAVIORAL

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.

Interventions

Enhanced Usual Care

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.

Intervention Type: BEHAVIORAL

Lactulose

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.

Intervention Type: DRUG

Investigator recommended exercise

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.

Intervention Type: BEHAVIORAL

TeleTai-Chi (virtual)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

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

• Non-English speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Elliot B. Tapper

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elliott Tapper, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Marina Serper, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Michigan

Ann Arbor, Michigan, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baylor Scott & White Research Institute (BSW)

Dallas, Texas, United States

Countries

United States

Other Identifiers

CER-2021C3-24907

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00225275

Identifier Type: -

Identifier Source: org_study_id