LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

PHASE3CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

June 13, 2023

Primary Completion Date

March 7, 2025

Study Completion Date

March 7, 2025

Conditions
Cirrhosis, LiverPortal Hypertension
Interventions
BEHAVIORAL

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.

DRUG

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."

BEHAVIORAL

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.

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.

Trial Locations (3)

19104

University of Pennsylvania, Philadelphia

48109

University of Michigan, Ann Arbor

75246

Baylor Scott & White Research Institute (BSW), Dallas

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Michigan

OTHER

NCT05794555 - LiveSMART Trial to Prevent Falls in Patients With Cirrhosis | Biotech Hunter | Biotech Hunter