Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Cirrhosis is severe scarring of the liver. Cirrhosis can cause weakness, poor balance, and confusion. These symptoms can lead to falls, worsen quality of life, and increase the risk of death. 

To prevent falls, people with cirrhosis can learn about ways to prevent falls and do exercises to improve strength and balance. For example, an exercise system called tai chi may improve balance and help prevent falls. Tai chi is a Chinese martial art that involves slow, gentle movements and controlled breathing. Also, a medicine called lactulose may help prevent falls by improving alertness.

In this study, the research team is comparing ways to prevent falls in people with cirrhosis. 

Who can this research help?

Results may help doctors and patients when considering ways to prevent falls in people with cirrhosis.

What is the research team doing?

The research team is enrolling 215 patients with cirrhosis from three liver disease centers in Michigan, Pennsylvania, and Texas. The team is assigning patients by chance to receive enhanced usual care with or without lactulose for three months. Enhanced usual care includes counseling on diet and ways to prevent falls. 

After three months, the research team is assigning the same patients by chance to continue with enhanced usual care alone or to add education on exercise or telehealth tai chi classes instead. A certified tai chi teacher leads the classes via Zoom three times per week for three months. Patients who started taking medicine during the first three months of the study continue to take the medicine during the second three months.

After six months, the research team is looking at electronic health records, surveying patients, and doing physical tests. The team wants to learn about: 

  • The number of falls, with and without injury 
  • Mental alertness
  • Quality of life
  • Physical function
  • Days alive and out of the hospital 

The research team is also looking to see how well the different ways of preventing falls work for different groups of patients, such as by age and gender. Finally, the team is interviewing patients with cirrhosis and their caregivers to learn which ways to prevent falls worked well and what could be improved.

Patients with cirrhosis and their caregivers are helping to plan and conduct this study.

Research methods at a glance

Design ElementDescription
DesignRandomized controlled trial
Population215 adults with cirrhosis and portal hypertension
Interventions/
Comparators
  • Enhanced usual care for 6 months
  • Enhanced usual care for 3 months followed by telehealth tai chi for 3 months
  • Enhanced usual care plus lactulose for 3 months followed by enhanced usual care with exercise education for 3 months
  • Enhanced usual care plus lactulose for 3 months followed by telehealth tai chi for 3 months
Outcomes

Primary: composite measure of injurious falls, noninjurious falls, overt hepatic encephalopathy, and all-cause mortality or liver transplantation

Secondary: cognitive function, days alive and outside of the hospital, injurious falls, noninjurious falls, overt hepatic encephalopathy, all-cause mortality or liver transplantation, health-related quality of life

Timeframe  Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 6-month follow-up for primary outcome

*Patient-Centered Economic Outcomes Funding Supplement 
This study received supplemental funding to build on existing PCORI-funded comparative clinical effectiveness research (CER) studies to improve the understanding of appropriate costs and other economic burdens that are meaningful and inclusive to patients, caregivers and other stakeholders.

Project Information

Elliot Tapper, MD
University of Michigan
$4,195,666
LIVE-SMART: Liver Cirrhosis Interventions for Fall prevention - A Sequential, Multiple Assignment Randomized Trial

Key Dates

July 2022
February 2027
2022

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: April 8, 2024