Tai-Chi and lactulose combo tested to stop falls in liver patients
NCT ID NCT05794555
First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This completed Phase 3 trial tested whether a combination of lactulose (a medicine) and virtual Tai-Chi (a gentle exercise) could reduce falls and other serious events in 230 people with cirrhosis and portal hypertension. Participants were randomly assigned to different sequences of these interventions over 24 weeks. The study aimed to see if this approach could lower the risk of falls, confusion (hepatic encephalopathy), and need for liver transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lactulose and virtual Tai-Chi
- What this could lead to
- If successful, this could offer a practical, non-drug way to reduce falls and serious liver complications in people with cirrhosis.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The combination may not prove better than usual care, and individual results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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233 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Scott & White Research Institute (BSW)
Dallas, Texas, 75246, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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