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Tai-Chi and lactulose combo tested to stop falls in liver patients

NCT ID NCT05794555

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

233 people

The number who actually took part.

Started

Jun 2023

Finished

Mar 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Baylor Scott & White Research Institute (BSW)

    Dallas, Texas, 75246, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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