Preventing falls in patients with cirrhosis using lactulose and virtual Tai-Chi
LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis
This study is testing if using lactulose and virtual Tai-Chi can help people with cirrhosis reduce falls and feel better overall.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | Atezolizumab, Bevacizumab, Regorafinib, Cabozatinib, radiation |
| Locations | 3 sites (Ann Arbor, Michigan and 2 other locations) |
| Trial ID | NCT05794555 on ClinicalTrials.gov |
What this trial studies
This multicenter trial aims to evaluate the effectiveness of a sequential treatment involving lactulose and TeleTai-Chi in reducing falls and improving health outcomes in patients with cirrhosis over a 24-week period. Participants will be randomized into two stages, each lasting approximately 12 weeks, to assess the impact of these interventions on fall rates, cognitive function, and overall quality of life. The study also includes a supplemental observational component to explore social determinants of health and caregiver involvement. The hypothesis is that this combined approach will lead to significant improvements compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with cirrhosis and evidence of portal hypertension who have access to technology for virtual participation.
Not a fit: Patients without a clinical diagnosis of cirrhosis or those who do not meet the criteria for portal hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of falls and improve the overall health and quality of life for patients with cirrhosis.
How similar studies have performed: Other studies have shown promise in using exercise and dietary interventions for fall prevention in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Ann Arbor, Michigan and 2 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Baylor Scott & White Research Institute (BSW) — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elliott Tapper, MD — University of Michigan
- Study coordinator: Samantha Nikirk
- Email: samjwalk@med.umich.edu
- Phone: 734-232-4182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.