Abstract
Introduction: Falls are a major threat to the well-being of patients with cirrhosis. We are performing a clinical trial to determine whether lactulose, TeleTai-Chi, or their combination will reduce falls in HE and improve health-related quality of life (HRQOL) among patients with cirrhosis. Methods and Analysis: Patients with cirrhosis and portal hypertension without HE will be enrolled in 3 US states and followed participants for 24 weeks. In stage 1 (12 wk), participants will be randomized to receive either lactulose therapy or enhanced usual care. In stage 2 (12 wk), participants will be randomized to either TeleTai-Chi or usual care. The primary outcome is a hierarchical composite: Injurious falls, noninjurious falls, incident HE, and death/transplantation. Secondary outcomes include cognitive function, days-alive and out-of-hospital, and HRQOL. After completion of the interventions, participants will be followed for 48 weeks for health and financial outcomes. Ethics and Dissemination: Our study has a central institutional review board with individual site IRB review. Dissemination includes the publication of study findings and patient-focused educational webinars.
| Original language | English (US) |
|---|---|
| Article number | e0626 |
| Journal | Hepatology Communications |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| State | Published - Feb 19 2025 |
Funding
In stage 2, participants will be randomized to TeleTai-Chi or enhanced usual care. Study tai-chi instructors have been certified in Sun-style Tai-chi, but classes will be modified to more closely resemble qi-gong movements. Instead of creating a martial arts-type progression from one form to the next, the forms are repeated several times before continuing to the next form. This accommodates rolling study admission and ease of learning and is a more practical option to implement among this population and in the context of a clinical trial. Prior to stage 2 randomization, eligibility criteria will be reconfirmed. A remote safety assessment will be performed. This entails a seated balance assessment, a standing assessment (while still) for balance, a standing while reaching with each arm across their midline for balance, a dynamic step assessment (marching in place), and a weight-shift assessment (holding positions after taking steps with left and right feet). TeleTai-Chi will be taught remotely for 45 minutes via live Zoom classes of up to 15 patients by a certified TeleTai-Chi instructor 3 times per week. TeleTai-Chi classes will be conducted via a HIPAA-compliant Zoom server through the University of Michigan. Participants will be instructed to access Zoom by smartphone, tablet, or computer. HDMI cables to connect devices to televisions or computers will be provided for all participants. Set-up and support for logging in will be provided by study coordinators. The safety of participants will be monitored by the instructor and study coordinator. The TeleTai-Chi program of LIVE-SMART will be supported by a coordinator at the lead site, who will assist participants at all sites and the instructors. TeleTai-Chi is provided as part of the standard of care in the VA Gerofit program. Many Tai-Chi programs transitioned to remote during the pandemic. Elliot B. Tapper has served as a consultant to Norvartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. In the last 12 months, Donna Evon has served as a consultant for Hightide Therapeutics, USA. Patricia Bloom has a research grant from Vedanta Biosciences and has served as a consultant for Nexilico. Ethan Weinberg has served as a consultant to Mallinckrodt, Biovie, and PharmaIN. Marina Serper received grants from Grifols and Transplant Genomics. The remaining authors have no conflicts to report.
Keywords
- ascites
- HE
- liver disease
- varices
ASJC Scopus subject areas
- Hepatology