预防肝硬化患者跌倒的 LiveSMART 试验

有源比较器：增强的通常护理小组，然后调查员建议锻炼

在第1阶段（12周）上增强了常规护理（EUC），然后在第2阶段将研究者推荐的练习重新运送到EUC

行为的：加强日常护理

将向患者提供两种可加强护理的方法并为其提供咨询。 第一个是关于营养建议和蛋白质补充的讲义。 这将包括白天高蛋白零食（例如蛋白质棒）和高蛋白夜间零食（例如花生酱和饼干）的推荐。 第二个将向参与者提供可以在日常生活中实施的跌倒预防方法的咨询。 将向所有参与者提供疾病控制和预防中心 (CDC) 认可的降低跌倒风险措施的标准分发材料。

行为的：调查员推荐的运动

被随机分配到强化常规护理的参与者将被提醒注意第 1 阶段提供的跌倒预防入门中概述的标准跌倒预防措施，并将收到锻炼建议。

实验性的：治疗（乳酸）以及增强的平时护理，然后teletai-chi运动课

乳糖加上增强的常规护理（EUC）在第1阶段（12周），然后将牛奶糖糖重新加送到EUC，然后在第2阶段的Teletai-Chi运动课程

行为的：加强日常护理

将向患者提供两种可加强护理的方法并为其提供咨询。 第一个是关于营养建议和蛋白质补充的讲义。 这将包括白天高蛋白零食（例如蛋白质棒）和高蛋白夜间零食（例如花生酱和饼干）的推荐。 第二个将向参与者提供可以在日常生活中实施的跌倒预防方法的咨询。 将向所有参与者提供疾病控制和预防中心 (CDC) 认可的降低跌倒风险措施的标准分发材料。

药品：乳果糖

患者将服用乳果糖，并且还将接受加强的常规护理。 将根据平均每天的平均排便次数按照特定的时间表服用乳果糖。 将从 15 毫升 (mL) 剂量开始，并按照指示在第一阶段参与的第一周内缓慢增加乳果糖剂量。 规定的最大剂量为 30 毫升（20 克），每日两次。 剂量将缓慢增加至最大剂量或直至参与者每天达到 2-3 次软便。

在第一阶段接受乳果糖的参与者将在第二阶段继续这样做。

行为的：远程太极拳（虚拟）

TeleTai-Chi 将由经过认证的 TeleTai-Chi 教练通过直播 Zoom 课程远程教授最多 15 名患者，每周 3 次（大约 12 周）。 课程将通过密歇根大学符合 HIPAA 标准的 Zoom 服务器进行。 参与者将被指导通过智能手机、平板电脑或计算机使用 Zoom。 将提供高清多媒体接口 (HDMI) 电缆和其他用于将设备连接到电视的设备特定设备。

实验性的：增强的通常护理小组，然后是Tele-Tai Chi练习课

在第1阶段（12周）上增强了常规护理（EUC），然后在第2阶段将Tele-tai Chi运动课重新运送到EUC

行为的：加强日常护理

将向患者提供两种可加强护理的方法并为其提供咨询。 第一个是关于营养建议和蛋白质补充的讲义。 这将包括白天高蛋白零食（例如蛋白质棒）和高蛋白夜间零食（例如花生酱和饼干）的推荐。 第二个将向参与者提供可以在日常生活中实施的跌倒预防方法的咨询。 将向所有参与者提供疾病控制和预防中心 (CDC) 认可的降低跌倒风险措施的标准分发材料。

行为的：远程太极拳（虚拟）

TeleTai-Chi 将由经过认证的 TeleTai-Chi 教练通过直播 Zoom 课程远程教授最多 15 名患者，每周 3 次（大约 12 周）。 课程将通过密歇根大学符合 HIPAA 标准的 Zoom 服务器进行。 参与者将被指导通过智能手机、平板电脑或计算机使用 Zoom。 将提供高清多媒体接口 (HDMI) 电缆和其他用于将设备连接到电视的设备特定设备。

实验性的：治疗（乳乳糖）以及增强的通常护理，然后建议进行运动

在第1阶段（12周）处乳lactulose和增强的常规护理（EUC），然后再将牛奶溶液加热到EUC，然后在第2阶段进行调查员训练者练习

行为的：加强日常护理

将向患者提供两种可加强护理的方法并为其提供咨询。 第一个是关于营养建议和蛋白质补充的讲义。 这将包括白天高蛋白零食（例如蛋白质棒）和高蛋白夜间零食（例如花生酱和饼干）的推荐。 第二个将向参与者提供可以在日常生活中实施的跌倒预防方法的咨询。 将向所有参与者提供疾病控制和预防中心 (CDC) 认可的降低跌倒风险措施的标准分发材料。

行为的：调查员推荐的运动

被随机分配到强化常规护理的参与者将被提醒注意第 1 阶段提供的跌倒预防入门中概述的标准跌倒预防措施，并将收到锻炼建议。

药品：乳果糖

患者将服用乳果糖，并且还将接受加强的常规护理。 将根据平均每天的平均排便次数按照特定的时间表服用乳果糖。 将从 15 毫升 (mL) 剂量开始，并按照指示在第一阶段参与的第一周内缓慢增加乳果糖剂量。 规定的最大剂量为 30 毫升（20 克），每日两次。 剂量将缓慢增加至最大剂量或直至参与者每天达到 2-3 次软便。

在第一阶段接受乳果糖的参与者将在第二阶段继续这样做。

Number of Participants Experiencing a Hierarchical Composite of Events Over 24 Weeks: Injurious Falls, Non-injurious Falls, Incident Hepatic Encephalopathy, Liver Transplant, and Death/Transplant

Composite outcome is defined as any of the following:

• Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring medical intervention including: Hospitalization or overnight observation in the Emergency Room (ER); surgery, transfusion, stitches

• Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level

  • Include falls that result in minor injuries that are addressed with first aid (e.g., ice, bandage)
• Incident Overt HE: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator
• Death: Mortality with any cause
• Liver transplant: Replacement of a diseased liver with the healthy liver from another person because of acute-on-chronic liver failure (using the EASL-CLIF-C definition consisting of an acute increase in the bilirubin and/or INR, acute kidney injury, overt HE, hypertension, and hypoxia).

Injurious Falls

Results reflect the number of participants who experienced at least one injurious fall. Injurious falls include: Fracture, dislocation, cut, head injury, soft - tissue injury requiring hospitalization.

Non-Injurious Falls

Results reflect the number of participants who experienced at least one non-injurious fall. Non- injurious falls include: Inadvertently coming to rest on the floor or lower level.

Incident Overt Hepatic Encephalopathy (HE)

Incident Overt HE includes: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator.

Death/Transplant for Acute-on-Chronic Liver Failure (ACLF)

Results reflect participants who died, or who received a liver transplant because of ACLF.

Incident of Liver Transplant for Non-ACLF Reason

Results reflect the number of participants who received replacement of a diseased liver with the healthy liver from another person for any reason other than ACLF.

Days-alive and Out-of-the-hospital

Days-alive and out-of-the-hospital is a continuous value, 1 for each day alive, 0 for days in hospital. Participants were queried and data was also abstracted from the Electronic Medical Record (EMR). Results reflect the average number of days participants were alive and out of the hospital.

Change in Cognitive Function Based on the Animal Naming Test (ANT)

The animal naming test assesses cognitive function. It is a timed test that that consists of participants listing as many unique animals as possible in 60 seconds. This is a validated test used for the assessment of hepatic encephalopathy. The score is the number of unique animals named (higher is better). Results reflect change from baseline.

Change in Visual Analog Scale (VAS)

This was a 1-item global rating of health scored 0-100. A score of 100 means the best health and 0 means the worst health imagined. Results reflect change from baseline.

Change in The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1 Profile (PROPr)

PROPr is the combined score of the two scales in the PROMIS 29+2, a quality-of-life scale and a pain-rating scale, and is used to calculate a preference score. The scores from both scales provide an overall summary of health-related quality of life based on multiple domains summarizing a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Results reflect change from baseline.

Change in Depression Based on The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1

There were 4 questions that participants completed regarding depression. The scores were converted to t scores, which were normalized from the raw scores. The t score ranged from 0-100 with 0 denoting worst depression and 100 indicating no depression. Results reflect the change from baseline.

Change in Sleep Quality Based on the PROMIS-29+2 v2.1

There were 4 questions that participants completed regarding sleep quality. The scores were converted to t scores, which were normalized from the raw scores. The t score ranged from 0-100 with 0 denoting worst sleep quality and 100 indicating best sleep quality. Results reflect change from baseline.

Physical Frailty Based on the Liver Frailty Index

Physical frailty was assessed with this index and was a composite of handgrip, timed chair-stands, and balance. The index ranged from -1.26 (robust) to 6.9 (frail), 50th percentile is 3.9. For individuals enrolled remotely, the study team assessed chair-stands.

Change in Physical Frailty Based on the Activities of Daily Living (ADLs)

Activities of daily living (ADLs), is a validated self-reported measure (disability is defined as >1 ADL deficit) recommended by the American Society for Transplantation and AASLD. The score ranged from 0 to 6 (6 indicating full independence, 4 moderate impairment, and 2 or less severe functional impairment). Results reflect change from baseline.

Intervention Fidelity

Evaluation of intervention fidelity was assessed at 50% and 100% of study completion. Results reflect participants who maintained fidelity by completing at least one of the following key intervention components: coordinator trainings, lactulose prescriptions ordered, enhanced usual care components delivered, Short Message Service (SMS) assessments sent, study visits completed, or exercise sessions completed.

Participant Adherence

Adherence to lactulose, Tai-Chi, and nighttime protein supplementation was monitored. Results reflect the number of participants who discontinued their assigned intervention.

Participant Satisfaction With the Trial and Interventions Based on the Patient Global Impression of Change (PGIC)

Satisfaction with the trial was assessed using the 6-item Patient Global Impression of Change (PGIC). Participants selected from 1 (very much improved) to 7 (very much worse). Lower scores indicated higher satisfaction.

Change in Short Form (SF) - 8

The SF-8 is an abbreviated 8-item version of an original 36-item health survey (SF-36). It is a generic multipurpose quality of life instrument. It contains psychometrically based physical and mental health summary measures. The eight domains include general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health and role emotional. The scores were converted to t scores, which were normalized from the raw scores. The t score ranged from 0-100 with 0 denoting worst quality of life and 100 indicating best quality of life. Results reflect change from baseline.