Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Clinical Outcomes - waitlist / post-transplant mortality
研究概览
简要总结
Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible.
In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins.
详细描述
Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy (PT) sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting.
The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
The central hypothesis is that the LIFT intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic
- •English-speaking
- •Patients with access to a smart phone (with videoconference capabilities)
- •Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.
排除标准
- •Patients < 18 years of age
- •Patients who require outpatient physical therapy.
- •Patients without the ability to consent for themselves or through a medical power of attorney.
研究组 & 干预措施
LIFT subgroup
Physical Therapy (PT) evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
干预措施: "LIver FrailTy" intervention (LIFT) (Behavioral)
结局指标
主要结局
Clinical Outcomes - waitlist / post-transplant mortality
时间窗: Every month for up to 5 years
Measured if a patient dies while listed on the transplant waitlist or post-transplant.
Placement on liver transplant waitlist
时间窗: Every month for up to 5 years
A clinical measure for the participant and where they are located on the liver transplant waiting list.
Clinical Outcomes - number and duration of hospitalizations
时间窗: Every month for up to 5 years
Clinical measure for how many times a patient is hospitalized and how long those hospitalizations last.
Clinical Outcomes - liver related complications
时间窗: Every month for up to 5 years
Data collected from medical chart for liver related complications including but not limited to diagnosis of: ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome, infection.
Frailty
时间窗: Every month for up to 5 years
Frailty is described as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. This outcome is measured by the Liver frailty index \[LFI\]. LFI is composed of 3 performance-based tests (grip strength, chair stands, and balance). There is no data to date describing the expected range of values. Higher LFI scores indicate a higher degree of frailty.
Clinical Outcomes - post transplant disposition
时间窗: Every month for up to 5 years
Determined by location of patient after transplant (can be listed such as acute rehabilitation, subacute rehabilitation center, home, etc.)
次要结局
- Endurance(Every 3 months for up to 5 years)
- Patient-reported quality of life(Every 3 months for up to 5 years)
- Patient adherence(Every week for up to 5 years)
- Degree of hepatic encephalopathy(Every 3 months for up to 5 years)
- Personality assessment(Every month for up to 5 years)
研究者
Daniela Ladner
Professor of Surgery - Organ Transplantation
Northwestern University