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临床试验/NCT04604860
NCT04604860已完成不适用

EL-FIT (Exercise and Liver FITness): Validation of an Innovative Virtual Tool to Promote Physical Activity in Liver Transplant Candidates With Advanced Liver Disease

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Change in six minute walk test (6MWT)

研究概览

简要总结

Transplant-eligible patients with cirrhosis and ESLD, age 40-70, MELD >/= 10 referred to transplant physical therapy will be invited to participate. The investigators will exclude those who lack a smartphone or the understanding of its functionality, lack home wireless internet, or have recurrent/persistent overt hepatic encephalopathy. Following signing of informed consent, each participant will be given a Fitbit Charge 3 and have EL-FIT and Fitbit apps downloaded to their smartphone. After a brief session with a member of the research team explaining the basic components and functionality of EL-FIT and Fitbit, patients will be provided with general physical activity recommendations (as per our current standard of care) and asked to explore all features of EL-FIT and Fitbit apps, up until their 12-week follow-up visit. Phone calls to incentivize physical activity and exercise will be performed by members of the research team.

详细描述

The study consists of two visits, baseline and 12-week follow-up, with at least one follow-up phone call on a weekly basis. Visit one is expected to last for 30 minutes and visit 2 for 60 minutes, whereas each phone call should take no more than 15 minutes. Twice during the study period, the investigators will draw serum and plasma samples for future translational research. Daily, the physical trainer will review collected data on EL-FIT research database and Fitabase. Each participant will have an exit interview by the end of week 12 with the trainer and a member of the research team to talk about their impressions of using EL-FIT and Fitbit, through a structured questionnaire assessing about how user friendly it was to use the EL-FIT app. Finally, trainers will be asked to compare the type of prescription that they provided to patients as part of the standard of care (based on liver frailty index or 6-minute walk test), to compare it with the allocation provided by EL-FIT stratification algorithm.

To learn about how to improve EL-FIT the investigators will ask patients and their caregivers open-ended questions as part of their exit interview. This will allow us to identify barriers precluding them from keeping up with physical trainer recommendations, and what would they like to include to enhance motivation as part of a physical activity program. A member of the research team will act as a facilitator during this session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cirrhosis and ESLD
  • transplant eligible
  • MELD >/=10
  • referred to transplant physical therapist

排除标准

  • those who lack a smartphone or the understanding of its functionality
  • lack home wireless internet
  • have recurrent/persistent overt hepatic encephalopathy

结局指标

主要结局

Change in six minute walk test (6MWT)

时间窗: 12 weeks

Change in six minute walk test from baseline to the end of the study

Change in liver frailty index (LFI) score

时间窗: 12 weeks

Change in liver frailty index from baseline to the end of the study

次要结局

  • Change in daily average steps(12 weeks)
  • Usability of EL-FIT app(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres Duarte-Rojo

Associate Professor

University of Pittsburgh

研究点 (2)

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