Clinical trial NCT04604860: Use of EL-FIT App to Promote Physical Activity
Official title: EL-FIT (Exercise and Liver FITness): Validation of an Innovative Virtual Tool to Promote Physical Activity in Liver Transplant Candidates With Advanced Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Liver DIsease
Cirrhosis, Liver
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Association for the Study of Liver Diseases (AASLD)
name: Pittsburgh Liver Research Center
First posted: 2020-10-27
Enrollment: 59
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in liver frailty index (LFI) score
timeFrame: 12 weeks
measure: Change in six minute walk test (6MWT)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in daily average steps
timeFrame: 12 weeks
measure: Usability of EL-FIT app
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References: