Use of EL-FIT App to Promote Physical Activity
EL-FIT
EL-FIT (Exercise and Liver FITness): Validation of an Innovative Virtual Tool to Promote Physical Activity in Liver Transplant Candidates With Advanced Liver Disease
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2020
CompletedFirst Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2022
CompletedJune 7, 2022
June 1, 2022
1.4 years
October 7, 2020
June 3, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change in liver frailty index (LFI) score
Change in liver frailty index from baseline to the end of the study
12 weeks
Change in six minute walk test (6MWT)
Change in six minute walk test from baseline to the end of the study
12 weeks
Secondary Outcomes (2)
Change in daily average steps
12 weeks
Usability of EL-FIT app
12 weeks
Study Arms (1)
EL-FIT
EXPERIMENTALPatients using the EL-FIT app
Interventions
Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).
Eligibility Criteria
You may qualify if:
- cirrhosis and ESLD
- transplant eligible
- MELD \>/=10
- referred to transplant physical therapist
You may not qualify if:
- those who lack a smartphone or the understanding of its functionality
- lack home wireless internet
- have recurrent/persistent overt hepatic encephalopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 27, 2020
Study Start
September 23, 2020
Primary Completion
February 24, 2022
Study Completion
February 24, 2022
Last Updated
June 7, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share