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OpenTrials
Completed

NCT Number: NCT04604860

Use of EL-FIT App to Promote Physical Activity

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitness intervention

Behavioral

Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).

Primary outcomes

  1. Change in liver frailty index (LFI) score

    Time frame: 12 weeks

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

  2. Change in six minute walk test (6MWT)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Change in daily average steps

    Time frame: 12 weeks

    Comparison of average daily steps from baseline until the end of study

  2. Usability of EL-FIT app

    Time frame: 12 weeks

    How patient interacts with each of the features of EL-FIT app based on responses to questionairre

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • American Association for the Study of Liver Diseases
  • Pittsburgh Liver Research Center

Registry information

Official study 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

Acronym: EL-FIT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2020
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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