End Stage Liver DIseaseEL-FITNCT04604860
Use of EL-FIT App to Promote Physical Activity
A study testing Fitness intervention in people with End Stage Liver DIsease and Cirrhosis, Liver, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- End Stage Liver DIsease, Cirrhosis, Liver
- What is being tested?
- Fitness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 24 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhosis and ESLD
- transplant eligible
- MELD >/=10
- referred to transplant physical therapist
Who cannot join
- those who lack a smartphone or the understanding of its functionality
- lack home wireless internet
- have recurrent/persistent overt hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
Read the 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.
- Conditions
- End Stage Liver DIsease, Cirrhosis, Liver
- Being tested
- Fitness intervention
- Medical subject headings
- End Stage Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness interventionBehavioural
Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).
| Study group | Role | What they receive |
|---|---|---|
| EL-FIT | Experimental | Patients using the EL-FIT app Receives: Behavioral: Fitness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver frailty index (LFI) score
Change in liver frailty index from baseline to the end of the study
Measured: 12 weeks
Change in six minute walk test (6MWT)
Change in six minute walk test from baseline to the end of the study
Measured: 12 weeks
Secondary outcomes (2)
Change in daily average steps
Comparison of average daily steps from baseline until the end of study
Measured: 12 weeks
Usability of EL-FIT app
How patient interacts with each of the features of EL-FIT app based on responses to questionairre
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start23 Sep 2020
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases, Pittsburgh Liver Research Center
- Responsible party
- Principal investigator, Andres Duarte-Rojo, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604860
- Sponsor's protocol ID
- STUDY19020063
- Acronym
- EL-FIT
- Status last verified
- Jun 2022
- First submitted
- 7 Oct 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04604860
- Acronym / sponsor ID
- EL-FIT / STUDY19020063
- Conditions
- End Stage Liver DIsease, Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Association for the Study of Liver Diseases, Pittsburgh Liver Research Center
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EL-FIT | Experimental | Behavioral: Fitness interventionPatients using the EL-FIT app |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cirrhosis and ESLD
- transplant eligible
- MELD >/=10
- referred to transplant physical therapist
Key exclusion criteria (3 listed)
- those who lack a smartphone or the understanding of its functionality
- lack home wireless internet
- have recurrent/persistent overt hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness interventionPatients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching). | Behavioural | EL-FIT |
Primary outcome
Change in liver frailty index (LFI) score
Time frame: 12 weeks
Change in liver frailty index from baseline to the end of the study
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
2 secondary outcomes
Change in daily average steps
Time frame: 12 weeks
Usability of EL-FIT app
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness intervention in people with End Stage Liver DIsease and Cirrhosis, Liver, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver frailty index (LFI) score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.