FrailtyNCT04836923
LIFT Intervention in Liver Transplant Candidates
A study testing "LIver FrailTy" intervention (LIFT) in people with Frailty and Cirrhosis, run by Northwestern University at 1 site in United States.
Trial summary
Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Cirrhosis, Liver Transplant
- What is being tested?
- "LIver FrailTy" intervention (LIFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic
- English-speaking
- Patients with access to a smart phone (with videoconference capabilities)
- Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.
Who cannot join
- Patients < 18 years of age
- Patients who require outpatient physical therapy.
- Patients without the ability to consent for themselves or through a medical power of attorney.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates
Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible.
In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins.
Read the detailed description
Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy (PT) sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting.
The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
The central hypothesis is that the LIFT intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.
- Conditions
- Frailty, Cirrhosis, Liver Transplant
- Being tested
- "LIver FrailTy" intervention (LIFT)
- Medical subject headings
- Frailty, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"LIver FrailTy" intervention (LIFT)Behavioural
Novel physical therapy intervention to decrease frailty in pre-transplant patients
| Study group | Role | What they receive |
|---|---|---|
| LIFT subgroup | Experimental | Physical Therapy (PT) evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. Receives: Behavioral: "LIver FrailTy" intervention (LIFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frailty is described as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. This outcome is measured by the Liver frailty index [LFI]. LFI is composed of 3 performance-based tests (grip strength, chair stands, and balance). Patients are classified using established cutoffs (frail: LFI ≥ 4.5, pre-frail: LFI 3.3-4.4, robust: LFI ≤ 3.2). Higher LFI scores indicate a higher degree of frailty.
Measured: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Patient-reported Physical Function
Patient-reported physical quality of life was measured using a validated patient-reported outcome measure (Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS-PF]) completed in clinic.
Patient-reported physical function was measured using a validated patient-reported outcome measure: Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS-PF] Version 2.0 - Short Form 8c.
A higher PROMIS T-score represents more of the concept being measured. A score of 50 is the average for the United States general population with a standard deviation of 10. A Physical Function T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. Physical Function T-Scores range from 20.3 to 60.1.
Measured: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Exercise Adherence Rate
Data continuously collected via TrueCoach smart phone application to document adherence to exercise regimen. If patients are unable to appropriately track adherence on the smart phone application, this data will be collected at weekly videoconference/telephone check-ins detailed below.
Exercise adherence rates are defined as the number of completed or attempted exercise days/total exercise days prescribed. Overall, patients were classified as adherent to the exercise regimen if their adherence rate was ≥ 75% and partially adherent if ≥ 50%. Patients were classified as non-adherent if their adherence rate was < 50%. The mean intervention rate was measured throughout the follow-up period (from enrollment to final assessment) - the mean follow-up time was 259 (±190) days.
Measured: 1 month and 3 months after Enrollment, throughout the follow-up period (mean follow-up time is 259 (±190) days)
Secondary outcomes (1)
Clinical Outcomes - Liver Related Complications
Data collected from medical chart for liver related complications including but not limited to diagnosis of: ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome, infection.
Measured: Throughout the follow-up period (mean follow-up time is 259 (±190) days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Oct 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Ladner, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836923
- Sponsor's protocol ID
- STU00213159
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2021
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thuluvath AJ, Polineni P, Morrissey S, Belfanti K, Nizamuddin M, Siddiqui O, Daud A, Simpson DC, Levitsky J, Flores AM, Duarte-Rojo A, Ladner DP. Home-based LIver FrailTy Intervention (LIFT) in Transplant Candidates: A Feasibility Study. Transplantation. 2025 Apr 1;109(4):e202-e212. doi: 10.1097/TP.0000000000005263. Epub 2024 Nov 6.
PubMed 40131764
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Physical Therapy Intervention to Decrease Frailty in Liver Transplant Candidates
- ClinicalTrials.gov ID
- NCT04836923
- Acronym / sponsor ID
- STU00213159
- Conditions
- Frailty, Cirrhosis, Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible.
In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins.
Detailed description
Frailty is defined as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. The concept of frailty has recently emerged as a critical determinant in the field of cirrhosis and liver transplantation. Frailty impacts pre- and post-transplant clinical outcomes, including waitlist mortality, post-transplant mortality, frequency of hospitalizations and duration of hospital admissions. Although the impact of frailty in liver transplantation has been established in the literature, there is a lack of data supporting effective interventions to decrease frailty prior to liver transplantation. Moreover, the studies that have tested interventions to improve physical function have relied on frequent supervised physical therapy (PT) sessions and access to exercise equipment that it is not financially or logistically feasible for the majority of patients. Patient engagement in PT also remains a critical barrier to overcome to decrease frailty in preparation for liver transplantation. Developing a practical and effective intervention to consistently engage patients in physical activity and decrease frailty is essential to improving clinical outcomes in the pre- and post-liver transplant setting.
The investigators goal is to pilot test a novel PT intervention to decrease frailty in pre-transplant patients. The investigators have designed a prototype "LIver FrailTy" intervention (LIFT) that includes: PT evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members.
The central hypothesis is that the LIFT intervention will 1) improve adherence to recommended levels of exercise in end-stage liver disease 2) reduce pre-transplant frailty and 3) will improve pre- and post-transplant clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFT subgroup | Experimental | Behavioral: "LIver FrailTy" intervention (LIFT)Physical Therapy (PT) evaluation, an individualized home exercise prescription (HEP), daily text message reminders to exercise and weekly telephone check-ins with team members. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of liver cirrhosis being evaluated for liver transplantation in hepatology/transplant evaluation clinic
- English-speaking
- Patients with access to a smart phone (with videoconference capabilities)
- Vulnerable populations: We will include patients who are cognitively impaired due to hepatic encephalopathy and unable to consent for themselves.
Key exclusion criteria (3 listed)
- Patients < 18 years of age
- Patients who require outpatient physical therapy.
- Patients without the ability to consent for themselves or through a medical power of attorney.
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 |
|---|---|---|
| "LIver FrailTy" intervention (LIFT)Novel physical therapy intervention to decrease frailty in pre-transplant patients | Behavioural | LIFT subgroup |
Primary outcome
Frailty
Time frame: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Frailty is described as a biologic syndrome of decreased physiologic reserve and increased vulnerability to health stressors. This outcome is measured by the Liver frailty index [LFI]. LFI is composed of 3 performance-based tests (grip strength, chair stands, and balance). Patients are classified using established cutoffs (frail: LFI ≥ 4.5, pre-frail: LFI 3.3-4.4, robust: LFI ≤ 3.2). Higher LFI scores indicate a higher degree of frailty.
Patient-reported Physical Function
Time frame: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)
Patient-reported physical quality of life was measured using a validated patient-reported outcome measure (Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS-PF]) completed in clinic. Patient-reported physical function was measured using a validated patient-reported outcome measure: Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS-PF] Version 2.0 - Short Form 8c. A higher PROMIS T-score represents more of the concept being measured. A score of 50 is the average for the United States general population with a standard deviation of 10. A Physical Function T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. Physical Function T-Scores range from 20.3 to 60.1.
Exercise Adherence Rate
Time frame: 1 month and 3 months after Enrollment, throughout the follow-up period (mean follow-up time is 259 (±190) days)
Data continuously collected via TrueCoach smart phone application to document adherence to exercise regimen. If patients are unable to appropriately track adherence on the smart phone application, this data will be collected at weekly videoconference/telephone check-ins detailed below. Exercise adherence rates are defined as the number of completed or attempted exercise days/total exercise days prescribed. Overall, patients were classified as adherent to the exercise regimen if their adherence rate was ≥ 75% and partially adherent if ≥ 50%. Patients were classified as non-adherent if their adherence rate was < 50%. The mean intervention rate was measured throughout the follow-up period (from enrollment to final assessment) - the mean follow-up time was 259 (±190) days.
1 secondary outcome
Clinical Outcomes - Liver Related Complications
Time frame: Throughout the follow-up period (mean follow-up time is 259 (±190) days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40131764Thuluvath AJ, Polineni P, Morrissey S, Belfanti K, Nizamuddin M, Siddiqui O, Daud A, Simpson DC, Levitsky J, Flores AM, Duarte-Rojo A, Ladner DP. Home-based LIver FrailTy Intervention (LIFT) in Transplant Candidates: A Feasibility Study. Transplantation. 2025 Apr 1;109(4):e202-e212. doi: 10.1097/TP.0000000000005263. Epub 2024 Nov 6.
- 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.
Daniela Ladner, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "LIver FrailTy" intervention (LIFT) in people with Frailty and Cirrhosis, run by Northwestern University 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 15 May 2026. 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frailty (time frame: Baseline and final frailty assessment (mean time from baseline to final frailty assessment was 216 (± 157) days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836923, which also lists 1 linked publication.
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 15 May 2026.