FrailtyFLEXNCT04200846
Frailty in Liver Transplant Exercise (FLEX) Trial
A study testing Exercise intervention in people with Frailty and Liver Transplants, run by Milton S. Hershey Medical Center.
Trial summary
Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frailty, Liver Transplants
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age ≥18 or ≤75 years
- Frail as defined by a LFI score of >4.5
- Under evaluation or listed for liver transplant
Who cannot join
- Active cardiac symptoms (e.g., chest pain, shortness of breath at rest, palpitations)
- Positive response to Get Active Questionnaire (GAQ) (validated activity questionnaire that indicates if exercise is unsafe)
- Institutionalized/prisoner
- Severe medical comorbidities/psychiatric illness at the discretion of the Study Principal Investigator (PI)
About this study
Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant candidates remains unknown.
Read the detailed description
The long-term goal is to better understand how exercise impacts frailty in order to identify treatments that can improve both patient-oriented outcomes and access to liver transplantation for end-stage liver disease patients. The specific objective of this proposal is to generate pilot feasibility data required for future multicenter R01 application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which will test the novel central hypothesis that exercise improves frailty and lessens waiting-list mortality. Additionally, another goal of the study is to establish an optimal frailty tool for liver transplant candidates.
- Conditions
- Frailty, Liver Transplants
- Being tested
- Exercise intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
Subjects in this group will be asked to exercise 5 days a week. Two days on-site with an Exercise Physiologist and the other 3 days at home.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Private supervised strength training exercise (e.g., body weight or dumbbell exercises) will occur in the Cancer Center Exercise Medicine Unit or the Hershey Center for Applied Research (HCAR) two days a week. In addition, subjects will be instructed to exercise on their own, at home, three days a week doing 30 minutes of moderate intensity aerobic exercise (e.g., walking at 45-55% maximum heart rate determined by the formula max heart rate = 220bpm - 0.64*age in years). Receives: Behavioral: Exercise intervention |
| Control | No intervention | Subjects in the control condition will be instructed to continue their medical care at the discretion of their treating medical professional and to maintain their current exercise level. Weekly phone calls will be performed to ensure adherence to the protocol (no changes in activity). Subjects will report to Penn State on a monthly basis for interim history and physical to confirm self-reports. Subjects will also be given a FitBit ChargeHR3 and downloaded data review will be performed monthly at the in-person visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants able to complete the trial
Defined as 50% of subjects completing >80% of the sessions.
Measured: up to 52 weeks
Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines
This study aims to examine the incidence of adverse events. If exercise in frail liver transplant candidates is safe. 5% serious adverse events or fewer will deem the trial as safe. If more than 5% serious adverse events occur, the trial is determined to be unsafe.
Measured: up to 52 weeks
Rate of enrollment
Net enrollment rates, which are calculated by dividing the number of subjects approached by the number of subjects that enroll in the trial. The work with the ongoing NASHFit and completed ENACT Trials and the work of others performing exercise-based trials in patients with cirrhosis(50) has established >50% enrollment of subjects approached as a threshold of acceptability.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Jul 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- An interventional pilot trial will be performed with 21 randomized subjects who are aged 18-75 years who are frail according to the LFI to a 3-month exercise intervention (n=14) versus standard of care (n=7) with no change in activity.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Stine, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200846
- Sponsor's protocol ID
- STUDY00014084
- Acronym
- FLEX
- Status last verified
- Jun 2021
- First submitted
- 11 Dec 2019
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Liver Transplant Exercise (FLEX) Trial
- ClinicalTrials.gov ID
- NCT04200846
- Acronym / sponsor ID
- FLEX / STUDY00014084
- Conditions
- Frailty, Liver Transplants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Dec 2019 (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.
Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant candidates remains unknown.
Detailed description
The long-term goal is to better understand how exercise impacts frailty in order to identify treatments that can improve both patient-oriented outcomes and access to liver transplantation for end-stage liver disease patients. The specific objective of this proposal is to generate pilot feasibility data required for future multicenter R01 application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which will test the novel central hypothesis that exercise improves frailty and lessens waiting-list mortality. Additionally, another goal of the study is to establish an optimal frailty tool for liver transplant candidates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An interventional pilot trial will be performed with 21 randomized subjects who are aged 18-75 years who are frail according to the LFI to a 3-month exercise intervention (n=14) versus standard of care (n=7) with no change in activity.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise interventionPrivate supervised strength training exercise (e.g., body weight or dumbbell exercises) will occur in the Cancer Center Exercise Medicine Unit or the Hershey Center for Applied Research (HCAR) two days a week. In addition, subjects will be instructed to exercise on their own, at home, three days a week doing 30 minutes of moderate intensity aerobic exercise (e.g., walking at 45-55% maximum heart rate determined by the formula max heart rate = 220bpm - 0.64*age in years). |
| Control | No intervention | –Subjects in the control condition will be instructed to continue their medical care at the discretion of their treating medical professional and to maintain their current exercise level. Weekly phone calls will be performed to ensure adherence to the protocol (no changes in activity). Subjects will report to Penn State on a monthly basis for interim history and physical to confirm self-reports. Subjects will also be given a FitBit ChargeHR3 and downloaded data review will be performed monthly at the in-person visits. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age ≥18 or ≤75 years
- Frail as defined by a LFI score of >4.5
- Under evaluation or listed for liver transplant
Key exclusion criteria (4 listed)
- Active cardiac symptoms (e.g., chest pain, shortness of breath at rest, palpitations)
- Positive response to Get Active Questionnaire (GAQ) (validated activity questionnaire that indicates if exercise is unsafe)
- Institutionalized/prisoner
- Severe medical comorbidities/psychiatric illness at the discretion of the Study Principal Investigator (PI)
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 |
|---|---|---|
| Exercise interventionSubjects in this group will be asked to exercise 5 days a week. Two days on-site with an Exercise Physiologist and the other 3 days at home. | Behavioural | Exercise intervention |
Primary outcome
Number of participants able to complete the trial
Time frame: up to 52 weeks
Defined as 50% of subjects completing >80% of the sessions.
Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines
Time frame: up to 52 weeks
This study aims to examine the incidence of adverse events. If exercise in frail liver transplant candidates is safe. 5% serious adverse events or fewer will deem the trial as safe. If more than 5% serious adverse events occur, the trial is determined to be unsafe.
Rate of enrollment
Time frame: up to 52 weeks
Net enrollment rates, which are calculated by dividing the number of subjects approached by the number of subjects that enroll in the trial. The work with the ongoing NASHFit and completed ENACT Trials and the work of others performing exercise-based trials in patients with cirrhosis(50) has established >50% enrollment of subjects approached as a threshold of acceptability.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Frailty
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Recruiting
Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty
Old Age; Debility, Digestive Cancer
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Frailty and Liver Transplants, run by Milton S. Hershey Medical Center.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants able to complete the trial (time frame: up to 52 weeks). 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?
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 29 Jun 2021.