End Stage Liver DiseaseNCT02444273
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
A study testing Exercise in people with End Stage Liver Disease and Physical Activity, run by Washington University School of Medicine.
Trial summary
The primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Liver Disease, Physical Activity
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2017
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being evaluated for liver transplantation by Barnes Jewish Hospital medical team
Who cannot join
- Non-english speaking
- Medical contraindications to exercise as determined by the medical team
About this study
The primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. The intervention group receives a personalized home exercise program along with weekly phone calls to provide coaching, mentoring and motivation. Data collected at baseline, post-transplant and, post-transplant follow up will be compared among the two study groups. The secondary outcomes include: normative data of functional measures for patients with end stage liver disease and to determine the effect size for future research on prehabilitation in the patient population.
- Conditions
- End Stage Liver Disease, Physical Activity
- Being tested
- Exercise
- Keywords
- liver diseases, liver transplantation, preoperative care, physical therapy
- Medical subject headings
- End Stage Liver Disease, Motor Activity, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
Subjects will be given and individualized exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects will receive standard care both pre and post transplant. |
| Exercise Group | Experimental | Subjects will receive a personalized home exercise program and regular phone calls from a therapist to monitor and promote activity. Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a prehabilitation program.
Feasibility will be measured by participation and outcome assessment measures.
Measured: 2 Years
Secondary outcomes (5)
Normative data on Timed Up and Go for patients with end stage liver disease.
Measured: Baseline
Normative data on 10 meter walk for patients with end stage liver disease.
Measured: Baseline
Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.
Measured: Baseline
Normative data on Five Time Sit to Stand for patients with end stage liver disease.
Measured: Baseline
Normative data on 6 Minute Walk Test for patients with end stage liver disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
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 Washington University School of MedicineThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444273
- Sponsor's protocol ID
- 201403118
- Status last verified
- May 2018
- First submitted
- 7 Apr 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
- ClinicalTrials.gov ID
- NCT02444273
- Acronym / sponsor ID
- 201403118
- Conditions
- End Stage Liver Disease, Physical Activity
- Keywords
- liver diseases, liver transplantation, preoperative care, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
The primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. The intervention group receives a personalized home exercise program along with weekly phone calls to provide coaching, mentoring and motivation. Data collected at baseline, post-transplant and, post-transplant follow up will be compared among the two study groups. The secondary outcomes include: normative data of functional measures for patients with end stage liver disease and to determine the effect size for future research on prehabilitation in the patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects will receive standard care both pre and post transplant. |
| Exercise Group | Experimental | Procedure: ExerciseSubjects will receive a personalized home exercise program and regular phone calls from a therapist to monitor and promote activity. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being evaluated for liver transplantation by Barnes Jewish Hospital medical team
Key exclusion criteria (2 listed)
- Non-english speaking
- Medical contraindications to exercise as determined by the medical team
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 |
|---|---|---|
| ExerciseSubjects will be given and individualized exercise program. | Procedure or surgery | Exercise Group |
Primary outcome
Feasibility of a prehabilitation program.
Time frame: 2 Years
Feasibility will be measured by participation and outcome assessment measures.
5 secondary outcomes
Normative data on Timed Up and Go for patients with end stage liver disease.
Time frame: Baseline
Normative data on 10 meter walk for patients with end stage liver disease.
Time frame: Baseline
Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.
Time frame: Baseline
Normative data on Five Time Sit to Stand for patients with end stage liver disease.
Time frame: Baseline
Normative data on 6 Minute Walk Test for patients with end stage liver disease.
Time frame: Baseline
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 11 May 2018.
- Individual participant dataSharing planned: Undecided
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Acute-on-Chronic Liver Failure (ACLF)
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with End Stage Liver Disease and Physical Activity, run by Washington University School of Medicine.
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 1 inclusion and 2 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 11 May 2018. 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 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?
Feasibility of a prehabilitation program. (time frame: 2 Years). 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 11 May 2018.