- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444273
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
May 9, 2018 updated by: Washington University School of Medicine
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being evaluated for liver transplantation by Barnes Jewish Hospital medical team
Exclusion Criteria:
- Non-english speaking
- Medical contraindications to exercise as determined by the medical team
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Subjects will receive standard care both pre and post transplant.
|
|
Experimental: Exercise Group
Subjects will receive a personalized home exercise program and regular phone calls from a therapist to monitor and promote activity.
|
Subjects will be given and individualized exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of a prehabilitation program.
Time Frame: 2 Years
|
Feasibility will be measured by participation and outcome assessment measures.
|
2 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Normative data on Timed Up and Go for patients with end stage liver disease.
Time Frame: Baseline
|
Baseline
|
Normative data on 10 meter walk for patients with end stage liver disease.
Time Frame: Baseline
|
Baseline
|
Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.
Time Frame: Baseline
|
Baseline
|
Normative data on Five Time Sit to Stand for patients with end stage liver disease.
Time Frame: Baseline
|
Baseline
|
Normative data on 6 Minute Walk Test for patients with end stage liver disease.
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 7, 2015
First Submitted That Met QC Criteria
May 11, 2015
First Posted (Estimate)
May 14, 2015
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
May 9, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201403118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Liver Disease
-
Vanderbilt University Medical CenterEnrolling by invitationEnd Stage Liver DIseaseUnited States
-
Virginia Commonwealth UniversityCompletedEnd Stage Liver DIseaseUnited States
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonCompletedEnd-stage Liver DiseaseUnited Kingdom
-
Proteonomix, Inc.University of Medicine and Dentistry of New Jersey; NumodaUnknownEnd Stage Liver DIseaseUnited States
-
University of ZurichUniversity Ghent; University Hospital of Sao Paulo, BrazilCompleted
-
RenJi HospitalNot yet recruitingEnd Stage Liver DIsease
-
Mayo ClinicRecruiting
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Huashan HospitalRecruiting
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown