Back to resultsThe Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
Primary Purpose
End Stage Liver Disease, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Liver Disease focused on measuring liver diseases, liver transplantation, preoperative care, physical therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Exercise Group
Arm Description
Subjects will receive standard care both pre and post transplant.
Subjects will receive a personalized home exercise program and regular phone calls from a therapist to monitor and promote activity.
Outcomes
Primary Outcome Measures
Feasibility of a prehabilitation program.
Feasibility will be measured by participation and outcome assessment measures.
Secondary Outcome Measures
Normative data on Timed Up and Go for patients with end stage liver disease.
Normative data on 10 meter walk for patients with end stage liver disease.
Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.
Normative data on Five Time Sit to Stand for patients with end stage liver disease.
Normative data on 6 Minute Walk Test for patients with end stage liver disease.
Full Information
NCT ID
NCT02444273
First Posted
April 7, 2015
Last Updated
May 9, 2018
Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02444273
Brief Title
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
Official Title
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease, Physical Activity
Keywords
liver diseases, liver transplantation, preoperative care, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects will receive standard care both pre and post transplant.
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Subjects will receive a personalized home exercise program and regular phone calls from a therapist to monitor and promote activity.
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Description
Subjects will be given and individualized exercise program.
Primary Outcome Measure Information:
Title
Feasibility of a prehabilitation program.
Description
Feasibility will be measured by participation and outcome assessment measures.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Normative data on Timed Up and Go for patients with end stage liver disease.
Time Frame
Baseline
Title
Normative data on 10 meter walk for patients with end stage liver disease.
Time Frame
Baseline
Title
Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.
Time Frame
Baseline
Title
Normative data on Five Time Sit to Stand for patients with end stage liver disease.
Time Frame
Baseline
Title
Normative data on 6 Minute Walk Test for patients with end stage liver disease.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital
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