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The 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
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 7, 2015
    Last Updated
    May 9, 2018
    Sponsor
    Washington University School of Medicine
    Collaborators
    Barnes-Jewish Hospital
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    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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