search
Back to results

Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women with end stage renal disease who are within 3-6 months of kidney transplantation and are on the kidney transplant waitlist at Johns Hopkins
  2. Must be at least 18 years or older at enrollment
  3. Must be English speaking
  4. Must be enrolled in an ongoing cohort study of adults with ESRD who are being evaluated for kidney transplantation
  5. Must be willing to participate in a prehabilitation program and able to give informed consent

Exclusion Criteria:

  1. Patients who have any of the following medical conditions will be excluded from the study:

    • Active Angina pectoris
    • Chronic lung disease and daily use of oxygen
    • Cerebral vascular disease
    • Musculoskeletal conditions that would limit participation in prehabilitation
    • Lower- or upper-extremity amputation
    • Orthopedic disorders exacerbated by physical activity
    • Decreased mental capacity
  2. Patients who live outside of Maryland will not be included in the study.

Sites / Locations

  • Johns Hopkins Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Post kidney transplant mortality
1 year patient survival

Secondary Outcome Measures

Full Information

First Posted
September 6, 2016
Last Updated
February 11, 2020
Sponsor
Johns Hopkins Bloomberg School of Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT02895243
Brief Title
Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist
Official Title
Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will be a clinical trial to test the feasibility and effectiveness of a kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease (ESRD) who are within 3-6 months of transplantation.
Detailed Description
Prehabilitation is the enhancement of functional capacity of a patient to improve their ability to withstand a future stressor. The investigators primary objective is to demonstrate feasibility for prehabilitation in Aim 1 and test whether the number of prehabilitation sessions is associated with increased physical activity. The investigators will formally test whether prehabilitation is associated with a reduction in short term and long term KT outcomes as part of Aim 2. The investigators will test whether there is an effect of prehabilitation on short-term (KT length of stay> 2 weeks, early hospital readmission and delayed graft function) and long-term (acute rejection (within the first year), 1 year patient and graft survival) outcomes compared to standard of care controls. Participants will be followed for 3-6 months or until they receive a kidney transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Other Intervention Name(s)
exercise training
Intervention Description
The study will use a generic prehabilitation program which will include the following components: Warm-up, cardiovascular training, strength training, flexibility training, and cool down. Prehabilitation will occur once per week and approximately 1 hour in duration. Participants will take part in prehabilitation until they receive a kidney transplant which by study design is approximately for 3-6 months.
Primary Outcome Measure Information:
Title
Post kidney transplant mortality
Description
1 year patient survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women with end stage renal disease who are within 3-6 months of kidney transplantation and are on the kidney transplant waitlist at Johns Hopkins Must be at least 18 years or older at enrollment Must be English speaking Must be enrolled in an ongoing cohort study of adults with ESRD who are being evaluated for kidney transplantation Must be willing to participate in a prehabilitation program and able to give informed consent Exclusion Criteria: Patients who have any of the following medical conditions will be excluded from the study: Active Angina pectoris Chronic lung disease and daily use of oxygen Cerebral vascular disease Musculoskeletal conditions that would limit participation in prehabilitation Lower- or upper-extremity amputation Orthopedic disorders exacerbated by physical activity Decreased mental capacity Patients who live outside of Maryland will not be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara McAdams DeMarco, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Physical Medicine and Rehabilitation
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist

We'll reach out to this number within 24 hrs