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Clinical Trials/NCT02895243
NCT02895243CompletedNot Applicable

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

Johns Hopkins Bloomberg School of Public Health1 site in 1 country18 target enrollmentStarted: May 27, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Post kidney transplant mortality

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Prehabilitation

Experimental

Intervention: Prehabilitation (Other)

Outcomes

Primary Outcomes

Post kidney transplant mortality

Time Frame: 1 year

1 year patient survival

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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