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

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Other: Prehabilitation

• Registration Number: NCT02895243
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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 Timeline

• Study Start: 2016-05-27
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-09
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation	-

Primary Outcome Measures

Name	Time	Method
Post kidney transplant mortality	1 year	1 year patient survival

Trial Locations

Locations (1)

Johns Hopkins Physical Medicine and Rehabilitation; 🇺🇸 Lutherville, Maryland, United States