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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895243
• Other study ID #: IRB00006786
• Status: Completed
• Phase: N/A
• Start date: May 27, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: February 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• Prehabilitation
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Physical Medicine and Rehabilitation	Lutherville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post kidney transplant mortality	1 year patient survival	1 year