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

NCT ID: NCT02895243

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-27

Study Completion Date

2018-04-01

Brief Summary

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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

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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.

Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prehabilitation

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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exercise training

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mara McAdams DeMarco, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Johns Hopkins Physical Medicine and Rehabilitation

Lutherville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00006786

Identifier Type: -

Identifier Source: org_study_id

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