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OpenTrials
Completed

NCT Number: NCT02895243

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Physical Medicine and Rehabilitation

Lutherville, Maryland, 21093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prehabilitation

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.

Other names: exercise training

Primary outcomes

  1. Post kidney transplant mortality

    Time frame: 1 year

    1 year patient survival

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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