Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT04954690

Structured Program of Exercise for Recipients of Kidney Transplantation

Led by University of California, San Francisco · Updated on 2023-10-16

136

Participants Needed

1

Research Sites

344 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Older patients with end- stage kidney disease (ESKD) are at very high risk for functional impairment. Kidney transplantation (KT) has the potential to ameliorate the detrimental effects of ESKD on physical activity and functional status. However, KT alone may not meet the full extent of this potential, particularly for older or more impaired adults. In fact, activity declines immediately post-KT and fails to return to expected levels even 5 years post-KT. Older patients waitlisted for KT (most of whom are on dialysis) are therefore reliant on their pre-KT levels of exercise, which are also predictive of post-KT mortality. "Prehabilitation" has been used in other surgical populations to minimize functional loss, and a structured exercise program may be beneficial in the pre- KT setting. However, few waitlisted patients are able to participate in typical exercise interventions due to barriers such as severe fatigue. Older patients have additional barriers such as further mobility impairment and requiring substantial caregiver support. Therefore for older living donor kidney transplant candidates, it is necessary to address issues such as specifics of coaching, timing, and importantly, incorporate caregiver participation. The overall objective of this proposal is to adapt a previously developed 8- week, home- based, structured exercise program among older (≥50 years) dialysis patients awaiting living donor KT, with a focus on caregiver involvement. The investigators will trial the exercise program as compared to usual care. The investigators will then pilot the refined intervention in a total of 72 patient-caregiver dyads, 48 of whom will undergo the proposed intervention (24 with caregiver participation, 24 without). The primary outcomes for the pilot will be change in physical performance and activity from baseline to after the intervention, along with measurements of exploratory quality of life outcomes. In addition, the investigators will measure these same outcomes at 3- months post KT to evaluate for a durable effect of the intervention. An additional post-transplantation outcome of interest will be number of days hospitalized within 3 months of transplantation.

CONDITIONS

Official Title

Structured Program of Exercise for Recipients of Kidney Transplantation

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • On hemodialysis or peritoneal dialysis
  • Age 50 years or older
  • Short Physical Performance Battery (SPPB) score of 10 or less
  • Access to a telephone
  • Access to the internet
  • Having a living donor kidney
Not Eligible

You will not qualify if you...

  • Currently participating in an exercise program
  • Non-English speakers

AI-Screening

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Trial Site Locations

Total: 1 location

1

Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

A

Anoop Sheshadri, MD, MAS

CONTACT

G

Gabriel Garcia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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