RECRUITING

Structured Program of Exercise for Recipients of Kidney Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Structured Program of Exercise for Recipients of Kidney Transplantation

Quick Facts

Study Start:2022-11-22
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04954690

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * On hemodialysis or peritoneal dialysis
  2. * Age ≥ 50 years
  3. * SPPB score ≤ 10
  4. * Telephone access
  5. * Internet access
  6. * Having a living donor kidney
  1. * Already in an exercise program
  2. * Non-English speakers

Contacts and Locations

Study Contact

Anoop Sheshadri, MD, MAS
CONTACT
415-221-4810
anoop.sheshadri@ucsf.edu
Gabriel Garcia
CONTACT
gabriel.garcia@ucsf.edu

Principal Investigator

Anoop Sheshadri, MD, MAS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Anoop Sheshadri, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-22
Study Completion Date2029-07

Study Record Updates

Study Start Date2022-11-22
Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Transplant; Complications
  • Dialysis; Complications
  • Physical Disability
  • Frailty Syndrome