NCT04954690 Structured Program of Exercise for Recipients of Kidney Transplantation
| NCT ID | NCT04954690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Kidney Transplant; Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2022-11-22 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * On hemodialysis or peritoneal dialysis * Age ≥ 50 years * SPPB score ≤ 10 * Telephone access * Internet access * Having a living donor kidney Exclusion Criteria: * Already in an exercise program * Non-English speakers
Contact & Investigator
Anoop Sheshadri, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT04954690 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Kidney Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04954690 currently recruiting?
Yes, NCT04954690 is actively recruiting participants. Contact the research team at anoop.sheshadri@ucsf.edu for enrollment information.
Where is the NCT04954690 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04954690 clinical trial?
NCT04954690 is sponsored by University of California, San Francisco. The principal investigator is Anoop Sheshadri, MD, MAS at University of California, San Francisco. The trial plans to enroll 136 participants.
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