Structured Exercise Program for Kidney Transplant Candidates
(SPaRKT Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on a structured exercise program for kidney transplant candidates.
What data supports the effectiveness of the treatment Structured Exercise Program for Kidney Transplant Recipients?
Research shows that exercise programs can improve physical fitness and quality of life for people with kidney disease, and studies suggest that exercise after kidney transplantation can enhance exercise capacity and overall health. A study found that patients who participated in supervised exercise after kidney transplantation improved their exercise capacity significantly, indicating that structured exercise programs can be beneficial for kidney transplant recipients.12345
Is a structured exercise program safe for kidney transplant recipients?
How is the Structured Exercise Program for Kidney Transplant Candidates different from other treatments?
The Structured Exercise Program for Kidney Transplant Candidates is unique because it involves a supervised exercise regimen that starts shortly after surgery and continues with unsupervised exercise, aiming to improve exercise capacity and overall health. Unlike standard medical treatments, this program focuses on physical activity to enhance recovery and long-term health outcomes for kidney transplant recipients.123510
Research Team
Anoop Sheshadri, MD, MAS
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for older adults (50+) with end-stage kidney disease on dialysis, who have a living donor for a kidney transplant and are not currently in an exercise program. They must have limited physical abilities (SPPB score ≤ 10), and access to both telephone and internet. Non-English speakers cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Adaptation
Recruitment of patient-caregiver dyads to refine the intervention and incorporate caregiver participation
Pre-intervention
Participants receive information on exercise benefits and are equipped with accelerometers for a lead-in period
Intervention
Participants engage in an 8-week structured exercise program with weekly coaching and caregiver involvement
Follow-up
Participants are monitored for changes in physical performance and activity post-intervention
Treatment Details
Interventions
- Structured Program of exercise for Recipients of Kidney Transplantation
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Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor