Structured Exercise Program for Kidney Transplant Candidates
(SPaRKT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAnoop Sheshadri, MD, MAS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Already in exercise program, others
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.
12345Is a structured exercise program safe for kidney transplant recipients?
Research shows that a structured exercise program, like resistance training, is generally safe for kidney transplant recipients. Studies found no adverse events, such as injuries or hospitalizations, related to the exercise program.
46789How 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.
123510Eligibility 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
I have a living donor for a kidney transplant.
Telephone access
Internet access
+3 more
Exclusion Criteria
I do not speak English.
Already in an exercise program
Trial Timeline
Adaptation
Recruitment of patient-caregiver dyads to refine the intervention and incorporate caregiver participation
2-4 weeks
Focus groups and weekly feedback sessions
Pre-intervention
Participants receive information on exercise benefits and are equipped with accelerometers for a lead-in period
1 week
1 visit (in-person) for equipment distribution and instruction
Intervention
Participants engage in an 8-week structured exercise program with weekly coaching and caregiver involvement
8 weeks
Weekly virtual coaching sessions
Follow-up
Participants are monitored for changes in physical performance and activity post-intervention
12 weeks
Assessments at 8 weeks and 3 months post-KT
Participant Groups
The study tests an 8-week home-based structured exercise program designed for older patients awaiting kidney transplants, involving caregivers in the process. It compares the effects of this program plus usual care against usual care alone on patients' physical performance, activity levels, quality of life, and post-transplant hospitalization days.
3Treatment groups
Active Control
Placebo Group
Group I: Weekly CoachingActive Control1 Intervention
Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise
Group II: Weekly Coaching + Caregiver ParticipationActive Control1 Intervention
Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise with the addition of caregiver participation to promote adherence and engagement
Group III: Usual CarePlacebo Group1 Intervention
Patients randomized to usual care will receive recommendations for exercise based on the Surgeon General's recommendations for physical activity among adults as well as the American Heart Association and American College of Sports Medicine recommendations for older individuals or individuals with chronic conditions. These guidelines are applicable to this patient population. Patients will not receive coaching but will receive accelerometers to obtain data for comparison to the intervention groups at each time point (baseline, 8 weeks, and 3 months post-KT).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical CenterSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
References
A nurse-led home-based exercise program for patients with chronic kidney disease. [2023]Exercise programs in patients with kidney disease improve functional capacity and health-related quality of life, but the implementation of exercise programs in nephrology services is not an easy task.
The efficacy of exercise training in kidney transplant recipients: a meta-analysis and systematic review. [2020]The effectiveness of exercise in kidney transplant recipients is not well established. We, therefore, performed a systematic review of the effects of exercise training in kidney transplantation recipients.
Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients. [2022]Physical activity is recommended for kidney transplant recipents as it may improve outcomes including mortality, exercise capacity, muscle strength, and health-related quality of life.
Exercise training in patients after kidney transplantation. [2021]Kidney transplantation is the treatment of choice for patients with end-stage renal disease. Next to the risk of allograft failure, major obstacles for disease-free survival after kidney transplantation include a higher incidence of cancer, infection and cardiovascular events. Risk factors for adverse clinical outcomes include pre-existent comorbidities, the introduction of an immunodeficient status and (lack of) lifestyle changes after transplantation. Indeed, physical inactivity and poor physical fitness are important targets to address in order to improve clinical outcomes after kidney transplantation. This review summarizes the current evidence on exercise training after kidney transplantation, derived from randomized controlled trials. As much as possible, results are discussed in the perspective of the Standardized Outcomes in Nephrology-Transplantation core outcomes, which were recently described as critically important outcome domains for trials in kidney transplant recipients.
Graded exercise testing and training after renal transplantation: a preliminary study. [2019]Aerobic exercise training has been used as part of the treatment for a variety of chronic disorders, most notably cardiovascular disease. In order to determine the feasibility and utility of regular exercise after renal transplantation, the responses of 10 patients to graded exercise testing were compared before training (T1), immediately after a program of supervised exercise training (T2), and a mean of 2.2 years after completion of the supervised program (T3). Supervised exercise sessions began a mean of 17 days postoperatively and continued for a mean of 5.5 weeks. Patients were encouraged to continue regular unsupervised exercise thereafter. All patients easily tolerated the supervised exercise sessions, which consisted of treadmill walking and cycle ergometry. Exercise capacity improved 90% between T1 and T2 and an additional 12% between T2 and T3. On the average, patients achieved a normal exercise capacity by 8 weeks after transplantation. Of the 10 patients, 7 had continued regular exercise training at T3. The observed increase in aerobic exercise capacity was probably related to improved renal function, an increased hemoglobin concentration, and the surgical healing process as well as the exercise training. We conclude that supervised exercise training for selected patients after renal transplantation is feasible and worthwhile.
Simultaneous Improvement of Habitual Physical Activity and Life Quality in Kidney Transplant Recipients Involved in Structured Physical Activity Program. [2019]The aim of the study was to compare the effects of a physical activity program on daily physical activity and quality of life in kidney transplant (KTx) recipients and in patients with chronic kidney disease (CKD).
Exercise training in kidney transplant recipients: a systematic review. [2020]Evidences on the benefits of physical exercise in kidney transplant patients (KTx) are not conclusive and concerns on safety remain. We here gather and interpret current evidence on the benefits/harms of exercise training intervention in KTx.
Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. [2021]Kidney transplant recipients are at risk of developing important adverse effects after transplantation. The objective of this study was to investigate the effects of a 10-week supervised resistance exercise-based intervention in kidney transplant recipients. Sixteen participants were randomized to a training (n = 8, 49.7 ± 9.6 years) or control group (n = 8, 48.6 ± 10.6 years). The primary endpoint was health-related quality of life evaluated through the Kidney Disease Quality of Life-Short Form (KDQOL-SF), which includes the 36-Item Short Form Survey (SF-36), and secondary endpoints included physical performance (6-minute walk distance [6-MWD], 60-second sit to stand test [60-STS], 8-foot up and go test, and handgrip and lower limb muscle strength), muscle mass, and biochemical parameters. Endpoints were assessed at baseline and after 10 weeks. Resistance exercise significantly increased (P .05) were found for the remaining endpoints. There were no adverse events, musculoskeletal injuries, hypoglycemic episodes, cardiovascular events, or hospitalizations related to the intervention. In conclusion, 10 weeks of supervised resistance training is enough to improve quality of life and physical performance without side effects such as musculoskeletal injuries, hypoglycemic episodes, cardiovascular events, or hospitalizations related to the intervention in kidney transplant recipients.
Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients. [2020]Background: Despite the benefits of physical activity on cardiovascular risk in kidney transplant recipients (KTRs), the long-term effects of exercise have been poorly investigated. This is a three-year observational study comparing graft function and cardiovascular risk factors in active KTRs (AKTRs) vs. sedentary KTRs (SKTRs). Methods: KTRs with stable renal function were assigned to active or sedentary group in relation to the level of daily physical activity based on World Health Organization (WHO) recommendations (<150 or >150 minutes/week, respectively). Complete blood count, renal function indices, lipid profile, blood pressure and anthropometric measures were collected yearly for an observation period of three years. The comparisons between the two groups were performed by repeated measures analyses of covariance (ANCOVAs), with age as a covariate. Results: Fifty-four subjects were included in the study. Thirty of them were identified as AKTRs (M/F 26/4, aged 45 ± 12 years) and 24 as SKTRs (M/F 18/6, aged 51 ± 14 years). Baseline characteristics were similar between the groups except body mass index (BMI) that was significantly higher in SKTRs (p = 0.043). Furthermore, over the three-year observation period, BMI decreased in AKTRs and increased in SKTRs (p = 0.006). Graft function was stable in AKTRs, while it showed a decline over time in SKTRs, as indicated by the rise in serum creatinine levels (p = 0.006) and lower eGFR (p = 0.050). Proteinuria, glucose and uric acid levels displayed a decrease in AKTRs and an increase in SKTRs during the three-year period (p = 0.015, p = 0.004 and p = 0.013, respectively). Finally, concerning lipid profiles, AKTRs had a significant reduction over time of triglycerides levels, which conversely showed a clinically relevant increase in SKTRs (p = 0.014). Conclusions: Our findings indicate that regular weekly exercise training may counteract the increased cardiovascular risks and also prevent graft function decline in KTRs.
Metabolic Profile and Myocardial Performance of Renal Transplant Recipients Participating in Unsupervised Physical Exercise as a Prescription Program. [2021]Renal transplant recipients (RTRs) are at high cardiovascular risk (CV) compared to the general population, especially after surgical treatment. The literature supports the role of supervised exercise intervention; however no data are available regarding the effects of unsupervised exercise programs. We investigated whether a home exercise program could reduce CV risk in RTR based on possible changes in renal and cardiometabolic parameters and myocardial performance measured by echocardiography.