136 Participants Needed

Structured Exercise Program for Kidney Transplant Candidates

(SPaRKT Trial)

AS
GG
Overseen ByGabriel Garcia
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco

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?

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.46789

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

AS

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

I have a living donor for a kidney transplant.
Telephone access
Internet access
See 3 more

Exclusion Criteria

I do not speak English.
Already in an exercise program

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

Treatment Details

Interventions

  • Structured Program of exercise for Recipients of Kidney Transplantation
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

A 12-week home-based exercise program significantly improved functional capacity in patients with chronic kidney disease (CKD) stage 5, as evidenced by better scores in physical performance tests like the short physical performance battery and the 6-minute walking test.
The program was well-received, with 70% of participants expressing high satisfaction and 64% feeling stronger after completing the exercises, indicating that it is a safe and effective intervention for enhancing quality of life in CKD patients.
A nurse-led home-based exercise program for patients with chronic kidney disease.Junqué-Jiménez, A., Esteve-Simó, V., Andreu-Periz, L., et al.[2023]
Supervised exercise training significantly improved exercise tolerance and quality of life in kidney transplant recipients, as shown by increased VO2 peak and quality of life scores in a systematic review of six randomized controlled trials involving these patients.
However, exercise training did not lead to significant improvements in kidney function (measured by eGFR), indicating that while exercise is beneficial for overall well-being, it may not directly enhance kidney allograft performance.
The efficacy of exercise training in kidney transplant recipients: a meta-analysis and systematic review.Oguchi, H., Tsujita, M., Yazawa, M., et al.[2020]
A study of 133 kidney transplant recipients revealed that they spent an average of 9.4 hours per day being sedentary and only engaged in about 20.7 minutes of moderate-to-vigorous physical activity, indicating a need for increased physical activity among this population.
Factors such as age, body mass index, education, and income were found to influence levels of physical activity and sedentary time, suggesting that targeted interventions could help improve activity levels and reduce sedentary behavior in kidney transplant recipients.
Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients.Vallance, JK., Johnson, ST., Thompson, S., et al.[2022]

References

A nurse-led home-based exercise program for patients with chronic kidney disease. [2023]
The efficacy of exercise training in kidney transplant recipients: a meta-analysis and systematic review. [2020]
Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients. [2022]
Exercise training in patients after kidney transplantation. [2021]
Graded exercise testing and training after renal transplantation: a preliminary study. [2019]
Simultaneous Improvement of Habitual Physical Activity and Life Quality in Kidney Transplant Recipients Involved in Structured Physical Activity Program. [2019]
Exercise training in kidney transplant recipients: a systematic review. [2020]
Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. [2021]
Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients. [2020]
Metabolic Profile and Myocardial Performance of Renal Transplant Recipients Participating in Unsupervised Physical Exercise as a Prescription Program. [2021]