Structured Exercise Program for Kidney Transplant Candidates

(SPaRKT Trial)

Overseen By Gabriel Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Already in exercise program, others

Compensation: Varies

Number of Visits: 9

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a structured exercise program can help older adults awaiting a kidney transplant improve their physical abilities and quality of life. It compares usual care to two types of exercise programs: one with weekly coaching and another with coaching plus caregiver support. The trial suits individuals aged 50 and older who are on dialysis and have a living donor kidney lined up. Researchers measure changes in physical activity and performance, as well as quality of life, both before and after the transplant. The goal is to determine if exercise can ease recovery and reduce hospital time post-transplant. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance recovery and quality of life for future kidney transplant patients.

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 prior data suggests that this structured exercise program is safe for kidney transplant candidates?

Research has shown that structured exercise programs can be safe for individuals who have had a kidney transplant. One study found that participants who exercised at home experienced very few short-term negative effects, indicating that most did not encounter significant problems from the routine.

The exercise program includes weekly coaching and sometimes involves a caregiver, which helps individuals increase their physical activity safely. Previous research has also shown that exercise can improve overall fitness and quality of life for kidney transplant recipients.

While researchers continue to study safety, the lack of serious side effects in earlier studies is encouraging. For those considering joining a trial, these findings suggest the exercise program is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how structured exercise programs can improve the health of kidney transplant candidates. Unlike the standard recommendations, which simply suggest exercise based on general guidelines, this trial offers a more personalized approach. The program includes weekly coaching that gradually increases physical activity and resistance exercises, and there's even an option to involve caregivers to boost motivation and adherence. This hands-on, tailored strategy could potentially enhance recovery and overall outcomes for transplant patients, setting it apart from current standard care.

What evidence suggests that this structured exercise program is effective for kidney transplant candidates?

Research has shown that exercise programs can enhance physical abilities and overall health in individuals who have undergone a kidney transplant. One study found that a structured home exercise program improved endurance, heart health, and muscle strength in these patients. Another study discovered that both supervised and home-based exercise programs effectively increased participants' exercise capacity. In this trial, participants will be assigned to different arms to evaluate the effectiveness of exercise interventions. One arm will receive usual care with general exercise recommendations. Another arm will receive weekly coaching to increase physical activity and resistance exercise. A third arm will include weekly coaching with caregiver participation to promote adherence and engagement. These findings suggest that regular exercise, especially with guidance and support, is crucial for kidney transplant candidates and recipients to maintain and improve physical function. Including caregivers in the exercise routine may also help participants adhere to the program and stay engaged, leading to better health outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Anoop Sheshadri, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Already in an exercise program

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Structured Program of exercise for Recipients of Kidney Transplantation

Trial Overview 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.

How Is the Trial Designed?

Group I: Weekly Coaching Active Control 1 Intervention

Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise

Group II: Weekly Coaching + Caregiver Participation Active Control 1 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 Care Placebo Group 1 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).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

A study involving 10 renal transplant patients showed that supervised aerobic exercise training, starting just 17 days post-surgery, significantly improved exercise capacity by 90% after 5.5 weeks and continued to improve by 12% over 2.2 years.

The increase in aerobic capacity was likely linked to better renal function, higher hemoglobin levels, and the healing process, indicating that regular exercise is both feasible and beneficial for recovery after renal transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded exercise testing and training after renal transplantation: a preliminary study. Miller, TD., Squires, RW., Gau, GT., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients. Vallance, JK., Johnson, ST., Thompson, S., et al.[2022]

A physical activity program significantly increased daily physical activity and energy expenditure in both kidney transplant (KTx) recipients and patients with chronic kidney disease (CKD) over a 3-month period, with KTx recipients showing a greater improvement in mental quality of life.

Both groups experienced significant improvements in their overall quality of life scores, indicating that increased physical activity is beneficial for both KTx and CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Improvement of Habitual Physical Activity and Life Quality in Kidney Transplant Recipients Involved in Structured Physical Activity Program. Masajtis-Zagajewska, A., Muras-Szwedziak, K., Nowicki, M.[2019]

A 10-week supervised resistance exercise program significantly improved health-related quality of life and physical performance in 16 kidney transplant recipients, with notable enhancements in specific quality of life domains and physical tests like the 6-minute walk distance and handgrip strength.

The exercise intervention was safe, with no reported adverse events or injuries, indicating that resistance training can be a beneficial and safe rehabilitation strategy for kidney transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. Hernández Sánchez, S., Carrero, JJ., Morales, JS., et al.[2021]

A systematic review of 24 studies involving 654 kidney transplant patients showed that structured exercise programs significantly improved cardiorespiratory fitness and muscle performance without causing harm in the short term.

Exercise training also enhanced the quality of life for kidney transplant patients, suggesting that aerobic or resistance exercise can be safely integrated into their treatment plans, although long-term studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in kidney transplant recipients: a systematic review. Calella, P., Hernández-Sánchez, S., Garofalo, C., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 6-month unsupervised home exercise program for 30 renal transplant recipients led to significant improvements in myocardial performance, particularly in ejection fraction (EF), indicating enhanced heart function.

While the lipid profile remained stable and within a low-risk range, the study suggests that regular moderate-intensity exercise can help maintain cardiovascular health in renal transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Profile and Myocardial Performance of Renal Transplant Recipients Participating in Unsupervised Physical Exercise as a Prescription Program. Moscarelli, L., Sofi, F., Mascherini, G., et al.[2021]

Kidney transplantation is the preferred treatment for end-stage renal disease, but patients face increased risks of cancer, infections, and cardiovascular issues post-surgery.

Exercise training is highlighted as a crucial intervention to improve clinical outcomes after kidney transplantation, addressing the common problems of physical inactivity and poor fitness among recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients after kidney transplantation. De Smet, S., Van Craenenbroeck, AH.[2021]

In a three-year study of 54 kidney transplant recipients, those who engaged in regular physical activity (active KTRs) maintained stable graft function and improved cardiovascular risk factors, while sedentary recipients (sedentary KTRs) experienced a decline in kidney function and increased cardiovascular risks.

Active KTRs showed significant improvements in body mass index, proteinuria, glucose, uric acid levels, and triglycerides compared to sedentary KTRs, highlighting the importance of exercise in managing health post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients. Totti, V., Fernhall, B., Di Michele, R., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04954690

Structured Program of Exercise for Recipients of Kidney ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11849866/

A structured, home-based exercise programme in kidney ... The ECSERT randomised controlled trial assessed the feasibility of delivering a structured, home-based exercise intervention in KTR at increased ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0316031

A structured, home-based exercise programme in kidney ... A structured, home-based exercise programme in kidney transplant recipients (ECSERT): A randomised controlled feasibility study · Background · Methods · Results.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1440244025001902

Physical activity and exercise performance in patients after ... A multimodal follow-up care program promoting physical activity improved markers of endurance, cardiovascular health, and muscular strength in kidney transplant ...

5. wjgnet.com wjgnet.com/2220-3230/full/v14/i4/96244.htm

Supervised vs home-based exercise program in kidney ... A 6-month moderate-intensity supervised or low-intensity home-based training program was equally effective at improving exercise capacity in KTRs.

6. tandfonline.com tandfonline.com/doi/full/10.1080/10833196.2021.2002641

The effect of exercise training interventions in adult kidney ... Exercise training may confer several benefits in adult KTRs, particularly by increasing cardiorespiratory function and exercise capacity, strength, HDL levels, ...

7. karger.com karger.com/kbr/article/49/1/548/909773/Physical-Exercise-in-Kidney-Renal-Recipients-Where

Physical Exercise in Kidney Renal Recipients Based on recent evidence, a combined exercise program (aerobic and strength exercise) is largely proposed to kidney transplant recipients.