Virtual Exercise for Kidney Transplant Candidates

Overseen By Christine K Liu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Nursing home, Severe low vision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a virtually supervised exercise program can enhance physical function for individuals awaiting a kidney transplant. Researchers will compare the exercise program to a health education program to determine which is more effective. The study involves two groups: one will begin with the exercise program, while the other will start with health education and then switch to exercise. Individuals listed for a kidney transplant who struggle with climbing stairs or walking half a mile may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pre-transplant care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtually supervised exercise program is safe for kidney transplant candidates?

Research shows that exercising at home with virtual guidance is generally safe for individuals awaiting a kidney transplant. One study on an 8-week home exercise program found it safe and well-received by participants. No major safety issues were reported, indicating that the exercise program is manageable and poses little risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the virtual exercise program for kidney transplant candidates because it offers a new way of supporting patients right from their homes. Unlike traditional exercise programs that require in-person attendance, this virtual approach allows for flexibility and accessibility, making it easier for patients to stay consistent with their workouts. Additionally, by integrating health education in the initial phase, participants gain valuable insights into managing their condition, which can enhance overall well-being before they even begin the exercise regimen. This blend of virtual exercise and education could potentially improve readiness for transplantation and post-surgery recovery.

What evidence suggests that this virtually supervised exercise program is effective for improving physical function in kidney transplant candidates?

Research has shown that online-supervised exercise programs can enhance the physical abilities of individuals awaiting a kidney transplant. In this trial, one group of participants will engage in a virtually supervised exercise program. A previous study found that home-based exercise benefited those preparing for a kidney transplant. Many patients experience difficulties with walking, balancing, and standing up from a chair, which can lead to complications post-transplant. Exercise programs, particularly those monitored online, improve strength and mobility. This suggests that such programs could ease the transplant process and speed up patient recovery. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals who are on the waiting list for a kidney transplant and want to improve their physical function. It's not specified, but typically participants should be able to perform basic exercises with virtual supervision.

Inclusion Criteria

I am on the kidney transplant list.

I have trouble with stairs, walking, or getting up from a chair.

Exclusion Criteria

I use supplemental oxygen.

I haven't had a heart attack, major heart surgery, stroke, blood clots, hip fracture, or hip/knee replacement in the last 6 months.

I do not have uncontrolled heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a virtually supervised exercise program or a health education program for 12 weeks

12 weeks

Virtually supervised sessions

Extended Treatment

Participants continue with the virtually supervised exercise program for an additional 12 weeks

12 weeks

Virtually supervised sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health education
• Virtually supervised exercise

Trial Overview The study is testing if exercising under virtual supervision can help people waiting for kidney transplants get in better shape compared to those who just receive health education about staying active and healthy.

How Is the Trial Designed?

Group I: Virtually supervised exercise Experimental Treatment 1 Intervention

In the first half of the study (weeks 0 to 12), participants will receive a virtually supervised exercise program. In the second half of the study (weeks 13 to 24), participant will continue to receive the virtually supervised exercise program.

Group II: Health education Active Control 2 Interventions

In the first half of the study (weeks 0 to 12), participants will receive a health education program. In the second half of the study (weeks 13 to 24), participant will receive a the virtually supervised exercise program.

Virtually supervised exercise is already approved in United States for the following indications:

Approved in United States as Virtually supervised exercise for:

• Improvement of physical function in kidney transplant candidates

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

A pilot study involving 24 kidney transplant candidates showed that a prehabilitation program, consisting of weekly physical therapy and at-home exercises, significantly improved physical activity levels by 64% over two months.

Participants who underwent prehabilitation had a shorter hospital stay after kidney transplant (5 days) compared to matched controls (10 days), suggesting that prehabilitation may enhance recovery outcomes post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to kidney transplantation: Results from a pilot study. McAdams-DeMarco, MA., Ying, H., Van Pilsum Rasmussen, S., et al.[2023]

The study will assess the feasibility of a home exercise program based on Enhanced Recovery After Surgery (ERAS) for 47 patients with end-stage renal disease (ESRD) awaiting kidney transplantation, focusing on personalized family exercise that includes aerobic, resistance, and flexibility training.

Key outcomes will include improvements in physical function measured by tests like the 6-minute walking test and grip strength, as well as secondary indicators of quality of life and psychological well-being after transplantation, evaluated at multiple time points before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the effect of pre-rehabilitation home-based on patients undergoing kidney transplantation with end-stage renal disease: A study protocol. Ma, X., Zhang, Z., Yao, B., et al.[2023]

This pilot study will evaluate the feasibility of a 12-week home-based exercise program for kidney transplant recipients (KTRs) at increased risk for cardiovascular disease, aiming to improve their cardiovascular health and overall quality of life.

The study will assess various outcomes, including cardiac structure and function, cardiorespiratory fitness, and patient activation, to inform future larger trials on the effectiveness of exercise interventions in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods. Billany, RE., Vadaszy, N., Bishop, NC., et al.[2021]

A randomized controlled trial involving 114 kidney transplant candidates (38 frail and 76 non-frail) is investigating the effectiveness of a multimodal prehabilitation program that includes exercise, nutritional support, and psychological advice to improve outcomes after kidney transplantation.

The study aims to demonstrate that this prehabilitation approach can reduce negative outcomes by 25% in frail patients and 12.5% in non-frail patients at 90 days post-transplant, highlighting its potential to enhance recovery and quality of life for patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. Pérez-Sáez, MJ., Morgado-Pérez, A., Faura, A., et al.[2021]

Kidney transplant recipients generally engage in lower levels of physical activity compared to the general population, which can lead to reduced quality of life and increased mortality risk.

Exercise training interventions are safe for kidney transplant recipients and have been shown to improve both quality of life and exercise capacity, indicating a potential benefit that warrants further research into long-term cardiovascular outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in Kidney Transplant Recipients: A Review. Takahashi, A., Hu, SL., Bostom, A.[2019]

A review of 6 studies on physical activity interventions for adult kidney transplant recipients revealed that weight gain is a common issue in the first year post-transplant, highlighting the need for early physical activity support.

Kidney transplant recipients expressed a strong desire for early interventions to increase physical activity, indicating a gap in current post-transplant care that could help address obesity and cardiovascular risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrative Literature Review of Physical Activity Recommendations for Adult Renal Transplant Recipients. O'Brien, T., Hathaway, D.[2018]

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 12-week home exercise prehabilitation program using remote guidance significantly improved physical fitness in patients with end-stage renal disease awaiting kidney transplantation, as evidenced by increased performance in the 6-minute walk test and other physical assessments.

The study demonstrated that this remote coaching approach is both safe and feasible, providing a valuable option for enhancing the physical function of patients in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Face-to-Face Mentoring, Remotely Supervised Home Exercise Prehabilitation to Improve Physical Function in Patients Awaiting Kidney Transplantation: A Randomized Clinical Trial. Ma, X., Zhang, Z., Peng, M., et al.[2022]

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]

Citations

1. database.clin-star.org database.clin-star.org/display/project-5R01DK13350903

Virtually Supervised Exercise for Kidney Transplant ... By the time they undergo transplantation, 47% of KT candidates have trouble walking, balancing, and/or getting out of a chair. These losses lead to poor post- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05355545

Virtually Supervised Exercise for Kidney Transplant ... In the first half of the study (weeks 0 to 12), participants will receive a virtually supervised exercise program. In the second half of the study (weeks 13 to ...

3. trialx.com trialx.com/clinical-trials/listings/321681/virtual-home-based-physical-pre-habilitation-in-kidney-transplant-candidates/

Virtual Home-based Physical Pre-habilitation in Kidney ... The exercise portion of the study will include a 12-week virtual home-based supervised exercise program and a 5-month maintenance phase with independent home ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11554345/

A Multicenter Home-based Prehabilitation Intervention in ... This pilot study demonstrates that a home-based 8-wk exercise intervention is a promising prehabilitation strategy in KT candidates.

5. stanfordhealthcare.org stanfordhealthcare.org/trials/v/NCT05355545.html

Virtually Supervised Exercise for Kidney Transplant ... This study is examining whether a virtually supervised exercise program can improve physical function in persons who are awaiting kidney transplant. The ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06089473/virtual-home-based-physical-pre-habilitation-in-kidney-transplant-candidates

Virtual Home-based Physical Pre-habilitation in Kidney ... The exercise portion of the study will include a 12-week virtual home-based supervised exercise program and a 5-month maintenance phase with ...