Wearable Sensors for Kidney Transplant Candidates

Overseen By Linda W Moore, PhD CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Inability to exercise, others

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

Compensation: Varies

Number of Visits: 1

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of wearable sensors in collecting data from individuals preparing for a kidney transplant during exercise. The goal is to determine if these sensors can facilitate real-time monitoring of patients' activity and health. Participants will wear sensors during a single supervised exercise event to test the technology. The trial seeks frail adults being evaluated for a kidney transplant at Houston Methodist Hospital who can safely exercise and are willing to follow study procedures. The study includes a prehabilitation program with exercises designed to improve fitness before surgery. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pre-surgery care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these wearable sensors are safe for kidney transplant candidates?

Research shows that using wearable sensors during exercise is generally safe for people awaiting a kidney transplant. Studies have found that participants using these devices did not experience any major problems. Another study suggested that exercising before surgery is both safe and feasible for these patients. The evidence indicates that this approach is well-tolerated, with no serious safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of wearable sensors for kidney transplant candidates, a novel approach in prehabilitation. Unlike traditional methods, which often focus on general lifestyle changes and medical management, this trial leverages technology to monitor patients in real-time. The wearable sensors collect data during exercise, providing personalized insights that can help optimize pre-surgery health. This innovative method could lead to better surgical outcomes by ensuring patients are in peak condition before their transplant.

What evidence suggests that wearable sensors are effective for monitoring kidney transplant candidates?

Research has shown that exercise and lifestyle changes, known as prehabilitation, could benefit people awaiting a kidney transplant. Studies suggest this approach might help them prepare better for surgery and recover more quickly afterward. Specifically, it can improve physical fitness and muscle strength, which are crucial for a successful kidney transplant. Evidence also indicates that prehabilitation might help more people qualify for transplants by reducing frailty. Although more research is needed, these findings suggest that prehabilitation could be beneficial for those awaiting a kidney transplant. In this trial, participants will have three wearable sensors placed during a single exercise event to assess the feasibility of using wearable technology in prehabilitation. ^{1 5 6 7 8}

Who Is on the Research Team?

Atyia Dhala, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for frail adults aged 55 or older who are being evaluated for a kidney transplant at Houston Methodist Hospital. Participants must be willing to follow study procedures and provide signed consent.

Inclusion Criteria

I am willing to follow the study's procedures and timeline.

I have signed and agreed to the study's consent form.

I am a frail adult being evaluated for a kidney transplant at Houston Methodist Hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation Exercise Session

Participants undergo a single exercise session with wearable sensors to monitor feasibility

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the exercise session

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation

Trial Overview The trial is testing the use of wearable sensors like Polar H10, Empatica EmbracePlus, and Apple Watch Ultra 2 to collect data from patients during supervised exercise routines.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 3 Interventions

Each participant will have 3 wearable sensors placed during a single exercise event. The data collected from the sensors will be transferred to a mHealth platform for monitoring feasibility.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

In a 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.

The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

A home-based intervention using wearable accelerometers and financial incentives successfully increased physical activity among kidney and liver transplant recipients, with participants in the intervention group achieving significantly more steps than the control group.

Despite the increase in physical activity, the intervention did not lead to significant weight change after 3 months, indicating that while promoting activity is feasible, it may not directly impact weight loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled, behavioral intervention to promote walking after abdominal organ transplantation: results from the LIFT study. Serper, M., Barankay, I., Chadha, S., et al.[2021]

Out of 823 downloads of the renal health application, only 12.3% were registered kidney transplant recipients, indicating limited engagement with the app among this population.

Although the app generated interest, with 36.7% of users entering health data like weight and creatinine levels, most users only engaged for a short time, highlighting challenges in long-term adherence to mHealth technologies in kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the use of a Renal Health application by kidney transplant recipients. Oliveira, JGR., Sanders-Pinheiro, H., Freitas Filho, RA., 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6342659/

Prehabilitation Prior to Kidney Transplantation: Results ... These pilot study findings suggest that prehabilitation is feasible in pre-transplant patients and may potentially be a strategy to improve post-KT outcomes.

2. ajkd.org ajkd.org/article/S0272-6386(25)01027-3/fulltext

Exercise Prehabilitation in Kidney Transplant Candidates Prehabilitation may not only improve transplant readiness but also promote equitable access to transplantation by targeting frailty as a ...

3. journals.lww.com journals.lww.com/transplantjournal/fulltext/2022/09001/340_7__prehabilitation_of_candidates_for_renal.467.aspx

Prehabilitation of Candidates for Renal Transplantation ... Prehabilitation focuses on implementing lifestyle changes with the goal to improve pre- and post-transplant outcomes. It comprises physical training ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06886256

Prehabilitation for Kidney Transplant Candidates This pilot study is a prospective, non-randomized, interventional trial of measures of prehabilitation in kidney transplant candidates who are frail. Kidney ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272638625009709

Exercise-Based Prehabilitation for Kidney Transplant ... This study evaluated the effects of an exercise-based prehabilitation program on exercise capacity, muscle function, and muscle size among KT candidates.

6. trialx.com trialx.com/clinical-trials/listings/324274/prehabilitation-for-kidney-transplant-candidates/

Prehabilitation for Kidney Transplant Candidates This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised ...

7. withpower.com withpower.com/trial/phase-renal-insufficiency-3-2025-8a0bb

Wearable Sensors for Kidney Transplant Candidates Research shows that using wearable sensors to promote physical activity in kidney transplant recipients is generally safe. In studies, participants used devices ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40816623/

Exercise-Based Prehabilitation for Kidney Transplant ... Conclusions: An 8-week exercise-based prehabilitation program may improve KT candidates' exercise capacity, muscle function, and muscle size, ...