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

Trial Summary

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 data supports the effectiveness of the treatment Prehabilitation for kidney transplant candidates?

Research shows that prehabilitation, which includes exercises before surgery, helped kidney transplant candidates increase their physical activity by 64% and reduced their hospital stay after surgery compared to those who didn't do prehabilitation. ^{1 2 3 4 5}

Is it safe to use 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 like accelerometers to track their steps, and no significant safety issues were reported. ^{1 6 7 8 9}

How does the treatment using wearable sensors for kidney transplant candidates differ from other treatments?

The use of wearable sensors for kidney transplant candidates is unique because it allows for continuous, non-invasive monitoring of fluid status and other vital parameters, which can help personalize treatment and improve outcomes. Unlike traditional methods that require hospital visits, these sensors provide real-time data remotely, potentially enhancing patient quality of life and reducing the need for frequent clinical interventions. ^{10 11 12 13 14}

What is the purpose of this trial?

This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.

Research Team

Atyia Dhala, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A randomized, controlled, behavioral intervention to promote walking after abdominal organ transplantation: results from the LIFT study. [2021]

2. United States 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Investigation of preoperative physical activity level in kidney transplant recipients and its impact on early postoperative recovery: A retrospective cohort study. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Self-Monitoring Kidney Function Post Transplantation: Reliability of Patient-Reported Data. [2018]

5. Denmark pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to kidney transplantation: Results from a pilot study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

7. Canada 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. [2023]

8. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of the use of a Renal Health application by kidney transplant recipients. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Maintenance phase of a physical activity intervention in older kidney transplant recipients: A 12-month follow-up. [2022]

10. England pubmed.ncbi.nlm.nih.gov

On the potential of wearable bioimpedance for longitudinal fluid monitoring in end-stage kidney disease. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Digital health technology to support care and improve outcomes of chronic kidney disease patients: as a case illustration, the Withings toolkit health sensing tools. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

In vitro trials of a wearable artificial kidney (WAK). [2019]

13. England pubmed.ncbi.nlm.nih.gov

Wearable sensors: can they benefit patients with chronic kidney disease? [2018]

14. Spain pubmed.ncbi.nlm.nih.gov

The future of the artificial kidney: moving towards wearable and miniaturized devices. [2022]