Kidney TransplantationNCT06886256
Prehabilitation for Kidney Transplant Candidates
A study testing Polar H10 Heart Rate Monitor, Empatica EmbracePlus and Apple Watch Ultra 2 in people with Kidney Transplantation and Frailty, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Kidney Transplantation, Frailty, Chronic Kidney Insufficiency
- What is being tested?
- Polar H10 Heart Rate Monitor, Empatica EmbracePlus and Apple Watch Ultra 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Frail patients who are being evaluated for kidney transplant at Houston Methodist Hospital
- Male or Female, aged 55 or older
- Provision of signed and dated informed consent by the participant
- Willingness to comply with study procedures and the duration of the study
Who cannot join
- Inability or contraindication to exercise
- Refusal to participate
- Inability to consent or effectively communicate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital System
Houston, Texas, 77030
Darrel Cleere, BSN, 713-441-6232, dwcleere@houstonmethodist.org
Shondra Word, 713-441-5122, sword@houstonmethodist.org
About this study
Official title: Enabling Access to Prehabilitation for Kidney Transplant Candidates Who Are Frail
This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.
Read the detailed description
This pilot study is a prospective, non-randomized, interventional trial of measures of prehabilitation in kidney transplant candidates who are frail. Kidney transplant candidates who meet criteria for the study will have wearable sensors placed for monitoring during the exercise session of their prehabilitation. The sensors will capture data during the single exercise session and transfer the data to a mobile health (mHealth) platform. The study aims to use the information from the sensors to develop future studies where the exercise is adjusted based on the sensor reports.
- Being tested
- Polar H10 Heart Rate Monitor, Empatica EmbracePlus, Apple Watch Ultra 2
- Keywords
- Kidney Transplantation, Frailty, Chronic Kidney Insufficiency
- Medical subject headings
- Frailty, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polar H10 Heart Rate MonitorDevice
Wearable sensors to capture movement-based data during physical therapy session. The Polar H10 Heart Rate Monitor measures heart rate and will transfer the data to the mHealth app.
Empatica EmbracePlusDevice
Wearable sensors to capture movement-based data during physical therapy session. The Empatica EmbracePlus measures physiological parameters and will transfer the data to the mHealth app.
Apple Watch Ultra 2Device
Wearable sensors to capture movement-based data during physical therapy session. The Apple Watch Ultra 2 measures heart rate, will transfer the data to the mHealth app, and will provide an alert when the heart rate is too high or too low.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: Polar H10 Heart Rate Monitor; Device: Empatica EmbracePlus; Device: Apple Watch Ultra 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%.
Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE)
Measured: Day 1
Secondary outcomes (10)
Muscle strength - Grip strength
hand-held dynamometer, Newtons; Measures upper body strength
Measured: Baseline
Muscle strength - Chair stand test
Number of times from chair sitting to standing in 30 seconds; Measures lower body strength and balance
Measured: Baseline
Physical performance - Gait speed
meters per second; Measures walking speed over a short distance
Measured: Baseline
Physical performance - Timed up and go
seconds; time to stand up from a chair, walk a short distance, turn around, walk back to the chair, and sit down; Assess mobility and balance
Measured: Baseline
Physical performance - Walking test, 6-minute walk
6-minute walk distance, meters; If the test is not available a 5-meter test can be used
Measured: Baseline
Physical performance - Walking test, 5-meter walk
5-meter test, seconds; If the 6-minute walk test is not available a 5-meter test can be used
Measured: Baseline
Respiratory capacity - Maximal inspiratory pressure
Record in units of cmH20; Measure of strength of inspiratory muscles
Measured: Baseline
Respiratory capacity - Adjust Inspiratory Muscle Trainer completion
A binary assessment of whether the inspiratory muscle trainer required adjustment
Measured: Baseline
Physical therapy - Aerobic exercise
Rate of perceived exertion as measured by Modified BORG CR10 Rating Perceived Exertion (RPE) scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).
Measured: Day 1
Physical therapy - Resistance exercise
Rate of perceived exertion as measured by Modified BORG CR10 Rating Perceived Exertion (RPE) scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start26 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiya Dhala, The Methodist Hospital Research Institute
- Investigators
- Atyia Dhala, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886256
- Sponsor's protocol ID
- PRO00038084
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing will be available from this study.
Publications
Lorenz EC, Hickson LJ, Weatherly RM, Thompson KL, Walker HA, Rasmussen JM, Stewart TL, Garrett JK, Amer H, Kennedy CC. Protocolized exercise improves frailty parameters and lower extremity impairment: A promising prehabilitation strategy for kidney transplant candidates. Clin Transplant. 2020 Sep;34(9):e14017. doi: 10.1111/ctr.14017. Epub 2020 Jul 24.
PubMed 32573816Yamagami M, Mack K, Mankoff J, Steele KM. "I'm Just Overwhelmed": Investigating Physical Therapy Accessibility and Technology Interventions for People with Disabilities and/or Chronic Conditions. ACM Transactions on Accessible Computing. 2022;15(4):1-22. doi: doi.org/10.1145/3563396.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Access to Prehabilitation for Kidney Transplant Candidates Who Are Frail
- ClinicalTrials.gov ID
- NCT06886256
- Acronym / sponsor ID
- PRO00038084
- Keywords
- Kidney Transplantation, Frailty, Chronic Kidney Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.
Detailed description
This pilot study is a prospective, non-randomized, interventional trial of measures of prehabilitation in kidney transplant candidates who are frail. Kidney transplant candidates who meet criteria for the study will have wearable sensors placed for monitoring during the exercise session of their prehabilitation. The sensors will capture data during the single exercise session and transfer the data to a mobile health (mHealth) platform. The study aims to use the information from the sensors to develop future studies where the exercise is adjusted based on the sensor reports.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Polar H10 Heart Rate Monitor, Device: Empatica EmbracePlus, Device: Apple Watch Ultra 2Each 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 may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Frail patients who are being evaluated for kidney transplant at Houston Methodist Hospital
- Male or Female, aged 55 or older
- Provision of signed and dated informed consent by the participant
- Willingness to comply with study procedures and the duration of the study
Key exclusion criteria (3 listed)
- Inability or contraindication to exercise
- Refusal to participate
- Inability to consent or effectively communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polar H10 Heart Rate MonitorWearable sensors to capture movement-based data during physical therapy session. The Polar H10 Heart Rate Monitor measures heart rate and will transfer the data to the mHealth app. | Device | Intervention |
| Empatica EmbracePlusWearable sensors to capture movement-based data during physical therapy session. The Empatica EmbracePlus measures physiological parameters and will transfer the data to the mHealth app. | Device | Intervention |
| Apple Watch Ultra 2Wearable sensors to capture movement-based data during physical therapy session. The Apple Watch Ultra 2 measures heart rate, will transfer the data to the mHealth app, and will provide an alert when the heart rate is too high or too low. | Device | Intervention |
Primary outcome
The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%.
Time frame: Day 1
Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE)
10 secondary outcomes
Muscle strength - Grip strength
Time frame: Baseline
Muscle strength - Chair stand test
Time frame: Baseline
Physical performance - Gait speed
Time frame: Baseline
Physical performance - Timed up and go
Time frame: Baseline
Physical performance - Walking test, 6-minute walk
Time frame: Baseline
Physical performance - Walking test, 5-meter walk
Time frame: Baseline
Respiratory capacity - Maximal inspiratory pressure
Time frame: Baseline
Respiratory capacity - Adjust Inspiratory Muscle Trainer completion
Time frame: Baseline
Physical therapy - Aerobic exercise
Time frame: Day 1
Physical therapy - Resistance exercise
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 32573816Lorenz EC, Hickson LJ, Weatherly RM, Thompson KL, Walker HA, Rasmussen JM, Stewart TL, Garrett JK, Amer H, Kennedy CC. Protocolized exercise improves frailty parameters and lower extremity impairment: A promising prehabilitation strategy for kidney transplant candidates. Clin Transplant. 2020 Sep;34(9):e14017. doi: 10.1111/ctr.14017. Epub 2020 Jul 24.
- BackgroundYamagami M, Mack K, Mankoff J, Steele KM. "I'm Just Overwhelmed": Investigating Physical Therapy Accessibility and Technology Interventions for People with Disabilities and/or Chronic Conditions. ACM Transactions on Accessible Computing. 2022;15(4):1-22. doi: doi.org/10.1145/3563396.
- Individual participant dataSharing planned: No. No IPD sharing will be available from this study.
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
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RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Atyia Dhala, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar H10 Heart Rate Monitor, Empatica EmbracePlus and Apple Watch Ultra 2 in people with Kidney Transplantation and Frailty, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darrel Cleere, BSN CCRP (713-441-6232, dwcleere@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886256, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.