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This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polar H10 Heart Rate Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength - Grip strength | hand-held dynamometer, Newtons; Measures upper body strength | Baseline |
| Muscle strength - Chair stand test | Number of times from chair sitting to standing in 30 seconds; Measures lower body strength and balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Darrel Cleere, BSN CCRP | Contact | 713-441-6232 | dwcleere@houstonmethodist.org | |
| Linda W Moore, PhD CCRP | Contact | 713-441-6144 | lwmoore@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Atyia Dhala, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital System | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32573816 | Background | 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. | |
| Background | Yamagami 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. |
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No IPD sharing will be available from this study.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| Empatica EmbracePlus | Device | 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 2 | Device | 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. |
|
| Baseline |
| Physical performance - Gait speed | meters per second; Measures walking speed over a short distance | 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 | 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 | 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 | Baseline |
| Respiratory capacity - Maximal inspiratory pressure | Record in units of cmH20; Measure of strength of inspiratory muscles | Baseline |
| Respiratory capacity - Adjust Inspiratory Muscle Trainer completion | A binary assessment of whether the inspiratory muscle trainer required adjustment | 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). | 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). | Day 1 |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |