Chronic Kidney Insufficiency, Frailty, Kidney Transplantation
Conditions
Keywords
Kidney Transplantation, Frailty, Chronic Kidney Insufficiency
Brief summary
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.
Interventions
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.
DEVICEEmpatica EmbracePlus
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.
DEVICEApple Watch Ultra 2
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.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult Frail patients who are being evaluated for kidney transplant at Houston Methodist Hospital 2. Male or Female, aged 55 or older 3. Provision of signed and dated informed consent by the participant 4. Willingness to comply with study procedures and the duration of the study
Exclusion criteria
1. Inability or contraindication to exercise 2. Refusal to participate 3. Inability to consent or effectively communicate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. | Day 1 | Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength - Chair stand test | Baseline | Number of times from chair sitting to standing in 30 seconds; Measures lower body strength and balance |
| Physical performance - Gait speed | Baseline | meters per second; Measures walking speed over a short distance |
| Physical performance - Timed up and go | Baseline | 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 |
| Physical performance - Walking test, 6-minute walk | Baseline | 6-minute walk distance, meters; If the test is not available a 5-meter test can be used |
| Muscle strength - Grip strength | Baseline | hand-held dynamometer, Newtons; Measures upper body strength |
| Respiratory capacity - Maximal inspiratory pressure | Baseline | Record in units of cmH20; Measure of strength of inspiratory muscles |
| Respiratory capacity - Adjust Inspiratory Muscle Trainer completion | Baseline | A binary assessment of whether the inspiratory muscle trainer required adjustment |
| Physical therapy - Aerobic exercise | Day 1 | 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). |
| Physical therapy - Resistance exercise | Day 1 | 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). |
| Physical performance - Walking test, 5-meter walk | Baseline | 5-meter test, seconds; If the 6-minute walk test is not available a 5-meter test can be used |
Countries
United States
Contacts
Primary ContactDarrel Cleere, BSN CCRP
Backup ContactLinda W Moore, PhD CCRP
Outcome results
None listed