Prehabilitation for Kidney Transplant Candidates

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorThe Methodist Hospital Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability or contraindication to exercise

Refusal to participate

Inability to consent or effectively communicate

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 1

Secondary outcomes

1

Muscle strength - Grip strength

hand-held dynamometer, Newtons; Measures upper body strength

Time frame
Baseline
2

Muscle strength - Chair stand test

Number of times from chair sitting to standing in 30 seconds; Measures lower body strength and balance

Time frame
Baseline
3

Physical performance - Gait speed

meters per second; Measures walking speed over a short distance

Time frame
Baseline
4

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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