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NCT Number: NCT06886256

Prehabilitation for Kidney Transplant Candidates

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

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Key information

Conditions

Kidney Transplantation Chronic Disease Chronic Kidney Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Inability or contraindication to exercise
  • Refusal to participate
  • Inability to consent or effectively communicate

Treatment and study plan

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.

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%.

    Time frame: Day 1

    Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE)

Secondary outcomes

  1. Muscle strength - Grip strength

    Time frame: Baseline

    hand-held dynamometer, Newtons; Measures upper body strength

  2. Muscle strength - Chair stand test

    Time frame: Baseline

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

  3. Physical performance - Gait speed

    Time frame: Baseline

    meters per second; Measures walking speed over a short distance

  4. Physical performance - Timed up and go

    Time frame: 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

  5. Physical performance - Walking test, 6-minute walk

    Time frame: Baseline

    6-minute walk distance, meters; If the test is not available a 5-meter test can be used

  6. Physical performance - Walking test, 5-meter walk

    Time frame: Baseline

    5-meter test, seconds; If the 6-minute walk test is not available a 5-meter test can be used

  7. Respiratory capacity - Maximal inspiratory pressure

    Time frame: Baseline

    Record in units of cmH20; Measure of strength of inspiratory muscles

  8. Respiratory capacity - Adjust Inspiratory Muscle Trainer completion

    Time frame: Baseline

    A binary assessment of whether the inspiratory muscle trainer required adjustment

  9. Physical therapy - Aerobic exercise

    Time frame: 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).

  10. Physical therapy - Resistance exercise

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Darrel Cleere, BSN CCRP

CONTACT

[email protected]

713-441-6232

Linda W Moore, PhD CCRP

CONTACT

[email protected]

713-441-6144

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Enabling Access to Prehabilitation for Kidney Transplant Candidates Who Are Frail

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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