Recruiting

Prehabilitation

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06886256

Conditions

Kidney Transplantation

Frailty

Chronic Kidney Insufficiency

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Polar H10 Heart Rate Monitor

Empatica EmbracePlus

Apple Watch Ultra 2

Study Details

Brief summary:

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

Conditions

Kidney Transplantation

Frailty

Chronic Kidney Insufficiency

Study ID

NCT06886256

Start date

Mar 26, 2025

Status verified date

Apr, 2025

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention

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.

Interventions

Polar H10 Heart Rate Monitor

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

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

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 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 ]

Central Contacts and Locations

Central contacts

Darrel Cleere, BSN CCRP

713-441-6232dwcleere@houstonmethodist.org

Linda W Moore, PhD CCRP

713-441-6144lwmoore@houstonmethodist.org

Locations

Houston Methodist Hospital System

Recruiting

Houston, Texas, United States, 77030

Contacts

Darrel Cleere, BSN

713-441-6232dwcleere@houstonmethodist.org

Shondra Word

713-441-5122sword@houstonmethodist.org

Principal Investigator:

Atiya Dhala, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 18, 2025

Last verified

Apr, 2025

Keywords

  • Kidney Transplantation
  • Frailty
  • Chronic Kidney Insufficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-04-18.