Prehabilitation for Kidney Transplant Candidates

NCT ID: NCT06886256

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Kidney Transplantation Frailty Chronic Kidney Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Polar H10 Heart Rate Monitor

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Atiya Dhala

Associate Professor of Clinical Medicine in Clinical Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atyia Dhala, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Houston Methodist Hospital System

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Darrel Cleere, BSN CCRP

Role: CONTACT

713-441-6232

Linda W Moore, PhD CCRP

Role: CONTACT

713-441-6144

Facility Contacts

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Darrel Cleere, BSN

Role: primary

713-441-6232

Shondra Word

Role: backup

713-441-5122

References

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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.

Reference Type BACKGROUND
PMID: 32573816 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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PRO00038084

Identifier Type: -

Identifier Source: org_study_id

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