Prehabilitation for Kidney Transplant Candidates

NCT06886256 | Recruiting

• 1 other identifier: PRO00038084
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Kidney Transplantation; Frailty; Chronic Kidney Insufficiency

Outcome Measures

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)

  Day 1

Secondary Outcomes (10)

• Muscle strength - Grip strength

  Baseline

• Muscle strength - Chair stand test

  Baseline

• Physical performance - Gait speed

  Baseline

• Physical performance - Timed up and go

  Baseline

• Physical performance - Walking test, 6-minute walk

  Baseline

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Device: Polar H10 Heart Rate Monitor; Device: Empatica EmbracePlus; Device: Apple Watch Ultra 2

Interventions

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.

Intervention

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.

Intervention

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.

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital System

Houston, Texas, 77030, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 32573816 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Frailty; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Atyia Dhala, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrel Cleere, BSN CCRP

CONTACT

713-441-6232; dwcleere@houstonmethodist.org

Linda W Moore, PhD CCRP

CONTACT

713-441-6144; lwmoore@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine in Clinical Surgery

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: March 26, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)