Prehabilitation for Kidney Transplant Candidates

Not Applicable

Recruiting

• Conditions: Kidney Transplantation; Frailty; Chronic Kidney Insufficiency

• Registration Number: NCT06886256
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-20
• Study Start: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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%.	Day 1	Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE)

Secondary Outcome Measures

Name	Time	Method
Muscle strength - Grip strength	Baseline	hand-held dynamometer, Newtons; Measures upper body strength
Muscle strength - Chair stand test	Baseline	Number of times from chair sitting to standing in 30 seconds; Measures lower body strength and balance
Physical performance - Gait speed	Baseline	meters per second; Measures walking speed over a short distance
Physical performance - Timed up and go	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
Physical performance - Walking test, 6-minute walk	Baseline	6-minute walk distance, meters; If the test is not available a 5-meter test can be used
Physical performance - Walking test, 5-meter walk	Baseline	5-meter test, seconds; If the 6-minute walk test is not available a 5-meter test can be used
Respiratory capacity - Maximal inspiratory pressure	Baseline	Record in units of cmH20; Measure of strength of inspiratory muscles
Respiratory capacity - Adjust Inspiratory Muscle Trainer completion	Baseline	A binary assessment of whether the inspiratory muscle trainer required adjustment
Physical therapy - Aerobic exercise	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).
Physical therapy - Resistance exercise	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).

Trial Locations

Locations (1)

Houston Methodist Hospital System; 🇺🇸 Houston, Texas, United States