RecruitingNot ApplicableNCT05608668

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Sponsor

Duke University

Enrollment

60 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

Pediatric Obesity Pediatric Asthma

Summary

This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma. Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity

Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a breathing muscle training program (called inspiratory pulmonary rehabilitation) done at home can help improve lung function and asthma control in children who have both obesity and mild asthma. **You may be eligible if...** - You are between 8 and 17 years old - You have obesity (BMI at or above the 95th percentile for your age and sex) and mild asthma - You take a prescription asthma medication (any type of albuterol or similar) - You (or your parent/guardian) have access to the internet and a smart device or computer - You speak and read English - You have a committed caregiver to help you complete the study **You may NOT be eligible if...** - You do not have both obesity and mild asthma - You do not have internet access or a smart device - You or your guardian do not speak or read English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPro2 - 60% of participant's MIP

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.

DEVICEPro2 - 15% of participant's MIP

Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP for each repetition