Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 27, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Pediatric ObesityPediatric Asthma
Interventions
DEVICE

Pro2 - 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.

DEVICE

Pro2 - 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

Trial Locations (1)

27704

RECRUITING

Duke Healthy Lifestyles Clinic, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

American Lung Association

OTHER

lead

Duke University

OTHER

NCT05608668 - Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma | Biotech Hunter | Biotech Hunter