Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• Documented informed consent from legal guardian and assent from participant as appropriate.

• Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma.

• Participants (or parent/guardian) must have access to the internet and an approved smart device/computer.

• Child must have a designated caregiver who expresses a commitment to encourage the participant to complete the study procedures.

• Participant and legal guardian must speak and read English.

• Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)

Locations
United States
North Carolina
Duke Healthy Lifestyles Clinic
RECRUITING
Durham
Contact Information
Primary
Veronica Carrion, BS
vmp19@duke.edu
9197041523
Backup
Jasong Lang, MD
jason.lang@duke.edu
9196843364
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
Experimental: Active inspiratory muscle rehabilitation (IMR) group
Each participant will be provided a PrO2™ device and trained on its use and 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 a precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.
Active_comparator: SHAM
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.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: American Lung Association

This content was sourced from clinicaltrials.gov