Actively Recruiting
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Led by Duke University · Updated on 2025-08-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
A
American Lung Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating inspiratory muscle rehabilitation (IMR) as an additional treatment to reduce shortness of breath and promote greater physical activity in children aged 8 to 17 years with obesity and asthma. This study is a single-center, randomized, sham-controlled, double-masked trial lasting 8 weeks, focusing on this population who often experience frequent asthma symptoms and limited exercise due to their condition. Participants will use a device called PrO2™ that provides resistance during breathing exercises. One group will train at 60% of their maximal inspiratory pressure (MIP) as the active intervention, while the control group will use the same device but with much lower resistance at 15% MIP. The device includes Bluetooth connectivity and an app for monitoring adherence and giving immediate feedback. The study will assess adherence, participant satisfaction, and inspiratory muscle function over approximately 2 months. During the study, children and their caregivers will be trained to use the device and app. Researchers will monitor breathing muscle strength, respiratory symptoms, and adherence to the treatment. The study will also track how many participants complete the program and gather feedback on their experience. The total participation time is about 8 weeks, with careful monitoring of safety and treatment effects throughout.
CONDITIONS
Brief Title
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 8 to 17 years with obesity defined as BMI at or above the 95th percentile for age and sex
- Diagnosed with mild asthma and currently taking prescription medicine for asthma (such as albuterol or inhaled steroids)
- Access to the internet and an approved smart device or computer
- Have a dedicated caregiver willing to encourage completion of study procedures
- Participant and legal guardian must speak and read English
- Documented informed consent from legal guardian and assent from participant as appropriate
You will not qualify if you...
- Prior intubation for asthma
- Current pregnancy or planning to become pregnant
- Forced expiratory volume in 1 second (FEV1) less than 50% of predicted at screening
- History of lung surgery or pulmonary embolism within the past two years
- History of recurrent spontaneous pneumothorax or pneumothorax within the past 12 months
- Current undiagnosed chest pain
- History of inner ear surgery within the past 12 months
- Undiagnosed fainting episodes in the past two years
- Progressive neurological or neuromuscular disorders or need for chronic oxygen therapy
- Inability to complete baseline measurements satisfactorily
- Any condition that would prevent safe study participation, such as physical disability, recent musculoskeletal injury, or ongoing evaluation for cardiopulmonary or neurological symptoms according to the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants use the PrO2™ device for inspiratory muscle rehabilitation at either 60% or 15% of their maximal inspiratory pressure with real-time biofeedback through the device's app.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Duke Healthy Lifestyles Clinic
Durham, North Carolina, United States, 27704
Actively Recruiting
Research Team
V
Veronica Carrion, BS
J
Jasong Lang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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