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
148 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
A
American Lung Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent from legal guardian and assent from participant as appropriate
- Children aged 8 to 17 years with obesity (BMI 95th percentile for age and sex) and mild asthma
- Access to the internet and an approved smart device or computer
- Child has a designated caregiver committed to supporting study participation
- Participant and legal guardian can speak and read English
- Child is currently taking prescription medicine for asthma (such as any type of albuterol or inhaled steroid)
You will not qualify if you...
- Prior intubation for asthma
- Current self-reported pregnancy or planning to become pregnant
- Forced expiratory volume in one second (FEV1) less than 50% of predicted at screening
- History of lung surgery in the past two years
- History of pulmonary embolism in the past two years
- History of recurrent spontaneous pneumothorax or pneumothorax in the past 12 months
- Current undiagnosed chest pain
- History of inner ear surgery in 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 in the opinion of the principal investigator would not allow safe conduct of study procedures such as physical disability, recent musculoskeletal injury or illness, or ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms
AI-Screening
AI-Powered Screening
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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
CONTACT
J
Jasong Lang, MD
CONTACT
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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