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Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Who can join
Ages 8 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Prior intubation for asthma * Current self-reported pregnancy or planning to become pregnant. * Have an FEV1 \< 50% of predicted at screening * History of lung surgery in the past two years, * History of pulmonary embolism in the past two years, * Any 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 syncopal episodes in the past two years, * Progressive neurological or neuromuscular disorders or need for chronic O2 therapy. * Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment. * Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms
About the study
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
What is being tested
- Pro2 - 60% of participant's MIP (device)
- Pro2 - 15% of participant's MIP (device)
Sponsor: Duke University · Participants: 60 · Started: Jul 27, 2023
Contact the study team
- Veronica Carrion, BS · Phone: 9197041523
- Jasong Lang, MD · Phone: 9196843364
Official record on ClinicalTrials.gov — NCT05608668
Locations in the U.S.
| North Carolina | Duke Healthy Lifestyles Clinic, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.