Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Pediatric Obesity, Pediatric Asthma
In brief
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
Key facts
- Study ID
- NCT05608668
- Run by
- Duke University
- People needed
- 60
- Starts
- 2023-07-27
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-08-22
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Duke Healthy Lifestyles Clinic — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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