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Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Recruiting

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

Sponsor: Duke University · Participants: 60 · Started: Jul 27, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05608668

Locations in the U.S.

North CarolinaDuke 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.