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Not Yet Recruiting NCT05608668

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Conditions: Pediatric Obesity, Pediatric Asthma

Sex: All
Ages: 8 Years – 17 Years
Phase: NA
Enrollment: 60
Sponsor: Duke University

Location: United States

Summary

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

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 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.Exclusion Criteria:Prior intubation for asthmaCurrent pregnancyHave an FEV1 < 50% of predicted at screeningContraindications for IMR including a history of recent lung surgery, recent pulmonary embolism, or history of recurrent spontaneous pneumothoraxProgressive neurological or neuromuscular disorders or need for chronic O2 therapy.Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI.Current self-reported pregnancy or planning to become pregnant.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, undiagnosed chest pain, pneumothorax in the past 12 months, inner ear surgery in the past 12 months, or undiagnosed syncopal episodes.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05608668). StuddyBuddy aggregates publicly available trial information.