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Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

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…

ClinicalTrials.gov IDNCT05608668

PhaseNA

Enrollment60

SponsorDuke University

Age8 Years

SexALL

I'm interested View official listing

Conditions studied

Pediatric Obesity, Pediatric Asthma

About this study

Interventions

Device: Pro2 - 60% of participant's MIP — Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.
Device: Pro2 - 15% of participant's MIP — Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP for each repetition

Primary outcomes

Adherence to active IMR Adherence to active IMR (approximately 2 months)
Participant satisfaction among active IMR participants (approximately 2 months)
Prevalence of completer status (approximately 2 months)

Eligibility information

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

Study locations

Duke Healthy Lifestyles Clinic, Durham, North Carolina 27704 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.