Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

This study is looking at an intervention called inspiratory muscle rehabilitation (IMR) to help children aged 8 to 17 who have both obesity and mild asthma. The goal is to see if using a device called PrO2™ can help reduce shortness of breath (dyspnea) and encourage more physical activity. Participants will be given a PrO2™ device and trained on how to use it with an app. Some will use the device at a higher resistance (60% of their maximum inspiratory pressure, or MIP) and others at a lower resistance (15% MIP). The study will measure how well participants stick to using the device and how satisfied they are with it after about two months. We are currently recruiting 60 children for this study.

Study design
This is an 8-week study where participants are randomly assigned to one of two groups, and neither you nor the researchers will know which group you are in (double-masked). It involves 60 children with obesity and asthma.
What's involved
You would use a PrO2™ device for 8 weeks and be trained on its use. Your adherence and satisfaction will be measured at approximately 2 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at approximately 2 months, which suggests the main follow-up period is around this time.

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NCT05608668

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Recruiting
NAAges 8–17InterventionalTreatment
Duke University
~60 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:Pro2 - 60% of participant's MIPPro2 - 15% of participant's MIP

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adherence to active IMR Adherence to active IMR
Measured over approximately 2 months
+2 more outcomes measured
Pediatric Obesity
Pediatric Asthma
1 sites across 1 states
North Carolina1
  • Jason Lang, MD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

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
  • Adherence to active IMR Adherence to active IMRapproximately 2 months

    Prevalence of IMR completion (actual / planned reps over intervention period) in active IMR group

  • Participant satisfaction among active IMR participantsapproximately 2 months

    Prevalence of agree or strongly agree to question of satisfaction with active IMR

  • Prevalence of completer statusapproximately 2 months

    Completion of study Visit 3