NCT05608668 · Duke University
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
(iPro)
What this study is about
This is a single-center, randomly assigned, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 22, 2025 · Source of record for eligibility and locations