NCT05608668Completed
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 25 Oct 2022
- Start date
- 27 Jul 2023
- Primary completion date
- 20 May 2026
- Lead sponsor
- Duke University
- NCT number
- NCT05608668
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 27 Jul 2023 to the primary completion date, 20 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior intubation for asthma
Other illness
- 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
- History of inner ear surgery in the past 12 months,
- Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
- 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
Other
- Current self-reported pregnancy or planning to become pregnant.
- Have an FEV1 \< 50% of predicted at screening
- Current undiagnosed chest pain,
- Undiagnosed syncopal episodes in the past two years,
- Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment.
Who the study is looking for
- 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)
Age in the registry: 8 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Healthy Lifestyles Clinic Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.