Inspiratory muscle rehabilitation for children with obesity and asthma
Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
This study is testing if a special breathing exercise program can help children with obesity and asthma feel less out of breath and be more active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05608668 on ClinicalTrials.gov |
What this trial studies
This interventional study focuses on children aged 8-17 years who have obesity and asthma, aiming to evaluate the effectiveness of inspiratory muscle rehabilitation (IMR) as an additional treatment. Conducted at Duke Health Center, the study involves a randomized, sham-controlled design over an 8-week period with 60 participants. The goal is to reduce feelings of breathlessness and encourage increased physical activity among these children. Participants will undergo specific interventions based on their maximum inspiratory pressure (MIP) to assess improvements in their respiratory function and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 17 years with obesity (BMI ≥ 95th percentile) and mild asthma who are currently on asthma medication.
Not a fit: Patients with severe asthma (FEV1 < 50% of predicted) or those with a history of significant pulmonary complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory function and quality of life for children suffering from both obesity and asthma.
How similar studies have performed: While the specific approach of inspiratory muscle rehabilitation in this context is novel, similar interventions have shown promise in improving respiratory outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Durham, North Carolina
- Duke Healthy Lifestyles Clinic — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jason Lang, MD — Duke University
- Study coordinator: Veronica Carrion, BS
- Email: vmp19@duke.edu
- Phone: 9197041523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.