Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Launched by DUKE UNIVERSITY · Nov 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called inspiratory muscle rehabilitation (IMR) to help children aged 8 to 17 who have both obesity and asthma. The goal is to see if this program can reduce feelings of shortness of breath (dyspnea) and encourage more physical activity among these kids. The study will take place at Duke Health Center Creekstone and involves 60 children who will be divided into groups to test the effectiveness of IMR over an 8-week period.

To be eligible for this study, children must be between 8 and 17 years old, have obesity (defined as being in the top 5% for weight based on age and sex), and have mild asthma while currently using asthma medication. Participants will need a supportive caregiver to help them complete the study, and both the child and their guardian must be able to read and speak English. Throughout the trial, participants can expect to engage in the IMR program and complete some assessments to see how their breathing and overall activity levels change. It's important to note that children with certain health conditions, such as severe lung issues or recent surgeries, may not be able to participate for their safety.

Gender

ALL

Eligibility 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