Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Duke University
Summary
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
Description
Asthma is a chronic respiratory disease affecting roughly 8% of US children, and is characterized by intermittent symptoms of breathlessness/dyspnea, chest tightness, wheeze, and cough. Although asthma is currently the most common chronic disease in childhood, there are no cures and the underlying etiologies of the various asthma phenotypes still remain unclear. More than half of the 7-8 million pediatric asthma patients in the US have one or more exacerbations each year. A sizable component of asthma's impact on children stems from the recurrent mild-moderate symptoms that cause impaired qual…
Eligibility
- Age range
- 8–17 years
- Sex
- All
- Healthy volunteers
- No
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 albutero…
Interventions
- DevicePro2 - 60% of participant's MIP
Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.
- DevicePro2 - 15% of participant's MIP
Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP for each repetition
Location
- Duke Healthy Lifestyles ClinicDurham, North Carolina