Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Duke University
60 participants
Jul 27, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria12
- 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
Interventions
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.
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05608668