Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorDuke University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Pro2 - 60% of participant's MIP
- Pro2 - 15% of participant's MIP
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
American Lung Association
Collaborator
Source ClinicalTrials.gov