Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
This study is looking at an intervention called inspiratory muscle rehabilitation (IMR) to help children aged 8 to 17 who have both obesity and mild asthma. The goal is to see if using a device called PrO2™ can help reduce shortness of breath (dyspnea) and encourage more physical activity. Participants will be given a PrO2™ device and trained on how to use it with an app. Some will use the device at a higher resistance (60% of their maximum inspiratory pressure, or MIP) and others at a lower resistance (15% MIP). The study will measure how well participants stick to using the device and how satisfied they are with it after about two months. We are currently recruiting 60 children for this study.
- Study design
- This is an 8-week study where participants are randomly assigned to one of two groups, and neither you nor the researchers will know which group you are in (double-masked). It involves 60 children with obesity and asthma.
- What's involved
- You would use a PrO2™ device for 8 weeks and be trained on its use. Your adherence and satisfaction will be measured at approximately 2 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured at approximately 2 months, which suggests the main follow-up period is around this time.
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Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jason Lang, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Adherence to active IMR Adherence to active IMRapproximately 2 months
Prevalence of IMR completion (actual / planned reps over intervention period) in active IMR group
- Participant satisfaction among active IMR participantsapproximately 2 months
Prevalence of agree or strongly agree to question of satisfaction with active IMR
- Prevalence of completer statusapproximately 2 months
Completion of study Visit 3