Purpose of this Study
We are doing this study to find out if breathing exercises can improve lung function for kids who have asthma.
Who Can Participate?
Eligibility
Children ages 6-17 who:<ul>
<li>Have asthma that requires 2 or more medications to control symptoms</li>
<li>Are seeing a doctor at Duke about their asthma</li>
<li>Have obesity or are a normal weight</li></ul>
For more information about this study, contact the study team at <a href= "mailto: taheerah.watson@duke.edu">taheerah.watson@duke.edu.</a>
<li>Have asthma that requires 2 or more medications to control symptoms</li>
<li>Are seeing a doctor at Duke about their asthma</li>
<li>Have obesity or are a normal weight</li></ul>
For more information about this study, contact the study team at <a href= "mailto: taheerah.watson@duke.edu">taheerah.watson@duke.edu.</a>
Age Range
6-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If your child is eligible and you allow them to join the study, they will:<ul>
<li>Come in for a visit to make sure they are eligible to join (V1). They will then complete a screening period which lasts about 2-3 weeks and includes using a PrO2 breathing device and wearing an activity watch and patch.</li>
<li>Come in for a 2nd visit (V2) and get a random assignment (fair, equal chance) to 1 of 3 levels of resistance breathing exercises (high, low, or no resistance). For about 8 weeks, your child will perform breathing exercises with the PrO2 device 3 times per week at the assigned level of resistance and continue to wear the activity watch and patch.</li>
<li>Have a phone call with a study team member to see how they are doing (V3) and come in for the last visit at 8 weeks (V4).</li>
<li>Have phone calls with the team at 2 and 6 weeks of doig the breathing exercies.</li></ul>
At all study visits, your child will complete questionnaires, perform breathing exercises, and physical activity tests.
<li>Come in for a visit to make sure they are eligible to join (V1). They will then complete a screening period which lasts about 2-3 weeks and includes using a PrO2 breathing device and wearing an activity watch and patch.</li>
<li>Come in for a 2nd visit (V2) and get a random assignment (fair, equal chance) to 1 of 3 levels of resistance breathing exercises (high, low, or no resistance). For about 8 weeks, your child will perform breathing exercises with the PrO2 device 3 times per week at the assigned level of resistance and continue to wear the activity watch and patch.</li>
<li>Have a phone call with a study team member to see how they are doing (V3) and come in for the last visit at 8 weeks (V4).</li>
<li>Have phone calls with the team at 2 and 6 weeks of doig the breathing exercies.</li></ul>
At all study visits, your child will complete questionnaires, perform breathing exercises, and physical activity tests.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Principal Investigator
Jason
Lang
Protocol Number
PRO00112858
NCT ID
NCT05945355
Phase
II
Enrollment Status
Open to Enrollment