No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
8 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for children aged 8 to 17 with obesity and asthma. Participants will use inspiratory muscle rehabilitation to help with breathing and get more active over 8 weeks.
Are You a Good Fit for This Trial?
Must be takingAlbuterolInhaled steroid
Rules you outProgressive neurological disordersProgressive neuromuscular disordersChronic O2 therapy
You may be able to join if
I am between 8 and 17 years old.
I have obesity.
I have been diagnosed with mild asthma.
I can access the internet and have a smart device or computer.
I have a caregiver who supports me in my participation.
I can speak and read English.
I am currently taking prescription medicine for asthma.
You may not be able to join if
I have been intubated for asthma before.
I am currently pregnant or planning to become pregnant.
I have an FEV1 less than 50% of predicted.
I have had lung surgery in the past two years.
I have had a pulmonary embolism in the past two years.
I have had any lung collapse in the past 12 months.
I have current undiagnosed chest pain.
I cannot complete baseline measurements as judged by the study team.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-b…
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
Trial Locations
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Eligibility Criteria
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 approve…
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 albuterol or inhaled steroid)
Exclusion Criteria:
* 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
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