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New treatment option for Pediatric Obesity
Official title Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
ClinicalTrials.gov ID: NCT05608668
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.