Breathing muscle training in children with asthma, with or without obesity

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 6 to 17 with moderate to severe asthma who are either obese or have a normal weight. It tests breathing-muscle (inspiratory) training for 8 weeks.

Age

6 to 17 years

Sex

All sexes can join

Disease stage

Doctor-diagnosed asthma that needs 2 or more controller medicines (moderate to severe persistent asthma).

Earlier treatment

Currently taking 2 or more controller medicines for asthma.

Biomarker or test result

Body mass index (BMI) either 5th to 84th CDC percentile (normal) or at or above the 95th percentile and less than 170% of the 95th percentile (obese).

Main reasons for not taking part

• Asthma control test (ACT) score below 17
• Ever put on a breathing tube (intubated) for asthma
• FEV1 below 50% of predicted at enrollment
• Currently pregnant
• Legal guardian cannot give consent in English or Spanish

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 6 and 17 years old?YesNo

What the trial wants to find out

This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status

The 3 groups in the trial

• Active Low Dose inspiratory muscle rehabilitation (IMR) groupTreatment being tested

  Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).

  Treatment: Pro2 - Low Dose - 40% of participant's MIP

• Active High Dose inspiratory muscle rehabilitation (IMR) groupTreatment being tested

  Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP (maximum inspiratory pressure).

  Treatment: Pro2 - High Dose - 75% of participant's MIP

• SHAMExisting treatment, for comparison

  Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).

  Treatment: Pro2 - SHAM - 15% of participant's MIP