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Behavioural Intervention

Inspiratory Muscle Training for Childhood Asthma (iPro Trial)

N/A

Recruiting

Led By Jason Lang, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma.

Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 months

Awards & highlights

iPro Trial Summary

This trial is conducted in children aged 8-17 years with obesity and asthma.

Who is the study for?

This trial is for children aged 8-17 with obesity and mild asthma. They must be on asthma medication, speak/read English, have internet access and a supportive caregiver. Excluded are those with severe respiratory history, pregnancy plans, lung surgery within two years or conditions preventing safe participation.Check my eligibility

What is being tested?

The study tests inspiratory muscle rehabilitation (IMR) to ease shortness of breath in obese children with asthma. It's an 8-week study at Duke Health comparing high-intensity IMR against low-intensity IMR to see if it improves breathing and activity levels.See study design

What are the potential side effects?

Potential side effects aren't specified but may include discomfort from the use of the Pro2 device during IMR therapy or fatigue due to increased respiratory effort.

iPro Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a child aged 8-17 with obesity and mild asthma.

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My child is on prescription asthma medication.

iPro Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to active IMR Adherence to active IMR

Participant satisfaction among active IMR participants

Prevalence of completer status

Secondary outcome measures

Demonstrate changes in inspiratory muscle function with IMR.

Demonstrate changes in respiratory symptoms following IMR.

Other outcome measures

Demonstrate the safety of IMR

iPro Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active inspiratory muscle rehabilitation (IMR) groupExperimental Treatment1 Intervention

Each participant will be provided a PrO2™ device and trained on its use and its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. 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 a precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 60% of their MIP.

Group II: SHAMActive Control1 Intervention

Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. 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 for each repetition.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,426 Total Patients Enrolled

21 Trials studying Asthma

55,192 Patients Enrolled for Asthma

American Lung AssociationOTHER

31 Previous Clinical Trials

10,913 Total Patients Enrolled

13 Trials studying Asthma

3,339 Patients Enrolled for Asthma

Jason Lang, MDPrincipal InvestigatorDuke University

4 Previous Clinical Trials

163 Total Patients Enrolled

2 Trials studying Asthma

106 Patients Enrolled for Asthma

Media Library

Inspiratory Pulmonary Rehabilitation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05608668 — N/A

Asthma Research Study Groups: Active inspiratory muscle rehabilitation (IMR) group, SHAM

Asthma Clinical Trial 2023: Inspiratory Pulmonary Rehabilitation Highlights & Side Effects. Trial Name: NCT05608668 — N/A

Inspiratory Pulmonary Rehabilitation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608668 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings available to join this research project?

"According to infomation found on clinicaltrials.gov, this investigation is no longer accepting any participants. It was first posted in December 2022 and last updated November of the same year. Nonetheless, there are over 1317 other studies currently recruiting for volunteers."

Answered by AI

Is the target demographic for this investigation adults aged 20 years and older?

"Patients between the ages of 8 and 17 are eligible to apply for this medical study. It should also be noted that there are 362 clinical trials dedicated to minors and 792 studies geared towards seniors."

Answered by AI

What criteria must be met for an individual to join this clinical research?

"This trial is specifically targeting those between 8 and 17 years old who have been diagnosed with pediatric obesity. A total of 60 patients are expected to be enrolled in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

2023. "Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05608668.