Inspiratory Muscle Training for Childhood Asthma

(iPro Trial)

Recruiting at 1 trial location

Overseen By Jasong Lang, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Albuterol, Inhaled steroids

Disqualifiers: Prior intubation, Pregnancy, FEV1 < 50%, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help children with obesity and asthma breathe easier and stay more active. It tests inspiratory muscle rehabilitation (IMR), which uses a special device that provides resistance while inhaling, similar to strength training for the lungs. The trial seeks children aged 8 to 17 who have mild asthma, are dealing with obesity, and are already using prescription asthma medication. Participants will use a device at home to determine if it can ease breathing and enhance activity levels. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could improve their quality of life.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study is testing an add-on intervention, it is likely that you can continue your current asthma medications.

What prior data suggests that this inspiratory muscle training is safe for children with obesity and asthma?

Research has shown that inspiratory muscle training (IMT) is generally safe for children. Studies have found that IMT can improve lung function and strengthen breathing muscles without causing major side effects. One study showed that eight weeks of IMT strengthened breathing muscles in children with chest burns, indicating it is well-tolerated. Another study found that IMT reduced symptoms and improved the quality of life for children with asthma. These studies did not report any serious negative effects, suggesting that IMT is safe and well-tolerated in similar groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training (IMR) for childhood asthma because it offers a fresh approach to managing the condition. Unlike traditional treatments, which often rely on medications like inhaled corticosteroids and bronchodilators, IMR focuses on strengthening the respiratory muscles. The PrO2™ device used in this training provides a unique delivery method by offering real-time biofeedback and personalized resistance levels, enhancing the effectiveness of each session. This method not only aims to improve lung function but also empowers patients by involving them actively in their treatment process.

What evidence suggests that inspiratory muscle rehabilitation is effective for childhood asthma?

Research has shown that inspiratory muscle training (IMT) can strengthen breathing muscles and improve lung function in children with asthma. In this trial, participants in the active inspiratory muscle rehabilitation (IMR) group will use the PrO2™ device to reach a target resistance of 60% of their maximum inspiratory pressure (MIP). Studies have found that this training can increase vital capacity, the maximum air a person can exhale after a deep breath, and peak expiratory flow rate, the speed of exhaling air. Other research indicates that IMT also enhances exercise ability and reduces breathlessness. These benefits are particularly important for children with both asthma and obesity, as they often experience more severe breathing problems. Overall, IMT has shown promising results in making breathing easier and more efficient for young asthma patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Jason Lang, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

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

Exclusion Criteria

I have been intubated for asthma before.

I do not have worsening nerve or muscle disorders and do not need ongoing oxygen therapy.

I am experiencing chest pain that has not been diagnosed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle rehabilitation (IMR) using the PrO2™ device for 8 weeks

8 weeks

Weekly follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Pulmonary Rehabilitation

Trial Overview 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.

How Is the Trial Designed?

Group I: Active inspiratory muscle rehabilitation (IMR) group Experimental Treatment 1 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: SHAM Active Control 1 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.

Inspiratory Pulmonary Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Inspiratory Pulmonary Rehabilitation for:

• Obesity-related asthma in children

Approved in European Union as Inspiratory Pulmonary Rehabilitation for:

• Chronic obstructive pulmonary disease (COPD)
• Asthma
• Pulmonary hypertension (PH)
• Interstitial lung disease (ILD)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

American Lung Association

Collaborator

Trials

32

Recruited

11,000+

Published Research Related to This Trial

Inspiratory muscle training (IMT) significantly improved muscle strength and peak expiratory flow (PEF) in children with asthma, with MIP increasing from -48.32 to -109.92 and PEF from 173.6 to 312, indicating enhanced respiratory function.

In contrast, the control group showed no significant improvements in muscle strength, highlighting the efficacy of IMT and respiratory exercises in reducing asthma severity and improving respiratory muscle efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training and respiratory exercises in children with asthma. Lima, EV., Lima, WL., Nobre, A., et al.[2019]

Inspiratory muscle training (IMT) improves the strength and endurance of inspiratory muscles, reduces dyspnoea during daily activities, and enhances quality of life, but does not offer additional benefits when combined with standard pulmonary rehabilitation programs.

IMT is beneficial for patients who cannot engage in full exercise training, and it shows promise in pre-operative programs, suggesting it may be a useful intervention in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. Beaumont, M., Le Tallec, F., Villiot-Danger, E.[2021]

A 6-month program of specific inspiratory muscle training significantly increased respiratory muscle strength and endurance in 20 patients with moderate to severe asthma, leading to improved asthma symptoms and reduced medication use.

Patients who underwent the training experienced fewer hospitalizations and emergency room visits, with some able to stop using corticosteroids, highlighting the potential of this training as an effective intervention for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training for bronchial asthma]. Weiner, P., Azgad, Y., Ganam, R.[2006]

A study involving 50 children with asthma showed that combining respiratory muscle and exercise training with standard drug treatment significantly improved inspiratory muscle strength, asthma control, and quality of life after three months.

While the rehabilitation group experienced notable improvements, there were no significant changes in exercise capacity or spirometry measurements compared to the control group, suggesting that the combined training specifically enhances certain aspects of asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Combined Respiratory Muscle and Exercise Training in Children with Bronchial Asthma: A Randomised Controlled Study. Yang, S., Zhang, Z., Liu, Y., et al.[2023]

A study involving 38 pediatric asthma patients showed that pulmonary rehabilitation (PR) significantly improved their 6-minute walk test (6MWT) distance and FEV1, indicating better lung function and exercise capacity after the program.

Despite improvements in physical performance and quality of life, there was no significant change in weight, highlighting the need for further research on the effects of PR on asthma control and childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of pulmonary rehabilitation in pediatric asthma. Kirkby, S., Rossetti, A., Hayes, D., et al.[2019]

Inspiratory muscle rehabilitation training (IMRT) has been shown to significantly improve respiratory muscle strength, endurance, and exercise performance in pediatric patients with chronic lung disease, indicating its potential efficacy in this population.

Despite its benefits, IMRT is underutilized in pediatric care, and there is a need for more standardized training protocols and larger randomized controlled trials to strengthen the evidence supporting its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Rehabilitation Training in Pediatrics: What Is the Evidence? Bhammar, DM., Jones, HN., Lang, JE.[2022]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

Inspiratory muscle training (IMT) significantly improved respiratory functions, muscle strength, and asthma symptoms in a study of 34 asthmatic children over 12 weeks, compared to a placebo group.

The IMT group showed notable enhancements in forced expiratory volume (FEV1), forced vital capacity (FVC), and asthma control test scores, indicating that IMT can be an effective addition to conventional respiratory rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled study investigating the efficacy of inspiratory muscle training in the treatment of children with bronchial asthma. Elnaggar, RK.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982517/

Effect of inspiratory muscle training in children with asthma Findings from randomized controlled trials indicate that inspiratory muscle training enhances respiratory muscle strength and pulmonary function in pediatric ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417924001475

Inspiratory muscle training impact on respiratory ... Eight weeks of inspiratory muscle training combined with pulmonary rehabilitation program improved children with chest burns' respiratory muscles strength.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39493893/

Effectiveness of Threshold-Pressure Inspiratory Muscle ... In conclusion, the results of this systematic review and meta-analysis support the effectiveness of TIMT training in restoring lung function ...

4. tandfonline.com tandfonline.com/doi/full/10.2147/JAA.S479398?src=

Effectiveness of Threshold-Pressure Inspiratory Muscle ... Studies have shown that this training method can increase key pulmonary function indicators such as vital capacity and peak expiratory flow rate in asthmatic ...

5. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1549652/full

Effectiveness of inspiratory muscle training in patients with ... Conclusion: IMT improved several clinically relevant outcomes, including MIP, exercise capacity, and dyspnoea in different CRDs. However, the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9410970/

Inspiratory Muscle Rehabilitation Training in Pediatrics Available literature demonstrates that IMRT can improve respiratory muscle strength and endurance, perceived dyspnea and exertion, maximum voluntary ...

7. tandfonline.com tandfonline.com/doi/full/10.2147/JAA.S475367

Progress in Research into the Effectiveness of Pulmonary ... The results show that inspiratory muscle training can reduce the symptoms, improve the quality of life and improve lung function in children ...

8. clinicaltrials.gov clinicaltrials.gov/show/NCT06516848

High-intensity Inspiratory Muscle Training in Patients With ... The aim of this study is to examine the effects of high-intensity and low-intensity inspiratory muscle training added to the standard pulmonary ...