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

Trial Summary

What is the purpose of this trial?

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

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 data supports the idea that Inspiratory Muscle Training for Childhood Asthma is an effective treatment?

The available research shows that Inspiratory Muscle Training (IMT) can be effective for children with asthma. Studies indicate that IMT improves muscle strength and helps with breathing, which can reduce asthma symptoms. One study found that IMT improved respiratory functions and muscle strength in children with asthma. Another study showed that combining IMT with exercise training enhanced exercise capacity and asthma control. Overall, these findings suggest that IMT can be a beneficial treatment for managing asthma in children. ^{1 2 3 4 5}

What safety data exists for inspiratory muscle training in children with asthma?

The available literature on inspiratory muscle training (IMT) in children with asthma suggests that it can improve respiratory muscle strength, endurance, and clinical outcomes. However, there is considerable variability in training methods, protocols, and outcome measures. While studies indicate potential benefits, more research is needed to refine protocols and establish comprehensive safety data. ^{1 2 4 6 7}

Is Inspiratory Pulmonary Rehabilitation a promising treatment for childhood asthma?

Yes, Inspiratory Pulmonary Rehabilitation is a promising treatment for childhood asthma. It can improve the strength and endurance of the breathing muscles, reduce asthma symptoms, and enhance overall fitness and quality of life for children with asthma. ^{1 2 4 6 8}

Research Team

Jason Lang, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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 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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training and respiratory exercises in children with asthma. [2019]

2. England 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. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

The Effects of Combined Respiratory Muscle and Exercise Training in Children with Bronchial Asthma: A Randomised Controlled Study. [2023]

4. Egypt pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Rehabilitation Training in Pediatrics: What Is the Evidence? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Benefits of pulmonary rehabilitation in pediatric asthma. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

8. Israel pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training for bronchial asthma]. [2006]