Inspiratory Muscle Training for Childhood Asthma

(MICA Trial)

Recruiting at 1 trial location

Overseen By Jason Lang, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Controller prescriptions

Disqualifiers: Pregnancy, Major chronic illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

76 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves children with moderate to severe asthma who are already on two or more controller prescriptions, it seems likely that participants will continue their current asthma medications.

What data supports the effectiveness of the treatment Inspiratory Muscle Training (IMT) for childhood asthma?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength and reduce asthma symptoms in children, making it a potentially effective treatment for managing asthma. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) has been used safely in various conditions, including pulmonary diseases, asthma, and chronic heart failure, and is generally considered safe for both healthy and diseased populations. ^{4 5 6 7 8}

How is the treatment Inspiratory Muscle Training (IMT) different from other treatments for childhood asthma?

Inspiratory Muscle Training (IMT) is unique because it focuses on strengthening the muscles used for breathing, which can improve respiratory muscle strength and reduce asthma symptoms, unlike typical asthma treatments that often involve medication to open airways or reduce inflammation. ^{1 2 3 5 8}

Research Team

Jason Lang, MD

Principal Investigator

Duke University

Eligibility Criteria

The MICA study is for children aged 6-17 with moderate to severe asthma, who need multiple medications. It includes those with normal weight or obesity but not extreme obesity. Kids can't join if they've been intubated for asthma, have very low lung function, are pregnant, have poor asthma control or another major illness.

Inclusion Criteria

My BMI is either in the obese range or normal according to CDC standards.

I need 2 or more medications to manage my condition.

I am between 6 and 17 years old.

Exclusion Criteria

Any major chronic illness that, in the opinion of the PI, would interfere with participation

Your lung function is less than half of what would be expected for someone your age and size.

Currently pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Evaluation

Baseline evaluation of respiratory mechanics and muscle functioning

2 weeks

2 visits (in-person)

Treatment

Randomized, SHAM-controlled trial of Inspiratory Training (IT) for 8 weeks at three intensity levels

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Inspiratory Training (IT)

Trial Overview This trial tests Inspiratory Training (IT) in lean and obese asthmatic kids. They'll do breathing exercises at different intensities: SHAM (very easy), low dose, and high dose compared to their maximum ability. The goal is to see how these exercises affect muscle and small airway function over 8 weeks.

Participant Groups

Group I: Active Low Dose inspiratory muscle rehabilitation (IMR) group Experimental Treatment 1 Intervention

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).

Group II: Active High Dose inspiratory muscle rehabilitation (IMR) group Experimental Treatment 1 Intervention

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).

Group III: SHAM Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

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]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength and exercise capacity in 38 asthmatic patients over 6 weeks, as evidenced by increased maximal inspiratory pressure and walking distance in the 6-minute walk test.

IMT also led to notable improvements in quality of life and daily living activities, with reductions in dyspnea and fatigue, highlighting its potential as an effective intervention for managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Inspiratory Muscle Training in the Management of Patients With Asthma: A RANDOMIZED CONTROLLED TRIAL. Duruturk, N., Acar, M., Doğrul, MI.[2019]

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) 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) 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) significantly improved inspiratory strength and lung function in young swimmers, with notable increases in the S-Index and maximum inspiratory flow after a four-week program.

Swimmers who underwent IMT showed significantly faster swimming times in 50-m, 100-m, and 200-m events compared to a control group, indicating that enhanced respiratory muscle strength positively impacts swimming performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. Yañez-Sepulveda, R., Alvear-Ordenes, I., Tapia-Guajardo, A., et al.[2021]

Inspiratory muscle training (IM training) has gained attention for its potential to enhance respiratory muscle performance across various clinical conditions beyond chronic obstructive pulmonary disease, including asthma and neuromuscular diseases.

Despite its growing use, the effectiveness of IM training remains debated due to methodological limitations in existing studies, highlighting the need for more rigorous research to clarify its benefits and applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training: integrative review of use in conditions other than COPD. Padula, CA., Yeaw, E.[2019]

Inspiratory muscle training (IMT) significantly improves balance in both healthy and diseased adults, based on a systematic review of 10 randomized control trials.

The effects of IMT on functional mobility were inconclusive, indicating that while balance benefits are clear, more research is needed to understand its impact on overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. Sheraz, S., Ferraro, FV., Siddiqui, FA., et al.[2023]

References

1. 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]

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

Effect of Inspiratory Muscle Training in the Management of Patients With Asthma: A RANDOMIZED CONTROLLED TRIAL. [2019]

3. Brazil pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

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

6. Italy pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. [2021]

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

Inspiratory muscle training: integrative review of use in conditions other than COPD. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]