Inspiratory Muscle Training for Exercise-Induced Asthma

(IMT_EIB Trial)

Overseen By Tim Mickleborough, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Short-acting beta-2-agonists

Must not be taking: Corticosteroids, SSRIs, ADHD meds

Disqualifiers: Smoking, Cardiovascular, Renal, Neurological, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether inspiratory muscle training (IMT) can alleviate exercise-induced asthma symptoms and enhance cycling performance. Participants will use the PrO2Fit device, an inspiratory muscle trainer, to strengthen their breathing muscles and determine if this reduces asthma symptoms and improves cycling ability. The study includes two groups: one using a high-resistance training model and the other using a lower-resistance model for comparison. It seeks competitive athletes with mild to moderate asthma or exercise-induced asthma who have cycled for at least 1-2 years. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve athletic performance and asthma management.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes participants who are currently taking asthma maintenance medications, SSRIs, ADHD medication, and those who chronically consume pain medication.

What prior data suggests that the PrO2Fit Device is safe for inspiratory muscle training?

Research shows that inspiratory muscle training (IMT), such as that used with the PrO2Fit device, is generally safe for people with asthma. One study demonstrated that a 6-month IMT program strengthened and increased the endurance of breathing muscles in 20 patients with moderate asthma, indicating good tolerance. Another study found that eight weeks of IMT improved muscle strength and endurance in individuals with bronchiectasis, another lung condition, without major safety issues. These findings suggest that using the PrO2Fit device for IMT is generally safe. However, as with any treatment, individual experiences may vary. Participants should monitor their body's responses and discuss any concerns with the study team during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Inspiratory Muscle Training (IMT) for exercise-induced asthma because it offers a novel approach by strengthening the muscles used for breathing. Unlike traditional treatments that often focus on medication to manage symptoms, this method aims to enhance the body's natural breathing efficiency through targeted muscle exercises. The PrO2Fit device used in the training allows for precise control and monitoring of inspiratory pressure, making the training more effective and tailored to individual needs. This approach could lead to improved exercise tolerance and reduced asthma symptoms without the reliance on medication.

What evidence suggests that the PrO2Fit Device is effective for exercise-induced asthma?

Research has shown that inspiratory muscle training (IMT) can help people with exercise-induced asthma by strengthening their breathing muscles. Studies have found that IMT boosts breathing power and stamina, making exercise easier. One study showed that after eight weeks of IMT, participants had better lung function and felt more capable during physical activities. Another study reported significant improvements in breathing muscle strength and reduced breathlessness. In this trial, participants in the Inspiratory Muscle Training (IMT) group will use the PrO2Fit device, which may effectively manage exercise-induced asthma symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Tim Mickleborough, Ph.D.

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for competitive recreational or college athletes aged 18-35 with mild to moderate persistent asthma or EIB, a BMI of 18.5-28, and at least 1-2 years of cycling experience. They must have an FEV1 >65% predicted and not be on asthma maintenance meds, SSRIs, ADHD meds, painkillers regularly, fish oil supplements, nor have cardiovascular or other specified diseases.

Inclusion Criteria

Required to be a competitive recreational or college athlete with at least 1-2 years of cycling or biking experience

Body Mass Index (BMI) of 18.5 to 28 kg/m^2

I have asthma or EIB, but can still breathe relatively well.

Exclusion Criteria

Resting Pulse rate of > 100 bpm

I have a history of smoking or have had heart, kidney, brain, or metabolic diseases.

I am currently on asthma maintenance medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle training (IMT) or sham IMT for 8 weeks, focusing on improving inspiratory muscle strength and endurance.

8 weeks

3 sessions per week

Follow-up

Participants are monitored for changes in exercise-induced bronchoconstriction severity, inspiratory muscle strength, and cycling performance.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PrO2Fit Device

Trial Overview

The study tests if inspiratory muscle training (IMT) using the PrO2Fit Device can reduce the severity of exercise-induced bronchoconstriction (EIB), lessen short-acting beta-agonist use, improve lung function and oxygenation during exercise, decrease breathlessness and enhance time-trial cycling performance in athletes.

How Is the Trial Designed?

Group I: Inspiratory Muscle Training (IMT) group Experimental Treatment 1 Intervention

The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.

Group II: Sham Inspiratory Muscle Training (Sham-IMT) group Placebo Group 1 Intervention

Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

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]

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) has been shown to significantly improve symptoms and quality of life in COPD patients, particularly through the use of specialized devices like AirOFit PRO™ and PowerBreath®.

The latest guidelines emphasize the importance of personalized respiratory rehabilitation programs, highlighting IMT as a beneficial component for enhancing health status and well-being in individuals with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease (COPD) as Part of a Respiratory Rehabilitation Program Implementation of Mechanical Devices: A Systematic Review. Vázquez-Gandullo, E., Hidalgo-Molina, A., Montoro-Ballesteros, F., et al.[2023]

In a study involving 300 asthma patients aged 55-60, both a conventional threshold loading device and an innovative respiratory training device showed significant improvements in exercise performance and pulmonary function after 10 weeks of lower torso sports training.

The new respiratory training device was found to be as effective as the conventional device, indicating that both methods can beneficially enhance respiratory training combined with athletic training for asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Threshold Loading Training and an Innovative Respiratory Training Devices with Lower Torso Sports Training in Asthma Patients: A Randomized Trial. Hamad, SH., Hadi, AH., Mohr, M., et al.[2023]

An electronic inspiratory loading device was validated for assessing breathing characteristics during inspiratory muscle training (IMT) in patients with weaning difficulties, showing good to excellent agreement with a reference spirometer across 1002 breaths from 27 training sessions.

The device allows for real-time feedback on breathing effort, enabling adjustments to the training load, which can enhance respiratory muscle function and potentially improve weaning outcomes for patients with chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement validity of an electronic training device to assess breathing characteristics during inspiratory muscle training in patients with weaning difficulties. Van Hollebeke, M., Poddighe, D., Gojevic, T., et al.[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]

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) has been shown to improve inspiratory muscle function in patients with chronic obstructive pulmonary disease (COPD), with most studies indicating positive effects when proper training methods are used.

IMT can lead to significant clinical benefits, including reduced dyspnea and increased exercise capacity, as evidenced by improved walking distances in 6 or 12-minute tests, particularly when using a threshold device at an intermediate load for at least 5 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training in patients with chronic obstructive pulmonary disease]. Lisboa, C., Borzone, G., Cruz, E.[2006]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength in patients with primary ciliary dyskinesia (PCD), as evidenced by increased maximal inspiratory pressure (MIP) after one month of training.

The study, which included 27 patients (19 with PCD and 8 with cystic fibrosis), found that while IMT was well-tolerated and effective for improving MIP, it did not lead to significant changes in overall pulmonary function measures like spirometry or lung clearance index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of inspiratory muscle training in PCD and CF patients: A pilot study. Gur, M., Manor, E., Hanna, M., et al.[2023]

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Our PrO2Health Connected Platform is the only fully connected, cost-effective option for remotely monitoring respiratory metrics and training data. Our ...