Breathing Muscle Training for Children

Overseen By Martina Miller

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Neuromuscular, Cardiac, Pulmonary, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

13 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment POWERbreathe Plus IMT for children?

Research shows that inspiratory muscle training (IMT) with devices like POWERbreathe can improve muscle strength and respiratory function in children with asthma, and it may also enhance exercise performance and lung function in general. ^{1 2 3 4 5}

Is inspiratory muscle training safe for children?

Inspiratory muscle training (IMT) has been studied in children with neuromuscular diseases, and no adverse events were reported, suggesting it is generally safe. ^{1 2 3 6 7}

How is the treatment POWERbreathe Plus IMT different from other treatments for breathing issues in children?

POWERbreathe Plus IMT is unique because it strengthens the breathing muscles by making it harder to breathe in, which can improve muscle strength and lung function. Unlike medications, it is a physical training device that provides real-time feedback to optimize breathing exercises. ^{1 2 4 6 8}

What is the purpose of this trial?

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

Research Team

Simon Ho

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

This trial is for typically developing children between the ages of 6 and 12. It aims to explore a training program designed to strengthen the muscles used for breathing.

Inclusion Criteria

I am between 6 and 12 years old.

Exclusion Criteria

I had an injury or condition within the last 6 months that stops me from doing strength tests or walking.

I do not have intellectual or developmental issues affecting my understanding.

I have a history of muscle, heart, or lung disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo pulmonary function and muscle performance tests followed by treadmill walking trials with expired gas analysis

1 day

1 visit (in-person)

Treatment

Participants perform inspiratory muscle training at home for 6 weeks with weekly telehealth follow-ups

6 weeks

6 visits (virtual)

Follow-up

Participants return for a follow-up visit to undergo the same assessments as the baseline

1 day

1 visit (in-person)

Treatment Details

Interventions

• POWERbreathe Plus IMT

Trial Overview The study tests the POWERbreathe Plus IMT device, which is intended to improve respiratory muscle function. Researchers will examine its impact on children's breathing regulation during exercise.

Participant Groups

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

Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.

POWERbreathe Plus IMT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as POWERbreathe Plus for:

• Asthma
• COPD
• Bronchitis
• Cystic Fibrosis
• Heart Failure
• Spinal Injury
• Respiratory Conditions

Approved in United States as POWERbreathe Plus for:

• Asthma
• COPD
• Bronchitis
• Cystic Fibrosis
• Heart Failure
• Spinal Injury
• Respiratory Conditions

Approved in Canada as POWERbreathe Plus for:

• Asthma
• COPD
• Bronchitis
• Cystic Fibrosis
• Heart Failure
• Spinal Injury
• Respiratory Conditions

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Findings from Research

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]

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]

In a study involving 12 normal subjects, the Powerbreathe inspiratory muscle trainer showed a significant improvement in maximal static inspiratory mouth pressure, but no significant difference in diaphragm strength or other respiratory measures after 6 weeks of training.

The results suggest that the Powerbreathe device does not provide sufficient evidence to justify its continued sale and use, highlighting the need for larger studies to confirm its efficacy in improving diaphragm strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an inspiratory muscle trainer in healthy humans. Hart, N., Sylvester, K., Ward, S., et al.[2004]

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]

Using the PowerBreath® device for respiratory muscle training can lead to significant improvements in maximum inspiratory pressure (54% increase) within just 4 weeks of training.

After 6 weeks of training, participants also showed notable enhancements in their maximum volume of oxygen (VO2max) and a decrease in blood lactate concentration, indicating improved athletic performance and pulmonary function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training Program Using the PowerBreath&#174;: Does It Have Ergogenic Potential for Respiratory and/or Athletic Performance? A Systematic Review with Meta-Analysis. Fernández-Lázaro, D., Gallego-Gallego, D., Corchete, LA., et al.[2021]

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) appears to be safe for children aged 5-18 with neuromuscular diseases, as no adverse events were reported in the reviewed studies involving 168 participants.

While IMT did not show significant improvements in pulmonary function tests, it did lead to notable enhancements in inspiratory muscle strength and endurance, indicating potential benefits for respiratory health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training for children and adolescents with neuromuscular diseases: A systematic review. Human, A., Corten, L., Jelsma, J., et al.[2018]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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. England pubmed.ncbi.nlm.nih.gov

Evaluation of an inspiratory muscle trainer in healthy humans. [2004]

4. Brazil pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training Program Using the PowerBreath&#174;: Does It Have Ergogenic Potential for Respiratory and/or Athletic Performance? A Systematic Review with Meta-Analysis. [2021]

6. United States 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. [2021]

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

Inspiratory muscle training for children and adolescents with neuromuscular diseases: A systematic review. [2018]

8. Italy pubmed.ncbi.nlm.nih.gov

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