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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special training tool, POWERbreathe Plus, can help children improve their breathing during exercise. It focuses on strengthening the breathing muscles through a program called inspiratory muscle training (IMT). The study targets children aged 6-12 without serious health issues, such as lung or heart problems. Participants will perform breathing exercises at home five days a week for six weeks. The trial aims to assess the effectiveness of this training in typically developing children. As an unphased trial, it offers a unique opportunity for children to enhance their breathing strength and overall exercise performance.

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 prior data suggests that this training program is safe for children?

Research shows that the POWERbreathe Plus device, used for Inspiratory Muscle Training (IMT), is generally safe and easy to use. This drug-free device strengthens breathing muscles. Studies have found that it does not cause harmful side effects when used as directed. However, children under 16 should use it with adult supervision, and it is not suitable for children under 7 due to small parts. When used properly, this training strengthens breathing muscles without causing discomfort or harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for breathing issues in children, which often involve medications or physical interventions, the POWERbreathe Plus IMT takes a unique approach by using a device to strengthen the breathing muscles through specific exercises. This inspiratory muscle training (IMT) is done at home, making it more accessible and convenient for families. Researchers are excited because this method might empower kids to improve their lung function actively, potentially reducing reliance on medications and enhancing overall respiratory health.

What evidence suggests that this inspiratory muscle training is effective for breathing regulation in children?

Research has shown that using the POWERbreathe Plus device for inspiratory muscle training (IMT), which participants in this trial will perform, can strengthen breathing muscles. One study found that using this device with resistance increased breathing strength by 54%, specifically strengthening the diaphragm, the main muscle used for breathing. The device features adjustable resistance levels, making it effective for various users. Although results vary regarding its impact on sports performance, the primary goal of POWERbreathe Plus is to strengthen the diaphragm, not the lungs. ^{3 6 7 8 9}

Who Is on the Research Team?

Simon Ho

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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) 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]

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]

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 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 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]

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]

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]

Citations

1.

powerbreathe.com

powerbreathe.com/us/product/powerbreathe-plus-light-resistance/

POWERbreathe Plus IMT - Light Resistance

Strengthen your diaphragm – Breathing training with the POWERbreathe Plus Light Resistance focuses on strengthening your diaphragm rather than your lungs.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7819540/

The effect of inspiratory muscle training on swimming ...

Twelve weeks of IMT had no significant effects on swimmers' performance, inspiratory muscle strength, lung function, and perceived breathlessness of elite ...

3.

powerbreathe.com

powerbreathe.com/us/product-category/breathing-trainers-imt-and-emt/plus-imt/

Plus IMT

Breathing training is more effective with the POWERbreathe Plus due to its optimized airflow. The IMT device boasts 11 adjustable levels, meaning its resistance ...

4.

mdpi.com

mdpi.com/1660-4601/18/13/6703

Inspiratory Muscle Training Program Using the PowerBreath

PowerBreath® administering a ≥ 15% resistive load of the maximum inspiratory pressure (PIM) achieves significant improvements (54%) in said pressure within 4 ...

5.

powerbreathe.com

powerbreathe.com/us/product/k3/

POWERbreathe K3 for Inspiratory Muscle Training

Features · More energy with less effort · Improved sports performance · Reduce heart rate and blood pressure · Faster recovery after exercise · Improve breathing ...

6.

powerbreathe.com

powerbreathe.com/us/precautions-contraindications/

Precautions & Contraindications

POWERbreathe EMT devices contain small parts and are not suitable for children under 7 years. Whilst training with the POWERbreathe EMT device, you should feel ...

7.

powerbreathe.com

powerbreathe.com/can-children-use-powerbreathe/

Can Children Use POWERbreathe? | FAQ

POWERbreathe is not suitable for children under 7 years (due to small parts) and anyone under 16 should only use POWERbreathe under the supervision of an adult.

8.

powerbreathe.com

powerbreathe.com/us/product/powerbreathe-plus-medium-resistance/

POWERbreathe Plus IMT - Medium Resistance

Precautions & Contraindications. POWERbreathe IMT breathing training is drug-free, suitable for almost anyone and should cause no harmful side effects when used ...

9.

powerbreathe.com

powerbreathe.com/us/product/powerbreathe-plus-heavy-resistance/

POWERbreathe Plus IMT - Heavy Resistance

This heavy resistance device is hugely taxing on your breathing muscles. · Strengthen your diaphragm- · 11 adjustable levels- · Ergonomic design- · See results ...